Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Ibuprofen 400mg; ; ;
Viatris Limited
Ibuprofen 400 mg
400 mg
Film coated tablet
Active: Ibuprofen 400mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Methylated spirits Microcrystalline cellulose Opadry white 06A28611 Opaspray white M-1-7111B Purified talc Purified water Sodium laurilsulfate
Blister pack, PVC/PVDC/Al Starter, 10 tablets
Prescription
Prescription
Strides Shasun Limited
Juvenile rheumatoid arthritis
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al Starter - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al Starter - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC or PVC/PVDC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 40 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 500 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE Starter pack - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 50 tablets - 36 months from date of manufacture stored at or below 25°C
2000-03-30
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION BRUFEN ® _IBUPROFEN FILM-COATED TABLET 400 MG _ _ _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Brufen This leaflet answers some common questions about Brufen. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Brufen against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT BRUFEN IS USED FOR Brufen relieves pain and reduces inflammation (swelling or redness) that may occur: • in different types of arthritis including rheumatoid arthritis, osteoarthritis and juvenile rheumatoid arthritis • in muscle and bone injuries such as sprains, strains, low back pain (lumbago), rheumatism, and tendonitis, such as tennis elbow • from swelling and pain after setting broken or dislocated bones • menstrual cramps (period pain) • following surgery • due to dental pain. Brufen also relieves fever (high temperature). Although Brufen can relieve the symptoms of pain and inflammation, it will not cure your condition. Brufen contains the active ingredient ibuprofen. Ibuprofen belongs to a group of medicines called non-steroidal anti- inflammatory drugs (or NSAIDs). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are not sure if you are taking any of these medicines, ask your pharmacist. This medicine is available only with a doctor’s prescription. Brufen is not addictive. BEFORE YOU TAKE BRUFEN _WHEN YOU MUST NOT TAKE _ _IT _ DO NOT TAKE BRUFEN IF YOU HAVE AN ALLERGY TO: • any medicine containing ibuprof Belgenin tamamını okuyun
Page 1 of 15 NEW ZEALAND DATA SHEET BRUFEN _ _ 1. PRODUCT NAME Brufen 400 mg and 600 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 400 mg film-coated tablet contains 400 mg of ibuprofen. Each 600 mg film-coated tablet contains 600 mg of ibuprofen. Excipients with known effect: contains sulfites and sugars as lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Brufen 400 mg and 600 mg tablets are white, pillow-shaped, film-coated tablets. Do not halve the tablets._ _ 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ • Rheumatoid arthritis • Osteoarthritis • Juvenile rheumatoid arthritis • Primary dysmenorrhoea • Pyrexia Brufen is also indicated for the relief of acute and/or chronic pain states in which there is an inflammatory component. _4.2 _ _DOSE AND METHOD OF ADMINISTRATION _ After assessing risk/benefit ratio in each individual patient, the lowest effective dose for the shortest duration should be used. ADULTS The recommended initial dosage of Brufen is 1200 mg - 1800 mg daily in divided doses. Some patients can be maintained on 600 - 1200 mg daily. In severe or acute conditions it can be advantageous to increase the dosage until the acute phase is brought under control, providing that the total daily dosage does not exceed 2400 mg in divided doses. Page 2 of 15 _PRIMARY DYSMENORRHOEA _ The initial dose is 400-800 mg at the first sign of pain or menstrual bleeding, then 400 mg 4-6 hourly with a maximum total daily dose of 1,600 mg._ _ _MAINTENANCE DOSE _ In all indications the dose should be adjusted for each patient and the smallest dose that results in acceptable control of the symptoms employed. In general, patients with rheumatoid arthritis and osteoarthritis tend to require higher doses than patients with other conditions. SPECIAL POPULATIONS _ELDERLY _ In elderly patients receiving 600 - 1,200 mg daily ibuprofen appeared to be well tolerated. However, since elderly patients may have a degree of impaired liver or renal f Belgenin tamamını okuyun