SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Cromo Singles 2% w/v Eye Drops

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium cromoglicate 2% w/v.

For a full list of excipients, see Section 6.1

3    PHARMACEUTICAL FORM

Eye drops, solution.

Clear, colourless to pale yellow sterile solution; practically free from visible particles

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For prophylaxis and symptomatic relief in acute allergic conjunctivitis such as hay fever, chronic allergic conjunctivitis and vernal kerato conjunctivitis.

Sodium cromoglicate inhibits the release of mediators of the allergic reaction from sensitised mast cells.

4.2    Posology and method of administration

For ocular use.

The recommended dose for adults (including the elderly) and children is one or two drops in each affected eye four times a day.

The eye drops are supplied in single-dose containers for single-dose administration only. Prior to administration, the sterile eye drops should be visually inspected for clarity, particulate matter, discolouration and the integrity of the container. The eye

drops should only be used if the solution is clear and the container is intact and undamaged. The eye drops should be administered immediately after opening the sealed container. Any unused solution should be discarded immediately after initial administration.

4.3 Contraindications

Hypersensitivity to sodium cromoglicate.

4.4 Special warnings and precautions for use

The eye drops do not contain antimicrobial preservatives and are supplied in singledose containers for single-dose administration only.

Soft contact lenses should not be worn whilst using this product.

4.5 Interaction with other medicinal products and other forms of interaction

None reported. Sodium cromoglicate has a local action and is poorly absorbed systemically. No interaction studies have been performed.

4.6 Fertility, Pregnancy and Lactation'

Pregnancy: Use of Cromo Singles in pregnancy has not been studied and anticipated benefit should be weighed against possible hazards. Experience with sodium cromoglicate suggests it has no effect on foetal development.

Breast feeding: It is unlikely that sodium cromoglicate is excreted in breast milk due to its physico-chemical properties. Poor systemic absorption would suggest there would be no adverse effects on the baby.

4.7 Effects on ability to drive and use machines

As with all eye drops, transient blurring of vision may occur. If affected, do not drive or operate machinery whilst vision is blurred.

4.8 Undesirable effects

Mild stinging or burning may occur for a short time after instillation.

No action other than medical observation should be necessary.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmocotherapeutic group: Other antiallergics. ATC Code: S01GX01

Sodium cromoglicate inhibits the release of the mediators of allergic reactions from sensitised mast cells. The exact mechanism of action is unknown but it is suggested that sodium cromoglicate stabilises the mast cell membrane.

5.2    Pharmacokinetic properties

Sodium cromoglicate is lipid insoluble and only effective by topical administration. Very small amounts are absorbed systemically and it is excreted unchanged in the bile and urine.

5.3    Preclinical safety data

None available.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Purified water

6.2    Incompatibilities

None known

Shelf life as packaged for sale: 3 years

Shelf life after first opening the single-dose container: For single-dose administration only. To be administered immediately after opening. Any unused solution should be discarded immediately after initial administration.

6.4 Special precautions for storage

Do not store above 25 °C. Keep the single-dose containers in the outer carton for protection from light.

6.5 Nature and contents of container

Low density polyethylene (LDPE) single-dose container fitted with a twist and pull off tamper-evident seal containing 0.4ml eye drops. Supplied as 20 single-dose containers (4 strips of 5 single-dose containers) in an outer carton.

6.6 Special precautions for disposal

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Four Pharmaceuticals Ltd., 23 Upper Green Road, Tewin, Welwyn, Herts, AL6 0LE, UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 17248/0003

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24/05/2013

10    DATE OF REVISION OF THE TEXT

24/05/2013