SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Galpharm Hayfever 2% Eye Drops Asda Hayfever 2% Eye Drops Numark Hayfever 2% Eye Drops Lloydspharmacy Hayfever 2% w/v Eye Drops Tesco Hayfever 2% Eye Drops Sainsbury’s Hayfever 2% Eye Drops

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium cromoglicate (equivalent to 20.0 mg/ml anhydrous sodium cromoglicate). [Sodium cromoglicate 2.0% w/v]

For a full list of excipients, see 6.1

3 PHARMACEUTICAL FORM

Eye drops

Sodium cromoglicate 2% w/v eye drops are a clear solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the relief and treatment of the eye symptoms of hayfever.

4.2 Posology and method of administration

Galpharm Hayfever Eye Drops should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist.

Adults and Children over 6 years:

One or two drops to be administered into each eye four times daily.

Elderly:

There is no evidence to suggest that dosage alteration is required for elderly patients.

4.3 Contraindications

Known hypersensitivity to any ingredient, including sodium cromoglicate, benzalkonium chloride and disodium edetate.

4.4 Special warnings and precautions for use

Soft contact lenses should not be worn during treatment with sodium cromoglicate eye drops.

The carton label and patient information leaflet will state:

•    the patient should consult a doctor or pharmacist if symptoms do not start to improve within 48 hours,

•    Galpharm Hayfever Eye Drops should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on foetal development. However, as with all medicines, caution should be exercised during pregnancy, and it should be used in pregnancy only when there is a clear need.

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

4.7 Effects on ability to drive and use machines

Instillation may cause transient blurring of vision. Do not drive or operate machinery if affected.

4.8 Undesirable effects

Transient stinging and blurring of vision may occur. Other symptoms of local irritation have been reported rarely.

4.9 Overdose

Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.

5.1 Pharmacodynamic properties

The solution exerts its effect locally in the eye.

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

5.2 Pharmacokinetic properties

Limited systemic absorption may be expected via the ocular mucosa. Sodium cromoglicate is not metabolised.

5.3 Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Disodium edetate

Benzalkonium chloride Water

6.2    Incompatibilities

None known.

6.3 Shelf life

24 months unopened - 28 days opened.

6.4 Special precautions for storage

Store below 25 °C, protected from direct sunlight.

6.5 Nature and contents of container

White polyethylene bottles fitted with integral dropper and closed with a polypropylene or polyethylene screw cap containing 5 or 10ml eye drops.

6.6 Special precautions for disposal

None stated.

7    MARKETING AUTHORISATION HOLDER

PLIVA Pharma Ltd.

Ridings Point Whistler Drive Castleford WF10 5HX

8    MARKETING AUTHORISATION NUMBER(S)

PL 10622/0237

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/01/2007

10 DATE OF REVISION OF THE TEXT

10/02/2016