Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen
Sigma Pharmaceuticals Plc
M01AE01
Ibuprofen
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
PATIENT INFORMATION LEAFLET FOR IBUPROFEN TABLETS 400MG _Read this leaflet carefully before taking your medicine. It does not contain all the information about _ _your medicine that you may need to know, so please ask your doctor or pharmacist if you have any _ _questions. This leaflet only applies to Ibuprofen Tablets 400mg. _ _ _ 1. WHAT THESE TABLETS DO Ibuprofen is a type of painkiller called a ‘non-steroidal anti-inflammatory drug’ (NSAID). It is used to relieve rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, period pains, feverishness and the symptoms of cold and flu. 2. CHECK BEFORE YOU TAKE DO NOT TAKE THESE TABLETS IF YOU: Are allergic to Ibuprofen or any of the other ingredients listed in section 6 Have a history of allergy to aspirin, ibuprofen or NSAID’s which includes attacks of asthma, swelling of the nose and throat, skin rashes or a runny nose Have an active or a history of recurrent peptic ulcers (more than two) Are over six months pregnant Are already taking aspirin at doses of above 75mg daily or taking any other NSAID Have severe liver, kidney or heart problems Have a history of gastro intestinal bleeding or perforation related to the use of NSAID’s WARNINGS AND PRECAUTIONS Anti-inflammatory pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke particularly when used at high doses. Do not exceed the recommended dose or duration of treatment. If you have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack ‘TIA’) or think that you may be at risk have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker. TAKE SPECIAL CARE AND TELL YOUR DOCTOR IF YOU: Suffering Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen Tablets 400mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ibuprofen BP 400.0mg Excipient(s) with known effect Sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of cold and influenza. Pain of non-serious arthritic conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). _Adults, the elderly and children over 12 years_: One tablet up to three times a day as required. The dose should not be repeated more frequently than every four hours and no more than three tablets in any 24-hour period. If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. _Paediatric population_: Do not give to children under 12 years except on the advice of a doctor. Method of administration For oral use. The tablets should be swallowed with or after food. 4.3 CONTRAINDICATIONS Ibuprofen is contraindicated in patients with a hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Ibuprofen should not be used in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, or urticaria) after taking ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Ibuprofen should not be used in patients with active, or history of, recurrent peptic ulcer or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Ibuprofen should not be given to patients with conditions involving an increased tendency to bleeding. Ibuprofen is also contra Belgenin tamamını okuyun