Catacrom Sodium Cromoglicate 2% Preservative Free Unit Dose Eye Drops

Catacrom 2% w/v eye drops are indicated for the relief and treatment of seasonal and perennial allergic conjunctivitis.

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.

Known hypersensitivity to sodium cromoglicate.

Catacrom 2% w/v eye drops are sterile, preservative free and presented in a single-use container which should be discarded after use.

None known.

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.

As with all eye drops, transient blurring of vision may occur on instillation. Do not drive or operate machinery until normal vision is restored.

Eye Disorders

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

Pharmacotherapeutic group: Other antiallergics; cromoglicic acid, ATC code: S01G X01

The solution exerts its effect locally in the eye.

In vitro and in vivo 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 antihistaminic or vasoconstrictor 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 humor and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.

In normal volunteers, analysis of drug excretion has shown that approximately 0.03% of sodium cromoglicate is absorbed following ocular administration.

There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC.

Purified water

Sodium chloride

None known. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

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.

Do not store above 25° C. Store in the original package.

For storage conditions after first opening of the medicinal product, see section 6.3.

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.

For single use only. Discard immediately after first use. Any unused product or waste material should be disposed of in accordance with local requirements.