Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Perindopril arginine; Indapamide; Amlodipine
Les Laboratoires Servier
C09BX; C09BX01
Perindopril arginine; Indapamide; Amlodipine
5 mg/1.25 mg/10 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors, other combinations; perindopril, amlodipine and indapamide
Marketed
2014-04-16
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COVERDINE 5MG/1.25MG/5MG FILM-COATED TABLETS COVERDINE 5MG/1.25MG/10MG FILM-COATED TABLETS COVERDINE 10MG/2.5MG/5MG FILM-COATED TABLETS COVERDINE 10MG/2.5MG/10MG FILM-COATED TABLETS perindopril arginine/indapamide/amlodipine 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 Coverdine is and what it is used for 2. What you need to know before you take Coverdine 3. How to take Coverdine 4. Possible side effects 5. How to store Coverdine 6. Content of the pack and other information 1. WHAT COVERDINE IS AND WHAT IT IS USED FOR Coverdine is a combination of three active ingredients: perindopril, indapamide and amlodipine. It is an anti- hypertensive medicine used in the treatment of high blood pressure (hypertension). Patients already taking perindopril/indapamide as fixed dose combination and amlodipine from separate tablets may instead receive one tablet of Coverdine which contains the three active ingredients in the same strength. Each of the active ingredients reduces blood pressure and they work together to control your blood pressure: - Perindopril belongs to a class of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. It works by widening the blood vessels, which makes it easier for your heart to pump blood through them. - Indapamide is a diuretic (which belongs to a class of medicines called sulphonamide derivatives with an indole ring). Diuretics increase the amount of urine produced by the kidneys. However, indapamide is differen Citiți documentul complet
Health Products Regulatory Authority 04 July 2023 CRN00DKJW Page 1 of 25 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coverdine 5mg/1.25mg/10mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine, 1.25 mg indapamide and 13.870 mg amlodipine besilate equivalent to 10mg of amlodipine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Coverdine 5/1.25/10 mg: white, oblong, film-coated tablet, 10.7 mm long and 5.66 mm wide engraved with on one face and on the other face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Coverdine is indicated as substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril/indapamide fixed dose combination and amlodipine, taken at the same dose level. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One Coverdine film-coated tablet per day as a single dose, preferably to be taken in the morning and before a meal_._ The fixed dose combination is not suitable for initial therapy. If a change of the posology is required, titration should be done with the individual components. Special population _Renal impairment (see section 4.3 and 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), Coverdine at the doses 10mg/2.5mg /5mg and 10mg/2.5mg/10mg is contraindicated.I t is recommended to start treatment with the adequate dosage of the free combination. Usual medical follow-up will include frequent monitoring of creatinine and potassium. Concomitant use of perindopril with aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3). _Hepatic impairment (see sections 4.3, 4.4 and 5.2)_ In severe hepatic impairment, Coverdine is contraindicated. In patients with mild to moderate hepatic impairment, Coverd Citiți documentul complet