Country: Israel
Language: English
Source: Ministry of Health
METOPROLOL TARTRATE
UNIPHARM LTD, ISRAEL
C07AB02
TABLETS
METOPROLOL TARTRATE 100 MG
PER OS
Required
UNIPHARM LTD, ISRAEL
METOPROLOL
Cardio-selective beta receptor blocker for the treatment of hypertension and angina pectoris, antiarrhithmic, prophlaxis of myocardial reinfarction and migraine.
2021-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only NEOBLOC FILM-COATED TABLETS COMPOSITION: Each film-coated NEOBLOC tablet contains: Metoprolol Tartrate 100 mg For the list of inactive and allergenic ingredients in the preparation, please see section 6 “Further information”. Also see in section 2 “Important information about some of the ingredients of the medicine”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. 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 the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. The medicine is not intended for children. 1. WHAT IS THE MEDICINE INTENDED FOR? THERAPEUTIC ACTIVITY: Selective beta receptor blocker for the treatment of hypertension, angina pectoris and irregular heart rhythm, prevention of migraine and prevention of myocardial reinfarction. THERAPEUTIC GROUP: selective beta receptor blocker. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive )allergic( to metoprolol, to other beta blockers, or to any of the additional ingredients contained in the medicine (see section 6 “Further information”). • You have heart conduction problems or heart rhythm disturbances. • You have severe or uncontrolled heart failure. • You have cardiogenic shock. • You have blocked blood vessels, including blood circulation problems (a phenomenon that can cause tingling or pallor/bluishness in the hands or feet). • You have a slow heart rate or have suffered a heart attack and as a result now have a very slow heart rate. • You suffer from a sensation of pressure and pain at rest (Prinzmetal’s angina). • You have an untreated pheochromocytoma (high blood pressure due to a tumor near the kidney). • You hav Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NEOBLOC 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100mg metoprolol tartrate . For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Cardio-selective beta receptor blocker for the treatment of hypertension and angina pectoris, antiarrhithmic, prophlaxis of myocardial reinfarction and migraine. 4.2 Posology and method of administration Posology _Hypertension: The usual starting dosage is generally 100 mg metoprolol tartrate per _ _day. The dosage may be increased to 200 mg per day, as a single dose or in divided _ _doses. _ _Angina Pectoris: 50-100 mg metoprolol tartrate, two or three times a day. _ _ _ _Heart rhythm disturbances: 50 mg metoprolol tartrate, two or three times a day. The _ _dosage may be increased up to 300mg per day, in divided doses. _ _ _ _Heart attack: 50 mg metoprolol tartrate every 6 hours. The recommended _ _maintenance dose is 200 mg per day, in divided doses. The medicine must be taken _ _for at least 3 months. _ _ _ _Prevention of Migraine: 100-200mg metoprolol tartrate daily, given in divided doses _ _(morning and evening)._ _Paediatric population: Metoprolol tartrate is not intended for use in children. _ _Renal and hepatic impairment:_ _Dose adjustment_ _may be necessary_ _._ Method of administration Neobloc tablet should be swallowed with a little water, the tablet can be halved for immediate use. There is no information about crushing or chewing the tablet. 4.3 Contraindications • Hypersensitivity to the active substance, other β-blockers or to any of the excipients listed in section 6.1 • Asthma or history of bronchospasm • Atrioventricular block of second or third degree • Uncontrolled heart failure • Clinically relevant sinus bradycardia (< 45-50 bpm) • Pri z etal’s angina • Sick-sinus syndrome (unless a pacemaker is in situ) • Severe peripheral arterial dis Read the complete document