Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Candesartan cilexetil
AstraZeneca AB
C09CA; C09CA06
Candesartan cilexetil
16 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
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 e Read the complete document
HealthProductsRegulatoryAuthority 21June2019 CRN009404 Page1of13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atacand16mgtablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachtabletcontains16mgcandesartancilexetil. Excipientwithknowneffect Each tabletcontains81.4mglactosemonohydrate. For thefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Tablet. Round(diameter7mm),pinktabletswithascoreandmarkedA/CHononesideandmarked016ontheotherside. Thetabletcanbedividedintoequaldoses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atacandisindicatedfor: Thetreatmentofprimaryhypertensioninadults. Thetreatmentofhypertensioninchildrenandadolescentsaged6 to<18 years. Thetreatmentofadultpatientswithheartfailureandimpairedleftventricularsystolicfunction(leftventricular ejectionfraction≤ 40%)whenAngiotensinConvertingEnzyme(ACE)‑inhibitorsarenottoleratedorasadd-on therapytoACE‑inhibitorsinpatientswithsymptomaticheartfailure,despiteoptimaltherapy,when mineralocorticoidreceptorantagonistsarenottolerated(seesections 4.2, 4.4, 4.5and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in Hypertension TherecommendedinitialdoseandusualmaintenancedoseofAtacandis8 mgoncedaily.Mostoftheantihypertensiveeffect isattainedwithin4 weeks.Insomepatientswhosebloodpressureisnotadequatelycontrolled,thedosecanbeincreasedto 16 mgoncedailyandtoamaximumof32 mgoncedaily.Therapyshouldbeadjustedaccordingtobloodpressureresponse. Atacandmay Read the complete document