Catacrom 2% w/v eye drops, solution.

Sodium cromoglicate 2.0% w/v.

Each individual single-dose-unit contains 6mg of sodium Cromoglicate in 0.3ml of solution

For a full list of excipients, see section 6.1.

Eye drops, solution (eye drops)

Clear, colourless solution drops in a single dose container.

The eye drops are sterile and preservative free.

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 fetal 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.

On instillation, transient stinging or burning may occur. Rarely, other symptoms of local irritation have been reported.

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; Cromoglicate acid

ATC-code: SO1G 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.

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.

Catacrom 2% w/v eye drops is 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 the local requirements.

Moorfields Eye Hospital NHS Foundation Trust

Trading as Moorfields Pharmaceuticals

34 Nile Street

London N1 7TP

PL11412/0002

06/08/2009

06/08/2009