Candesartan Viatris 8 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Candesartán Viatris 8 mg tablets EFG

(Candesartán cilexetilo)

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, ask 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 reduce blood pressure). It also helps the heart pump blood to all parts of the body.

Candesartán Viatris is used for:

• The treatment of high blood pressure (hypertension) in adult patients, children, and adolescents aged 6 to under 18 years.
• The treatment of 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 any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver disease or biliary obstruction (a problem with bile leaving 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 to take Candesartán Viatris:

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

• If you have recently had vomiting or have 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 (MRA). 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. Use of candesartan is not recommended during early pregnancy (first 3 months), 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 undergoing 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 carry out blood tests from time to time.

In particular, tell 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 for the treatment of heart failure known as mineralocorticoid receptor antagonists (MRA) (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 thin the blood).
• Diuretics (medicines that increase urine production).
• 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. Usually, your doctor will 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 start, 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 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 candesartan 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 treatment), your doctor may prescribe a lower starting dose.

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

Treatment of heart failure:

The recommended starting dose of candesartan is 4 mg once daily. Your doctor may double this dose at intervals of at least 2 weeks, up to a maximum of 32 mg once daily. Candesartan may be taken together with other heart failure medications, and your doctor will decide which treatment is appropriate 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 candesartan 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 candesartan without first consulting your doctor.

If you have any further questions about using 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 contact your doctor, or go to the nearest emergency facility, 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 causing 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 reduced or absence of 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 blood potassium levels, which may be detected in blood tests, especially if you already have kidney problems or heart failure. If this condition is severe, you may experience 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 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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via 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 Candesartan 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 should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to properly dispose of containers and medicines 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 8 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 “C5”, and smooth with a break line on the other side.

Candesartán Viatris is available in blister packs, with or without an outer pouch and contained in a carton, or in pouches and bottles of 7, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets. Pouches and bottles contain a desiccant. Bottles may or may not contain cotton. The desiccant must not be ingested.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

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

Germany Candesartancilexetil Mylan 8 mg Tabletten
Denmark Kandrozid 8 mg tabletter
Spain Candesartán Viatris 8 mg comprimidos EFG
Finland Kandrozid 8 mg tabletit
Norway Kandrozid 8 mg tabletter
Netherlands Candesartan cilexetil Viatris 8 mg tabletten
Portugal Candesartan Mylan 8 mg comprimidos
United Kingdom Candesartan cilexetil 8 mg Tablets
Sweden Kandrozid 8 mg tabletter

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

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