Patient Information Leaflet

Candesartán Viatris 16 mg Tablets EFG

(Candesartán cilexetilo)

Read this leaflet carefully before you start taking this medicine, as 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Candesartán Viatris

3.How to take Candesartán Viatris

4.Possible side effects

5.Storage of Candesartán Viatris

6.Contents of the pack and additional information

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

Candesartán Viatrisis used for:

• The treatment of high blood pressure (hypertension) in adult patients, in children, and in adolescents aged 6 years and younger than 18 years.
• The treatment of adult patients with reduced heart muscle function, when it is not possible to use angiotensin-converting enzyme (ACE) inhibitors or when ACE inhibitors are added to patients with persistent symptoms despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACE inhibitors and MRAs are medicines used for the treatment of heart failure).

Do not takeCandesartán Viatris

• If you are allergic to candesartán cilexetilo or any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver disease or bile duct obstruction (problem with the bile flowing out of the gallbladder).
• If you are more than 3 months pregnant. (In any case, it is best to avoid taking candesartán at the beginning of your pregnancy – see Pregnancy section).
• If the patient is a child under 1 year.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskirén.

Warnings and precautions

Consult your doctor before starting to take Candesartán Viatris:

• If you have heart, liver, or kidney problems or are undergoing dialysis.
• If you have recently had a kidney transplant.
• If you have vomiting, have recently had severe vomiting, or have diarrhea.
• If you have a condition called Conn's syndrome (also known as primary aldosteronism).
• If you have low blood pressure.
• If you have ever had a stroke.
• If you are taking any of the following blood pressure-lowering medicines (hypertension):

-Un inhibitor of the angiotensin-converting enzyme (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

-Aliskirén.

• If you are taking an ACE inhibitor, along with a medicine that belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Use of Candesartán Viatris with other medicines").
• If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. It is not recommended to use candesartán at the beginning of pregnancy (first 3 months) and in any case, it should not be administered from the third month of pregnancy because it may cause serious harm to your baby (see Pregnancy section).

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

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

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

If you are to undergo surgery, inform your doctor or dentist that you are taking candesartán. This is because candesartán, in combination with some anesthetics, may cause a drop in blood pressure.

Children and adolescents

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

Use of Candesartán Viatris with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken, or may need to take other medicines, including those purchased without a prescription.

Candesartán may affect how some medicines work and some medicines may influence the effect of candesartán. Your doctor may need to adjust your dose and/or take other precautions. If you are using certain medicines, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medicines:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and the so-called ACE inhibitors (such as enalapril, captopril, lisinopril, or ramipril) or aliskirén (see also the information under the sections “Do not take Candesartán Viatris” and “Warnings and precautions”).
• An ACE inhibitor along with other medicines specifically used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).
• Nonsteroidal anti-inflammatory drugs (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) (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 to increase blood fluidity).
• Diuretics (medicines that promote urine elimination).
• Lithium (a medicine used to treat mental disorders).

Use of Candesartán Viatris with food and alcohol

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

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. Normally, your doctor will recommend that you stop taking candesartán before becoming pregnant or as soon as you know you are pregnant and recommend another medicine. It is not recommended to use candesartán at the beginning of pregnancy and in any case, it should not be administered from the third month of pregnancy because it may cause serious harm to your baby when administered from that time.

Breastfeeding

If you are breastfeeding or plan to start, consult your doctor or pharmacist before taking this medicine. It is not recommended to administer candesartán to women during this period, and your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially to newborns or premature babies.

Driving and operating machines

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

Candesartán Viatris contains lactose

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

This is a long-term treatment.

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

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

The tablet can be divided into equal doses.

Hypertension treatment:

The recommended initial dose is 8 mg once a day. Your doctor may increase this dose up to 32 mg once a day based on blood pressure response.

In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids, for example by vomiting, diarrhea, or because they are taking diuretics, the doctor may prescribe a lower initial dose.

Some black patients may present a reduced response to this type of medication, when given as a single treatment, and these patients may need a higher dose.

Heart failure treatment:

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

Use in children and adolescents with high blood pressure:

Children aged 6 to under 18 years:

The recommended initial dose is 4 mg once a day.

For patients weighing less than 50 kg, it is the doctor who may decide if the dose should be increased up to a maximum of 8 mg once a day.

For patients weighing 50 kg or more, it is the doctor who may decide if the dose should be increased up to 8 mg once a day, and then up to 16 mg once a day, if necessary.

If you take more Candesartán Viatris than you should:

If you take more candesartan than your doctor indicated, contact your doctor or pharmacist immediately or call the Toxicological Information Service (phone 91 562 04 20) indicating the medication and the amount ingested. Your blood pressure may decrease and you may feel tired.

If you forgot to take Candesartán Viatris:

Do not take a double dose to compensate for the missed doses. Simply take the next dose.

If you interrupt the treatment with Candesartán Viatris:

If you stop taking this medication, your blood pressure may increase again. Therefore, do not stop taking candesartan before consulting your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

It is important that you know which side effects could occur.

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

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 frequency of infections that may cause fever, intense chills, sore throat, mouth ulcers, or bronchial cough. These symptoms may indicate low white blood cell count (leucopenia).
• Liver function changes, including liver inflammation (hepatitis), symptoms may include nausea, vomiting, loss of appetite, general feeling of discomfort, fever, itching, yellowing of the skin or eyes, pale stools, or cloudy urine. These may be symptoms of severe liver problems.
• Decreased kidney function, symptoms may include decreased urine production or absence of urine production, cloudy or bloody urine, pain while urinating, or lower back pain. These symptoms may indicate severe kidney problems. In rare cases, it may cause kidney failure.

Other possible side effects include:

Frequent(may affect up to 1 in 10 people)

• Dizziness or sensation of rotational movement while standing (vertigo).
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause dizziness or fainting.
• Increased levels of potassium in the blood that may be seen in blood tests, especially if you already have kidney problems or heart failure. If this is severe, you may feel tired, weak, have an irregular heartbeat, or tingling in your hands or feet.

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

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

Unknown frequency(cannot be estimated from available data)

• Diarrhea.

Other side effects in children and adolescents

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

Reporting side effects

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

Keep out of sight and reach of children.

Do not take this medicationafter the expiration date that appears on the packaging, blister pack, or bottle after the abbreviation CAD: The expiration date is the last day of the month indicated. After opening the bottle for the first time, use it within100 days.

Do not store above 25ºC. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at your local SIGREcollection point at your usual pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment..

Composition of Candesartán Viatris

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

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

Appearance of the product and contents of the package

The tablets are white or almost white, round, biconvex, marked on one face with the inscription “M” over “C6” and smooth, with a breaking line, on the opposite face.

Candesartán Viatris is available in blisters, inside or not inside a pack, and inside 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 packs and bottles contain a desiccant. The bottles may contain or not cotton. The desiccant should not be ingested.

Only some package 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

GermanyCandesartancilexetil Mylan 16 mg Tabletten

DenmarkKandrozid 16 mg tabletter

SpainCandesartán Viatris 16 mg comprimidos EFG

FinlandKandrozid 16 mgtabletit

NorwayKandrozid 16 mg tabletter

NetherlandsCandesartan cilexetil Viatris 16 mg tabletten

PortugalCandesartan Mylan 16 mg comprimidos

United KingdomCandesartan cilexetil 16 mg Tablets

SwedenKandrozid 16 mgtabletter

Last review date of thisleaflet:February 2025

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/