Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen
Crescent Pharma Ltd
M01AE01
Ibuprofen
600mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5017123292156
Package leaflet: Information for the patient Ibuprofen Tablets BP 200 mg, 400 mg and 600 mg Ibuprofen Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ibuprofen Tablets is and what it is used for 2. What you need to know before you take Ibuprofen Tablets 3. How to take Ibuprofen Tablets 4. Possible side effects 5. How to store Ibuprofen Tablets 6. Contents of the pack and other information 1. WHAT IBUPROFEN TABLETS IS AND WHAT IT IS USED FOR Ibuprofen belongs to a group of medicines called NSAID (non-steroidal anti- inflammatory drugs) which work by reducing pain inflammation and fever. Ibuprofen is used for the symptomatic treatmen of mild to moderate pain including migraine headache period pain and/or fever. In addition, Ibuprofen is used for the symptomatic treatmen of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis) and in painful swelling and inflammation aftersoft tissue injuries . 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN TABLETS DO NOT TAKE IBUPROFEN: • You are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) • If you are suffering from an ulcer or bleeding in the stomach or small intestine (duodenum) or if you have had two or more of these episodes in the past • If you have suffered from gastrointestinal bleeding or perforation related to previous use of drugs for pain and inflammation (NSAIDs) If you have had allergic reactions such as Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen Tablets BP 600mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 600 mg of Ibuprofen, BP. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ibuprofen is indicated for symptomatic treatment of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis) degenerative arthritic conditions (e.g. osteoarthritis), and in painful swelling and inflammation after soft tissue injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). The treating physician decides on the duration of treatment. In rheumatic diseases the use of ibuprofen can be required for a longer period. Ibuprofen is contraindicated in children and adolescents younger than 15 years of age. (See section 4.3). Posology The ibuprofen dose depends on the patient’s age and body weight. The maximum single dose for adults should not exceed 800 mg of ibuprofen. Rheumatic diseases _ _ _Adults: _ _ _ The recommended dose is 1200 – 1800 mg daily in divided doses. Maintenance doses of 600 mg-1200 mg daily may be effective in some patients. In acute and severe conditions the dose may be (temporarily) increased to a maximum of 2400 mg in 3 or 4 divided doses. _Paediatric population _ _ _ _Adolescents 15 to 17 years of age: _ The recommended dose should be adjusted by weight: 20 mg/kg to a maximum of 40 mg/kg body weight daily (max 2400 mg daily) in 3 to 4 divided doses. _Elderly: _ NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events and are at increased risk of potentially fatal gastrointestinal haemorrhage, ulceration or perforation (see section 4.4). If treatment is considered necessary, the lowest dose for the shortest duration necessary to control symptoms should be used. Treatment should be reviewed at regular intervals Baca dokumen lengkap