Land: Nederländerna
Språk: nederländska
Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ENALAPRILMALEAAT 20 mg/stuk SAMENSTELLING overeenkomend met ; ENALAPRIL 15,3 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk
Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)
C09BA02
ENALAPRILMALEAAT 20 mg/stuk SAMENSTELLING overeenkomend met ; ENALAPRIL 15,3 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk
Tablet
CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; TALK (E 553 B),
Oraal gebruik
Enalapril And Diuretics
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMWATERSTOFCARBONAAT (E 500 (II)); TALK (E 553 B);
1900-01-01
Hexal AG Page 1/10 Enalaprilmaleaat/Hydrochloorthiazide 20/12,5, tabletten 20/12,5 mg RVG 34510 1313-V13 1.3.1.3 Package Leaflet December 2021 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ENALAPRILMALEAAT/HYDROCHLOORTHIAZIDE 20/12,5, TABLETTEN 20/12,5 MG enalapril maleate/hydrochlorothiazide 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [nationally completed name] is and what it is used for 2. What you need to know before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [nationally completed name] tablets contain a combination of enalapril and hydrochlorothiazide and are used as a treatment for high blood pressure when treatment with enalapril as a single agent on its own has proven insufficient. Your doctor may also prescribe [nationally completed name] tablets instead of separate tablets of the same doses of enalapril and hydrochlorothiazide. This fixed dose combination is not suitable for initial therapy. You must talk to a doctor if you do not feel better or if you feel worse. ENALAPRIL belongs to a group of medicines called angiotensin converting enzyme inhibitors (ACE inhibitors) and lowers blood pressure by widening the blood vessels. HYDROCHLOROTHIAZIDE belongs to a group of medicines called diuretics (“water tablets”) and lowers blood pressure by increasing urine output. 2. W Läs hela dokumentet
Hexal AG Page 1/25 Enalaprilmaleaat/Hydrochloorthiazide 20/12,5, tabletten 20/12,5 mg RVG 34510 1311-V12 1.3.1.1 Summary of Product Characteristics December 2021 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Enalaprilmaleaat/Hydrochloorthiazide 20/12,5, tabletten 20/12,5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg enalapril maleate and 12.5 mg hydrochlorothiazide. Excipient with known effect Each tablet contains 85.1 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, oval, biconvex snap tap tablet, one side scored, other side marked “EH” The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with enalapril alone. This fixed dose may also replace the combination of 20 mg enalapril maleate and 12.5 mg hydrochlorothiazide in patients who have been stabilised on the individual active substances given in the same proportions as separate medicinal products. This fixed dose combination is not suitable for initial therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one tablet daily. [nationally completed name] can be administered in a single dose/day with or without food. Individual dose titration with both active substances can be recommended. When clinically appropriate, direct change from ACE inhibitor monotherapy to the fixed combination may be considered. _ _ Prior diuretic therapy Treatment with diuretics should be discontinued 2 to 3 day before the start of the treatment with [Nationally completed name]. Hexal AG Page 2/25 Enalaprilmaleaat/Hydrochloorthiazide 20/12,5, tabletten 20/12,5 mg RVG 34510 1311-V12 1.3.1.1 Summary of Product Characteristics December 2021 2 _ _ Renal impairment - Creatinine clearance greater than 30 Läs hela dokumentet