Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Perindopril arginine; Indapamide
TAD Pharma GmbH
C09BA04
Perindopril arginine; Indapamide
Tablet
perindopril and diuretics
Marketed
2022-09-09
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL ARGININE/INDAPAMIDE TAD 5 MG/1.25 MG TABLETS PERINDOPRIL ARGININE/INDAPAMIDE TAD 10 MG/2.5 MG TABLETS perindopril arginine/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 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 arginine/Indapamide TAD is and what it is used for 2. What you need to know before you take Perindopril arginine/Indapamide TAD 3. How to take Perindopril arginine/Indapamide TAD 4. Possible side effects 5. How to store Perindopril arginine/Indapamide TAD 6. Contents of the pack and other information 1. WHAT PERINDOPRIL ARGININE/INDAPAMIDE TAD IS AND WHAT IT IS USED FOR WHAT ARE PERINDOPRIL ARGININE/INDAPAMIDE TAD TABLETS? Perindopril arginine/Indapamide TAD is a combination of two active ingredients, perindopril and indapamide. Perindopril arginine/Indapamide TAD is an anti-hypertensive and is used in the treatment of high blood pressure (hypertension) in adults. WHAT PERINDOPRIL ARGININE/INDAPAMIDE TAD TABLETS ARE USED FOR? Perindopril belongs to a class of medicines called angiotensin-converting enzyme inhibitors (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 pre Lue koko asiakirja
Health Products Regulatory Authority 28 September 2022 CRN00D5XQ Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril arginine/Indapamide TAD 5 mg/1.25 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg perindopril arginine (equivalent to 3.395 mg perindopril) and 1.25 mg indapamide For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White or almost white, capsule-shaped tablet, scored on both sides. Tablet is engraved with mark A on one side of the score line and with mark 1 on the other side of the score line. Tablet dimensions: approx. 8 mm x 5 mm. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Perindopril arginine/indapamide TAD 5 mg/1.25 mg tablets is indicated in patients whose blood pressure is not adequately controlled on perindopril alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One Perindopril arginine/indapamide TAD 5 mg/1.25 mg tablet per day as a single dose, preferably to be taken in the morning, and before a meal. When possible individual dose titration with the components is recommended. Perindopril/indapamide TAD 5 mg/1.25 mg tablet should be used when blood pressure is not adequately controlled on perindopril arginine 2.5 mg/indapamide 0.625 mg (half a Perindopril arginine/indapamide TAD 5 mg/1.25 mg tablet). When clinically appropriate, direct change from monotherapy to Perindopril arginine/indapamide TAD 5 mg/1.25 mg tablets may be considered. _Elderly (see section 4.4)_ Treatment with Perindopril arginine/indapamide TAD 5 mg/1.25 mg tablet should be initiated after considering blood pressure response and renal function. _ _ _Renal impairment (see section 4.4)_ 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), it is recommended to initiate treatment with the adequate dose Lue koko asiakirja