OPTICROM EYE DROPS

עעבקנהזןולעטמרופ " שואוקדבנונכותותואירבהדרשמי ילויבר 2008

OPTICROM EYE DROPS

1 TRADE NAME OF THE MEDICINAL PRODUCT

OpticromEye Drops

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodiumcromoglicate 2.0% w/v.

3 PHARMACEUTICAL FORM

Solution for administration to the eyes.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Preventive treatment for all types of allergicconjunctivitis.

4.2 Posology and Method of Administration

Topical Ophthalmic administration

One or two drops in each eye four times a day or as indicated by the doctor.

Elderly

No current evidence for alteration of the dose.

4.3 Contraindications

The product is contraindicated in patients who have shown hypersensitivity to Sodium

cromoglicate, Benzalkoniumchloride or Disodiumedetate.

4.4 Special Warnings and Special Precautions for Use

Discard any remaining contents four weeks after opening the bottle.

As with other ophthalmic solutions containing Benzalkoniumchloride, soft contact

lenses should not be worn during treatment period.

4.5 Interactionswith Other Medicaments and Other Forms of Interaction

None known.

4.6 Pregnancy and Lactation

As with all medication, caution should be exercised especially during the first trimester

of pregnancy. Cumulative experience with Sodiumcromoglicate suggests that it has

no adverse effects on foetal development. It should be used in pregnancy only where

there is a clear need.

It is not known whether Sodiumcromoglicate is excreted in human breast milk but, on

the basis of its physicochemical properties, this is considered unlikely. There is no

information to suggest the use of Sodiumcromoglicate has any undesirable effects on

the baby.

4.7 Effects on Ability to Drive and Use Machines

As with all eye drops, instillation of theseeye drops may cause a transient blurring of

vision.

4.8 Undesirable Effects

Transient stinging and burning may occur after instillation. Other symptomsof local

irritation have beenreported rarely.

4.9 Overdose

No action other than medical observation shouldbe necessary.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

In vitroandin vivoanimal studies have shown thatSodiumcromoglicate inhibits the

degranulation ofsensitised mast cells which occurs after exposure to specific antigens.

Sodiumcromoglicate acts by inhibiting the release of histamine and various membrane

derived mediators fromthe mast cell.

Sodiumcromoglicate has demonstrated the activityin vitroto inhibit the degranulation

of non-sensitised rat mast cells by phospholipase A and subsequent release of chemical

mediators. Sodiumcromoglicate did notinhibit the enzymatic activity ofreleased

phospholipase A on its specific substrate.

Sodiumcromoglicate has no intrinsic vasoconstrictor or antihistamine activity.

5.2 Pharmacokinetic Properties

Sodiumcromoglicate is poorly absorbed. When multiple doses of Sodium

cromoglicate ophthalmic solution are instilled into normal rabbiteyes, less than 0.07%

of the administered dose of Sodiumcromoglicate is absorbed into the systemic

circulation (presumably by way of the eye, nasal passages, buccal cavity and

gastrointestinal tract). Trace amounts (less than 0.01%) of the Sodiumcromoglicate

does penetrate into the aqueous humour and clearance fromthis chamber is virtually

complete within 24 hours after treatment is stopped.

In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of

Sodiumcromoglicate is absorbed following administration to the eye.

5.3 Preclinical Safety Data

None.

6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients

Disodiumedetate, Benzalkoniumchloride, Purified water.

6.2 Incompatibilities

None known.

6.3 Special Precautions for Storage

Store below 30 o

C and protect fromdirect sunlight. Discard any remaining contents

four weeks after opening.

7 MARKETING AUTHORISATION HOLDER

Sanofi-aventis Israel ltd.

8 MANUFACTURER

Aventis France