Pays: Arménie
Langue: anglais
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
enalapril (enalapril maleate)
Denk Pharma GmbH & Co. KG
enalapril (enalapril maleate)
20mg
tablets
Prescription
_Ena-Denk 20_ Tablet – oral use ACE inhibitor Active substance: Enalapril PACKAGE LEAFLET: INFORMATION FOR THE PATIENT. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CON- TAINS 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT ENA-DENK 20 IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENA-DENK 20 3. HOW TO TAKE ENA-DENK 20 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ENA-DENK 20 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT ENA-DENK 20 IS AND WHAT IT IS USED FOR Ena-Denk 20 is an ACE inhibitor, i.e. an antihyper- tensive drug that relieves the heart. ENA-DENK 20_ _IS USED • in the treatment of high blood pressure (hypertension) • in the treatment of cardiac insufficiency – sup- plementary to diuretics and, in the event of severe heart insufficiency, to digitalis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENA-DENK 20 DO NOT TAKE ENA-DENK 20_ _ • if you are allergic to enalapril or any of the other ingredients of this medicine (listed in section 6) • if you have ever had an allergic reaction to a type of medicine similar to this medicine called an ACE inhibitor • if you have ever had swelling of your face, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing (angioedema) when the reason why was not known or it was inherited • if you have diabetes or impaired kidney function and you are treated with a blood pressure low- ering medicine containing aliskiren • if you are more than 3 months pregnant. (It is also better to avoid Ena-Denk 20 in early pregnancy – see pregnancy sect Lire le document complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ena-Denk 20 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Enalapril Each tablet contains 20 mg enalapril maleate. Excipient with known effect: Each tablet contains 117.8 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets Round, flat, bevelled-edged, one-sided scored tablet, pale orange with dark orange spots. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Hypertension - Cardiac insufficiency - supplementary to diuretics and, in the event of severe heart insufficiency, to digitalis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The absorption of enalapril is not affected by food. The dosage should be individualised according to patient profile (see section 4.4) and blood pressure response. _Hypertension _ The initial dose is 5 mg to maximally 20 mg of enalapril maleate, depending on the degree of hypertension and the condition of the patient. Ena-Denk 20 _ _ is administered once daily. In mild hypertension, the recommended starting dose is 5-10 mg. Patients with a strongly activated renin- angiotensin-aldosterone system (e.g. renovascular hypertension, salt and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive blood pressure fall following the initial dose. A starting dose of 5 mg or lower is recommended in such patients and the initiation of treatment should take place under medical supervision. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating treatment with enalapril. A starting dose of 5 mg or lower is recommended in such patients. If possible, diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with Ena-Denk 20. Renal function and serum potassium should be monitored. The usual maintenance dose is 20 mg of enalapril maleate daily. The maximum maintenance dose is 40 mg of enalapril maleate daily. 2 _Heart failure / asym Lire le document complet