VALSARTAN VIATRIS 80 mg FILM-COATED TABLETS

Introduction

Prospect: patient information

Valsartan Viatris 80 mg film-coated tablets EFG

Read the entire 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 to you only, and you should not give it to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus. See section 4.

Contents of the prospectus

1. What is Valsartan Viatris and what is it used for
2. What you need to know before taking Valsartan Viatris
3. How to take Valsartan Viatris
4. Possible adverse effects
5. Storage of Valsartan Viatris
6. Package contents and additional information

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

Valsartan Viatris belongs to a class of medications known as angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, resulting in increased blood pressure. Valsartan Viatris works by blocking the effect of angiotensin II. As a result, 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 left untreated, it can damage blood vessels in the brain, heart, and kidneys, and can lead to a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal values reduces the risk of developing these disorders.
• To treat adult patients after a recent heart attack(myocardial infarction). "Recent" here means between 12 hours and 10 days.
• To treat symptomatic heart failure in adult patients.Valsartan Viatris is used when a group of medications called Angiotensin-Converting Enzyme (ACE) inhibitors (a medication for treating heart failure) cannot be used, or it can be used in combination with ACE inhibitors when other medications 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 provide all the blood needed by the body.

2. What you need to know before taking Valsartan Viatris

Do not take Valsartan Viatris

• If you are allergicto valsartan or any of the other components of this medication (included in section 6).

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartan Viatris

• If you have liver disease.
• If you have severe kidney disease or are undergoing dialysis.
• If you have a narrowing of the kidney artery.
• If you have recently undergone a kidney transplant (received a new kidney).
• If you are being treated for a 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 medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. It may be necessary to regularly monitor the amount of potassium in the blood.
• If you are under 18 years old and take Valsartan Viatris along with other medications that inhibit the renin-angiotensin-aldosterone system (medications that lower blood pressure), your doctor may periodically check your kidney function and blood potassium levels.
• If you have aldosteronism, a disease in which 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 (medications to increase urine production).
• Tell your doctor if you are pregnant (or think you might be). It is not recommended to use Valsartan Viatris at the start of pregnancy, and in no case should it be administered if you are pregnant for more than three months, as it can cause serious harm to your baby when administered from that time on (see the Pregnancy section).
• If you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking another medication (including ACE inhibitors), inform your doctor. If you experience these symptoms while taking Valsartan Viatris, stop taking Valsartan Viatris immediately and never take it again. See also the section 4 "Possible adverse effects".
• If you are taking any of the following medications used to treat high blood pressure (hypertension):

• An Angiotensin-Converting Enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

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

Consult 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 medication has an unusual odor and/or taste. This is normal and characteristic of the active ingredient valsartan.

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

Other medications and Valsartan Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• Other medications that lower blood pressure,especially diuretics(medications to increase urine production).
• Medications that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.
• Certain pain medicationscalled non-steroidal anti-inflammatory drugs (NSAIDs).
• Lithium,a medication used to treat certain types of psychiatric disorders.
• Some antibiotics (rifampicin group), a medication used to prevent transplant rejection (cyclosporine), or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications 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 medication for treating a heart attack).
• If you are being treated for heart failure,it is not recommended to combine with ACE inhibitors and beta-blockers(a medication for treating heart failure).

Your doctor may need to modify 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 along with other medications for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

• Tell your doctor if you think you are (or might be) pregnant.Your doctor will generally recommend that you stop taking Valsartan Viatris before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medication instead of Valsartan Viatris. It is not recommended to use Valsartan Viatris at the start of pregnancy, and in no case should it be administered if you are pregnant for more than three months, as it can cause serious harm to your baby when administered from that time on.
• Tell your doctor if you are breastfeeding or plan to start breastfeeding.It is not recommended to use Valsartan Viatris during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, or operating machines, or carrying out other activities that require concentration, make sure you know how Valsartan Viatris affects you. Like many other medications used to treat high blood pressure, Valsartan Viatris can cause, in rare cases, dizziness and affect concentration.

Valsartan Viatris contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free".

3. How to take Valsartan Viatris

To get the best results and reduce the risk of adverse effects, follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. People with high blood pressure often do not notice any signs of the disease; many feel normal. This makes it very important to attend your doctor's appointments, even if you feel well.

Adult patients with high blood pressure:the usual dose is 80 mg per day. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Valsartan Viatris can also be combined with another medication (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 a day. In patients who weigh 35 kg or more, the usual starting dose is 80 mg of valsartan once a day. 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 the tablets, it is recommended to administer valsartan oral solution.

Adult patients after a recent heart attack:after a heart attack, treatment usually starts 12 hours later, normally with a low dose of 20 mg, administered twice a day. 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 a day. The final dose will depend on your particular tolerance.

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

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

Valsartan Viatris can be administered along 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 approximately at the same time each day.

The tablet can be divided into equal doses.

If you take more Valsartan Viatris than you should

If you notice 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 medication and the amount ingested. Bring the packaging and remaining tablets with you.

If you forget to take Valsartan Viatris

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

If you interrupt treatment with Valsartan Viatris

If you stop your treatment with Valsartan Viatris, your disease may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other questions about the use of this medication, 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).
• Purpura, fever, itching (signs of vasculitis, also known as inflammation of blood vessels).
• 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 known as neutropenia).
• Decrease in hemoglobin level and decrease in red blood cell percentage 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 abnormal heart rhythm).
• Elevation of liver function values (which may indicate liver damage), including an increase in bilirubin level in the blood (which, in severe cases, can cause yellowing of the skin and eyes).
• 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.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. 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 the 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 80 mg of valsartan.

The other ingredients 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), red iron oxide (E-172).

Appearance of the Product and Package Contents

Valsartan Viatris 80 mg film-coated tablets are pale red, round, biconvex, beveled with a score line on one side and marked with the inscription "M" over "VN 2" on the other side.

The score line serves 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 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)under the following names:

GermanyValsartan dura 80 mg Filmtabletten

SpainValsartán Viatris 80 mg film-coated tablets EFG

FranceValsartan Viatris 80 mg, sécable film-coated tablet

IrelandValsartan Viatris 80 mg

ItalyValsartan Mylan Generics 80 mg

NetherlandsValsartan Viatris 80 mg filmomhulde tabletten

PortugalValsartan Mylan

United Kingdom(Northern Ireland)Valsartan Film-coated Tablets 80 mg

Date of the last revision of this leaflet: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/