البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen
Ennogen Healthcare Ltd
M01AE01
Ibuprofen
200mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
IBUPROFEN 200MG CAPSULES PATIENT INFORMATION LEAFLET Read this leaflet carefully because it contains important information for you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor or pharmacist if your symptoms worsen or do not improve. IN THIS LEAFLET: 1. What this medicine is for 2. Before you take the medicine 3. How to take the medicine 4. Possible side effects 5. Storing the medicine 6. Further information WHAT THIS MEDICINE IS FOR Ibuprofen 200mg Capsules contain ibuprofen, which belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing how the body responds to pain, swelling and high temperature. This medicine is used to relieve: • rheumatic and muscular pain, backache • neuralgia (nerve pain) • headache, migraine • dental pain, period pain • fever (high temperature) • the symptoms of colds and flu. BEFORE YOU TAKE THE MEDICINE Do not take Ibuprofen 200mg Capsules if you: • have or have had a stomach ulcer, perforation or bleeding of the stomach • are allergic to ibuprofen, to any of the ingredients (listed in section 6), or to aspirin or other painkillers (an allergic reaction may be recognised as shortness of breath, runny nose, skin rash or itching) • have kidney or heart failure or severe liver failure • are taking more than 75mg of aspirin a day • are in the last 3 months of pregnancy. 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. Skin reactions Serious skin reactions have been reported in association with Ibuprofen 200mg Capsules treatment. You should stop taking Ibuprofen 200mg Capsules and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of al اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen 200mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ibuprofen 200mg For excipients, see 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. White and pink capsule printed with “IBU 200”. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Rheumatic or muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhea (period pain), 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: _ The minimum effective dose should be used for the shortest time necessary to relieve symptoms. Swallow 200mg – 400mg (1-2 capsules), preferably with water, up to three times a day, as required. Leave at least four hours between doses and do not take more than 1200mg (6 capsules) in any 24 hour period. If in adults this medicinal product is required for more than 10 days, or if symptoms worsen the patient should consult a doctor. If in children and adolescents between 12 and 18 years this medicinal product is required for more than 3 days, of if symptoms worsen a doctor should be consulted. Not to be given to children under 12 years. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). 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, 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 upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV) , renal failure or hepatic failure (see section 4.4 Special Warnings and Preca اقرأ الوثيقة كاملة