Land: Storbritannia
Språk: engelsk
Kilde: myHealthbox
Ibuprofen, Phenylephrine hydrochloride
Reckitt Benckiser Healthcare (UK) Limited
M01AE51
Ibuprofen, Phenylephrine hydrochloride
200mg/5mg
Film-coated Tablet
Oral use
4, 6, 8, 10, 12, 14 and 16 tablets
GSL - General Sales List
Reckitt Benckiser Healthcare International Ltd
It is indicated for the relief of symptoms of cold and ‘flu with associated congestion, including aches and pains, headache, fever, sore throat, blocked nose and sinuses.
Authorised
2014-12-11
Nurofen Sinus Pain Relief 200mg/5mg Tablets Summary of Product Characteristics Updated 03Jul2015 | Reckitt Benckiser Healthcare (UK) Ltd 1. Name of the medicinal product Nurofen Sinus Pain Relief 200mg/5mg Tablets 2. Qualitative and quantitative composition Active Ingredients Ibuprofen Phenylephrine hydrochloride Quantity 200.0mg 5.0mg For full list of excipients, see Section 6.1 3. Pharmaceutical form Yellow film coated tablet, printed with an identifying motif (IPE) in black ink 4. Clinical particulars 4.1 Therapeutic indications For the relief of symptoms of cold and 'flu with associated congestion, including aches and pains, headache, fever, sore throat, blocked nose and sinuses. 4.2 Posology and method of administration For oral administration and shortterm use only. Adults, the elderly and children over 12 years: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days. Two tablets every 8 hours. Leave at least 4 hours between doses and do not exceed six tablets in any 24 hour period. Not to be given to children under 12 years. 4.3 Contraindications Hypersensitivity to ibuprofen, phenylephrine or any of the excipients in the product. Hypertension and severe coronary heart disease. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs). Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes or proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure, renal failure or h Les hele dokumentet