Package leaflet: Information for the user Candesartan cilexetil 2 mg tablets Candesartan cilexetil 4 mg tablets Candesartan cilexetil 8 mg tablets Candesartan cilexetil 16 mg tablets Candesartan cilexetil 32 mg tablets candesartan cilexetil

Read all of this leaflet carefully If you are going to have an operation, before you start taking this tell your doctor or dentist that you are medicine because it contains taking Candesartan cilexetil. This is important information for you. because Candesartan cilexetil, when - Keep this leaflet. You may need combined with some anaesthetics, to read it again. may cause an excessive drop in - If you have any further questions, blood pressure. ask your doctor or pharmacist. - This medicine has been Children and adolescents prescribed for you only. Do not Candesartan Cilexetil has been pass it on to others. It may harm studied in children. For more them, even if their signs of illness information, talk to your doctor. are the same as yours. Candesartan Cilexetil must not be - If you get any side effects, talk to given to children under 1 year of your doctor or pharmacist. This age due to the potential risk to the includes any possible side effects developing kidneys. not listed in this leaflet. See Other medicines and Candesartan section 4. cilexetil What is in this leaflet Tell your doctor or pharmacist if you 1. What Candesartan cilexetil is and are taking, have recently taken or what it is used for might take any other medicines. 2. What you need to know before you take Candesartan cilexetil Candesartan cilexetil can affect the 3. How to take Candesartan cilexetil way some other medicines work and 4. Possible side effects some medicines can have an effect Half fold: 290 mm 5. How to store Candesartan on Candesartan cilexetil. If you are cilexetil using certain medicines, your doctor 6. Contents of the pack and other may need to do blood tests from time information to time. 1. What Candesartan cilexetil is In particular, tell your doctor if and what it is used for you are using any of the following medicines: The name of your medicine is • Other medicines to help lower Candesartan cilexetil. The active your blood pressure, including ingredient is candesartan cilexetil. beta-blockers, diazoxide and This belongs to a group of medicines ACE inhibitors such as enalapril, called angiotensin II receptor captopril, lisinopril or ramipril. antagonists. It works by making your • Non-steroidal anti-inflammatory blood vessels relax and widen. This drugs (NSAIDs) such as helps to lower your blood pressure. It ibuprofen, naproxen, diclofenac, also makes it easier for your heart to pump blood to all parts of your body. celecoxib or etoricoxib (medicines to relieve pain and inflammation). This medicine is used for: • Acetylsalicylic acid (if you are • treating high blood pressure taking more than 3 g each day) (hypertension) in adult patients (medicine to relieve pain and and in children and adolescents inflammation). aged 6 to <18 years. • Potassium supplements or salt • Candesartan cilexetil can substitutes containing potassium be used to treat adult heart (medicines that increase the failure patients with reduced amount of potassium in your heart muscle function when Angiotensin Converting Enzyme blood). (ACE) inhibitors cannot be used • Heparin (a medicine for thinning or in addition to ACE-inhibitors the blood). when symptoms persist despite • Water tablets (diuretics). treatment and mineralocorticoid • Lithium (a medicine for mental receptor antagonists (MRA) health problems). cannot be used. (ACE-inhibitors Your doctor may need to change and MRAs are medicines used to your dose and/or to take other treat heart failure). precautions: • If you are being treated with 2. What you need to know an ACE-inhibitor together with before you take Candesartan certain other medicines to treat cilexetil your heart failure, which are Do not take Candesartan cilexetil: known as mineralocorticoid • if you are allergic to candesartan receptor antagonists (MRA) cilexetil or any of the other (for example: spironolactone, ingredients of this medicine eplerenone). (listed in section 6). Candesartan cilexetil with food, • if you are more than drink and alcohol 3 months pregnant (it • You can take Candesartan is also better to avoid cilexetil with or without food. Candesartan cilexetil • When you are prescribed in early pregnancy see Candesartan cilexetil, discuss pregnancy section). with your doctor before drinking • if you have severe alcohol. Alcohol may make you liver disease or biliary feel faint or dizzy. obstruction (a problem with the drainage of the Pregnancy , breast-feeding and bile from the gall bladder). fertility • if the patient is a child under 1 Pregnancy year of age. You must tell your doctor if you think • if you have diabetes or impaired you are (or might become) pregnant. kidney function and you are Your doctor will normally advise you treated with a blood pressure to stop taking Candesartan cilexetil lowering medicine containing before you become pregnant or as aliskiren soon as you know you are pregnant If you are not sure if any of these and will advise you to take another apply to you, talk to your doctor medicine instead of Candesartan or pharmacist before taking cilexetil. Candesartan cilexetil is not Candesartan cilexetil. recommended in early pregnancy, and must not be taken when more Warnings and precautions Talk to your doctor or pharmacist than 3 months pregnant, as it may before taking Candesartan cilexetil cause serious harm to your baby • if you have heart, liver or kidney if used after the third month of problems, or are on dialysis. pregnancy. • if you have recently had a kidney Breast-feeding transplant. Tell your doctor if you are breast- • if you are vomiting, have recently feeding or about to start breast- had severe vomiting, or have feeding. Candesartan cilexetil is not diarrhoea. recommended for mothers who are • if you have a disease of the breast-feeding, and your doctor may adrenal gland called Conn’s choose another treatment for you if syndrome (also called primary you wish to breast-feed, especially if hyperaldosteronism). your baby is newborn, or was born • if you have low blood pressure. prematurely. • if you have ever had a stroke. • you must tell your doctor if you Driving and using machines think you are (or might become) Some people may feel tired or dizzy pregnant. Candesartan cilexetil when taking Candesartan cilexetil. If is not recommended in early this happens to you, do not drive or pregnancy, and must not be use any tools or machines. taken if you are more than 3 Candesartan cilexetil contains months pregnant, as it may Lactose monohydrate cause serious harm to your Candesartan cilexetil contains baby if used at that stage (see lactose monohydrate. If you have pregnancy section). been told by your doctor that you • if you are taking any of the have an intolerance to some sugars, following medicines used to treat contact your doctor before taking this high blood pressure: medicinal product. - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), 3. How to take Candesartan in particular if you have cilexetil diabetes-related kidney Always take this medicine exactly problems. as your doctor or pharmacist has - aliskiren told you. Check with your doctor or • if you are taking an ACE-inhibitor pharmacist if you are not sure. together with a medicine which It is important to keep taking belongs to the class of medicines Candesartan cilexetil every day. known as mineralocorticoid You can take Candesartan cilexetil receptors antagonists (MRA). with or without food. These medicines are for the Swallow the tablet with a drink of treatment of heart failure water. (see “Other medicines and Candesartan cilexetil ”).” Try to take the tablet at the same time each day. This will help you to Your doctor may check your kidney remember to take it. function, blood pressure, and the amount of electrolytes (e.g. High blood pressure: potassium) in your blood at regular • The recommended dose of intervals. Candesartan cilexetil is 8 mg once a day. Your doctor may See also information under the increase this dose to heading “Do not take Candesartan 16 mg once a day and cilexetil” further up to 32 mg once Your doctor may want to see you a day depending on blood more often and do some tests if you pressure response.

have any of these conditions. N13077

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Version: 08 Date & Time: 26.11.2020 & 4:45 PM Submission Code: N13077 • In some patients, such as those Reporting of side effects with liver problems, kidney If you get any side effects, talk to problems or those who recently your doctor, pharmacist or nurse. have lost body fluids, e.g., This includes any possible side through vomiting or diarrhoea or effects not listed in this leaflet. You by using water tablets, the doctor can also report side effects directly may prescribe a lower starting (see details below). By reporting dose. side effects you can help to provide • Some black patients may have a more information on the safety of this reduced response to this type of medicine. medicine, when given as the only Malta treatment, and these patients ADR Reporting may need a higher dose. The Medicines Authority Use in children and adolescents with Post-Licensing Directorate high blood pressure: 203 Level 3, Rue D’Argens Children 6 to <18 years of age: GŻR-1368 Gżira The recommended starting dose is Website: 4 mg once daily. www.medicinesauthority.gov.mt For patients weighing < 50 kg: In e-mail: postlicensing. some patients whose blood pressure [email protected] is not adequately controlled, your doctor may decide the dose needs to The United Kingdom be increased to a maximum of 8 mg Yellow Card Scheme once daily. Website: www.mhra.gov.uk/ For patients weighing ≥ 50 kg: In yellowcard or search for MHRA some patients whose blood pressure Yellow Card in Google Play or Apple is not adequately controlled, your App Store doctor may decide the dose needs to 5. How to store Candesartan be increased to 8 mg once daily and cilexetil to 16 mg once daily. Keep this medicine out of the sight Heart failure in adults: and reach of children. • The recommended starting dose 0 of Candesartan cilexetil is 4 mg Store below 30 C. once a day. Your doctor may Do not use this medicine after the increase your dose by doubling expiry date which is stated on the Half fold: 290 mm the dose at intervals of at least carton, blister and bottle label after 2 weeks up to 32 mg once a EXP. The expiry date refers to the day. Candesartan cilexetil can last day of that month. be taken together with other medicines for heart failure, and Do not throw away any medicines via your doctor will decide which wastewater or household waste. Ask treatment is suitable for you. your pharmacist how to throw away medicines you no longer use. These If you take more Candesartan measures will help to protect the

cilexetil than you should environment. If you take more Candesartan cilexetil than prescribed by 6. Contents of the pack and your doctor, contact a doctor or other information pharmacist immediately for advice. What Candesartan cilexetil If you forget to take Candesartan contains cilexetil - The active substances is Do not take a double dose to make candesartan cilexetil. Each tablet up for a forgotten tablet. Just take contains 2 mg, 4 mg, 8 mg, the next dose as normal. 16 mg or 32 mg of candesartan If you stop taking Candesartan cilexetil. cilexetil If you stop taking Candesartan - The other ingredients are Lactose cilexetil, your blood pressure may monohydrate, hydroxypropyl increase again. Therefore do not cellulose, carmellose calcium, stop taking Candesartan cilexetil magnesium aluminometasilicate, without first talking to your doctor. propylene glycol, magnesium stearate, iron oxide red (E172) If you have any further questions on (8 mg tablets only), iron oxide the use of this medicine, ask your yellow (16 mg & 32 mg tablets doctor or pharmacist. only) 4. Possible side effects What Candesartan cilexetil looks like and contents of the pack Like all medicines, this medicine Tablet can cause side effects, although not everybody gets them. It is important Candesartan cilexetil 2 mg tablets that you are aware of what these White to off-white, biconvex, side effects may be. uncoated, round shaped tablets Stop taking Candesartan debossed with “CN2” on one side cilexetil and seek medical help and plain on other side. immediately if you have any of the Candesartan cilexetil 4 mg tablets following allergic reactions: White to off-white, biconvex, • difficulties in breathing, with or uncoated, round shaped tablets without swelling of the face, lips, debossed with “CN” and “4” tongue and/or throat separated by score-line on one side • swelling of the face, and plain on other side. The tablet lips, tongue and/or can be divided into equal doses. throat, which may cause difficulties in swallowing Candesartan cilexetil 8 mg tablets • severe itching of the skin Pale pink, biconvex, uncoated, round (with raised lumps) shaped tablets debossed with “CN” and “8” separated by score-line on Candesartan cilexetil may one side and plain on other side. cause a reduction in number The tablet can be divided into equal of white blood cells. Your doses. resistance to infection may be decreased and you Candesartan cilexetil 16 mg tablets Yellow, biconvex, uncoated, round may notice tiredness, an shaped tablets debossed with “CN” infection or a fever. If this happens contact your doctor. Your doctor and “16” separated by score-line on may occasionally do blood tests to one side and plain on other side. check whether Candesartan cilexetil The tablet can be divided into equal has had any effect on your blood doses. (agranulocytosis). Candesartan cilexetil 32 mg tablets Other possible side effects include: Yellow, biconvex, uncoated, round Common (affects 1 to 10 users in shaped tablets debossed with “CN” 100) and “32” separated by score-line on • Feeling dizzy/spinning sensation. one side and plain on other side. • Headache. The tablet can be divided into equal • Respiratory infection. doses. • Low blood pressure. This may Candesartan cilexetil tablets are make you feel faint or dizzy. available in PVC/PVdC – Aluminium • Changes in blood test results: foil blister pack and HDPE container - An increased amount of pack with polypropylene closure. potassium in your blood, especially if you already Pack sizes: have kidney problems or Blister pack: 7, 14,28, 30, 50,56, 90, heart failure. If this is severe 98 & 500 tablets you may notice tiredness, HDPE pack: 30, 90 & 500 tablets weakness, irregular heart beat or pins and needles. Not all pack sizes may be marketed. • Effects on how your kidneys Marketing Authorization Holder work, especially if you already UK_ Milpharm Limited have kidney problems or heart Ares Block, Odyssey failure. In very rare cases, kidney Business Park failure may occur. West End Road Very rare (affects less than 1 user Ruislip HA4 6QD in 10,000) United Kingdom • Swelling of the face, lips, tongue MT_ Aurobindo Pharma (Malta) and/or throat. Limited • A reduction in your red or white Vault 14, Level 2, Valletta blood cells. You may notice Waterfront tiredness, an infection or a fever. Floriana FRN 1913 • Skin rash, lumpy rash (hives). Malta • Itching. • Back pain, pain in joints and Manufacturer muscles. APL Swift Services (Malta) Limited • Changes in how your liver is HF26, Hal Far Industrial Estate, Hal working, including inflammation Far of the liver (hepatitis). You may Birzebbugia, BBG 3000 notice tiredness, yellowing of Malta your skin and the whites of your or eyes and flu like symptoms. • Nausea. Milpharm Limited • Changes in blood test results: Ares Block, Odyssey Business Park - A reduced amount of sodium West End Road in your blood. If this is Ruislip HA4 6QD severe then you may notice United Kingdom weakness, lack of energy, or or muscle cramps. • Cough Generis Farmacêutica S.A., Rua João de Deus, no 19, Not known (frequency cannot be Venda Nova, estimated from the available data) Amadora 2700-487, • Diarrhoea Portugal. Additional side effects in children This leaflet was last revised in In children treated for high blood 11/2020. pressure, side effects appear to be similar to those seen in adults, but they happen more often. Sore throat is a very common side effect in children but not reported in adults and runny nose, fever and increased heart rate are common in children but not reported in adults. N13077