Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Olsalazine sodium 250mg
Clinect NZ Pty Limited
Olsalazine sodium 250 mg
250 mg
Capsule
Active: Olsalazine sodium 250mg Excipient: Gelatin Magnesium stearate Opacode black S-1-17822 Opacode black S-1-17823
Bottle, plastic, 100 capsules
Prescription
Prescription
Dottikon Exclusive Synthesis AG
Maintenance of patients with ulcerative colitis in remission. Treatment of acute ulcerative colitis of mild to moderate severity with or without the concomitant use of steroids.
Package - Contents - Shelf Life: Bottle, plastic, - 100 capsules - 60 months from date of manufacture stored at or below 30°C
1987-09-24
DIPENTUM ® (pronounced "dye-PENT-um") _Contains the active ingredient olsalazine sodium (pronounced "ole-SAL-a-zeen")_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Dipentum. 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 Dipentum against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DIPENTUM IS USED FOR This medicine is used to treat a disease of the bowel called ulcerative colitis. It belongs to a group of medicines called amino salicylates. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. BEFORE YOU TAKE DIPENTUM _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE DIPENTUM IF YOU HAVE AN ALLERGY TO: • olsalazine, the active ingredient in Dipentum • medicines containing salicylates e.g. aspirin • any of the ingredients listed at the end of this leaflet. SYMPTOMS OF AN ALLERGIC REACTION MAY INCLUDE: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE DIPENTUM IF: • you are taking any medicine for preventing blood clotting • you have any bleeding disorder • you have any stomach diseases such as ulcers in the stomach or duodenum. DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGN OF TAMPERING. If it has expired or is damaged, return it to your pharmacist for disposal. IF YOU ARE NOT SURE WHETHER YOU SHOULD START TAKING THIS MEDICINE, TALK TO YOUR DOCTOR. _BEFORE YOU START Olvassa el a teljes dokumentumot
1 NEW ZEALAND DATA SHEET 1. DIPENTUM ® 250 MG CAPSULES AND 500 MG TABLETS DIPENTUM 250 mg capsules and 500 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DIPENTUM capsules contain 250 mg olsalazine sodium. DIPENTUM tablets contain 500 mg olsalazine sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 250 mg capsules: Beige, opaque, hard, gelatin capsules size 1, filled with yellow powder and without print or radially printed "DIPENTUM 250mg". 500 mg tablets: Yellow, capsule-shaped tablets, with the letters 'KPh' on one side and the product code '110' and a score line on the other. The tablets are 16mm long and 7mm wide. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Maintenance of patients with ulcerative colitis in remission. Treatment of acute ulcerative colitis of mild to moderate severity with or without the concomitant use of steroids. 4.2 DOSAGE AND METHOD OF ADMINISTRATION _DOSE _ _Adults: Long Term Maintenance of Remission _ Adults including the elderly: 1 g/day (2 capsules or 1 tablet, twice daily), to be continued indefinitely. _Adults: Acute Ulcerative Colitis _ Adults including the elderly: Normal dose 2 g/day, in divided doses. To ensure maximum tolerability, commence treatment with 0.5g the first day and increase the dose each day by 0.5 g to 2 g daily in divided doses. As bioequivalence between the 250 mg capsule and 500 mg tablet has not been established, care should be taken when changing from one dosage form to the other to ensure an equivalent clinical effect. A dose of 250 mg should be given as the 250 mg capsule; the 500 mg tablet should not be divided. If no response is achieved with 2 g and the drug is well tolerated the total dose may be increased to 3 g/day. A single dose should not exceed 1 g. Should a patient experience a drug related watery diarrhoea during escalation of the dose, reduce the dose to a previously tolerated level for three days and then increase again. Further subdivision of the dose may be beneficial. Concomitant oral or rectal Olvassa el a teljes dokumentumot