国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen
Sun Pharma UK Ltd
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 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen 400mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ibuprofen 400mg For excipients, see 6.1 3 PHARMACEUTICAL FORM Film-Coated tablets White film coated capsule shaped tablets (caplets) with letter 'I' marked on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatic or muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For oral administration and short-term use only. Adults, the elderly and children over 12 years: One tablet up to 3 times a day, as required. Leave at least 4 hours between each dose. 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. Leave at least four hours between doses and do not take more than 1200mg in any 24 hour period. If this medicinal product is required for more than 3 days in children and adolescents between the age of 12 to 18 years or if symptoms worsen a doctor should be consulted. 4.3 CONTRAINDICATIONS Hypersensitivity to ibuprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure, renal failure or hepatic failure (see section 4.4) Last trimester of pregnancy (see section 4.6) 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control sym 完全なドキュメントを読む