Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
nifedipine
Denk Pharma GmbH & Co. KG
C08CA05
nifedipine
10mg
tablets prolonged-release
(100/10x10/) in blister
Prescription
Registered
2019-07-09
_Nifedi-Denk 10 Retard_ Prolonged-release tablet – oral use Calcium antagonist Active substance: nifedipine Package leaflet: Information for the patient 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 or pharma - cist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. WHAT NIFEDI-DENK 10 RETARD IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NIFEDI-DENK 10 RETARD 3. HOW TO TAKE NIFEDI-DENK 10 RETARD 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE NIFEDI-DENK 10 RETARD 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. What Nifedi-Denk 10 Retard is and what it is_ _used for Nifedi-Denk 10 Retard contains the active substance nifedipine. Nifedi-Denk 10 Retard_ _ is used in the treatment of cardiac complaints, which are associated with insufficient oxygen supply to the heart muscle (angina pectoris), and in the treatment of hypertension. Nifedi-Denk 10 Retard_ _is used for: • complaints (e.g. pain or tightness in the chest) in condi - tions with an inadequate supply of oxygen to the heart muscle during exertion: chronic stable angina pectoris (effort angina) • vasospastic angina pectoris (Prinzmetal’s angina, variant angina) • non-organ-related high blood pressure (essential hyper - tension). 2. What you need to know before you take Nifedi-Denk 10 Retard Do not take Nifedi-Denk 10 Retard • if you are allergic to nifedipine or any of the other ingredi- ents of this medicine (listed in section 6) • if you have had a cardiogenic shock • if you have heart valve stenosis (aortic stenosis) • if you suffer from complaints at rest (e.g. p Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nifedi-Denk 10 Retard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: nifedipine Each prolonged-release tablet contains 10 mg nifedipine. Excipient with known effect: Each prolonged-release tablet contains 39 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet Round, slightly pink, biconvex film-coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chronic stable angina pectoris (effort angina) Vasospastic angina pectoris (Prinzmetal’s angina, variant angina) Essential hypertension 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment should as far as possible be administered individually on the basis of the severity of the condition and the patient's response. The target dose should be reached gradually, depending on the medical condition concerned. Patients with severe cerebrovascular disorders should be treated with low doses. Nifedipine 10 mg prolonged-release is particularly suitable for patients with high blood pressure, who suffer from cerebrovascular disease and for those, where an excessive reaction to nifedipine can be expected because of low body weight or because of concomitant treatment with other blood pressure reducing medicines. Patients whose side effects to the nifedipine treatment would seem to make a more subtle adjustment of the dosage level desirable should also have the dose of Nifedipine 10 mg prolonged-release adapted individually. If not prescribed otherwise, the recommended dose for adults is: _Chronic stable angina pectoris_ 1 prolonged-release tablet (nifedipine 10 mg) twice daily. If necessary the daily dose may be increased gradually to 2 x 20 mg up to 2 x 40 mg of nifedipine. 2 _Vasospastic angina pectoris (Prinzmetal’s angina, variant angina)_ 1 prolonged-release tablet (nifedipine 10 mg) twice daily. If necessary the dose may be increased gradually to 2 x 20 mg up to 2 x 40 mg of nifedipine Read the complete document