Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aspirin
Aspar Pharmaceuticals Ltd
N02BA01
Aspirin
300mg
Dispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5024071230055 5024071230130
Aspar Aspirin 300 PIL UTV17 AW(O)pop.pdf 1 17/01/2019 00:26 Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dispersible Aspirin Tablets 300mg Dispersible Aspirin 300mg Tablets Boots Aspirin 300mg Dispersible Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains active: Aspirin 300mg Also contains lactose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet for Oral Suspension White flat circular bevel edged tablets embossed with a breakline on one face and aD 300 on the other. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Anti-inflammatory indications: _ Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, muscular aches, fibrositis, joint swelling and stiffness. _Analgesic and antipyretic indications: _ Mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, symptomatic relief of influenza and feverish colds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and children over 16 years:_ 1 to 3 tablets every four hours, or as directed by a doctor. Not more than 4 doses in 24 hours. Do not give to children under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease). _Elderly persons: _Lower dose is recommended. The tablets are to be taken orally with water. 4.3 CONTRAINDICATIONS Aspirin is contraindicated in patients with; • active peptic ulceration or a history of peptic ulceration. • Haemophilia, haemorrhagic disease or a history of bleeding disorders. • Gout or a history of gout. • Hypersensitivity to aspirin (e.g. asthma, rhinitis, angioedema or urticaria), other NSAIDs or other tablet excipients • During the third trimester of pregnancy 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE There is a possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which affects the brain and liver and can be fatal. For this reason aspirin should not be given to children under 16 years unless spe Les hele dokumentet