Summary of medicine characteristics - GALPHARM HAYFEVER EYE DROPS, LLOYDSPHARMACY HAYFEVER 2% W/V EYE DROPS, TESCO HAYFEVER 2% EYE DROPS, NUMARK HAYFEVER 2% EYE DROPS, ASDA HAYFEVER EYE DROPS, SAINSBURYS HAYFEVER 2% EYE DROPS, MURINE HAYFEVER 2% W/V EYE DROPS
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]
Excipient(s) with known effect: Benzalkonium chloride
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops
Sodium cromoglicate 2% w/v eye drops are a clear solution.
4.1 Therapeutic indications
For the relief and treatment of the eye symptoms of hayfever.
4.2 Posology and method of administration
Posology
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.
Older people:
There is no evidence to suggest that dosage alteration is required for elderly patients.
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
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 Fertility, pregnancy and lactation
Pregnancy
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.
Breast-feeding
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
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: Transient stinging and blurring of vision
Other symptoms of local irritation have been reported rarely.
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
4.9 OverdoseOverdosage 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 ocular mucosa. Sodium cromoglicate is not metabolised.
5.3 Preclinical safety data
5.3 Preclinical safety dataNone 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
6.6 Special precautions for disposalNo special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
PLIVA Pharma Ltd.
Ridings Point
Whistler Drive
Castleford
WF10 5HX
8 MARKETING AUTHORISATION NUMBER(S)
PL 10622/0237