Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Candesartan cilexetil
CHEPLAPHARM Arzneimittel GmbH
C09CA; C09CA06
Candesartan cilexetil
8 milligram(s)
Tablet
Angiotensin II antagonists, plain; candesartan
Marketed
2002-04-29
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Atacand 4 mg tablets Atacand 8 mg tablets Atacand 16 mg tablets candesartan cilexetil 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. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET : 1. What Atacand is and what it is used for 2. What you need to know before you take Atacand 3. How to take Atacand 4. Possible side effects 5. How to store Atacand 6. Contents of the pack and other information 1. WHAT ATACAND IS AND WHAT IT IS USED FOR The name of your medicine is Atacand. The active ingredient is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and widen. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body. Atacand can be used to: • treat high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to <18 years. • treat adult heart failure patients with reduced heart muscle function when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used or in addition to ACE-inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) cannot be used (ACE-inhibitors and MRAs are medicines used to treat heart failure). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATACAND DO NOT TAKE ATACAND: • if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6). • if you are more than 3 months pregnant (it is also better to avoid Atacand in Read the complete document
Health Products Regulatory Authority 15 August 2023 CRN00DLDP Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atacand 8 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg candesartan cilexetil. Excipient with known effect Each tablet contains 89.4 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Round (diameter 7 mm), light pink tablets with a score and marked A/CG on one side and marked 008 on the other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atacand is indicated for: - The treatment of primary hypertension in adults. - The treatment of hypertension in children and adolescents aged 6 to <18 years. - The treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) when Angiotensin Converting Enzyme (ACE)‑inhibitors are not tolerated or as add-on therapy to ACE‑inhibitors in patients with symptomatic heart failure, despite optimal therapy, when mineralocorticoid receptor antagonists are not tolerated (see sections 4.2, 4.4, 4.5 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in Hypertension The recommended initial dose and usual maintenance dose of Atacand is 8 mg once daily. Most of the antihypertensive effect is attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 16 mg once daily and to a maximum of 32 mg once daily. Therapy should be adjusted according to blood pressure response. Atacand may also be administered with other antihypertensive agents(see sections 4.3, 4.4, 4.5 and 5.1). Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of Atacand. _Elderly_ No initial dose adjustment is necessary in elderly patients. _Patients with intravascular volume depletion_ An initial dose of 4 mg may be considered in Read the complete document