Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen
DE Pharmaceuticals
M01AE01
Ibuprofen
600mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
_Title:_ _Ref:_ _Date:_ _Size (mm):_ _Modified:_ Ibuprofen 600mg PIL D-IBU 13/02/18 297(H) x 210(W) 03/12/19 _Colours_ _(Printed)_ PROCESS BLACK _Colours_ _(Non printed)_ SPECIAL CUTTER D A L K E I T H L A B O R A T O R I E S In this leaflet: 1. What Ibuprofen Tablets are and what they are used for 2. Before you take Ibuprofen Tablets 3. How to take Ibuprofen Tablets 4. Possible side effects 5. How to store Ibuprofen Tablets 6. Further information Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet. You may need to read it again. • This medicine is only for you. Do not give it to anyone else to take. It may harm them, even if their symptoms are the same as yours. • If you have any further questions, please ask your doctor or pharmacist. • 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. Patient Information Leaflet Ibuprofen 600 mg Tablets BP This medicine will be called Ibuprofen Tablets in this leaflet. D0001/2 1. What Ibuprofen Tablets are and what they are used for These tablets contain the active ingredient, ibuprofen. Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) which relieves pain and reduces inflammation. Ibuprofen Tablets are used to relieve mild or moderate pain for instance when you have: • Rheumatoid arthritis or osteoarthritis • Ankylosing spondylitis (where you get stiff and painful back and hip joints) • Pain and swelling in and around other joints • An injury to the soft tissues such as sprains and strains. 2. Before you take Ibuprofen Tablets Some people must not take these tablets. Do not take these tablets if: • You know you are allergic to ibuprofen or to any of the other ingredients (these are listed in section 6) • You have had allergic reactions (e.g. asthma, blocked or runny nose, swelling of the face or throat or itching) when you have taken aspirin or other NSAID painkillers e.g. naproxen • You have a peptic ulcer Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen Tablets B.P. 600 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ibuprofen 600 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pink capsule shaped, biconvex 22 x 10 mm, film coated tablets marked with “ FIL/ I600” on one side and decorative scoreline on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ibuprofen is indicated for its analgesic and anti-inflammatory effect in rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease) ankylosing spondylitis, osteoarthritis and other non-rheumatoid arthropathies. In non-articular rheumatoid conditions, ibuprofen is indicated in periarticular conditions e.g. frozen shoulder, bursitis, tendinitis, tenosynovitis and low back pain. Ibuprofen can be used in soft-tissue injuries, e.g. sprains and strains. It is also indicated for the relief of mild to moderate pain, e.g. dental and post- operative pain and dysmenorrhoea. It is also indicated for the relief of migraine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. To be taken preferably with or after food. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Adults: Initial dosage is 1800 mg daily in divided doses. Some patients can be maintained on 600 -1800 mg daily. In severe or acute conditions it may be advantageous to increase the dosage provided that the total daily dosage does not exceed 2400 mg in divided doses. Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. Children: Ibuprofen BP 600 mg tablets are not suitable for children. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration n Przeczytaj cały dokument