Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen
Bristol Laboratories Ltd
M01AE01
Ibuprofen
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5060013943324 5060013943348
SAME SIZE ARTWORK 560 x 150 mm Front IXXXXXX PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN 400MG CAPLETS IBUPROFEN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ALWAYS TAKE THIS MEDICINE EXACTLY AS DESCRIBED IN THIS LEAFLET OR AS YOUR DOCTOR OR PHARMACIST HAVE TOLD YOU. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET: 1. What Ibuprofen Caplets are and what are they used for 2. What you need to know before you take Ibuprofen Caplets 3. How to take Ibuprofen Caplets 4. Possible side effects 5. How to store Ibuprofen Caplets 6. Contents of the pack and other information 1. WHAT IBUPROFEN CAPLETS ARE AND WHAT THEY ARE USED FOR The active substance used in these caplets is Ibuprofen. Ibuprofen belongs to a class of medicines called the non-steroidal anti-inflammatory drugs (NSAIDs), which helps relieve pain, reduces inflammation and lowers temperature when you have a fever. These caplets are used to treat rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, and period pains. They are also used for the relief of feverishness, colds and influenza. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN CAPLETS DO NOT TAKE THESE CAPLETS IF YOU: • have ever been told you are allergic to ibuprofen, aspirin, other non-steroidal anti-inflammatory drugs, or to any of the other ingredients (listed in section 6). • have a stomach ulcer, perforation or bleeding, or have had one twice or more in the past • suffer from severe heart, liver or kidney problems • are in the last 3 months of pregnancy • have a condition which increases your tendency to bleeding Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen 400 mg Tablets BP Ibuprofen 400 mg Caplets Ibuprofen 400 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400mg of Ibuprofen. _Excipients with known effect_: Each tablet contains: 137.8 mg sucrose and 140 mg lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet (tablet). White, sugar coated capsule shaped tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS _Adults, elderly and Children over 12 years:_ For symptomatic relief of Rheumatic or muscular pain, pain of non-serious arthritic conditions, back ache, neuralgia, migraine, headache, dental pain, dysmenorrhoea. Ibuprofen relieves pain and reduces inflammation and temperature as well as relieving headaches and other types of pain. It also relieves cold and flu symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration and short term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). _Adults and the elderly:_ If this medicinal product is required for more than 10 days, or if symptoms persist or worsen, consult your doctor. _Children and Adolescents _(_age range: _ ≥ _ 12 years to < 18 years):_ If this medicinal product is required for more than 3 days, or if symptoms persist or worsen, consult your doctor. 400mg (1 tablet) to be taken with water up to three times a day as required. _Adult:_ Take 1 capsule with water, up to three times a day as required. Leave at least four hours between doses and do not take more than 1200mg (3 tablets) in any 24 hour period. _Children under 12 years of age_: Not recommended. 4.3 CONTRAINDICATIONS Hypersensitivity to ibuprofen or any of the excipients listed in section 6.1. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticuria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent p Прочитать полный документ