SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Hay-Crom Hayfever Eye Drops, 2% w/v Aqueous Eye Drops, Solution

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium Cromoglicate Ph.Eur. 2.0% w/v

(equivalent to 20.0 mg/ml anhydrous sodium cromoglicate).

Excipient(s) with known effect: Benzalkonium chloride For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Sterile preserved ophthalmic solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the treatment of acute seasonal (allergic) conjunctivitis, including hay fever.

4.2    Posology and method of administration

Posology

Adults, Children and Older people:

One or two drops into each affected eye up to four times daily, or as instructed by the physician.

Route of Administration

Topical application to the eye up to four times daily.

4.3    Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4    Special warnings and precautions for use

Store below 30°C protected from light. Dispose of any unused solution 28 days after opening the pack. The product contains benzalkonium chloride as preservative. The eye drops should not be used whilst wearing soft contact lenses.

Not for injection. Do not use if the pack is open when supplied or if any cloudiness is evident.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6    Fertility, pregnancy and lactation

Pregnancy

As with all medication, caution should be exercised, especially during the first trimester of pregnancy. Cumulative experience suggests that sodium cromoglicate has no adverse effects on foetal development. It should be used in pregnancy only where there is a clear need.

Breast-feeding

It is not known whether sodium cromoglicate is excreted into human breast milk but on the basis of its physico-chemical properties, this is considered unlikely. There is no information to suggest that the use of sodium cromoglicate has any undesirable effects on the baby.

4.7    Effects on ability to drive and use machines

This preparation may cause transient blurring of vision, following instillation. Do not drive or operate machinery until clarity of vision is restored.

4.8 Undesirable effects

List of adverse reactions

The frequencies of adverse events are ranked according to the following: very common (>1/10), common (>1/100 to < 1/10), uncommon (>1/1,000 to < 1/100), rare (>1/10,000 to < 1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Eye disorders

Not known: Burning, stinging, blurring of vision or other transient symptoms.

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 professional are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9    Overdose

Sodium cromoglicate is poorly absorbed through the gastrointestinal tract. Overdosage is very unlikely. In case of overdose no action other than medical observation should be necessary.

5    PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Both in-vitro and in-vivo studies have consistently suggested that sodium cromoglycate prevents the release of granules that produce the allergen-mediated inflammatory reaction in the eye. Sodium cromoglycate appears to inhibit reactions caused by both antigenic and non antigenic stimuli. Sodium cromoglycate has no intrinsic antihistaminic or antiinflammatory activity. Most evidence suggests that the effects of sodium cromoglycate are due to a stabilisation of mast cell membranes, although the precise mechanism remains unknown.

Pharmacokinetic properties

Due to lipid insolubility, sodium cromoglycate is effective only by topical application and only very small amounts are systemically absorbed in man. Any systemically absorbed drug is excreted unchanged in the bile and urine.

5.3 Preclinical safety data

None available

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Benzalkonium Chloride 50% Solution 1980 * BP Benzalkonium Chloride * BP Disodium Edetate BP Purified Water BP

*equivalent to 0.01% w/v Benzalkonium Chloride in final product

6.2    Incompatibilities

None known.

6.3    Shelf life

2 years

28 days after opening the bottle

6.4 Special precautions for storage

Store below 30°C. Keep bottle in outer container to protect from light.

6.5 Nature and contents of container

Sterile, blow filled seal polyethylene eye dropper bottle with a two piece dropper assembly consisting of a white or translucent main body and white nozzle together with a blue nozzle cap. The eye dropper assembly is composed of a styrene acrylonitrile co-polymer.

The pack size is 10.0 ml.

6.6 Special precautions for disposal

No special requirements for disposal.

7 MARKETING AUTHORISATION HOLDER

Teva UK Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG

8    MARKETING AUTHORISATION NUMBER(S)

PL 00289/1547

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 14 April 1993 / 23 April 1998

10 DATE OF REVISION OF THE TEXT

12/01/2015