देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
MIZOLASTINE
PHARMA SHALOM
R06AX25
FILM COATED TABLETS
MIZOLASTINE 10 MG
PER OS
Required
SANOFI WINTHROP INDUSTRIE, FRANCE
MIZOLASTINE
MIZOLASTINE
Symptomatic treatment of seasonal allergic rhinoconjuctivitis (hay fever), perennial allergic rhino-conjuctivitis and urticaria.
2014-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only MIZOLLEN TABLETS 10 MG FILM-COATED TABLETS ACTIVE INGREDIENT: Mizolastine 10 mg. Inactive ingredients: See Section 6. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. Keep this leaflet as you may need to read it again. This leaflet contains concise information about the medicine. If you have further questions, refer to the 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. This medicine is intended for adults and children above the age of 12. 1. WHAT IS THE MEDICINE INTENDED FOR? Mizollen is intended for treatment of symptoms of: • Runny nose and conjunctivitis due to seasonal allergy (hay fever). • Runny nose and conjunctivitis due to a chronic allergy. • Urticaria (an itchy skin rash). THERAPEUTIC GROUP: ANTIHISTAMINE. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredient mizolastine or to any other ingredient of the medicine (see Section 6). • You are taking a macrolide antibiotic, such as erythromycin, clarithromycin, azithromycin. • You are taking an imidazole antifungal preparation, such as ketoconazole, fluconazole, itraconazole. • You suffer from liver problems. • You suffer from heart problems. • You have a history of irregular heartbeat or a slow heart rate. • Your ECG (electrical recording of cardiac activity) test results are abnormal. • You are being treated with medicines for heart rhythm disorders. • You suffer from electrolyte imbalance, particularly a low blood level of potassium (hypokalaemia). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: IN THE ELDERLY - Mizollen can make some people feel drowsy and cause a fast heartbeat or heart rhythm disturbances. These effects are more common in the elderly. TESTS AND FOLLO पूरा दस्तावेज़ पढ़ें
1 MIZOLLEN TABLETS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT MIZOLLEN TABLETS 10 MG, film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mizolastine 10mg per tablet. Excipients with known effect: Lactose monohydrate (125mg/tablet) Hydrogenated castor oil (25mg/tablet) Propylene glycol (0.45mg/tablet) For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Modified-release tablet. Oblong, white tablets with a scored line on one side and a mark "MZI 10" on the reverse side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mizolastine is a long acting H1- antihistamine indicated for the symptomatic treatment of seasonal allergic rhinoconjunctivitis (hay fever), perennial allergic rhinoconjunctivitis and urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, including the elderly, and children 12 years of age and over: The recommended daily dose is one 10mg tablet 4.3 CONTRAINDICATIONS − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. − Concomitant administration with macrolide antibiotics or systemic imidazole antifungals. − Significantly impaired hepatic function. − Clinically significant cardiac disease or a history of symptomatic arrhythmias. − Patients with known or suspected QT prolongation or with electrolyte imbalance, in particular hypokalaemia. − Clinically significant bradycardia. − Medicinal products known to prolong the QT interval, such as Class I and III anti-arrhythmics. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Mizolastine has a weak potential to prolong the QT interval in a few individuals. The degree of prolongation is modest and has not been associated with cardiac arrhythmias. The elderly may be particularly susceptible to the sedative effects of mizolastine and the potential effects of the medicinal product on cardiac repolarisation. 2 Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galacto पूरा दस्तावेज़ पढ़ें