Prospecto: information for the patient

Candesartán Viatris 8 mg tablets EFG

(Candesartán cilexetilo)

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. See section 4.

1.What isCandesartán Viatrisand for what it is used

2.What you need to know before starting to takeCandesartán Viatris

3.How to takeCandesartán Viatris

4.Possible adverse effects

5.Storage ofCandesartán Viatris

6.Contents of the package 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 and under 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 whose symptoms persist 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 medication (listed in section 6).
• If you have severe liver disease or bile duct obstruction (problem with the bile flow from 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 medication 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 medications used to treat high blood pressure (hypertension):

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

-Aliskirén.

• If you are taking an ACE inhibitor, along with a medication that belongs to the class of medications known as mineralocorticoid receptor antagonists (MRAs). These medications are used to treat heart failure (see "Use of Candesartán Viatris with other medications").
• 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 no case should it be administered after the third month of pregnancy because it may cause serious harm to your baby (see Pregnancy section).

Speak with 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 (such as 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, speak with your doctor. Candesartán should not be administered to children under 1 year of age due to the potential risk of kidney development.

Use of Candesartán Viatris with other medications

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

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

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

• Other medications 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 specific medications for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone).
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications used to relieve pain and inflammation).
• Aspirin (if you take more than 3 g per day) (medication to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medications that increase the amount of potassium in your blood).
• Heparin (a medication to increase blood fluidity).
• Diuretics (medications that promote urine elimination).
• Lithium (a medication used to treat mental disorders).

Use of Candesartán Viatris with food and alcohol

• You can take candesartán with or without food.
• When 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 medication. 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 medication. It is not recommended to use candesartán at the beginning of pregnancy and in no case should it be administered after the third month of pregnancy because it may cause serious harm to your baby when administered from that point on.

Breastfeeding

If you are breastfeeding or plan to start, consult your doctor or pharmacist before taking this medication. 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 machinery

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

Candesartán Viatris contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This is a long-term treatment.

Follow exactly the administration instructions of 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 increase this dose by doubling it in intervals of at least 2 weeks up to 32 mg once a day. Candesartan 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 Toxicology 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 medications, this medication may have side effects, although not everyone may experience them.

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

Stop taking candesartan and talk to your doctor, or go to the nearest emergency center, 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.
• Increased number of infections that may cause fever, intense chills, sore throat, mouth ulcers, or bronchial cough. These symptoms may be indicative of low white blood cell count (leucopenia).
• Liver function changes, including liver inflammation (hepatitis) symptoms may be feeling unwell (nausea), feeling unwell (vomiting), loss of appetite, feeling unwell in general, fever, itching, yellowing of the skin or the white of the eyes, pale stools or cloudy urine. These may be symptoms of severe liver problems.
• Decreased kidney function, symptoms may be little urine production or absence of urine production, cloudy or bloody urine, pain while urinating or lower back pain. These symptoms may be indicative of severe kidney problems. In very rare cases, it may cause kidney failure.

Other possible side effects include:

Frequent(may affect up to 1 in 10 people)

• Dizziness/feeling 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 situation is severe, you will feel tired, 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 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 secretion, 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 25°C. 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 SIGREdrop-off 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 candesartán cilexetilo. Each tablet contains 8 mg of candesartán cilexetilo.

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 “C5” and smooth, with a line of breakage, on the opposite face.

Candesartán Viatris is available in blisters, either inside or outside a pack and inside a box, or pack 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 responsible for manufacturing

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

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

Further information on this medicinal product can be obtained by contacting 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 with the following names:

GermanyCandesartancilexetil Mylan 8 mg Tabletten

DenmarkKandrozid 8 mg tabletter

SpainCandesartán Viatris 8 mg comprimidos EFG

FinlandKandrozid 8 mgtabletit

NorwayKandrozid 8 mg tabletter

NetherlandsCandesartan cilexetil Viatris 8 mg tabletten

PortugalCandesartan Mylan 8 mg comprimidos

United KingdomCandesartan cilexetil 8 mg Tablets

SwedenKandrozid 8 mgtabletter

Last revision date of thisleaflet:February 2025

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