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

One ml contains 50 mg povidone K25

For a full list of excipients, see section 6.1.

Eye drops, solution in single-dose containers

Almost colourless, clear aqueous solution

Symptomatic treatment of dry eyes.

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.

Hypersensitivity to any of the components of the product.

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

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.

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.

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

Adverse reactions are ranked under heading of frequency, using the following convention: Very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1,000 to < 1/100); rare ( 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

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

No case of overdose has been reported.

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.

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.

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.

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.

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.

Unopened single-dose container: 2 years

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

Do not store above 25°C.

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

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.

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.

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

United Kingdom

PL 00101/0611

Date of first authorisation: 04.12.2001

Date of last renewal: 02.09.2006

23.04.2010

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