VALSARTAN VIATRIS 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valsartan Viatris 160 mg film-coated tablets EFG

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

• Keep this package 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 package leaflet

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

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

Valsartan Viatris belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, leading to an increase in blood pressure. Valsartan Viatris works by blocking the effect of angiotensin II. As a result, the blood vessels relax and blood pressure decreases.

Valsartan Viatris film-coated tablets can be used for three different conditions:

• To treat high blood pressure in adults and in children and adolescents from 6 to less than 18 years.High blood pressure increases the workload of the heart and arteries. If not treated, it can damage the blood vessels in the brain, heart, and kidneys, and may lead to a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these disorders.
• To treat adult patients after a recent heart attack(myocardial infarction). “Recent” means here between 12 hours and 10 days.
• To treat symptomatic heart failure in adult patients.Valsartan Viatris is used when a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medicine for treating heart failure) cannot be used or can be used in combination with ACE inhibitors when other medicines for treating heart failure cannot be used.

Among the symptoms of heart failure are difficulty breathing and swelling of the feet and legs due to fluid retention. This is because the heart muscle cannot pump blood with enough force to supply the body with the blood it needs.

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

Do not take Valsartan Viatris

• If you are allergicto valsartan or any of the other ingredients of this medicine (listed in section 6).

• If you have severe liver disease.
• If you are more than 3 months pregnant(it is also better to avoid Valsartan Viatris during the first months of pregnancy – see section Pregnancy).
• If you have diabetes or kidney problems and are being treated with a medicine that contains aliskiren.

If any of these apply to you, do not take Valsartan Viatris.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valsartan Viatris

• If you have liver disease.
• If you have severe kidney disease or are having dialysis.
• If you have narrowing of the kidney artery.
• If you have recently had a kidney transplant.
• If you are being treated for heart attack or heart failure, your doctor may check your kidney function.
• If you have severe heart disease other than heart failure or heart attack.
• If you are taking medicines that increase the amount of potassium in your blood.These include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparin. It may be necessary to check your potassium blood levels regularly.
• If you are under 18 years old and are taking Valsartan Viatris with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure),your doctor may check your kidney function and potassium blood levels regularly.
• If you have aldosteronism, a condition where the adrenal glands produce too much aldosterone hormone.In this case, it is not recommended to take Valsartan Viatris.
• If you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines that increase urine production).
• Tell your doctor if you are pregnant (or think you might be).Do not take Valsartan Viatris if you are more than 3 months pregnant, as it may cause serious harm to your baby. See section Pregnancy.
• If you have ever had swelling of the tongue and face caused by an allergic reaction called angioedema when taking another medicine (including ACE inhibitors),tell your doctor. If you get these symptoms while taking Valsartan Viatris, stop taking Valsartan Viatris immediately and never take it again. See also section 4 “Possible side effects”.
• 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),especially if you have kidney problems related to diabetes.
• Aliskiren.

• If you are being treated with an ACE inhibitor together with other medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartan. Your doctor will decide whether to continue treatment. Do not stop taking valsartan on your own.

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

See also the information under the heading “Do not take Valsartan Viatris”.

Patients may notice that this medicine has an unusual odor and/or taste. This is normal and characteristic of the active substance valsartan.

If any of these apply to you, tell your doctor before taking Valsartan Viatris.

Other medicines and Valsartan Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of treatment with Valsartan Viatris may be affected if you take it with certain other medicines. It may be necessary to change the dose, take other precautions, or in some cases, stop treatment with one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• Other medicines that lower blood pressure,especially diuretics(medicines that increase urine production).
• Medicines that increase the amount of potassium in the blood.These include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparin.
• Certain pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• Lithium,a medicine used to treat certain types of psychiatric diseases.
• Some antibiotics (rifampicin group), a medicine used to prevent transplant rejection (ciclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir).These medicines may increase the effect of Valsartan Viatris.

In addition:

• If you are being treated after a heart attack,it is not recommended to combine with ACE inhibitors(a medicine for treating heart attack).
• If you are being treated for heart failure,it is not recommended to combine with ACE inhibitors and beta-blockers(a medicine for treating heart failure).

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren(see also the information under the headings “Do not take Valsartan Viatris” and “Warnings and precautions”).
• If you are being treated with an ACE inhibitor together with other medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Tell your doctor if you think you are (or might be) pregnant.Your doctor will normally advise you to stop taking Valsartan Viatris before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Valsartan Viatris. It is not recommended to take Valsartan Viatris during the first few months of pregnancy, and in any case, it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby.
• Tell your doctor if you are breast-feeding or about to start breast-feeding.It is not recommended to take Valsartan Viatris during breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed, especially if your baby is a newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or carrying out other activities that require concentration, make sure you know how Valsartan Viatris affects you. Like many other medicines used to treat high blood pressure, Valsartan Viatris may cause dizziness and affect your ability to concentrate.

Valsartan Viatris contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose, which is essentially “sodium-free”.

3. How to take Valsartan Viatris

To get the best results and reduce the risk of side effects, follow exactly the instructions for taking this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again. People with high blood pressure often do not notice any symptoms of the disease; many feel normal. This makes it very important to keep your appointments with your doctor, even if you feel well.

Adult patients with high blood pressure:the usual dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). You may also take Valsartan Viatris in combination with another medicine (e.g., a diuretic).

Use in children and adolescents (6 to less than 18 years) with high blood pressure:in patients who weigh less than 35 kg, the recommended dose is 40 mg of valsartan once daily. In patients who weigh 35 kg or more, the usual starting dose is 80 mg of valsartan once daily. In some cases, your doctor may prescribe higher doses (the dose can be increased to 160 mg and up to a maximum of 320 mg).

In children who have difficulty swallowing tablets, it is recommended to administer valsartan oral solution.

Adult patients after a recent heart attack:after a heart attack, treatment is usually started at 12 hours, normally with a low dose of 20 mg, given twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan Viatris can be given with other treatments for heart attack, and your doctor will decide which treatment is suitable for you.

Adult patients with heart failure:treatment is usually started with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan Viatris can be given with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

You can take Valsartan Viatris with or without food. Swallow Valsartan Viatris with a glass of water.

Take Valsartan Viatris at about the same time each day.

The tablet can be divided into equal doses.

If you take more Valsartan Viatris than you should

If you feel a strong dizziness and/or fainting, contact your doctor immediately and lie down.

In case of overdose or accidental ingestion, contact your doctor or pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. Bring the package and remaining tablets with you.

If you forget to take Valsartan Viatris

Try to take Valsartan Viatris daily as prescribed. However, if you miss a dose, do nottake a double dose to make up for the missed doses. Simply return to your regular schedule.

If you stop taking Valsartan Viatris

If you stop taking Valsartan Viatris, your condition may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any further questions on 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 all people suffer from them.

Stop taking this medicine and consult your doctor or visit the emergency department of the nearest hospital if you experience any of the following adverse effects:

Uncommon(may affect up to 1 in 100 people)

• Angioedema (a specific allergic reaction) with symptoms such as:
• • Swelling of the face, lips, tongue, or throat.
  • Difficulty breathing or swallowing.
  • Hives, itching.
• Shortness of breath, difficulty breathing while lying down, swelling of the feet or legs (signs of heart failure).

Frequency not known(cannot be estimated from available data)

• Severe blisters on the skin (bullous dermatitis).

Other adverse effects:

Common(may affect up to 1 in 10 people)

• Dizziness.
• Low blood pressure, with or without symptoms, such as dizziness and fainting when standing up.
• Reduced kidney function (signs of renal impairment).

Uncommon(may affect up to 1 in 100 people)

• Sudden loss of consciousness (syncope).
• Feeling of rotation (vertigo).
• Marked reduction of kidney function (signs of acute renal failure).
• Muscle spasms, abnormal heart rhythm (signs of hyperkalemia).
• Headache.
• Cough.
• Abdominal pain.
• Nausea.
• Diarrhea.
• Fatigue.
• Weakness.

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

• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known(cannot be estimated from available data)

• Allergic reactions with skin rash, itching, and hives; symptoms of fever, swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness).
• Purplish red spots, fever, itching (signs of blood vessel inflammation, also called vasculitis).
• More frequent bleeding or bruising than usual (signs of thrombocytopenia).
• Muscle pain (myalgia).
• Fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also called neutropenia).
• Decreased hemoglobin level and decreased percentage of red blood cells in the blood (which, in severe cases, can cause anemia).
• Increased potassium level in the blood (which, in severe cases, can cause muscle spasms and an abnormal heart rhythm).
• Elevated liver function values (which may indicate liver damage), including an increased bilirubin level in the blood (which, in severe cases, can cause the skin and eyes to turn yellow).
• Increased urea nitrogen level in the blood and increased serum creatinine level (which may indicate kidney function abnormalities).
• Low sodium level in the blood (which can cause fatigue, confusion, muscle spasms, and/or convulsions in severe cases).

The frequency of some adverse effects may vary depending on your condition. For example, certain adverse effects such as dizziness and reduced kidney function were observed less frequently in adult patients treated with high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

The adverse effects in children and adolescents are similar to those observed in adults.

Reporting adverse effects:

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

5. Storage of Valsartan Viatris

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box after CAD or EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartan Viatris

The active ingredient is valsartan. Each tablet contains 160 mg of valsartan.

The other components are: microcrystalline cellulose, crospovidone, povidone, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The coating includes hypromellose (E-464), titanium dioxide (E-171), macrogol, vanillin, yellow iron oxide (E-172), black iron oxide (E-172), and red iron oxide (E-172).

Appearance of the Product and Package Contents

Valsartan Viatris 160 mg film-coated tablets are yellow/dark yellow, oval, biconvex, beveled, marked with the inscription "M" on the left side of the score line on one side and "VN 3" on the other side of the tablet.

The score line is used to divide the tablet into two equal doses.

Valsartan Viatris tablets are dispensed in blisters of 7, 10, 14, 28, 30, 56, 90, 98, 100 tablets, in a multiple package of 98 tablets which consists of 2 cartons (each containing 49 tablets), in HDPE bottles containing 56, 98, 500, and 1000 tablets, and HDPE bottles with desiccant containing 28, 30 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturers

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

or

Mylan Germany GmbH

Zweigniederlassung Bad Homburg Benzstrasse 1

61352 Bad Homburg v. d. Höhe

Germany

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

GermanyValsartan dura 160 mg Filmtabletten

SpainValsartán Viatris 160 mg film-coated tablets EFG

FranceValsartan Viatris 160 mg, sécable film-coated tablet

IrelandValsartan Viatris 160 mg

ItalyValsartan Mylan Generics 160 mg

NetherlandsValsartan Viatris 160 mg filmomhulde tabletten

PortugalValsartan Mylan

United Kingdom(Northern Ireland)Valsartan Film-coated Tablets 160 mg

Date of the last revision of this prospectus:January 2025

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