البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
MESALAZINE
TRADIS GAT LTD
A07EC02
MODIFIED RELEASE TABLETS
MESALAZINE 1600 MG
PER OS
Required
TILLOTTS PHARMA GMBH, GEMANY
MESALAZINE
ASACOL 1600 is indicated for:Ulcerative colitis-For the treatment of mild to moderate acute disease-For the maintenance of remission
2023-07-27
1 1986 - REGULATIONS (PREPARATIONS) PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' This medicine is dispensed with a doctor’s prescription only ASACOL 1600 Modified release tablets ACTIVE INGREDIENT : Each tablet contains 1600 mg mesalazine Inactive ingredients and allergens: see 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? Asacol is indicated: - For treatment of mild to moderate acute ulcerative colitis. - For maintenance of disease remission. THERAPEUTIC GROUP: Anti-inflammatory medicine against bowel inflammation Asacol is an anti-inflammatory medicine used for the treatment of ulcerative colitis. Ulcerative colitis is a disease in which the wall of the colon or the back passage (rectum) become inflamed (red and swollen). This may lead to frequent and bloody stools, often accompanied by abdominal cramps. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to mesalazine or to any of the other ingredients in this medicine (see section 6). • You are sensitive (allergic) to salicylates (e.g. acetylsalicylic acid). • You have severe liver problems. • You have severe kidney problems. SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE STARTING TREATMENT WITH ASACOL, TELL YOUR DOCTOR IF YOU HAVE ANY ILLNESSES, PARTICULARLY IF: - You have any lung problems, e.g. asthma. - You have impaired function of kidneys, liver or lungs, especially if you are elderly. - You suffered from allergy to sulphasalazine in the past. 2 - You had an allergic reaction of the heart, such as inflammation of the heart muscle or heart sac. If you have had previous suspected mesalazine-induced al اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Asacol 1600 mg modified-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains: 1600 mg mesalazine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release tablet. Film-coated, red/brown oblong tablets dimension of 23 x 11 x 9 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Ulcerative colitis. _ For the treatment of mild to moderate acute disease. For the maintenance of remission. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults, including the elderly (>65 years) The dose should be adjusted according to the severity of the disease and tolerance. _Acute disease_: In the event of exacerbation, the dose can be increased to 4800 mg daily, once daily or in 2-3 divided doses. Once clinical remission is achieved, the dose should gradually be decreased to maintenance dose. Continued therapy should be carefully considered in subjects not responding by week 8. _Maintenance treatment_: 1600 mg once daily. Other oral mesalazine formulations are available if an alternative dose for maintenance treatment is considered more appropriate. Elderly population No studies have been carried out in older people. Paediatric population The safety and efficacy of Asacol in children and adolescents aged younger than 18 years of age has not been established. Method of administration: oral. The tablets must be swallowed whole with a glass of water. They must not be chewed, crushed or broken before swallowing. The tablets can be taken with or without food. If one or more doses have been missed, the next dose is to be taken as usual. 4.3 CONTRAINDICATIONS • Hypersensitivity to salicylates (including mesalazine) or any of the excipients listed in section 6.1. • Severe liver impairment. • Severe renal impairment (GFR < 30 ml/min/1.73 m 2 ) 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Blood tests (differential blood count; liver function parameters such as ALT or AST; serum creatinine اقرأ الوثيقة كاملة