Land: Nederländerna
Språk: nederländska
Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
INDAPAMIDE 0-WATER 0,625 mg/stuk ; PERINDOPRIL-TERT-BUTYLAMINE 2 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 1,669 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
C09BA04
INDAPAMIDE 0-WATER 0,625 mg/stuk ; PERINDOPRIL-TERT-BUTYLAMINE 2 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 1,669 mg/stuk
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE, HYDROFOOB, CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE, HYDROFOOB,
Oraal gebruik
Perindopril And Diuretics
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE, HYDROFOOB;
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PERINDOPRIL /INDAPAMIDE STADA < 2 MG/0.625 MG TABLETS PERINDOPRIL /INDAPAMIDE STADA 4 MG/1.25 MG TABLETS Perindopril tert-butylamine / Indapamide 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 of the 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 Perindopril/Indapamide is and what it is used for 2. What you need to know before you take Perindopril/Indapamide 3. How to take Perindopril/Indapamide 4. Possible side effects 5. How to store Perindopril/Indapamide 6. Contents of the pack and other information 1. WHAT PERINDOPRIL/INDAPAMIDE IS AND WHAT IT IS USED FOR WHAT IS PERINDOPRIL/INDAPAMIDE ? Perindopril/Indapamide is a combination of two active ingredients, perindopril and indapamide. It is an anti-hypertensive and is used in the treatment of high blood pressure (hypertension). WHAT IS PERINDOPRIL/INDAPAMIDE USED FOR? Perindopril belongs to a class of medicines called ACE inhibitors. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. Each of the active ingredients reduces blood pressure and they work together to control your blood pressure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL/INDAPAMIDE DO NOT TAKE PERINDOPRIL/INDAPAMIDE • if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any othe Läs hela dokumentet
1 Each tablet contains 4 mg perindopril tert-butylamine salt, equivalent to 3.338 mg perindopril and 1.25 mg indapamide Excipient with known effects 58.47 mg of lactose monohydrate Each tablet contains 2 mg perindopril tert-butylamine salt, equivalent to 1.669 mg perindopril and 0.625 mg indapamide. Excipient with known effects 58.47 mg of lactose monohydrate Treatment of essential hypertension, Perindopril/Indapamide 4 mg/1.25 mg is indicated in patients whose blood pressure is not adequately controlled on perindopril alone. Essential hypertension. Posology The usual dose is one Perindopril/Indapamide 2 mg/0.625 mg tablet per day as a single dose, preferably to be taken in the morning and before a meal. If blood pressure is not controlled after one month of treatment, the dose can be doubled_. _ _SPECIAL POPULATIONS _ Elderly (see section 4.4) Treatment should be started at the normal dose of one Perindopril/Indapamide 2 mg/0.625 mg tablet per day. Renal impairment (see section 4.4) SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Perindopril tert-butylamine/Indapamide STADA 2/0,625 mg, tabletten Perindopril tert-butylamine/Indapamide STADA 4/1,25 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, rod shaped tablets having ‘PI’ debossed on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 4.2 POSOLOGY AND METHOD OF ADMINISTRATION White, rod shaped tablets having ‘P’ and ‘I’ engraved on either side of score line on one side and score line on the other side. The tablet can be divided into equal doses. 2 In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated. In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), the maximum dose should be one tablet of Perindopril/Indapamide 2 mg/0.625 mg per day. In patients with creatinine clearance greater than or equal to 60 ml/min, no dose modification i Läs hela dokumentet