Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium cromoglicate
Aspire Pharma Ltd
S01GX01
Sodium cromoglicate
20mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11040200; GTIN: 5060209731360
OBJECT 1 HAYFEVER RELIEF 2%W/V EYE DROPS Summary of Product Characteristics Updated 04-Apr-2018 | Aspire Pharma Ltd 1. Name of the medicinal product Aspire Hayfever Relief 2% w/v Eye Drops, solution Boots Hayfever Relief 2% w/v Eye Drops, solution Numark Hayfever Relief 2% w/v Eye Drops, solution Optrex Hayfever Relief 2%w/v Eye Drops, solution EM Pharma Hayfever Relief 2%w/v Eye Drops, solution Pollenase Hayfever Relief 2%w/v Eye Drops, solution Opticrom Hayfever 2%w/v Eye Drops, solution 2. Qualitative and quantitative composition Each ml of eye drops contains Active substance: 20 mg sodium cromoglicate (2.0% w/v), (one drop contains 0.7mg sodium cromoglicate). Excipient with known effect: 0.1mg benzalkonium chloride For a full list of excipients, see section 6.1. 3. Pharmaceutical form Eye Drops, Solution (eye drops) Clear colourless to pale yellow 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 Sodium cromoglicate 2%w/v eye drops should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist. Ocular use Adults and Children over 6 years: One or two drops to be administered into each eye four times daily. Children under 6 years There is no relevant indication for use of sodium cromoglicate in children. Sodium cromoglicate is contraindicated in children under 2 years of age. Elderly 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 4.4 Special warnings and precautions for use Discard any remaining contents four weeks after opening the bottle. Sodium cromoglicate eye drops contain benzalkonium chloride. May cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses. The carton and patient information l Pročitajte cijeli dokument