Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Chlortalidone; Atenolol
Rowex Ltd
C07CB; C07CB03
Chlortalidone; Atenolol
50 mg/12.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective, and other diuretics; atenolol and other diuretics
Marketed
1999-11-26
PACKAGE LEAFLET: INFORMATION FOR THE USER ATECOR-CT 50 MG/12.5 MG & 100 MG/25 MG FILM-COATED TABLETS ATENOLOL/CHLORTALIDONE 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Atecor-CT is and what it is used for 2. What you need to know before you take Atecor-CT 3. How to take Atecor-CT 4. Possible side effects 5. How to store Atecor-CT 6. Contents of the pack and other information. 1 WHAT ATECOR-CT IS AND WHAT IT IS USED FOR Atecor-CT is used to treat high blood pressure (hypertension). It contains two different medicines called atenolol and chlortalidone. • Atenolol belongs to a group of medicines called ‘beta-blockers’. It works by slowing down your heartbeat and making it beat with less force. • Chlortalidone belongs to a group of medicines called water tablets (diuretics). It works by increasing the amount of urine made by your kidneys. These medicines work together to lower your blood pressure. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATECOR-CT DO NOT TAKE ATECOR-CT IF: • you are allergic to atenolol, chlortalidone or any of the other ingredients of this medicine (listed in section 6) • you are allergic to sulphonamide derived medicines e.g. some antibiotics • you have heart failure that has not been treated or is not under control. Signs may include shortness of breath and swelling of your ankles. • you have a second or third degree heart block (you may have a pacemaker) • you have sick sinus syndrome or a very slow or a very uneven heartbeat • you have ver Прочетете целия документ
Health Products Regulatory Authority 08 August 2023 CRN00DQMF Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atecor CT 50 mg/12.5 mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50mg of atenolol and 12.5mg of chlortalidone. Excipients with known effect: Each tablet contains 1.8mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, round, biconvex, film-coated tablet with a score-notch on one side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atecor-CT tablets are indicated for the treatment of hypertension. The combination product may be suitable for use when satisfactory control of arterial blood pressure cannot be obtained with either a diuretic or a beta-blocking agent used alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled. POSOLOGY: ADULTS The usual maintenance dose of Atecor-CT 50 mg/12.5 mg is one tablet daily. There is little or no further fall in blood pressure with increased dosage, and where necessary, another antihypertensive drug, such as a vasodilator, can be added. Patients can be transferred directly to Atecor-CT 50 mg/12.5 mg tablets from other antihypertensive treatments, with the exception of clonidine (see section 4.4). OLDER PEOPLE Dosage requirements are often lower in this age group. PAEDIATRIC POPULATION Children and Adolescents (<18 years) There is no paediatric experience with Atecor-CT tablets; therefore, this preparation is not recommended for children. RENAL IMPAIRMENT Due to the properties of the chlortalidone component, Atecor-CT tablets has reduced efficacy in the presence of renal insufficiency. This fixed dose combination should thus not be administrated to patients with severe renal impairment (see section 4.3). HEP Прочетете целия документ