Pajjiż: Olanda
Lingwa: Olandiż
Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMLODIPINEBESILAAT 7 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk
Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 90449 NÜRNBERG (DUITSLAND)
C08CA01
AMLODIPINEBESILAAT 7 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk
Tablet
CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON (E 1201), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON (E 1201),
Oraal gebruik
Amlodipine
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); MAGNESIUMSTEARAAT (E 470b); POVIDON (E 1201);
1900-01-01
Amlodipine Heumann, 5 mg, tablets – NL/H/0776/001 NL pl Page 1 NL/p/004/22/2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMLODIPINE HEUMANN 5 MG, TABLETTEN Amlodipine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again • If you have any further questions, ask your doctor or pharmacist • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Amlodipine Heumann is and what it is used for 2. What you need to know before you take Amlodipine Heumann 3. How to take Amlodipine Heumann 4. Possible side effects 5. How to store Amlodipine Heumann 6. Contents of the pack and other information 1. WHAT AMLODIPINE HEUMANN IS AND WHAT IT IS USED FOR Amlodipine Heumann contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Amlodipine Heumann is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina. In patients with high blood pressure this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipine Heumann works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. This medicine does not provide immediate relief of chest pain from angina. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODIPINE HEUMANN DO NOT TAKE AMLODIPINE HEUMANN • If you are allergic to amlodipine, or any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing. • Aqra d-dokument sħiħ
Amlodipine Heumann, 5 mg, tablets – NL/H/0776/001 NL SmPC NL/s/001/22/2 Page 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amlodipine Heumann 5 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains amlodipine besilate equivalent to 5 mg amlodipine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White round tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Chronic stable angina pectoris Vasospastic (Prinzmetal’s) angina 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults For both hypertension and angina the usual initial dose is 5 mg amlodipine once daily which may be increased to a maximum dose of 10 mg depending on the individual patient's response. In hypertensive patients, amlodipine has been used in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. For angina, amlodipine may be used as monotherapy or in combination with other antianginal medicinal products in patients with angina that is refractory to nitrates and/or to adequate doses of beta blockers. No dose adjustment of Amlodipine Heumann is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors. Special populations _Elderly patients _ Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care (see sections 4.4 and 5.2). Amlodipine Heumann, 5 mg, tablets – NL/H/0776/001 NL SmPC NL/s/001/22/2 Page 2 _Patients with hepatic impairment _ Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range (see sections 4.4 and 5.2). The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initia Aqra d-dokument sħiħ