Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
MESALAZINE
TRADIS GAT LTD
A07EC02
TABLETS ENTERIC COATED
MESALAZINE 400 MG
PER OS
Required
TILLOTTS PHARMA AG, SWITZERLAND
MESALAZINE
MESALAZINE
Ulcerative colitis:-For the treatment of mild to moderate acute exacerbations. -For the maintenance of remission.Crohn's disease:-For the treatment of acute episodes.
2014-04-30
Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 This medicine is dispensed with a doctor’s prescription only Asacol 400 mg Enteric-coated tablets ACTIVE INGREDIENT: mesalazine (5-aminosalicylic acid) 400 mg/tablet Asacol 800 mg Enteric-coated tablets ACTIVE INGREDIENT: mesalazine (5-aminosalicylic acid) 800 mg/tablet Inactive ingredients and allergens: see section 2 ‘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? This medicine is intended for treating ulcerative colitis (acute exacerbation of colitis) and Crohn’s disease (acute episodes) and for preventing recurrent episodes of ulcerative colitis. THERAPEUTIC GROUP: aminosalicylates. 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 ‘Additional information’) • You are sensitive (allergic) to salicylates such as aspirin • You have severe kidney problems • You have severe liver problems • Children under two years old SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE STARTING TREATMENT WITH ASACOL, TELL THE DOCTOR IF: - you have ever had any problems with your liver or kidneys, particularly if you are elderly - you have any problems with the lungs, such as asthma - you suffered an allergy to sulfasalazine in the past - you have ever had allergic reactions of your heart such as inflammation of the heart muscle or heart sac. If you have had previous allergic reactions of your heart that may have been caused Lesen Sie das vollständige Dokument
1. NAME OF THE MEDICINAL PRODUCT ASACOL® 400 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each enteric coated tablet contains: Mesalazine (5-aminosalicylic acid) 400 mg Excipient with known effect: 76.4 mg lactose, see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Enteric coated Tablet. Reddish to brownish oblong tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Ulcerative colitis: _ For the treatment of mild to moderate acute exacerbations. For the maintenance of remission. _Crohn's disease: _ For the treatment of acute episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Ulcerative colitis: _ _Mild acute disease:_ 2.4 g (six tablets) once daily or in divided doses, with concomitant corticosteroid therapy to be taken when clinically indicated. _Moderate acute disease: _2.4 g to 4.8 g (six to twelve tablets) a day in divided doses, with concomitant corticosteroid therapy where clinically indicated. 2.4 g may be taken once daily or in divided doses. Above 2.4 g daily should be taken in divided doses. The maximum adult dose should not exceed twelve tablets a day and not exceed six tablets taken together at any one time. _Maintenance of remission_:_ _ 1.2 to 2.4 g per day once daily or in divided doses. _ _ Crohn’s disease: 2.4 g per day in divided doses. Elderly population Use in the elderly should be handled with caution and only for patients having a normal renal function. Pediatric population There is no specific dose recommendation for children. Method of administration The tablets should be taken before meals and must be swallowed whole preferably with some liquid. They must not be chewed, crushed or broken before swallowing 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Known hypersensitivity to salicylates - Severe liver impairment. - Severe renal impairment (GFR less than 30 mL/min/1.73 m2). - Children under the age of 2 years. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Bl Lesen Sie das vollständige Dokument