البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
MESALAZINE
FERRING PHARMACEUTICALS LTD
A07EC
ENEMA
MESALAZINE 1 G / 100 ML
RECTAL
Required
FERRING GmbH ,GERMANY
AMINOSALICYLIC ACID AND SIMILAR AGENTS
Ulcerative colitis - Chron's disease
2022-11-30
Patient leaflet in accordance with the Pharmacists’ Regulations (Preparations) - 1986 This medicine is dispensed with a doctor’s prescription only Pentasa Enema 1 gram Composition: Each enema contains: 1 gram of mesalazine Inactive ingredients: 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 with 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 treatment of ulcerative colitis and Crohn’s disease. Therapeutic group: Anti-inflammatory medicine of the salicylates class. 2. Before using this medicine Do not use this medicine if you: are sensitive (allergic) to mesalazine or to any of the other ingredients of this medicine (see section 6). are sensitive (allergic) to other salicylates (such as aspirin). have severe liver or kidney problems. Special warnings about using this medicine BEFORE TREATMENT WITH THIS MEDICINE, TELL YOUR DOCTOR IF YOU: are allergic to sulphasalazine (risk of allergy to salicylates). currently or previously had liver or kidney disease. have a medical condition that can make you prone to bleeding. are taking medicines that may affect your kidney function, e.g. nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin. have a lung problem, particularly asthma. have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking mesalazine. Mesalazine may produce red-brown urine discoloration after a reaction with sodium hypochlorite (household bleach) in the toilet water. It occurs due to a chemical reaction and is harmless to your health. Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, toxic epidermal necrolysis have been repo اقرأ الوثيقة كاملة
Page 1 of 8 1. NAME OF THE MEDICINAL PRODUCT Pentasa® Suppositories 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Pentasa suppository contains: 1g mesalazine For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suppositories. Oblong, compressed white to light tan, speckled suppositories 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Ulcerative Proctitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 1 suppository 1-2 times daily. Method of administration For rectal use. A visit to the toilet is recommended before administration of suppositories. See separate instructions for use. 4.3 CONTRAINDICATIONS PENTASA is contraindicated in: - patients with known hypersensitivity to mesalazine, salicylates or any of the excipients , listed in section 6.1 - patients with severe liver and/or renal impairment 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution is recommended when treating patients allergic to sulphasalazine (risk of allergy to salicylates). Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. In case of acute symptoms of intolerance i.e. abdominal cramps, abdominal pain, fever and severe headache and/or the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other signs of hypersensitivity, the treatment should be discontinued immediately. Caution is recommended in patients with impaired liver function. Liver function parameters like ALT or AST should be assessed prior to and during treatment, at the discretion of the treating physician . The drug is not recommended for use in patients with impaired renal function and in patients with haemorrhagic diathesis. Baseline renal function measurement is required in all patients initiating treatment with mesalazine. Urinary status (dip sticks) should be determined prior to and during t اقرأ الوثيقة كاملة