This information is intended for use by health professionals
Hayfever 2.0% w/v Eye Drops, Solution
Sodium cromoglicate 2.0% w/v.
For full list of excipients, see section 6.1
Eye Drops, Solution (Eye Drops)
A clear colourless or pale yellow liquid.
For the relief and treatment of the eye symptoms of hayfever.
Opticrom Hayfever Eye Drops should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist.Adults and Children over 6 years
One or two drops to be administered into each eye four times daily.
There is no evidence to suggest that dosage alteration is required for elderly patients.
The product is contraindicated in patients who have shown hypersensitivity to Sodium cromoglicate, Benzalkonium chloride or Disodium edetate.
Soft contact lenses should not be worn during treatment with sodium cromoglicate eye drops.
The carton label and patient information leaflet will state:
• the patient should consult a doctor or pharmacist if symptoms do not start to improve within 48 hours,
• Opticrom Hayfever Eye Drops should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist.
As with all medication, caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with Sodium cromoglicate 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 Sodium cromoglicate 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 Sodium cromoglicate has any undesirable effects on the baby.
As with all eye drops, instillation of these eye drops may cause a transient blurring of vision or local irritation. Do not drive or operate machinery if affected.
Transient stinging, burning and blurring of vision may occur after instillation. Other symptoms of local irritation have been reported rarely.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.
Pharmacotherapeutic group: Ophthalmologicals; Other antiallergics, ATC Code: S01GX01
The solution exerts its effect locally in the eye.In vitro
and in vivo
animal studies have shown that Sodium cromoglicate inhibits the degranulation of sensitised mast cells which occurs after exposure to specific antigens. Sodium cromoglicate acts by inhibiting the release of histamine and various membrane derived mediators from the mast cell.
Sodium cromoglicate has demonstrated the activity in vitro
to inhibit the degranulation of non-sensitised rat mast cells by phospholipase A and subsequent release of chemical mediators. Sodium cromoglicate did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.
Sodium cromoglicate has no intrinsic vasoconstrictor or antihistamine activity.
Sodium cromoglicate is poorly absorbed. When multiple doses of Sodium cromoglicate ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of Sodium cromoglicate 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 Sodium cromoglicate does penetrate into the aqueous humour and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.
In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of Sodium cromoglicate is absorbed following administration to the eye.
Sodium cromoglicate is not metabolised.
36 months unopened, 28 days opened
Store below 30°C and protect from direct sunlight. Discard any remaining contents four weeks after opening.
Low density polyethylene bottle without lauric diethanolamide and plug with a polypropylene cap with a shrink-type security seal containing 5 ml or 10 ml solution.
Aventis Pharma Limited
One Onslow Street
or trading as:-
Sanofi-aventis or Sanofi
One Onslow Street