Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Ibuprofen 800mg;
Viatris Limited
Ibuprofen 800 mg
800 mg
Modified release tablet
Active: Ibuprofen 800mg Excipient: Colloidal silicon dioxide Hydroxymethylcellulose Hypromellose Methylated spirits Povidone Purified talc Purified water Stearic acid Titanium dioxide Xanthan gum
Blister pack, Opaque PVC/PVDC/Al, Physican's sample, 4 tablets
Prescription
Prescription
Strides Shasun Limited
Juvenile rheumatoid arthritis
Package - Contents - Shelf Life: Blister pack, Opaque PVC/PVDC/Al, Physican's sample - 4 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Opaque PVC/PVDC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Opaque PVC/PVDC/Al - 40 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Opaque PVC/PVDC/Al - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Opaque PVC/PVDC/Al - 500 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, Physican's sample - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 60 tablets - 36 months from date of manufacture stored at or below 25°C
1990-10-03
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION BRUFEN ® SR _IBUPROFEN MODIFIED RELEASE TABLET 800 MG _ _ _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Brufen SR. This leaflet answers some common questions about Brufen SR. 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 SR 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 SR IS USED FOR Brufen SR 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 SR also relieves fever (high temperature). Although Brufen SR can relieve the symptoms of pain and inflammation, it will not cure your condition. Brufen SR 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 SR is not addictive. BEFORE YOU TAKE BRUFEN SR _WHEN YOU MUST NOT TAKE _ _IT _ DO NOT TAKE BRUFEN SR IF YOU HAVE AN ALLER Pročitajte cijeli dokument
Page 1 of 14 NEW ZEALAND DATA SHEET BRUFEN SR _ _ 1. PRODUCT NAME Brufen SR 800 mg modified release tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified release tablet contains 800 mg of ibuprofen. Excipient with known effect: contains sulfites For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Brufen SR tablets are white, pillow-shaped, film coated tablets. These tablets are not capable of providing a divided dose. Do not halve the tablets. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ • Rheumatoid arthritis • Osteoarthritis • Juvenile rheumatoid arthritis • Primary dysmenorrhoea • Pyrexia Brufen SR 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. DOSE _ADULT _ The recommended daily dosage is two Brufen SR tablets taken as a single dose, preferably in the early evening, well before retiring to bed. The tablets should be swallowed whole with plenty of fluids. In severe or acute conditions, the total daily dosage may be increased to three tablets taken as two tablets in the early evening and an additional tablet in the morning. Page 2 of 14 _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 function the adult dosage should be used with caution. HEPATIC IMPAIRMENT Ibuprofen should be used with caution in patients with impaired liver function (see section 4.4). RENAL IMPAIRMENT Pročitajte cijeli dokument