Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
piroxicam
Pfizer Australia Pty Ltd
Registered
FELDENE ® ; FELDENE-D ® _Piroxicam (pir-oks-i-kam)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FELDENE. 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 FELDENE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE STARTING FELDENE AND KEEP IT WITH YOUR MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT FELDENE IS USED FOR FELDENE treats the symptoms of • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily affects, but is not limited to, the spine. Although FELDENE can relieve the symptoms of pain and inflammation, it will not cure your condition. FELDENE belongs to a group of medicines called Non-Steroidal Anti- inflammatory Drugs (NSAIDs). These medicines work by relieving pain and inflammation (heat, throbbing, swelling, redness). Your doctor may have prescribed FELDENE for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY FELDENE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE FELDENE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE FELDENE IF YOU HAVE AN ALLERGY TO: • piroxicam (the active ingredient in FELDENE) or any of the capsule or tablet ingredients listed at the end of this leaflet (see Product Description) • other medicines containing piroxicam e.g. PIRIFEL, FELDENE Gel. Other brands are available. • any medicine that is a COX-2 inhibitor • aspirin • any other medicine that is also an NSAID. 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 ONE OF THESE MEDICINES, ASK YOUR PHARMACIST. Symptoms of an allergic reaction to the Belgenin tamamını okuyun
Version: pfpfelda10122 Supersedes: pfpfelda11021 Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION – FELDENE ® AND FELDENE-D ® (PIROXICAM) 1. NAME OF THE MEDICINE Piroxicam 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FELDENE (piroxicam) 10 mg and 20 mg capsules. FELDENE-D (piroxicam) 20 mg tablets. EXCIPIENT(S) WITH KNOWN EFFECT FELDENE 10 mg and 20 mg capsules contain lactose monohydrate. FELDENE-D 20 mg dispersible tablets contain lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM FELDENE 10 mg capsules are blue and red in colour, marked _FEL10_ on one side and _Pfizer _ on the other. FELDENE 20 mg capsules are maroon in colour, marked _FEL20_ on one side and _Pfizer_ on the other. FELDENE-D 20 mg dispersible tablets are white, oblong, scored, capsule-shaped and marked _FEL/20_ on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Piroxicam is indicated for symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. 4.2 DOSE AND METHOD OF ADMINISTRATION Pregnancy: see Section 4.6 Fertility, pregnancy and lactation. RHEUMATOID ARTHRITIS, OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS After assessing the risk versus benefit for each patient, use the minimum effective dose for the shortest duration possible. The duration of treatment should preferably be limited to 14 days. If continued treatment is considered necessary, this should be accompanied by evaluation at Version: pfpfelda10122 Supersedes: pfpfelda11021 Page 2 of 16 14 days and subsequent frequent review with regards to efficacy, risk factors and ongoing need for treatment. The dose should be adjusted to each individual patient’s response and toleration. In studies to date, the optimal response generally has been achieved at a daily dose of 20 mg, given as a single dose. The recommended starting dose is 10 mg and administration of doses higher than 20 mg daily carries an increased risk of adverse effects and is not recommended. FELDENE- Belgenin tamamını okuyun