Candesartan Viatris 32 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Candesartán Viatris 32 mg tablets EFG

(Candesartan cilexetil)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Candesartán Viatris is and what it is used for
2. What you need to know before taking Candesartán Viatris
3. How to take Candesartán Viatris
4. Possible side effects
5. How to store Candesartán Viatris
6. Contents of the pack and other information

1. What Candesartán Viatris is and what it is used for

Candesartán Viatris contains the active substance candesartan, which belongs to a group of medicines called angiotensin II receptor antagonists that lower blood pressure. It works by causing the blood vessels to relax and widen (this helps lower blood pressure). It also helps your heart pump blood to all parts of your body.

Candesartán Viatris is used for:

• Treating high blood pressure (hypertension) in adult patients, children, and adolescents aged 6 years up to but less than 18 years of age.
• Treating adult 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 (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure.)

2. What you need to know before taking Candesartán Viatris

Do not take Candesartán Viatris

• If you are allergic to candesartan cilexetil or to any of the other components of this medicine (listed in section 6).
• If you have severe liver disease or biliary obstruction (a problem with bile outflow from the gallbladder).
• If you are more than 3 months pregnant. (In any case, it is better to avoid taking candesartan also during early pregnancy – see Pregnancy section).
• If the patient is a child under 1 year of age.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before starting Candesartán Viatris:

• If you have heart, liver or kidney problems, or are undergoing dialysis.

• If you have recently received a kidney transplant.

• If you are experiencing vomiting, have recently had severe vomiting, or have diarrhoea.

• If you have an adrenal gland disorder called Conn's syndrome (also known as primary hyperaldosteronism).

• If you have low blood pressure.

• If you have ever had a stroke.

• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

  • An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • Aliskiren.
    • If you are taking an ACE inhibitor together with a medicine belonging to a class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Taking Candesartán Viatris with other medicines").
    • If you are pregnant, think you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of candesartan is not recommended during the first trimester of pregnancy and must not be given from the third month of pregnancy onwards, as it may cause severe harm to your baby (see Pregnancy section).

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking candesartan cilexetil. Your doctor will decide on the appropriate course of action. Do not stop taking candesartan cilexetil on your own.

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals.

See also the information under the section “Do not take Candesartán Viatris”.

If you are scheduled for surgery, inform your doctor or dentist that you are taking candesartan. This is because candesartan, in combination with certain anaesthetics, may cause a drop in blood pressure.

Children and adolescents

Candesartan has been studied in children. For further information, speak with your doctor. Candesartan must not be given to children under 1 year of age due to the potential risk to kidney development.

Taking Candesartán Viatris with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Candesartan may affect how some medicines work, and some medicines may influence the effect of candesartan. Your doctor may need to adjust your dose and/or take other precautions. If you are taking certain medicines, your doctor may need to perform blood tests from time to time.

In particular, inform your doctor if you are taking any of the following medicines:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and so-called ACE inhibitors (such as enalapril, captopril, lisinopril or ramipril) or aliskiren (see also information under sections “Do not take Candesartán Viatris” and “Warnings and precautions”).
• An ACE inhibitor together with specific medicines used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines used to relieve pain and inflammation).
• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine used to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine used to increase blood fluidity).
• Diuretics (medicines that increase urine elimination).
• Lithium (a medicine used to treat mental disorders).

Taking Candesartán Viatris with food and alcohol

• You may take candesartan with or without food.
• When prescribed candesartan, consult your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will usually advise you to stop taking candesartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartan is not recommended during early pregnancy and must not be administered from the third month of pregnancy onwards, as it may cause severe harm to your baby when used from that time.

Breastfeeding

If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before taking this medicine. Candesartan is not recommended for women during this period, and your doctor may decide to prescribe a treatment more suitable if you intend to breastfeed, especially if the infant is a newborn or premature.

Driving and using machines

Some patients may feel tired or dizzy while taking this medicine. If this happens to you, do not drive or operate tools or machinery.

Candesartán Viatris contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Candesartán Viatris

This is a long-term treatment.

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist. It is important that you continue taking candesartán every day.

You may take Candesartán Viatris with or without food. Swallow the tablet with a little water. Try to take the tablet at the same time each day. This will help you remember to take it.

The tablet may be divided into equal doses.

Treatment of high blood pressure:

The recommended starting dose is 8 mg once daily. Your doctor may increase this dose up to 32 mg once daily depending on your blood pressure response.

In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids (for example due to vomiting, diarrhoea, or diuretic use), your doctor may prescribe a lower starting dose.

Some black patients may have a reduced response to this type of medicine when used as monotherapy, and these patients may require a higher dose.

Treatment of heart failure:

The recommended starting dose of candesartán is 4 mg once daily. Your doctor may double the dose at intervals of at least 2 weeks up to a maximum of 32 mg once daily. Candesartán may be taken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.

Use in children and adolescents with high blood pressure:

Children aged 6 to under 18 years:

The recommended starting dose is 4 mg once daily.

For patients weighing less than 50 kg, your doctor may decide whether the dose should be increased up to a maximum of 8 mg once daily.

For patients weighing 50 kg or more, your doctor may decide whether the dose should be increased to 8 mg once daily, and then, if necessary, up to 16 mg once daily.

If you take more Candesartán Viatris than you should

If you take more candesartán than your doctor has prescribed, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), stating the medicine and the amount taken. Your blood pressure may drop and you may feel tired.

If you forget to take Candesartán Viatris

Do not take a double dose to make up for forgotten doses. Simply take the next dose as scheduled.

If you stop taking Candesartán Viatris

If you stop taking this medicine, your blood pressure may rise again. Therefore, do not stop taking candesartán without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

It is important that you are aware of what these adverse effects could be.

Stop taking candesartan and speak with your doctor, or go to the nearest emergency room, if you experience any of the following symptoms:

Very rare (may affect up to 1 in 10,000 people)

• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
• Increase in the number of infections, which may cause fever, severe chills, sore throat, mouth ulcers, or bronchial cough. These symptoms could indicate a low concentration of white blood cells (leucopenia).
• Changes in liver function, including inflammation of the liver (hepatitis). Symptoms may include feeling unwell (nausea), discomfort (vomiting), loss of appetite, general malaise, fever, itching, yellowing of the skin or whites of the eyes, pale stools, or cloudy urine. These may be signs of serious liver problems.
• A decrease in kidney function. Symptoms may include low or no urine production, cloudy or bloody urine, pain when urinating, or lower back pain. These symptoms could indicate serious kidney problems. In very rare cases, kidney failure may occur.

Other possible adverse effects include:

Frequent (may affect up to 1 in 10 people)

• Dizziness/spinning sensation when standing (vertigo).
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause dizziness or fainting.
• Increased levels of potassium in the blood, which may be seen in blood tests, especially if you already have kidney problems or heart failure. If this condition is severe, you may notice fatigue, weakness, irregular heartbeat, or tingling in the hands or feet.

Very rare (may affect up to 1 in 10,000 people)

• Skin rash, hives.
• Itching.
• Cough.
• Back pain, joint pain, and muscle pain.
• Feeling unwell (nausea).
• Changes in blood test results, such as reduced sodium levels or increased liver enzymes in the blood.
• Intestinal inflammation with symptoms such as abdominal pain, nausea, vomiting, and diarrhea (intestinal angioedema).

Frequency not known (cannot be estimated from available data)

• Diarrhea.

Other adverse effects in children and adolescents

In children treated for hypertension, adverse effects appear to be similar to those observed in adults, but occur more frequently. Sore throat is a very common adverse effect in children but has not been reported in adults, and nasal discharge, fever, and increased heart rate are common in children but have not been reported in adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartán Viatris

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container, blister pack, or bottle after the abbreviation EXP: The expiry date refers to the last day of the month indicated. After first opening the bottle, use within 100 days.

Do not store above 25°C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your usual pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Candesartán Viatris

The active substance is candesartan cilexetil. Each tablet contains 32 mg of candesartan cilexetil.

The other components are: calcium carmellose, hydroxypropylcellulose, lactose monohydrate (see section 2 “Candesartán Viatris contains lactose”), magnesium stearate and mannitol.

Appearance of the product and contents of the pack

The tablets are white or almost white, round, biconvex, marked on one side with the inscription “M” over “C7”, and smooth with a break line on the other side.

Candesartán Viatris is available in blisters, with or without an outer pouch, and in cardboard boxes containing 7, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets, and in bottles containing 30, 49, 56, 90 and 98 tablets. The pouches and bottles contain a desiccant. The bottles may or may not contain cotton wool. The desiccant must not be ingested.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

McDermott Laboratories t/a Gerard Laboratories Ltd.
Unit 35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland

or

Mylan Hungary Kft.
Mylan utca 1
H-2900 Komárom
Hungary

or

Mylan Germany GmbH,
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1,
Bad Homburg v. d. Hoehe, Hessen, 61352
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany Candesartancilexetil Mylan 32 mg Tabletten
Austria Candesartan cilexetil Arcana 32 mg tabletten
Denmark Kandrozid 32 mg tabletter
Spain Candesartán Viatris 32 mg comprimidos EFG
Finland Kandrozid 32 mg tabletit
Norway Kandrozid 32 mg tabletter
Netherlands Candesartan cilexetil Viatris 32 mg tabletten
Portugal Candesartan Mylan 32 mg comprimidos
United Kingdom Candesartan cilexetil 32 mg Tablets
Sweden Kandrozid 32 mg tabletter

Date of the most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/