Vantage Allergy 2% Eye Drops
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Sodium Cromoglicate Eye Drops 2% w/v Vantage Allergy 2% Eye Drops Tesco Allergy 2% Eye Drops Sainsbury’s Allergy 2% Eye Drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium cromoglicate BP (equivalent to 20.0 mg/ml
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: For the treatment of Hayfever (P):
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 Interactions 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.
PHARMACOLOGICAL PROPERTIES
5
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.
6.6 Instructions for use/handling
None stated.
7 MARKETING AUTHORISATION HOLDER
PLIVA Pharma Ltd.
Ridings Point Whistler Drive Castleford WF10 5HX
8. MARKETING AUTHORISATION NUMBER
PL 10622 / 0016
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19th January 2000 (Renewal)
10 DATE OF REVISION OF THE TEXT
10/02/2016