Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
Piroxicam
Pfizer Australia Pty Ltd
Medicine 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 ( Pirifel, FELDENE Gel) • aspirin • any other medicine that is a 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 these medicines may include: • asthma, wheezing or shortness of b Đọc toàn bộ tài liệu
Version:pfpfelda10813 Supersedes: pfpfelda10413 Page 1 of 13 PRODUCT INFORMATION FELDENE ® AND FELDENE-D ® (PIROXICAM) NAME OF THE MEDICINE FELDENE (piroxicam) 10 mg and 20 mg capsules. FELDENE-D (piroxicam) 20 mg tablets. FELDENE and FELDENE-D contain the active ingredient piroxicam. Piroxicam is a non- steroidal anti-inflammatory drug (NSAID) of the chemical class N-heterocyclic carboxamides of 1, 2-benzothiazine-1, 1-dioxide. The structural formula of piroxicam is shown below: Chemical name: 4-Hydroxy-2-methyl-N-(pyridin-2-yl)-2H-1,2-benzothiazine-3- carboxamide 1,1-dioxide Molecular formula: C 15 H 13 N 3 O 4 S Molecular weight: 331.4 CAS Registry Number: 36322-90-4. DESCRIPTION Piroxicam is an amphoteric compound. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.5) as determined by ultraviolet absorption spectrophotometry in methanol-water (2.5/97.5, v/v) solvent medium. It occurs as a white to off-white crystalline solid, poorly soluble in water, dilute acid and most organic solvents. It is slightly soluble in alcohols and in aqueous alkaline solution. It is a hygroscopic solid, which melts in the range 196 to 200°C. FELDENE capsules contain the following inert ingredients: lactose, maize starch, magnesium stearate/sodium lauryl sulfate 9:1 blend, gelatine, erythrosine, titanium dioxide, brilliant blue FCF (10 mg capsule_ _only), indigo carmine (20 mg capsule_ _only). FELDENE-D dispersible tablets contain the following inert ingredients: lactose, microcrystalline cellulose, hydroxypropyl cellulose, sodium stearyl fumarate. Version:pfpfelda10813 Supersedes: pfpfelda10413 Page 2 of 13 PHARMACOLOGY PHARMACODYNAMICS Piroxicam is a NSAID which also Đọc toàn bộ tài liệu