Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
amlodipine (amlodipine besilate)
Acino Pharma AG
C08CA01
amlodipine (amlodipine besilate)
10mg
tablets
(30/3x10/) and (100/10x10/) in blister
Prescription
Registered
2018-11-07
Amlocim 5 mg and 10 mg Tablets Version: 01 AM Originator: Pfizer (Norvasc) November 2014 1 / 3 INFORMATION FOR THE PATIENT Read this package leaflet carefully before you take or use this medicine. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. Keep this leaflet. You may need to read it again. AMLOCIM 5 MG AMLOCIM 10 MG WHAT AMLOCIM IS AND WHAT IT IS USED FOR On medical prescription. Amlocim can be used alone or in combination with other blood pressure-lowering medicines for the treatment of excessively high blood pressure. The blood pressure falls slowly after a tablet is taken and therefore there is no sudden drop in blood pressure. One tablet daily is sufficient to lower the blood pressure for 24 hours. Amlocim is used alone or together with other medicines to treat oxygen deficiency of the heart muscle, known as angina pectoris. Taking Amlocim once a day increases the length of time for which your heart can work hard and reduces the number of angina pectoris attacks. WHEN NOT TO USE AMLOCIM Do not use Amlocim if you are hypersensitive to the active substance in the product, to any of the ingredients or to other dihydropyridines. TAKE SPECIAL CARE WITH AMLOCIM Because of its possible side effects, this medicine may affect your reactions and your ability to drive or to use tools or machines. Amlocim should not be taken together with grapefruit or grapefruit juice, as this can cause an increased fall in blood pressure. Tell your doctor or pharmacist if you are suffering from other diseases, particularly a liver disease, have any allergies or are taking or externally using any other medicines (including those bought over the counter). 2 of 3 TAKING AMLOCIM DURING PREGNANCY AND BREAST-FEEDING In general, Amlocim should not be taken during pregnancy. Tell your doctor if you are pregnant or want to become pregnant. Only your doctor can decide whether in very specific circumstances you may nevertheless take Amlocim. Do not bre Read the complete document
Amlocim 5mg and 10mg, Tablets Version: 01 AM Originator: Pfizer (Norvasc) November 2014 1 / 8 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amlocim 5 mg Amlocim 10 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Active substance:_ amlodipine (as amlodipine besilate). _Excipients: _povidone K30, microcrystalline cellulose (E 460), anhydrous calcium hydrogen phosphate (E 341), crospovidone, magnesium stearate (E 470b). 3. PHARMACEUTICAL FORM 1 Amlocim 5 mg tablet contains: 5 mg amlodipine (as 7 mg amlodipine besilate). 1 Amlocim 10 mg tablet contains: 10 mg amlodipine (as 14 mg amlodipine besilate). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ _1. Arterial hypertension_ Amlocim is indicated for the basic treatment of hypertension. Combination therapy may be of advantage in patients who have insufficiently responded to monotherapy. Amlocim has been used together with thiazide diuretics, with alpha-blockers, with beta-blockers and with ACE inhibitors. _2. Prophylaxis of attacks in stable angina pectoris _ caused by fixed vasoconstriction. _3. Prinzmetal’s or vasospastic angina_ which is caused by coronary vasospasm. Amlocim may be used in those cases where the clinical picture suggests a vasospasm component but this has not been confirmed. Amlocim may be administered as monotherapy or in combination with other anti-anginal medicinal products in patients whose angina pectoris does not sufficiently respond to nitrates and/or adequate doses of beta-blockers. N.B.: Amlocim is not suitable for treating an acute attack of angina pectoris (attack suppression) because of its slow onset of action. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For both indications – hypertension and angina pectoris – treatment is usually started with a dose of 5 mg Amlocim once daily. Depending on the individual response of the patient, the dose may be increased to 10 mg Amlocim once daily. 2 / 8 An adjustment in the dose of Amlocim is not necessary when co-administered with thiazide diuretics, be Read the complete document