Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
PIROXICAM AS BETA-CYCLODEXTRIN
TARO INTERNATIONAL LTD, ISRAEL
M02AA07
TABLETS
PIROXICAM AS BETA-CYCLODEXTRIN 20 MG
PER OS
Required
CHIESI FARMACEUTICI S.P.A., ITALY
PIROXICAM
PIROXICAM
Piroxicam is indicated for symptomatic relief of osteoarthritis rheumatoid arthritis or ankylosing spondylitis. When an NSAID is indicated piroxicam should be considered as a second line option. The desicion to prescribe piroxocam should be based on an assesment of the individual's patient overall risk.
2022-04-30
1 Brexin – PIL- HEB – 09.23 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only BREXIN TABLETS ACTIVE INGREDIENT Each tablet contains piroxicam (as beta-cyclodextrin) 20 mg Inactive ingredients and allergens in this medicine: see section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Additional information' . READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? For symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis. Your doctor will prescribe this medicine for you only after failure of treatment with another non- steroidal anti-inflammatory drug (NSAID). THERAPEUTIC GROUP: Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine (listed in section 6). • You previously had any allergic reaction and/or skin reactions, regardless of severity, such as erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis, after taking other medicines, including other NSAIDs, or medicines containing the same active substance. • You have had symptoms of angioedema, asthma, rash, nasal polyps or rhinitis due to the use of NSAIDs or acetylsalicylic acid (aspirin). • You are taking other NSAIDs or acetylsalicylic acid (aspirin) to relieve pain. • You currently have a stomach and/or duodenal ulcer, or you have digestion problems (dyspepsia) or stomach inflammation (gastritis). • You have had intestinal or stomach ulcer Прочитайте повний документ
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT: BREXIN TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each tablet contains: piroxicam β -cyclodextrin 191.2 mg, (equivalent to piroxicam 20 mg). Excipient with known effect: lactose monohydrate, sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Piroxicam is indicated for symptomatic relief of osteoarthritis rheumatoid arthritis or ankylosing spondylitis. When an NSAID is indicated piroxicam should be considered as a second line option. The decision to prescribe piroxicam should be based on an assessment of the individual's patient overall risk. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The prescription of piroxicam should be initiated by physicians with experience in the diagnosis and treatment of patients with inflammatory or degenerative rheumatic diseases. The maximum recommended daily dose is 20 mg. Undesirable effects may be minimised by using the minimum effective dose for the shortest duration of treatment necessary to control symptoms. The benefit and tolerability of treatment should be reviewed within 14 days. If it is considered necessary to continue treatment, this should be accompanied by frequent review. Given that piroxicam has shown to be associated with an increased risk of gastrointestinal complications, the possible need for combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients. PAEDIATRIC POPULATION Dosage and indications in children have not been established yet. ELDERLY In elderly patients, the posology must be carefully established by the physician who will have to consider a possible reduction of the dosage indicated above. METHOD OF ADMINISTRATION BREXIN should be administered once daily. 1 tablet per day. The tablet is for oral use. The score on the tablet is intended to Page 2 of 14 ease the spli Прочитайте повний документ