البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
SULFASALAZINE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
A07EC01
TABLETS
SULFASALAZINE 500 MG
PER OS
Required
RECIPHARM UPPSALA AB, SWEDEN
SULFASALAZINE
SULFASALAZINE
Treatment of ulcerative colitis and Crohn's disease.
2013-12-31
Salazopyrin, Salazopyrin EN WC 15 Feb 2022 2021-0073859 2 NS IO ARMACISTS' REGULAT E PH WITH TH N ACCORDANCE I KAGE INSERT AC ENT P PATI 986 1 - S) ON (PREPARATI This medicine is dispensed with a doctor’s prescription only SALAZOPYRIN ® Tablets SALAZOPYRIN ® EN Enteric-coated tablets Each tablet contains sulfasalazine 500 mg Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 “Further information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE 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 for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? • Treatment of ulcerative colitis and Crohn’s disease. • Salazopyrin EN enteric-coated tablets are also used for treatment of rheumatoid arthritis and inflammatory skin ulcers (pyoderma gangrenosum). THERAPEUTIC GROUP: Anti-inflammatory drug of aminosalicylic acid type. 2. BEFORE USING THIS MEDICINE DO NOT USE THE MEDICINE: • If you are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine (see section 6), to salicylates (such as aspirin) or to sulfonamides (a certain type of antibiotic). • If you have a disease known as porphyria (a rare blood system disorder). • IN CHILDREN UNDER THE AGE OF TWO YEARS. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE BEFORE TREATMENT WITH SALAZOPYRIN, TELL YOUR DOCTOR: • If you have a deficiency of the G6PD enzyme which is responsible for normal function of red blood cells. • If you have or have ever had asthma. • If you have or have ever had impaired function of the liver or the kidney. • If you have or have ever had impaired function of the blood system (such as coagulation). • If you have or have ever had an acute allergy. • In اقرأ الوثيقة كاملة
Salazopyrin, Salazopyrin EN LPD CC 19 Oct 2023 2021-0073860, 2013 -0002669, 2023-0087979 1 Salazopyrin ® Salazopyrin ® EN SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Salazopyrin ® Salazopyrin ® EN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Salazopyrin ® uncoated tablet for oral administration contains 500 mg of sulfasalazine. Each Salazopyrin ® EN coated gastro-resistant tablet for oral administration contains 500 mg of sulfasalazine. Excipient with known effect: Salazopyrin ® EN contains 5 mg propylene glycol in each tablet. For the full list of excipients, see Section 6.1 3. PHARMACEUTICAL FORM Tablets: Yellow-orange round embossed “KPh” on one side and “101” and a score line on the other. Enteric coated tablets: Yellow-orange film-coated, elliptical, convex, embossed “Kph” on one side and “102” on the other. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications Salazopyrin ® : Treatment of ulcerative colitis and Crohn’s disease. Salazopyrin ® EN : For active rheumatoid arthritis which is not controlled by antiinflammatory drugs. Ulcerative colitis, Crohn's disease and Pyoderma gangrenosum. 4.2. Posology and Method of Administration The dosage of Salazopyrin ® should be individually adjusted according to the patient's tolerance and response to treatment. EN-tabs must be swallowed intact, preferably after meals, and should not be crushed or broken. Elderly Patients No special precautions are necessary. A) Ulcerative colitis Adults Salazopyrin, Salazopyrin EN LPD CC 19 Oct 2023 2021-0073860, 2013 -0002669, 2023-0087979 2 _Severe Attacks _ Salazopyrin ® 2-4 tablets four times a day may be given in conjunction with steroids as part of an intensive management regime. Rapid passage of the tablets may reduce effect of the drug. Night-time interval between doses should not exceed 8 hours. _Moderate Attack _ 2-4 tablets four times a day may be given in conjunction with steroids. For the EN tablets: Mild Attack: 2 tablets four times a day with or without ster اقرأ الوثيقة كاملة