Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
ibuprofen, Quantity: 400 mg
Generic Health Pty Ltd
Ibuprofen
Tablet, film coated
Excipient Ingredients: sodium lauryl sulfate; povidone; colloidal anhydrous silica; macrogol 6000; stearic acid; croscarmellose sodium; titanium dioxide; purified water; purified talc; hypromellose; microcrystalline cellulose; lactose monohydrate
Oral
40, 12, 10, 50, 20, 30
(S3) Pharmacist Only Medicine, (S2) Pharmacy Medicine
For the temporary relief of pain and/or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, arthritis, rheumatic pain and aches and pains associated with colds and flu. Reduces fever.
Visual Identification: white to off-white, pillow shaped, film coated tablets, plain on both sides; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-10-06
CONSUMER MEDICINE INFORMATION PHARMACY ACTION IBUPROFEN 400 (IBUPROFEN) FILM-COATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pharmacy Action Ibuprofen 400. 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 pharmacist or doctor has weighed the risks of you taking Pharmacy Action Ibuprofen 400 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 PHARMACY ACTION IBUPROFEN 400 IS USED FOR Pharmacy Action Ibuprofen 400 is used for the temporary relief of pain and/or inflammation associated with: • headache; • migraine headache; • tension headache; • sinus pain; • toothache; • dental procedures; • backache; • muscular aches and pains; • period pain; • sore throat; • tennis elbow; • arthritis; • rheumatic pain; and • the aches and pains associated with colds and flu. It also reduces fever. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (or NSAIDs). ASK YOUR PHARMACIST OR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT THIS MEDICINE. Your pharmacist or doctor may have given it to you for another reason. Pharmacy Action Ibuprofen 400 is only available from your pharmacist. Pharmacy Action Ibuprofen 400 is not addictive. BEFORE YOU TAKE PHARMACY ACTION IBUPROFEN 400 _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PHARMACY ACTION IBUPROFEN 400 IF YOU HAVE AN ALLERGY TO: • any medicine containing ibuprofen, aspirin or other NSAIDs; • any of the ingredients listed at the end of this leaflet. 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. Some of the symptoms of an allergic reaction may include: • asthma, wheezing or s Прочитајте комплетан документ
AUSTRALIAN PRODUCT INFORMATION – PHARMACY ACTION IBUPROFEN 400 (IBUPROFEN) FILM-COATED TABLET 1 NAME OF THE MEDICINE Ibuprofen. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ibuprofen 400 mg. List of excipients with known effect: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM White to off-white, pillow-shaped, film coated tablets, plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the temporary relief of pain and/or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, arthritis, rheumatic pain and aches and pains associated with colds and flu. Reduces fever. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN 12 YEARS AND OVER The recommended dose is one tablet to be taken every 4 to 6 hours as necessary. (Maximum 3 tablets in 24 hours). Do not exceed the recommended dose. CHILDREN UNDER 12 YEARS Pharmacy Action Ibuprofen 400 should not be administered to children aged less than 12 years. This product should not be used for more than 3 days at a time except on medical advice, in which case the patient should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage. Pharmacy Action Ibuprofen 400 v3.0 Page 2 of 11 (ibuprofen) film-coated tablet 4.3 CONTRAINDICATIONS Ibuprofen is contraindicated for use in patients with: • known hypersensitivity or idiosyncratic reaction to ibuprofen (or any of the inactive ingredients); • known hypersensitivity to aspirin and other NSAIDs; • asthma that is aspirin or NSAID sensitive; • active gastrointestinal bleeding or peptic ulceration; • renal impairment; • heart failure; • severe liver impairment; • undergoing treatment of perioperative pain in a setting of coronary artery bypass surg Прочитајте комплетан документ