Oculotect

1. Name Of The Medicinal Product

Oculotect 50 mg/ml, eye drops solution in single-dose containers

2. Qualitative And Quantitative Composition

One ml contains 50 mg povidone K25

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Eye drops, solution in single-dose containers

Almost colourless, clear aqueous solution

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic treatment of dry eyes.

4.2 Posology And Method Of Administration

One drop into the conjunctival sac of the eye 4 times daily, or as required, depending upon the severity of the condition. The contents of a single-dose container are sufficient for one administration into the left and right eye.

The single-dose containers must be discarded immediately after use. Unused contents must not be stored.

Oculotect eye drops contain a sterile solution until the original closure is broken. The tip of the container should not come into contact with any surface including the eye, as this may cause injury to the eye and contaminate the solution.

4.3 Contraindications

Hypersensitivity to any of the components of the product.

4.4 Special Warnings And Precautions For Use

If irritation of the dry eye persists or worsens, treatment should be discontinued and the patient should consult the physician/ ophthalmologist.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

If the patient instils other medication(s) into the eyes (e.g. for the treatment of glaucoma), there must be an interval of at least 5 minutes between medications. Oculotect should always be instilled last.

4.6 Pregnancy And Lactation

Pregnancy:

There are no data from the use of povidone in pregnant women. Systemic exposure via ocular administration is likely to be negligible.

Animal studies are insufficient with respect to reproductive toxicity. The use of Oculotect eye drops may be considered during pregnancy, if necessary.

Lactation:

It is unknown whether povidone is excreted in human milk. However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman is negligible. Ocular eye drops can be used during breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

In the event of blurring of vision, patients must refrain from driving vehicles or operating machinery.

4.8 Undesirable Effects

Adverse reactions are ranked under heading of frequency, using the following convention: Very common (

The following adverse events have been reported:

• Immune system disorders

Very rare: Irritation or hypersensitivity reactions

• Eye disorders

Common: Mild transient burning or sticky sensation

Not known: Blurred vision

4.9 Overdose

No case of overdose has been reported.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Ophtalmologicals, artificial tears and other products, ATC code: S01XA20

The product does not contain any active pharmacological compounds. Due to their physical properties, non-irritant water soluble polymers can be used for moistening and lubrication of the ocular surface.

5.2 Pharmacokinetic Properties

Orally administered povidone with a molecular weight of 12,600 is rapidly excreted in the urine, with the major part being excreted within 11 hours.

Following intravenous administration, long-term accumulation of povidone can be avoided by reducing the proportion of povidone of molecular weight higher than 25,000. Because of the relatively large size of the povidone molecule, penetration through the cornea is unlikely.

5.3 Preclinical Safety Data

No toxic effects were observed during or after two years administration of 5 and 10 % PVP K25 (povidone) in to the feed of rats. No data on mutagenicity or teratogenicity are available.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Boric acid

Calcium chloride

Potassium chloride

Magnesium chloride

Sodium chloride

Sodium lactate

Sodium hydroxide for pH adjustment

Water for injections

The product contains no preservative.

6.2 Incompatibilities

High salt concentrations, e.g. of sodium sulphate in cold and of sodium chloride in warm conditions, can result in precipitation of povidone. Depending on the ionic strength of the solution methyl- and propylhydroxybenzoates easily form complexes with povidone.

6.3 Shelf Life

Unopened single-dose container: 2 years

The contents of a single-dose container must be used immediately after first opening.

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep container in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

The container is a transparent 0.4ml LDPE single-dose container.

Packs of 20, 60 and 120 single-dose containers. Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

The single-dose container itself is not sterile whereas the contents of single-dose containers remain sterile until the original closure is broken.

Oculotect eye drops in single-dose containers must be used immediately once after the container has been opened. The single-dose containers must be discarded after the use. Unused contents must not be stored.

7. Marketing Authorisation Holder

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

United Kingdom

8. Marketing Authorisation Number(S)

PL 00101/0611

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 04.12.2001

Date of last renewal: 02.09.2006

10. Date Of Revision Of The Text

23.04.2010

LEGAL CATEGORY

P