Israel - English - Ministry of Health
עעבקנהזןולעטמרופ " שואוקדבנונכותותואירבהדרשמי ילויבר 2008
OPTICROM EYE DROPS
1 TRADE NAME OF THE MEDICINAL PRODUCT
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.
No current evidence for alteration of the dose.
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
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
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
4.8 Undesirable Effects
Transient stinging and burning may occur after instillation. Other symptomsof local
irritation have beenreported rarely.
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
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Disodiumedetate, Benzalkoniumchloride, Purified water.
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.