Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
piroxicam, Quantity: 20 mg
Pfizer Australia Pty Ltd
Piroxicam
Tablet, dispersible
Excipient Ingredients: sodium stearylfumarate; microcrystalline cellulose; hyprolose; lactose monohydrate
Oral
2, 25, 5
(S4) Prescription Only Medicine
Feldene is indicated for symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.
Visual Identification: White to off-white oblong tablet being 17mm long, 6mm wide and 5.9mm in depth, marked "fel" scoreline"20" on one side and plain on the other, with a scoreline; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1992-11-24
FELDENE ® ; FELDENE-D ® F E L D E N E ® C a p s u l e s ; F E L D E N E - D ® D i s p e r s i b l e T a b l e t s CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING FELDENE? FELDENE contains the active ingredient piroxicam. FELDENE is used to treat the symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, a chronic inflammatory rheumatic disorder that primarily affects, but is not limited to, the spine. For more information, see Section 1. Why am I using FELDENE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE FELDENE? Do not use if you have ever had an allergic reaction to FELDENE, any other medicine containing piroxicam, any COX-2 inhibitor, aspirin or NSAID medicines or any of the ingredients listed at the end of the CMI. Do not take FELDENE if you are pregnant, or intend on becoming pregnant, unless your doctor says otherwise Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use FELDENE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with FELDENE and affect how it works. Examples of such medicines include aspirin or other NSAIDs, warfarin, digoxin, medicine for diabetes or epilepsy or depression, certain antibiotics, diuretics, medicine for blood pressure or cholesterol and alcohol. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE FELDENE? The usual dose of FELDENE is between 10 mg and 20 mg, taken as a single dose each day. However, depending on your condition and how you react to the medicine, your doctor may ask you to take some other dose. More instructions can be found in Section 4. How do I use FELDENE? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING FELDENE? THINGS Leggi il documento completo
Version: pfpfelda10822 Supersedes: pfpfelda10122 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 capsules. FELDENE-D (piroxicam) 20 mg tablets. EXCIPIENT(S) WITH KNOWN EFFECT FELDENE 10 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-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 14 days and subsequent frequent review with regards to efficacy, risk factors and ongoing need for treatment. Version: pfpfelda10822 Supersedes: pfpfelda10122 Page 2 of 16 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-D dispersible tablets should be dispersed in a minimum of 50 mL of water and then swallowed. 4.3 CONTRAINDICATIONS Piro Leggi il documento completo