Candesartan Viatris 16 mg Tablets

Introduction

Package Leaflet: Information for the Patient

Candesartan Viatris 16 mg Tablets EFG

(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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Candesartan Viatris contains the active substance candesartan, which belongs to a group of medicines called angiotensin II receptor antagonists. These medicines lower blood pressure by relaxing and widening the blood vessels, making it easier for the heart to pump blood to all parts of the body.

Candesartan Viatris is used to:

• Treat high blood pressure (hypertension) in adult patients, and in children and adolescents aged 6 to less than 18 years.
• Treat adult patients with reduced heart muscle function, when it is not possible to use ACE inhibitors or when added to ACE inhibitors when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before you take Candesartan Viatris

Do not takeCandesartan 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 (problem with bile secretion from the gallbladder).
• If you are more than 3 months pregnant. (In any case, it is better to avoid taking candesartan also at the start of your pregnancy – see section Pregnancy).
• If the patient is a child under 1 year of age.
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Tell your doctor before you start taking Candesartan Viatris:

• If you have heart, liver, or kidney problems, or are on dialysis.
• If you have recently had a kidney transplant.
• If you have recently had vomiting, severe vomiting, or have diarrhea.
• If you have a disease of the adrenal gland 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 ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren.
• If you are taking an ACE inhibitor, along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Using Candesartan Viatris with other medicines").
• If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Candesartan is not recommended during the first trimester of pregnancy (first 3 months) and must not be taken after the third month of pregnancy as it may cause serious harm to your baby (see section Pregnancy).

Tell your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking candesartan cilexetil. Your doctor will decide on the treatment to follow. Do not stop taking candesartan cilexetil on your own.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

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

If you are going to have surgery, inform your doctor or dentist that you are taking candesartan. This is because candesartan, in combination with some anesthetics, can cause a drop in blood pressure.

Children and adolescents

Candesartan has been studied in children. For more information, talk to your doctor. Candesartan should not be given to children under 1 year of age due to the potential risk to kidney development.

Taking Candesartan Viatris with other medicines

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

Candesartan may affect how some medicines work and some medicines may affect the effect of candesartan. Your doctor may need to change 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, tell your doctor if you are taking any of the following medicines:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and ACE inhibitors (such as enalapril, captopril, lisinopril, or ramipril) or aliskiren (see also the information under the sections “Do not take Candesartan Viatris” and “Warnings and precautions”).
• An ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone).
• Non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines used to relieve pain and inflammation).
• Aspirin (if you take 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 promote urine elimination).
• Lithium (a medicine used to treat mental disorders).

Taking Candesartan Viatris with food and drink

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

Pregnancy and breast-feeding

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Normally, your doctor will recommend that you stop taking candesartan before becoming pregnant or as soon as you know you are pregnant and will recommend another medicine. Candesartan is not recommended during the first trimester of pregnancy (first 3 months) and must not be taken after the third month of pregnancy as it may cause serious harm to your baby.

Breast-feeding

If you are breast-feeding or plan to start breast-feeding, consult your doctor or pharmacist before taking this medicine. Candesartan is not recommended for women during breast-feeding, and your doctor may decide to prescribe a treatment that is more suitable if you wish to breast-feed, especially newborns or premature babies.

Driving and using machines

Some patients may feel tired or dizzy when taking this medicine. If this happens, do not drive or operate tools or machines.

Candesartan Viatris contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Candesartan Viatris

This is a long-term treatment.

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist. It is important that you keep taking candesartan every day.

You can take Candesartan 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 can be divided into equal doses.

Treatment of high blood pressure:

The recommended initial dose is 8 mg once a day. Your doctor may increase this dose to 32 mg once a day 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, diarrhea, or because they are taking diuretics), the doctor may prescribe a lower initial dose.

Some black patients may have a reduced response to this type of medicine when given as sole treatment, and these patients may need a higher dose.

Treatment of heart failure:

The recommended initial dose of candesartan is 4 mg once a day. Your doctor may increase this dose, doubling it at intervals of at least 2 weeks up to 32 mg once a day. Candesartan can be taken with other medicines for heart failure, and your doctor will decide what treatment is right for you.

Use in children and adolescents with high blood pressure:

Children from 6 to less than 18 years of age:

The recommended initial dose is 4 mg once a day.

For patients who weigh less than 50 kg, the doctor may decide to increase the dose up to a maximum of 8 mg once a day.

For patients who weigh 50 kg or more, the doctor may decide to increase the dose up to 8 mg once a day, and then up to 16 mg once a day if necessary.

If you take more Candesartan Viatris than you should

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

If you forget to take Candesartan Viatris

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

If you stop taking Candesartan Viatris

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It is important that you know what these side effects may be.

Stop taking candesartan and talk to your doctor or go to the nearest emergency center if you get 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.
• Increased risk of infections that can cause fever, chills, sore throat, mouth ulcers, or bronchial cough. These symptoms could be indicative of low white blood cell count (leucopenia).
• Changes in liver function, including liver inflammation (hepatitis), symptoms may be nausea, vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin or the whites of the eyes, pale stools, or dark urine. These may be symptoms of serious liver problems.
• A decrease in kidney function, symptoms may be low urine production or absence of urine production, cloudy or bloody urine, pain when urinating, or lower back pain. These symptoms could be indicative of serious kidney problems. In very rare cases, kidney failure may occur.

Other possible side effects include:

Common(may affect up to 1 in 10 people)

• Dizziness/spinning sensation when standing up (vertigo).
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause dizziness or fainting.
• High 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 situation is severe, you may feel tired, weak, have an irregular heartbeat, or tingling in your hands or feet.

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

• Rash, hives.
• Itching.
• Cough.
• Back pain, joint and muscle pain.
• Feeling sick (nausea).
• Changes in blood test results, such as low 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 the available data)

• Diarrhea.

Other side effects in children and adolescents

In children treated for high blood pressure, side effects seem to be similar to those observed in adults but occur more frequently. Sore throat is a very common side effect in children but has not been reported in adults, and runny nose, fever, and increased heart rate are common in children but have not been reported in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Candesartan Viatris

Keep out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the carton, blister, or bottle after EXP. The expiry date refers to the last day of the month stated. After opening the bottle for the first time, use within 100 days.

Do not store above 25°C. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Candesartan Viatris

The active ingredient is candesartan cilexetil. Each tablet contains 16 mg of candesartan cilexetil.

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

Appearance of the Product and Container Content

The tablets are white or almost white, round, biconvex, marked with the inscription "M" over "C6" on one side and smooth, with a break line, on the other side.

Candesartan Viatris is available in blisters, with or without a pouch and in a box, of 7, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98, and 100 tablets, and in bottles of 30, 49, 56, 90, and 98 tablets. The pouches and bottles contain a desiccant. The bottles may or may not contain cotton. The desiccant should not be ingested.

Only some 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 on this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanyCandesartancilexetil Mylan 16 mg Tabletten

DenmarkKandrozid 16 mg tabletter

SpainCandesartán Viatris 16 mg comprimidos EFG

FinlandKandrozid 16 mg tabletit

NorwayKandrozid 16 mg tabletter

NetherlandsCandesartan cilexetil Viatris 16 mg tabletten

PortugalCandesartan Mylan 16 mg comprimidos

United KingdomCandesartan cilexetil 16 mg Tablets

SwedenKandrozid 16 mg tabletter

Date of the last revision of this leaflet:February 2025

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