Country: Israel
Language: English
Source: Ministry of Health
AMLODIPINE AS BESYLATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
C08CA01
TABLETS
AMLODIPINE AS BESYLATE 5 MG
PER OS
Required
PFIZER INC, USA
AMLODIPINE
AMLODIPINE
Mild to moderate hypertension. Vasospastic angina ( Prinzmetal's or variant angina). Chronic stable angina.
2023-11-30
Norvasc PIL CC 180123 2 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only NORVASC ® 5 MG NORVASC ® 10 MG TABLETS EACH TABLET CONTAINS: AMLODIPINE (AS BESYLATE) 5 MG, 10 MG Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Further information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. Consult your doctor or pharmacist if you have any further questions. 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 to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? • treating hypertension • treating chronic stable angina pectoris • treating vasospastic angina pectoris (called Prinzmetal angina) THERAPEUTIC GROUP: calcium channel blockers (dihydropyridines). 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 (see section 6) or other calcium channel blockers. This sensitivity may be experienced as itching, reddening of the skin, or difficulty in breathing. • You have severe low blood pressure (hypotension). • You have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body). • You have heart failure after a heart attack. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE STARTING TREATMENT WITH NORVASC TELL YOUR DOCTOR IF YOU HAVE OR HAVE EVER HAD ANY OF THE FOLLOWING CONDITIONS: • a recent heart attack • heart failure • severe increase in blood pressure (hypertensive crisis) • liver disease • you are elderly and need a dose increase CHILDREN AND ADOLESCENTS There is no information regarding the safety and effectiven Read the complete document
Norvasc LPD CC 270722 Pfleet 2022-0078743 1 NORVASC ® 5 MG TABLETS NORVASC ® 10 MG TABLETS 1. NAME OF THE MEDICINAL PRODUCT Norvasc ® 5mg Tablets Norvasc ® 10mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains amlodipine (as besylate) equivalent to 5 or 10mg amlodipine. Excipients: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Norvasc 5mg tablets: White to off-white, emerald-shaped tablets engraved "AML-5" and breaker score on one side and Pfizer logo on the other side or blank on the other side. Norvasc 10mg tablets: White to off-white, emerald-shaped tablets engraved "AML-10" on one side and Pfizer logo on the other side or blank on the other side. The 5 mg tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Treatment of mild to moderate Hypertension. It may be used alone or in combination with other antihypertensive agents. 2. Treatment of chronic stable Angina. Norvasc may be used alone or in combination with other antianginal agents. 3. Treatment of confirmed or suspected vasospastic Angina (Prinzmetal’s or variant Angina). Norvasc may be used as monotherapy or in combination with other antianginal drugs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults For both hypertension and angina, the usual initial dose is 5 mg once daily which may be increased to a maximum dose of 10 mg depending on the individual patient's response. In hypertensive patients, Norvasc has been used as monotherapy or in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. For angina, Norvasc may be used as monotherapy or in combination with other antianginal medicinal products. Norvasc LPD CC 270722 Pfleet 2022-0078743 2 No dose adjustment of Norvasc is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors. Dosage should be adjusted according to each patient’s need. In general, titration should pro Read the complete document