Boots Hayfever Relief Eye Drops

1. Name Of The Medicinal Product

Sodium Cromoglicate Eye Drops 2% w/v

Pollenase Allergy Eye Drops

Lloyds Pharmacy Allergy Relief Eye Drops

Vantage Allergy Eye Drops

Boots Hayfever Relief Eye Drops

2. Qualitative And Quantitative Composition

Sodium cromoglicate BP (equivalent to anhydrous sodium cromoglicate)

3. Pharmaceutical Form

Eye drops

4. Clinical Particulars

4.1 Therapeutic Indications

A) 13.5m1 packs:	(POM): For the relief and treatment of acute allergic conjunctivitis such as hayfever, chronic allergic conjunctivitis and vernal kerato conjunctivitis.
B) 5m1 and 10ml packs:	(P): For the treatment of Hayfever

4.2 Posology And Method Of Administration

Adults and Children:

One or two drops to be administered into each eye four times daily, or as prescribed by the doctor.

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.

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.

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. Pharmacological Properties

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 occular 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 And Other Handling

None stated.

7. Marketing Authorisation Holder

PLIVA Pharma Ltd.

Ridings Point

Whistler Drive

Castleford

WF10 5HX

8. Marketing Authorisation Number(S)

PL 10622/0016

9. Date Of First Authorisation/Renewal Of The Authorisation

19th January 2000 (Renewal)

10. Date Of Revision Of The Text

13th September 2011