Medical supervision only should be necessary.
If the solution is accidentally ingested, as sodium cromoglicate is only poorly absorbed, no action other than medical supervision should be necessary.
Unopened: 3 years.
After opening the sachet: use contents within 28 days.
After opening the single-dose unit: use immediately after opening the single-dose unit. Discard any unused contents.
Known hypersensitivity to sodium cromoglicate.
None known. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Purified water
Sodium chloride
Eye drops, solution (eye drops)
Clear, colourless solution in a single-dose container.
The eye drops are sterile and preservative free.
On instillation, transient stinging or burning may occur. Rarely, other symptoms of local irritation have been reported.
Reporting of suspected adverse reactions
Reporting 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
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC.
Catacrom 2% w/v eye drops are indicated for the relief and treatment of seasonal and perennial allergic conjunctivitis.
Pharmacotherapeutic group: Other antiallergics; cromoglicic acid, ATC code: S01G X01
The solution exerts its effect locally in the eye. Sodium cromoglicate has been shown to inhibit the degranulation of sensitised mast cells occurring after exposure to specific antigens. Sodium cromoglicate inhibits release of histamine and various membrane derived mediators from mast cells.
Sodium cromoglicate has no intrinsic antihistaminic or vasoconstrictor activity.
Limited systemic absorption may be expected via ocular instillation.
In normal volunteers, analysis of drug excretion has shown that approximately 0.03% of sodium cromoglicate is absorbed following ocular administration.
31 Mar 2017
Catacrom 2% w/v eye drops, solution.
Rayner Pharmaceuticals Ltd,
10 Dominion Way,
Worthing,
West Sussex
BN14 8AQ,
United Kingdom.
Do not store above 25°C. Store in the original package.
Catacrom 2% w/v eye drops are available in 0.3 ml low density polyethylene single-dose containers. The single-dose containers are packed into laminate sachets, within a cardboard carton.
Pack sizes: 10, 12, 18, 20, 24, 30 or 90 single doses.
Not all pack sizes may be marketed.
PL 47069/001
Catacrom 2% w/v eye drops should be used with caution in pregnancy, especially during the first trimester. Extensive experience with sodium cromoglicate suggests that there are no adverse effects on foetal development. Nevertheless, it should only be used in pregnancy where there is a clinical need.
It is not known whether sodium cromoglicate is excreted in breast milk; however, on the basis of its physicochemical properties, it is considered unlikely. There is no evidence that the use of sodium cromoglicate has any undesirable effects on the baby.
Sodium cromoglicate 2.0% w/v.
Each individual single-dose unit contains 6 mg of sodium cromoglicate in 0.3 ml of solution
Catacrom 2% w/v eye drops are sterile, preservative free and presented in a single-use container which should be discarded after use.
As with all eye drops, transient blurring of vision may occur on instillation. Do not drive or operate machinery until normal vision is restored.
Topical ophthalmic use.
Adults, children and the elderly: one or two drops into each eye four times per day, or as directed by the doctor.
For single use only. Discard immediately after first use. Any unused product or waste material should be disposed of in accordance with local requirements.
Date of first authorisation: 6 Aug 2009
Date of latest renewal: 27 Aug 2014
None known.
