Pnu-Imune 23

Generic Name: pneumococcal polysaccharide vaccine (PPV adult, 23-valent) (new moe CAW cull pah lee SAH cah ride)

Brand Names: Pneumovax 23, Pnu-Imune 23

What is pneumococcal polysaccharide vaccine?

Pneumococcal disease is a serious disease caused by a bacteria. Pneumococcal polysaccharide vaccine (PPV) exposes the individual to a small dose of the bacteria (or a protein from the bacteria) and causes the body to develop immunity to the disease.

Pneumococcal infection can cause ear infection, sinus infection, pneumonia, blood infection (bacteremia), and meningitis (infection of the covering of the brain). About 1 out of every 20 people who get pneumococcal pneumonia dies from it, as do about 2 out of every 10 who get bacteremia, and 3 out of 10 who get meningitis. Pneumococcal disease kills more people in the United States every year than all other vaccine-preventable diseases combined.

PPV (adult, 23-valent) is recommended for: all adults 65 years of age and older; anyone over 2 years of age who has long-term health problems such as sickle cell disease; heart disease; lung disease; alcoholism; diabetes; cirrhosis; or leaks of cerebrospinal fluid; anyone over 2 years of age who has a condition that lowers the body's resistance to infection such as: Hodgkin's disease, lymphoma, leukemia, kidney failure, multiple myeloma, nephrotic syndrome, damaged spleen or no spleen, or organ transplant; anyone over 2 years of age who is taking any drug or treatment that lowers the body's resistance to infection such as long-term steroids, radiation therapy, and certain cancer drugs; and all Alaskan natives and certain Native American populations.

Pneumococcal polysaccharide vaccine can help prevent the disease. Many more people would get the disease if vaccination did not occur.

What is the most important information I should know about pneumococcal polysaccharide vaccine?

People with minor illnesses, such as a cold, may be vaccinated. Those who are moderately or severely ill or have a fever should usually wait until they recover before getting pneumococcal polysaccharide vaccine.

What should I discuss with my healthcare provider before receiving pneumococcal polysaccharide vaccine?

Anyone who has had a life-threatening allergic reaction after receiving a dose of PPV should not get another dose.

People with minor illnesses, such as a cold, may be vaccinated. Those who are moderately or severely ill or have a fever should usually wait until they recover before getting pneumococcal polysaccharide vaccine.

Before receiving PPV, talk to your doctor if you:

• 
  

  are over the age of 65 years and if the first dose was given when you were younger than 65 and 5 or more years have passed since that dose;

  
  


• 
  

  have HIV or AIDS or another disease that affects the immune system;

  
  


• 
  

  are taking a medication that affects the immune system (e.g. steroids, anti-rejection medications);

  
  


• 
  

  have had an organ or bone marrow transplant;

  
  


• 
  

  have cancer;

  
  


• 
  

  are receiving cancer treatment with x-rays, radiation, or medication;

  
  


• 
  

  have a damaged spleen or no spleen;

  
  


• 
  

  have sickle-cell disease; or

  
  


• have kidney failure or nephrotic syndrome.

A second dose of the vaccine may be recommended in some cases.

Talk to your doctor before receiving pneumococcal polysaccharide vaccine if you are pregnant or breast-feeding a baby.

How is pneumococcal polysaccharide vaccine administered?

Your doctor, nurse, or other healthcare provider will administer the pneumococcal polysaccharide vaccine as an injection.

Most people need only one dose of PPV.

A second dose may be recommended for some individuals. Your healthcare provider will determine if a second dose is needed and when it should be given.

Otherwise healthy children who often get ear infection, sinus infection, or other upper respiratory diseases do not need to get PPV because of these conditions.

Your doctor may recommend reducing fever or pain that may occur by taking an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil, others) when the shot is given and for the next 24 hours. Your healthcare provider can tell you the appropriate dosages of these medications.

What happens if I miss a dose?

Since only one dose of the vaccine is usually given, missing a dose should not occur. If a second dose is recommended and it is missed or delayed, contact your doctor.

What happens if I overdose?

An overdose of pneumococcal polysaccharide vaccine is unlikely to occur.

What should I avoid before or after getting pneumococcal polysaccharide vaccine?

There are no restrictions on food, beverages, or activity before or after receiving pneumococcal polysaccharide vaccine.

Pneumococcal polysaccharide vaccine side effects

Getting pneumococcal disease is much riskier than getting pneumococcal polysaccharide vaccine. However, a vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of pneumococcal polysaccharide vaccine causing serious harm, or death, is extremely small.

Seek emergency medical attention or contact your doctor immediately if any of the following rare but serious side effects from pneumococcal polysaccharide vaccine are experienced:

• 
  

  a serious allergic reaction including swelling of the lips, tongue, or face; difficulty breathing; closing of the throat; hives; paleness; weakness; dizziness; or a fast heart beat within a few minutes to a few hours after the shot; or

  
  


• 
  

  high fever; or

  
  


• 
  

  behavior changes.

  
  

About half of those who get PPV have very mild side effects, such as redness or pain where the shot is given. Less and 1% develop fever, muscle aches, or more severe local reactions.

Your doctor may recommend reducing fever or pain that may occur by taking an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil, others) when the shot is given and for the next 24 hours. Your healthcare provider can tell you the appropriate dosages of these medications.

Side effects other than those listed here may also occur. Contact your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect pneumococcal polysaccharide vaccine?

Talk to your doctor before receiving pneumococcal polysaccharide vaccine if you are taking any of the following medications that may affect the immune system:

• 
  

  an oral or injectable steroid medication such as betamethasone (Celestone), cortisone (Cortone), dexamethasone (Decadron, Dexone), hydrocortisone (Cortef, Hydrocortone), methylprednisolone (Medrol), prednisolone (Prelone, Pediapred), prednisone (Orasone, Deltasone, others), or triamcinolone (Aristocort);

  
  


• 
  

  an inhaled or nasal steroid such as beclomethasone (Qvar, Beclovent, Beconase, Vanceril, Vancenase), budesonide (Pulmicort, Rhinocort), flunisolide (Aerobid, Nasalide, Nasarel), fluticasone (Flovent, Flonase), mometasone (Nasonex), or triamcinolone (Azmacort, Nasacort);

  
  


• 
  

  treatment for cancer with chemotherapy (medication), radiation, or x-rays;

  
  


• 
  

  azathioprine (Imuran);

  
  


• 
  

  basiliximab (Simulect);

  
  


• 
  

  cyclosporine (Sandimmune, Neoral, Gengraf);

  
  


• 
  

  etanercept (Enbrel);

  
  


• 
  

  leflunomide (Arava);

  
  


• 
  

  muromonab-CD3 (Orthoclone);

  
  


• 
  

  mycophenolate mofetil (CellCept);

  
  


• 
  

  sirolimus (Rapamune); or

  
  


• 
  

  tacrolimus (Prograf).

  
  

Pneumococcal polysaccharide vaccine can be given at the same time as other vaccinations.

Where can I get more information?

• Your doctor or pharmacist may have additional information or suggest additional resources regarding pneumococcal polysaccharide vaccine.

Norinyl-1

Norinyl-1

Please read this leaflet carefully before you start to take Norinyl-1.

This leaflet gives you some information about how to take your pills. The leaflet can’t tell you everything about Norinyl-1. So if you have any questions or are not sure about anything, ask your doctor, clinic or pharmacist.

Some information about Norinyl-1

Norinyl-1 contains two hormones - a progestogen hormone called norethisterone and an oestrogen hormone called mestranol. These two hormones act together to prevent pregnancy.

What is in Norinyl-1?

Each Norinyl-1 pill contains:

• 1 milligram of norethisterone and 50 micrograms of mestranol (the ‘active’ ingredients); and


• maize starch, polyvidone, magnesium stearate and lactose (the ‘inactive’ ingredients).

Norinyl-1 pills are white and have the word ‘SEARLE’ on one side and ‘1’ on the other side. They are packed in blister strips and come in packs of 63 pills.

Who supplies Norinyl-1?

Norinyl-1 is supplied by:

PHARMACIA

Pharmacia Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UK

Who makes Norinyl-1?

Norinyl-1 is made by:

Pharmacia Limited

Morpeth

Northumberland

NE61 3YA

UK

What is Norinyl-1 for?

Norinyl-1 is a combined oral contraceptive pill you take to prevent you becoming pregnant.

Before you take Norinyl-1

Norinyl-1 may not be suitable for all women. Before you take Norinyl-1, make sure your doctor knows if you have ever had any of the following conditions.

• Blood clots in the legs, blood clots in varicose veins, the lungs, the brain or elsewhere (coronary and cerebral thrombotic disorders).


• A heart attack, angina or a stroke.


• High levels of fats in your blood (hyperlipidaemia or other disorders of body fats).


• Cancer of the breast, cervix, vagina or womb (mammary or endometrial cancer).


• If during pregnancy you had:
  
  
  • pruritus (itching of the whole body);
  • jaundice, for which your doctor could not find the cause; or
  • pemphigoid gestationis (a rash previously known as herpes gestationis).


• Certain types of jaundice (Dubin-Johnson or Rotor syndrome).


• Bad migraines.


• Vaginal bleeding, for which your doctor could not find the cause.


• Liver tumours.


• Liver disease.

If you are pregnant or are trying to get pregnant, you should not take the pill.

What I should know before taking Norinyl-1

If you had irregular periods or no periods in the past, you may stop ovulating (releasing eggs from your ovaries). You may also stop having normal periods after you have stopped using the combined pill. If you have any of these conditions you may find it better to use a different contraceptive method. You should ask your doctor or clinic for advice.

It is possible that sometimes certain long-term diseases may get worse while you are taking the pill. See the section, ‘Reasons for careful medical checks’.

The pill and thrombosis

Some evidence suggests that women who take the pill are more likely to develop various blood circulation disorders than women who don’t take the pill.

A thrombosis is a blood clot. A thrombosis can develop in veins or in arteries and can cause a blockage. The chance of a thrombosis forming in women taking the pill and women not taking the pill is rare. When blood clots form in the arteries they can cause chest pain (angina), strokes (blood clots in or bleeding from the blood vessels in the brain) and heart attacks.

If blood clots form in veins, they can often be treated with no long term long term danger. On rare occasions a piece of thrombosis may break off. It can travel to the lungs to cause a condition called pulmonary embolism. Therefore in rare cases a thrombosis can cause serious permanent disability or could even be fatal.

It is important to note that a thrombosis can form in people who are not taking the pill as well as those who are taking it. The risk is higher in women who take the pill than in women who don’t take the pill, but is not as high as the risk during pregnancy. The excess risk of thrombosis is highest during the first year a woman ever uses a combined oral contraceptive pill.

For healthy non-pregnant women:

the chance of having a blood clot is about 5 in 100,000 each year.

For women taking the pill containing either levongestrel or norethisterone (a second generation pill):

the chance of having a blood clot is about 15 in 100,000 each year.

For women taking the pill containing desogestrel or gestodene (a third generation pill):

the chance of having a blood clot is about 25 in 100,000 each year.

For women who are pregnant:

the chance of having a blood clot is about 60 in 100,000 pregnancies.

The risk of heart attacks and strokes for women who use the combined pill increases with age and smoking. Other conditions also increase the risk of blood clots in the arteries. These include being greatly overweight, having diseased arteries (atherosclerosis), high blood pressure during pregnancy (pre-eclamptic toxaemia), high blood levels of cholesterol, and diabetes. If you have any of these conditions, you should check with your doctor or clinic to see if the pill is suitable for you. Smokers over 35 are usually told to stop taking these pills.

Breast Cancer

Every woman is at risk of breast cancer whether or not she takes the pill. Breast cancer is rare under the age of 40 years, but the risk increases as a woman gets older.

Breast cancer has been found slightly more often in women who take the pill than in women of the same age who do not take the pill. If women stop taking the pill, this reduces the risk so that 10 years after stopping the pill, the risk of finding breast cancer is the same as for women who have never taken the pill. Breast cancer seems less likely to have spread when found in women who take the pill than in women who do not take the pill.

It is not certain whether the pill causes the increased risk of breast cancer. It may be that women taking the pill are examined more often, so that breast cancer is noticed earlier. The risk of finding breast cancer is not affected by how long a woman takes the pill but by the age at which she stops. This is because the risk of breast cancer strongly increases as a woman gets older.

The chart below shows the background chances of breast cancer at various ages for 10,000 women who have never taken the pill (black bars) and for 10,000 women whilst taking the pill and during the 10 years after stopping it (grey bars). The small extra risk of finding breast cancer can be seen for each age group. This small possible additional risk in women who take the pill has to be balanced against the fact that the pill is a very effective contraceptive and it helps prevent cancer of the womb or ovary.

Taking any medicine carries some risk. You can use the information in this leaflet, and the advice your doctor or clinic has given you to weigh up the risks and benefits of taking the pill. Don’t be embarrassed, ask as many questions as you need to.

Reasons for careful medical checks

Your doctor or clinic will give you regular check-ups while you are taking Norinyl-1. Your blood pressure will be checked before you start the pill and then at regular intervals whilst you are on the pill. If your blood pressure goes up, your doctor may tell you to stop taking Norinyl-1. They may also check your breasts and reproductive organs, including taking a cervical smear at regular intervals, if this is considered necessary by the doctor.

Tell your doctor if you have any of the following conditions.

• Migraine, asthma, epilepsy, heart or kidney disease, high blood pressure (hypertension) or you have a previous history of these conditions. This is because the pill may cause fluid retention which can make these conditions worse.


• Diabetes.

If you have any of the following conditions and they appear to get worse or they appear for the first time, your doctor or clinic may tell you to stop taking the pill.

• High blood pressure.


• Diabetes.


• Multiple sclerosis


• Tetany (muscle twitches)


• Breast problems


• Varicose veins.


• Migraine.


• Epilepsy.


• Kidney disease.


• Severe depression.


• Fibroids in your uterus.


• Gallstones.


• Liver problems.


• Sickle-cell anaemia.


• Diseases of the heart and blood vessels (cardiovascular disease).


• Otosclerosis (an inherited form of deafness).


• Porphyria (a metabolic disease).


• Chloasma (brown patches on your skin which can happen during pregnancy but may not fade completely).


• Any disease that is likely to get worse during pregnancy.

If you use any combined pill you may retain fluid which can make it uncomfortable to wear contact lenses.

Other medicines and Norinyl-1

Several medicines can interfere with the way the pill works. These include some drugs that treat epilepsy, arthritis, tuberculosis and some antibiotics or sedatives. Other less common medicines may also have this effect. You may have to use another contraceptive method, such as a condom, while you are taking these medicines and during the next seven days. In some situations, your doctor or clinic may tell you to use extra precautions for longer. If while using these extra precautions you run beyond the end of the blister strip, start the next blister strip without a break. Always mention you are on the pill if a doctor, dentist or hospital prescribes you any medicine.

The herbal remedy St John’s wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take a St John’s wort preparation, stop taking the St John’s wort and mention it to your doctor.

Blood tests

The pill may affect the results of certain blood tests, so tell your doctor that you are on the pill if you need any blood tests.

How to take Norinyl-1

Starting your first blister strip

• Take the first pill on your first day of bleeding. This is the day when your period starts. If you are not having periods, ask your doctor or clinic when you should start taking your pill.


• Take the pill marked with the correct day of the week.


• You will be protected at once as long as you take a pill every day.


• You can take the pill at a time that suits you, but you must take it at about the same time every day.


• Take a pill every day until you finish a blister strip.


• If you cannot start the pill on the first day of your period you may start to take it on any day up to the fifth day. However, if you do this, you may not be protected for the first seven days, so you should use another method of contraception such as a condom during those days.

Starting the next blister strip

• Once you have finished all 21 pills, stop for seven days. You will probably bleed during some or all of these seven days.


• Then, start the next blister strip. Do this whether or not you are still bleeding. You will always start the next blister strip on the same day of the week.


• You are protected during the seven day break, but only if you start to take the next blister strip on time. The first pill in your blister strip is the worst pill of all to miss or take late.

What do I do if I have a stomach upset or I am sick?

Norinyl-1 may not work if you are sick or have severe diarrhoea. You should carry on taking your pills as normal, but use a condom while you are ill and for the next seven days. If these seven days run beyond the end of the blister strip, start the next blister strip without a break.

What do I do if I miss a period?

If you have taken all your pills properly, it is very unlikely that you are pregnant. Take your next blister strip as normal. If you have not taken them correctly, see your doctor or clinic at once. You should do the same if you miss a second period. If you do get pregnant whilst you are taking this type of pill there may be a very small increased risk that your baby will have an abnormality. Ask your doctor to discuss this risk with you.

What do I do if my periods are different?

This is normal when you start the pill. You will probably have less bleeding. You may also have a little bleeding while you are taking the pills (this is called ‘break-through bleeding’). If this happens, do not stop taking your pills. This should stop within two or three months. If the bleeding is heavy, do not stop taking the pill but talk to your doctor or clinic. If your periods seem different, do not stop taking the pills and just mention it to your doctor or clinic at your next visit.

What do I do if I am having an operation?

If you are planning to have an operation, which will mean lying in bed for more than a whole day, or any operation on your legs, it is best that you stop taking this type of pill at least four weeks before your operation. This does not apply to some minor operations. You can usually start to take the pill again two weeks after the operation. Talk to your doctor or clinic about another method of contraception you can use until the operation. For example, you may use a progestogen-only pill.

If you are having treatment for varicose veins, stop taking the combined pill four weeks before your treatment and stay off it until 3 months after your last treatment.

What do I do if I have an accident or I am ill?

If you have an accident or illness which means that you will have to stay in bed, it is best to stop taking the pill until you are active again.

Smoking

Smoking increases the risks to your health and some of the risks of taking the pill. It is always best to stop smoking. If you do smoke, your doctor or clinic may tell you to change your method of contraception when you are 35 or over.

What do I do if I want a baby?

If you want to have a baby it is best to wait until you have stopped taking the pill for three months or at least until your regular periods have returned. You can always use another contraceptive method such as a condom. Only rarely do regular periods take some time to return. Once you have had one period, it is easier to work out when your baby is due. However, if you do get pregnant as soon as you stop taking Norinyl-1, this is not harmful.

What do I do if I am changing pill brands?

Take the first pill of your new blister strip on the day immediately after you have finished your old blister strip. Your period will usually be delayed until the new blister strip is finished, but you may have some break-through bleeding during the first few days of the new blister strip. This is quite normal and you will still be protected against pregnancy. If you do have a break, ask your doctor or clinic whether you need an extra contraceptive method such as a condom.

What do I do if I have just had a baby?

• If you are breast feeding, you should not take the combined pill. This is because the oestrogen in the pill may reduce the amount of milk you produce. You should be able to take the progestogen-only pill instead. Ask your doctor or clinic for advice.


• If you are not breast feeding, you may start taking the pill 21 days after your baby is born. This will protect you immediately. If you start later than this, you may not be protected until you have taken the pill for seven days.

What do I do if I have just had a miscarriage or abortion?

You may be able to start taking the pill immediately. If you can, you will be protected straight away. Ask your doctor or clinic if you should do so.

Overdose

If you take more than the recommended number of pills, or if you discover someone has taken a lot of pills, contact your doctor immediately.

What do I do if I forget to take a pill?

• If you forget to take a pill take it as soon as you remember and take the next one at your normal time. This may mean taking two pills on the same day.


• If you are 12 or more hours late in taking one or more pills, it may not work. As soon as you remember, take your last missed pill and carry on taking your pills normally. However, you may not be protected for the next seven days, so either avoid sexual intercourse or use an extra contraceptive method, such as a condom.


• If you have fewer than seven pills in your blister strip after you have missed taking your pill, you should complete the blister strip and start the next blister strip without a break. This will give you protection from when you took the last missed pill. You may not have a period until the end of two blister strips, but this will not harm you. You may also have some bleeding on days when you take the pill.

Norinyl-1 Side Effects

All medicines can sometimes cause problems. If you are worried about side effects, talk to your doctor. These effects should become less of a problem as your body becomes used to the pills. You may notice a change in your sex drive, and have irregular vaginal bleeding or changes in your period.

Other side effects that you might have include nausea, stomach upsets, tender breasts, weight gain, changes in appetite, headaches, depression, high blood pressure, and changes in the way your body breaks down sugars, fats or vitamins. If you have fibroids in your uterus, these may also get worse.

Reasons to get medical help immediately

The cause of these symptoms may have nothing to do with the pill but you may need treatment. Stop taking your pills at once and tell your doctor if you have:

• a sudden sharp or severe pain in the chest;


• suddenly become short of breath or breathing is painful;


• coughed up blood;


• painful or inflamed veins in your legs;


• a crushing type of chest pain or your chest feels heavy;


• a very first attack of migraine (a bad headache with sickness);


• migraines which get worse, especially if your sight is affected, you see flashing lights, your limbs feel weak, you lose the sensation or feel a different sensation in your limbs, or you have a fit;


• sudden and unusual severe headaches;


• dizziness or you faint;


• a problem with your sight or speech;


• swollen arms or legs;


• jaundice (your skin or the whites of your eyes look yellow);


• a severe rash; or


• swelling or tenderness in your stomach.

How to store Norinyl-1

Store your Norinyl-1 pills in a dry place, away from direct sunlight and below 25°C. Make sure children cannot see or reach them.

Don’t take Norinyl-1 after the ‘expiry date’ shown on the box. If your pack is out of date, take it to your pharmacist who will get rid of the pills safely.

If you have any comments on the way this leaflet is written, please write to Medical Information at Pharmacia Limited.

This leaflet was written in May 2007.

Norinyl-1 is a contraceptive. It will not protect you against sexually-transmitted diseases including AIDS. For safer sex, use a condom as well as your usual contraceptive.

Norinyl-1 and Pharmacia are registered trademarks.

Ref: NR2_0

Nizoral 2% Cream

1. Name Of The Medicinal Product

Nizoral 2% cream

2. Qualitative And Quantitative Composition

Ketoconazole 2% w/w (each gram of cream contains 20mg).

Excipients;

propylene glycol, 20%w/w (each gram of cream contains 200mg).

stearyl alcohol, 7.5%w/w (each gram of cream contains 75mg).

cetyl alcohol, 2.0%w/w (each gram of cream contains 20mg).

For a full list of excipients, see 6.1.

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

For topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris, tinea manus and tinea pedis infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Nizoral 2% cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.

4.2 Posology And Method Of Administration

Tinea pedis:

Nizoral 2% cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week. For more severe or extensive infections (eg involving the sole or sides of the feet) treatment should be continued until a few days after all signs and symptoms have disappeared in order to prevent relapse.

For other infections:

Nizoral 2% cream should be applied to the affected areas once or twice daily, depending on the severity of the infection.

The treatment should be continued until a few days after the disappearance of all signs and symptoms. The usual duration of treatment is: tinea versicolor 2–3 weeks, tinea corporis 3–4 weeks.

The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures in regard to hygiene should be observed to control sources of infection or reinfection.

Seborrhoeic dermatitis is a chronic condition and relapse is highly likely.

Method of administration: Cutaneous administration.

4.3 Contraindications

Nizoral 2% cream is contra-indicated in patients with a known hypersensitivity to any of the ingredients or to ketoconazole itself.

4.4 Special Warnings And Precautions For Use

Nizoral 2% cream is not for ophthalmic use.

To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying a mild topical corticosteroid in the morning and to apply Nizoral 2% cream in the evening, and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed

4.6 Pregnancy And Lactation

There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole.

Plasma concentrations of ketoconazole are not detectable after topical application of Nizoral 2% Cream to the skin of non-pregnant humans. (See Pharmacokinetic properties, section 5.2) There are no known risks associated with the use of Nizoral 2% Cream in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Nizoral 2% cream has no influence on the ability to drive and use machines

4.8 Undesirable Effects

The safety of ketoconazole cream was evaluated in 1079 subjects who participated in 30 clinical trials. Ketoconazole cream was applied topically to the skin. Based on pooled safety data from these clinical trials, the most commonly reported (

Including the above-mentioned adverse drug reactions (ADRs), the following table displays ADRs that have been reported with the use of ketoconazole cream from either clinical trial or postmarketing experiences. The displayed frequency categories use the following convention:

Very common (

Common (

Uncommon (

Rare (

Very rare (<1/10,000)

Not Known (cannot be estimated from the available clinical trial data).

System Organ Class	Adverse Drug Reactions
Frequency Category
Common (	Uncommon (	Not Known
Immune System Disorders		Hypersensitivity
Skin and Subcutaneous Tissue Disorders	Skin burning sensation	Bullous eruption Dermatitis contact Rash Skin exfoliation Sticky skin	Urticaria
General Disorders and Administration Site Conditions	Application site erythema Application site pruritus	Application site bleeding Application site discomfort Application site dryness Application site inflammation Application site irritation Application site paraesthesia Application site reaction

4.9 Overdose

Topical Application

Excessive topical application may lead to erythema, oedema and a burning sensation, which will disappear upon discontinuation of the treatment.

Ingestion

In the event of accidental ingestion, supportive and symptomatic measures should be carried out.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Imidazole and triazole derivatives

ATC Code: D01AC08

Ketoconazole has a potent antimycotic action against dermatophytes and yeasts. Ketoconazole cream acts rapidly on the pruritus, which is commonly seen in dermatophyte and yeast infections. This symptomatic improvement often occurs before the first signs of healing are observed.

A study in 250 patients has shown that application twice daily for 7 days of ketoconazole 2% cream vs clotrimazole 1% cream for 4 weeks on both feet demonstrated efficacy in patients with tinea pedis (athlete's foot) presenting lesions between the toes. The primary efficacy endpoint was negative microscopic KOH examination at 4 weeks. Ketoconazole 2% treatment showed equivalent efficacy to 4 weeks clotrimazole 1% treatment. There was no evidence of relapse following treatment with ketoconazole cream at 8 weeks.

5.2 Pharmacokinetic Properties

Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral 2% Cream in adults on the skin. In one study in infants with seborrhoeic dermatitis (n = 19), where approximately 40 g of Nizoral 2% cream was applied daily on 40% of the body surface area, plasma levels of ketoconazole were detected in 5 infants, ranging from 32 to 133 ng/mL.

5.3 Preclinical Safety Data

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Propylene Glycol

Stearyl Alcohol

Cetyl Alcohol

Sorbitan Stearate

Polysorbate 60

Isopropyl Myristate

Sodium Sulphite Anhydrous (E221)

Polysorbate 80

Water purified (Ph. Eur)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

60 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Tube made of 99.7% aluminum, lined on inner side with heat polymerised epoxyphenol resin with a latex coldseal ring at the end of the tube. The cap is made of 60% polypropylene, 30% calcium carbonate and 10% glyceryl monostearate.

Tube of 30g.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Bucks

HP12 4EG

UK

8. Marketing Authorisation Number(S)

PL 00242/0107

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorization: 02 December 1983

Renewed 3 December 2002

10. Date Of Revision Of The Text

21 June 2011

LEGAL CATEGORY

POM

Atarax 25mg Tablets

1. Name Of The Medicinal Product

Atarax^® 25mg Film-coated tablets

2. Qualitative And Quantitative Composition

Hydroxyzine hydrochloride 25mg

3. Pharmaceutical Form

25mg film-coated tablets, coloured green and coded on one side with 'AX'.

4. Clinical Particulars

4.1 Therapeutic Indications

Atarax is indicated to assist in the management of anxiety in adults.

Atarax is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children.

4.2 Posology And Method Of Administration

Method of administration: oral.

Dosage:

Anxiety

Adults 50-100mg four times daily.

Pruritus

Adults Starting dose of 25mg at night increasing as necessary to 25mg three or four times daily.

Use in the elderly Atarax may be used in elderly patients with no special precautions other than the care always necessary in this age group. The lowest effective maintenance dose and careful observation for side-effects are important.

Use in children From 6 months to 6 years 5-15mg rising to 50mg daily in divided doses and for children over 6 years, 15-25mg rising to 50-100mg daily in divided doses.

As with all medications, the dosage should be adjusted according to the patient's response to therapy.

Renal impairment The total daily dosage should be reduced by half (see 'Special Warnings and Precautions for Use').

4.3 Contraindications

Atarax is contra-indicated in patients who have shown previous hypersensitivity to it.

4.4 Special Warnings And Precautions For Use

Atarax should be used with caution in patients with impaired renal function (see 'Posology and Method of Administration'). It is uncertain whether the drug may accumulate or have other adverse effects in such patients. Atarax is completely metabolised and one of the metabolites is the active metabolite cetirizine. Cetirizine is renally excreted and clearance is reduced in patients with moderate renal impairment and on dialysis compared to normal volunteers.

Because of its potential anticholinergic effects, Atarax should be used with caution in patients with bladder outflow obstruction.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Patients should be warned that Atarax may enhance their response to alcohol, barbiturates and other CNS depressants.

4.6 Pregnancy And Lactation

Atarax is contra-indicated in early pregnancy. Hydroxyzine, when administered to the pregnant mouse, rat and rabbit, induced foetal abnormalities at doses substantially above the human therapeutic range. Clinical data in humans are inadequate to establish safety in early pregnancy. There is inadequate evidence of safety in the later stages of pregnancy. Use in pregnancy only when there is no safe alternative or when the disease itself carries risks for the mother or child.

Use in nursing mothers It is not known whether Atarax is excreted in human milk. Since many drugs are so excreted, Atarax should not be given to nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned that Atarax may impair their ability to perform activities requiring mental alertness or physical co-ordination such as operating machinery or driving a vehicle.

4.8 Undesirable Effects

Therapeutic doses of Atarax seldom produce marked impairment of mental alertness. Drowsiness may occur; if so, it is usually transitory and may disappear after a few days of continued therapy or upon reduction of the dose. Dryness of the mouth may be encountered at higher doses. Dizziness, weakness, headache and confusion, and urinary retention have been reported.

Extensive clinical use has substantiated the absence of toxic effects on the liver or bone marrow when administered for over four years of uninterrupted therapy. The absence of side-effects has been further demonstrated in experimental studies in which excessively high doses were administered.

Involuntary motor activity, including rare instances of tremor and convulsions, have been reported, usually with doses considerably higher than those recommended. Continuous therapy with over 1g/day has been employed in some patients without these effects having been encountered.

4.9 Overdose

The most common manifestation of Atarax overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If vomiting has not occurred spontaneously in conscious patients it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and noradrenaline, or metaraminol. Adrenaline should not be used in this situation as Atarax counteracts its pressor action.

There is no specific antidote. It is doubtful whether haemodialysis has any value in the treatment of overdosage with Atarax. However, if other agents such as barbiturates have been ingested concomitantly, haemodialysis may be indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Atarax is unrelated chemically to phenothiazine, reserpine and meprobamate.

Atarax has been shown clinically to be a rapid-acting anxiolytic with a wide margin of safety. It induces a calming effect in anxious tense adults. It is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system.

Antihistamine effects have been demonstrated experimentally and confirmed clinically; it is highly effective in alleviating pruritus.

5.2 Pharmacokinetic Properties

Atarax is rapidly absorbed from the gastro-intestinal tract and effects are usually noted within 15 to 30 minutes after oral administration.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

• Lactose (anhydrous) • Calcium Hydrogen Phosphate Anhydrous • Starch, Pregelatinised. • Magnesium Stearate • Sodium Laurilsulphate • Silica, colloidal anhydrous.

Tablet coating:

Opadry II Green 85G24674 (25mg only) -contains:

• Poly (vinyl alcohol) • Talc • Macrogol 3350 • Quinoline yellow (E104) • Titanium dioxide (E171) • Brilliant blue (E1331) • Indigo carmine ( E132) • Lecithin (E322).

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 Months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

White opaque 250/5/120 micron PVC/TE/PVdC - 20 micron aluminium foil blister strips containing 28 x 25mg tablets (2 blister strips per carton).

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Limited

Avonbridge House

Chippenham

Wiltshire

SN15 2BB

United Kingdom

8. Marketing Authorisation Number(S)

PL 16853/0095

9. Date Of First Authorisation/Renewal Of The Authorisation

24 July 1985/24 July 2002

10. Date Of Revision Of The Text

April 2010

Fluoritab Fluoride Drops

Generic Name: sodium fluoride

Dosage Form: oral drops
Fluoritab Fluoride Drops 1 fluid ounce size

CONTAINS: SODIUM FLUORIDE IN AN AQUEOUS VEHICLE WITH PRESERVATIVE.

EACH 8 DROPS EQUIVALENT TO 1 MG. F. (FROM 2.2 MG SODIUM FLUORIDE)

PPM FLUORIDE ION                                                        DAILY DOSAGE

IN DRINKING WATER      AGE 6 MO. – 3 YRS.         AGE 3-6 YRS.      AGE 6-16 YRS.

LESS THAN 0.3 PPM         2 DROPS                               4 DROPS               8 DROPS

0.3 TO 0.6 PPM                  NONE                                    2 DROPS               4 DROPS

OVER 0.6 PPM                   NONE                                    NONE                    NONE

KEEP OUT OF REACH OF CHILDREN.
CAUTION: FEDERAL (U.S.A.) LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

CONTRAINDICATIONS: PATIENTS WITH MEDICAL CONDITION OF DENTAL FLUOROSIS.

PRODUCT CATEGORY: DENTAL CARIES PROPHYLACTIC, NUTRITIONAL SUPPLEMENT (MINERAL)

ACTIONS AND INDICATIONS: FLUORITAB DROPS CONTAINING SODIUM FLUORIDE (SYSTEMIC) IS INDICATED AS A DIETARY SUPPLEMENT FOR PREVENTION OF DENTAL CARIES IN CHILDREN IN THE AREAS WHERE THE LEVEL OF FLUORIDE IN DRINKING WATER IS INADEQUATE.

INACTIVE INGREDIENTS: WATER, PRESERVATIVE.
EXCESSIVE DOSES OF SODIUM FLUORIDE MAY RESULT IN FLUOROSIS OF TEETH IF TAKEN DURING FORMATION YEARS. Fluoritab Fluoride Drops

DISTRIBUTED BY:

FLUORITAB CORPORATION

"BETTER TEETH - BETTER HEALTH"

MUSKEGON, MI 49441


MADE IN U.S.A.

FLUORIDE DROPS   sodium fluoride  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0288-5523 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 2.5 g  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   METHYLPARABEN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0288-5523-01 30 mL In 1 BOTTLE, DROPPER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/09/2011

Labeler - Fluoritab Corporation (005376702)

Registrant - Fluoritab Corporation (005376702)

Establishment
Name	Address	ID/FEI	Operations
Medical Products Laboratories		002290302	manufacture, analysis

Establishment
Name	Address	ID/FEI	Operations
Fluoritab Corporation		005376702	label

Revised: 05/2011Fluoritab Corporation

More Fluoritab Fluoride Drops resources

• Fluoritab Fluoride Drops Use in Pregnancy & Breastfeeding
• Drug Images
• Fluoritab Fluoride Drops Support Group
• 0 Reviews for Fluoritab Fluoride - Add your own review/rating

Compare Fluoritab Fluoride Drops with other medications

• Prevention of Dental Caries

Coenzyme Q10 Chewable Tablets

Pronunciation: Not applicable.
Generic Name: Coenzyme Q10
Brand Name: Generics only. No brands available.

Coenzyme Q10 Chewable Tablets are used for:

Heart conditions (heart failure, chest pain, high blood pressure). It is also claimed to help heart damage caused by certain cancer medicines and for breast cancer, gum disease, or muscle problems (muscular dystrophy). It may also have other uses. Check with your pharmacist for more details regarding the particular brand you use.

Coenzyme Q10 Chewable Tablets are an herbal product. It works by protecting cells from harmful chemicals and increasing cell growth and maintenance.

Do NOT use Coenzyme Q10 Chewable Tablets if:

• you are allergic to any ingredient in Coenzyme Q10 Chewable Tablets

Contact your doctor or health care provider right away if any of these apply to you.

Before using Coenzyme Q10 Chewable Tablets:

Some medical conditions may interact with Coenzyme Q10 Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have heart problems, rheumatoid arthritis, a disease that affects the immune system (eg, HIV), or diabetes

Some MEDICINES MAY INTERACT with Coenzyme Q10 Chewable Tablets. However, no specific interactions are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Coenzyme Q10 Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Coenzyme Q10 Chewable Tablets:

Use Coenzyme Q10 Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Coenzyme Q10 Chewable Tablets daily, preferably with food.


• Dosing depends on the use and the source of the product.


• Use as directed on the package, unless instructed otherwise by your doctor.


• Chew thoroughly before swallowing.


• If you miss taking a dose of Coenzyme Q10 Chewable Tablets for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use Coenzyme Q10 Chewable Tablets.

Important safety information:

• This product has not been approved by the FDA as safe and effective for any medical condition. The long-term safety of herbal products is not known. Before using any alternative medicine, talk with your doctor or pharmacist.


• If you are using Coenzyme Q10 Chewable Tablets for heart failure, do not stop using the product without first consulting your doctor or pharmacist.


• Keep all doctor and lab appointments while you are using this product.


• Diabetes patients - This product may lower blood sugar. Check your blood or urine sugar regularly (daily or as directed). Check with your doctor before changing the dose of your diabetes medicine.


• Use Coenzyme Q10 Chewable Tablets with caution in CHILDREN.


• PREGNANCY and BREAST-FEEDING: Coenzyme Q10 Chewable Tablets are not recommended for use during pregnancy. If you are or will be breast-feeding while you are using this product, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Coenzyme Q10 Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; loss of appetite; nausea; stomach upset; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Coenzyme Q10 side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Coenzyme Q10 Chewable Tablets:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep Coenzyme Q10 Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Coenzyme Q10 Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Coenzyme Q10 Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Coenzyme Q10 Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Coenzyme Q10 resources

• Coenzyme Q10 Side Effects (in more detail)
• Coenzyme Q10 Use in Pregnancy & Breastfeeding
• Drug Images
• Coenzyme Q10 Drug Interactions
• Coenzyme Q10 Support Group
• 2 Reviews for Coenzyme Q10 - Add your own review/rating

Compare Coenzyme Q10 with other medications

• Dietary Supplementation

Ethosuximide

Pronunciation: ETH-oh-SUX-i-mide
Generic Name: Ethosuximide
Brand Name: Zarontin

Ethosuximide is used for:

Controlling absence epilepsy (previously known as petit mal seizures). It may also be used for other conditions as determined by your doctor.

Ethosuximide is an anticonvulsant. It acts in the brain to reduce the number of absence seizures.

Do NOT use Ethosuximide if:

• you are allergic to any ingredient in Ethosuximide or similar medicines

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ethosuximide:

Some medical conditions may interact with Ethosuximide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have liver or kidney disease, lupus, or a blood disorder (eg, porphyria)


• if you have a history of mood or mental problems, including suicidal thoughts or attempts

Some MEDICINES MAY INTERACT with Ethosuximide. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Ethosuximide


• Valproic acid because it may affect the amount of Ethosuximide in your blood

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ethosuximide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ethosuximide:

Use Ethosuximide as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Ethosuximide comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ethosuximide refilled.


• Take Ethosuximide by mouth with or without food.


• Taking Ethosuximide at the same time each day will help you remember to take it. Take Ethosuximide on a regular schedule to get the most benefit from it.


• Continue to take Ethosuximide even if you feel well. Do not miss any doses.


• If you miss a dose of Ethosuximide, take it as soon as possible. If it is almost time for you next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ethosuximide.

Important safety information:

• Ethosuximide may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ethosuximide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ethosuximide; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Increasing or decreasing the dose as well as adding or stopping other medicines should be done slowly. Rapidly stopping Ethosuximide may suddenly make absence seizures worse.


• Ethosuximide may cause swelling and tenderness of your gums. Brush and floss your teeth on a regular schedule and have regular dental checkups.


• Patients who take Ethosuximide may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Ethosuximide closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Lab tests, including complete blood cell counts and liver and kidney function tests, may be performed while you use Ethosuximide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Ethosuximide should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ethosuximide while you are pregnant. Ethosuximide is found in breast milk. If you are or will be breast-feeding while you use Ethosuximide, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ethosuximide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; headache; loss of appetite; nausea; stomach pain; stomach upset; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); increased number of seizures; lupus symptoms (eg, butterfly-shaped rash on the face, joint pain or swelling); new or worsening mood or mental changes (eg, depression); nightmares; red, swollen, blistered, or peeling skin; signs of infection (eg, fever, sore throat); suicidal thoughts or attempts; trouble concentrating; trouble sleeping; unusual bruising, bleeding, or fatigue.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ethosuximide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include central nervous system depression (eg, coma with slow, shallow breathing); nausea; vomiting.

Proper storage of Ethosuximide:

Store Ethosuximide at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Ethosuximide out of the reach of children and away from pets.

General information:

• If you have any questions about Ethosuximide, please talk with your doctor, pharmacist, or other health care provider.


• Ethosuximide is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ethosuximide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ethosuximide resources

• Ethosuximide Side Effects (in more detail)
• Ethosuximide Dosage
• Ethosuximide Use in Pregnancy & Breastfeeding
• Drug Images
• Ethosuximide Drug Interactions
• Ethosuximide Support Group
• 5 Reviews for Ethosuximide - Add your own review/rating

• Ethosuximide Prescribing Information (FDA)


• Ethosuximide Monograph (AHFS DI)


• Ethosuximide Professional Patient Advice (Wolters Kluwer)


• ethosuximide Concise Consumer Information (Cerner Multum)


• ethosuximide Advanced Consumer (Micromedex) - Includes Dosage Information


• Zarontin Prescribing Information (FDA)

Compare Ethosuximide with other medications

• Seizures

Pannaz S

Generic Name: carbinoxamine, methscopolamine, and pseudoephedrine (car bin OX uh meen, meth sko PAW luh meen, and soo doh ee FED rin)

Brand Names: Pannaz, Pannaz S

What is Pannaz S (carbinoxamine, methscopolamine, and pseudoephedrine)?

Carbinoxamine and methscopolamine are antihistamines that reduce the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Carbinoxamine, methscopolamine, and pseudoephedrine is used to treat sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Carbinoxamine, methscopolamine, and pseudoephedrine may also be used for purposes other than those listed here.

What is the most important information I should know about Pannaz S (carbinoxamine, methscopolamine, and pseudoephedrine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

What should I discuss with my healthcare provider before taking Pannaz S (carbinoxamine, methscopolamine, and pseudoephedrine)?

Do not give this medication to a child younger than 2 years old, even if the label has dosing instructions for children this young. Death can occur from the use of carbinoxamine in very young children. Talk with your doctor about other FDA-approved products available for young children with cold or allergy symptoms. Do not use a cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cold medicine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to carbinoxamine, methscopolamine, or pseudoephedrine, or if you have:

• 
  

  epilepsy or another seizure disorder;

  
  


• 
  

  peripheral vascular disease such as Raynaud's syndrome;

  
  


• 
  

  thyroid problems;

  
  


• 
  

  asthma, emphysema, or chronic obstructive pulmonary disease (COPD);

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  an ulcer or an obstruction in the stomach;

  
  


• 
  

  an enlarged prostate or urination problems;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• kidney disease; or


• liver disease.

If you have any of the conditions listed above, you may not be able to take carbinoxamine, methscopolamine, and pseudoephedrine, or you may require a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Carbinoxamine, methscopolamine, and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Pannaz S (carbinoxamine, methscopolamine, and pseudoephedrine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Carbinoxamine, methscopolamine, and pseudoephedrine can be taken with or without food.

Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include dry mouth, blurred vision, flushing, nausea, vomiting, hyperactivity, hallucinations, fainting, or seizure (convulsions).

What should I avoid while taking Pannaz S (carbinoxamine, methscopolamine, and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by carbinoxamine, methscopolamine, and pseudoephedrine. Tell your doctor if you need to use any of these other medicines while you are taking this drug.

Pannaz S (carbinoxamine, methscopolamine, and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  feeling light-headed, fainting;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  wheezing, tightness in your chest;

  
  


• 
  

  fast or pounding heartbeat; or

  
  


• 
  

  pale skin, easy bruising or bleeding.

  
  

Continue taking this medication and talk to your doctor if you have any of these less serious side effects:

• 
  

  drowsiness, dizziness;

  
  


• 
  

  lack of coordination;

  
  


• 
  

  upset stomach;

  
  


• 
  

  stuffy nose, chest congestion;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  feeling restless or excited (especially in children);

  
  


• 
  

  dry mouth or nose; or

  
  


• 
  

  blurred vision.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Pannaz S (carbinoxamine, methscopolamine, and pseudoephedrine)?

There may be other drugs that can affect carbinoxamine, methscopolamine, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Pannaz S resources

• Pannaz S Side Effects (in more detail)
• Pannaz S Use in Pregnancy & Breastfeeding
• Pannaz S Drug Interactions
• Pannaz S Support Group
• 0 Reviews for Pannaz S - Add your own review/rating

• Pannaz S Syrup MedFacts Consumer Leaflet (Wolters Kluwer)


• Carbinoxamine/Methscopolamine/Pseudoephedrine Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Pannaz S with other medications

• Rhinitis

Where can I get more information?

• Your pharmacist has additional information about carbinoxamine, methscopolamine, and pseudoephedrine written for health professionals that you may read.

See also: Pannaz S side effects (in more detail)

One-Alpha Drops

One-Alpha Drops

alfacalcidol

Please read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.


• In this leaflet One-Alpha Drops will be called One-Alpha.

In this leaflet:

• 1. What One-Alpha is and what it is used for


• 2. Before you take One-Alpha


• 3. How to take One-Alpha


• 4. Possible side effects


• 5. How to store One-Alpha


• 6. Further information

What One-Alpha Is And What It Is Used For

One-Alpha belongs to a group of medicines called vitamin D analogues. It is a type of vitamin D.

Vitamin D controls the levels of two substances in your body. These substances are called calcium and phosphate. Your body needs both of these substances for healthy bones and teeth.

One-Alpha works by increasing the amount of vitamin D in your body. This means the levels of calcium and phosphate in your body will increase too.

One-Alpha is used to treat diseases where the amount of calcium in your body needs changing. It is used to treat:

• Changes in bone caused by kidney failure (osteodystrophy).


• Changes to your parathyroid glands. These are small glands found in your neck. They make a substance called the parathyroid hormone. This changes the amount of calcium in your body.
  
  
  • The glands may make the amount of calcium in your blood too high (hyperparathyroidism).
  
  
  • The glands may make the amount of calcium in your blood too low (hypoparathyroidism).
  
  



• Low levels of calcium in the blood of newborn babies (hypocalcaemia).


• Softening and deformity of the bones due to lack of calcium (rickets or osteomalacia).

Before You Take One-Alpha

Do not take One-Alpha

• If you are allergic (hypersensitive) to alfacalcidol or any of the other ingredients. You can find a list of these ingredients in section 6 of this leaflet.


• If you know you have a condition called hypercalcaemia. This means you have high levels of calcium in your blood.


• If you know that you have a condition called calcification. This means you have high levels of calcium in your body tissues.


• If you know that you have any sugar intolerance. You may have inherited this condition from someone else in your family.

If you are unsure if any of the above apply to you, talk to your doctor before taking One-Alpha.

Take special care with One-Alpha

Before you take One-Alpha tell your doctor:

• If you are taking another type of medicine called a cardiac glycoside, such as digoxin. These medicines are used to treat problems with your heart.


• If you have any problems with your kidneys. This includes if you have kidney stones.

You may get too much calcium or phosphate in your blood when you take this medicine. Please read section 4 of this leaflet so you can spot any signs this may be happening to you. Your doctor may need to change your dose.

While you are taking One-Alpha your doctor will take regular blood tests. This is very important in children, patients with kidney problems, or patients on a high dose of medicine. This is to check the level of calcium and phosphate in your blood while you take your medicine.

Your doctor may prescribe another medicine called a phosphate binding agent to take as well as One-Alpha. This will help to keep the right amount of phosphate in your blood.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

You must tell your doctor or pharmacist if you are taking any of the following medicines:

• Anticonvulsants: for epilepsy or fits. You may need a larger dose of One-Alpha.


• Barbiturates: for sleeping disorders. You may need a larger dose of One-Alpha.


• Cardiac glycosides, such as digoxin: for heart problems. You may get too much calcium in your blood. This may cause an abnormal heart beat.


• Colestyramine: for lowering your cholesterol level, or to help stop some types of diarrhoea or itching. Your One-Alpha may not enter your blood as usual.


• Thiazide diuretics, often called "water pills": for increasing the amount of water (urine) that your body makes. You may get too much calcium in your blood.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before taking One-Alpha:

• If you are pregnant, or think you are pregnant.


• If you are breast-feeding.

Tell your doctor if you become pregnant while taking this medicine.

Driving and using machines

Usually your medicine may have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.

Important information about some of the ingredients of One-Alpha

One-Alpha contains:

• Ethanol. This is an alcohol. This medicine contains a very small amount of ethanol.


• Methylparahydroxybenzoate. This is a preservative. It may give you an allergic reaction. This may happen at any time after you take your medicine. Please read section 4 of this leaflet so you can spot any signs this may be happening to you.


• Polyoxyl 40 hydrogenated castor oil. This is used to make your medicine. It may give you an upset stomach or diarrhoea.


• Sorbitol. This is a type of sugar. If you cannot tolerate any sugar (sometimes called sugar intolerance) contact your doctor before you take this medicine. Your medicine contains 22.6 milligrams of sorbitol in one drop.

Please ask your doctor if you are worried about any of the ingredients in this medicine.

How To Take One-Alpha

Always use One-Alpha exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How to measure a drop

Do not shake the bottle. Unscrew the bottle cap. You will see a dropper in the top of the bottle. It is ready to use. Hold the bottle upside down. A drop will form at the end of the dropper. Let the drop fall directly into your mouth. You can catch the drop on a spoon if this is easier.

If the drops do not come out of the bottle straight away, tap the bottle gently until a drop forms.

How much One-Alpha to take

Your doctor will tell you how many drops to take, or to give your child. One-Alpha is only to be taken by mouth.

Be careful not to take more drops than you should. You must check with your doctor or pharmacist if you are not sure how to take this medicine correctly. This medicine is very strong (concentrated).

At first you will have weekly blood tests to check the levels of some substances in your blood. These tests are to check the levels of calcium, an enzyme called alkaline phosphatase or the parathyroid hormone. This is so your doctor knows that you are taking the dose that is right for you. When you are getting the correct dose you will not need blood tests so often.

You may also have other tests such as X-rays. This is also so your doctor knows that the dose is right for you.

Your doctor may adjust your dose. Your doctor may ask you to take more or less drops depending on your test results. You may get too much calcium or phosphate in your blood when you take this medicine. Please read section 4 of this leaflet so you can spot any signs this may be happening to you. Your doctor will tell you not to take any more medicine. You will need to have some blood tests. When the blood tests are normal you can start your medicine again. It is important that you only take half the dose you had before.

Adults:
The usual starting dose is 10 drops each day. People usually take between 10 and 30 drops each day.

Most people take between 3 and 10 drops each day once the blood test results show the medicine is working.

If you have very low levels of calcium in your blood, the doctor may prescribe between 30 to 50 drops each day. Your doctor may prescribe another medicine called a calcium supplement to take as well as One-Alpha. This will help to keep the right amount of calcium in your blood.

Elderly:
The usual starting dose is 5 drops each day.

Children:
The dose depends on the weight of the child (called bodyweight).

• Newborn and premature babies:
  The usual starting dose is 1 to 2 drops per 2 kilograms of bodyweight each day.
  
  If the level of calcium in their blood is very low, up to 40 drops per 2 kilograms of bodyweight may be needed each day.
  
  A dose of 2 drops per 2 kilograms bodyweight each day is used to stop low blood calcium levels in premature babies.
  
  



• Children weighing less than 20 kilograms:
  The usual starting dose is 1 drop per 2 kilograms bodyweight each day.
  
  



• Children weighing more than 20 kilograms:
  The usual starting dose is 10 drops each day.

If you take more One-Alpha than you should

Tell your doctor straight away. You may need to stop taking this medicine.

You may get too much calcium or phosphate in your blood. Please read section 4 of this leaflet so you can spot any signs this may be happening to you.

If you forget to take One-Alpha

If you forget to take your medicine take it as soon as you remember. Then take the next dose at the usual time.

If you have any further questions about taking this medicine, please ask your doctor or pharmacist.

One-Alpha Drops Side Effects

Like all medicines, One-Alpha can cause side effects, although not everybody gets them.

Important side effects to look out for:

You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:

• You have difficulty breathing


• Your face or throat swell


• Your skin develops a severe rash.

You should tell your doctor straight away if you spot any of the following signs which may be due to too much calcium or phosphate in your blood:

• You need to pass water (urine) more often


• You feel thirsty


• You have a dry mouth, or a metallic taste in your mouth


• You feel weak or have pain in your muscles or bones


• You feel sick or have constipation.

Other possible side effects:

Skin problems:

• Itching skin


• Rash


• Hives (urticaria)

Kidney problems:

• Needing to pass water (urine) less often.


• Swelling of any parts of your body.


• Fever with a pain in your side.

These are signs that there may be problems developing with your kidneys. Kidney stones may be forming. Kidney stones may cause a sharp spasm in one side of your lower back.

The possible side effects described in this section of the leaflet probably affect about 1 in 10,000 people. Skin problems or too much calcium in your blood are the side effects most people get.

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How To Store One-Alpha

• Keep out of the reach and the sight of children.


• Do not use the drops after the expiry date on the carton. The expiry date is the last day of that month.


• Store in a refrigerator (2-8°C).


• Store the bottle in the outer carton.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

Further Information

What One-Alpha contains

• The active ingredient is alfacalcidol. One-Alpha contains 2 micrograms of alfacalcidol in each millilitre (ml).
  Each drop contains 0.1 microgram of alfacalcidol.



• The other ingredients are citric acid monohydrate, ethanol, methylparahydroxybenzoate, polyoxyl 40 hydrogenated castor oil, purified water, sodium citrate, sorbitol and d,l-α-tocopherol.

You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.

What One-Alpha looks like and contents of the pack

One-Alpha is a solution of oral drops. One-Alpha is a slightly hazy or clear colourless solution. One-Alpha comes in an amber glass bottle containing 10 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

LEO Laboratories Limited

Princes Risborough

Bucks.

HP27 9RR

UK

Manufacturer:

LEO Pharmaceutical Products

DK-2750

Ballerup

Denmark

This leaflet was last revised in June 2008.

Registered Trade Mark

LEO

017010-03