Package Insert: Information for the Patient

Valsartan Viatris 160 mg Film-Coated Tablets

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

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

1. What isValsartan Viatrisand what is it used for

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

3. How to takeValsartan Viatris

4. Possible side effects

5. Storage ofValsartan Viatris

6. Contents of the package and additional information

Valsartán 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 constrict, resulting in increased blood pressure. Valsartán Viatris acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

ValsartánViatrisfilm-coated tabletscan be used to treat three different conditions:

• To treat high blood pressure in adults and in children and adolescents aged 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 may cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values 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.ValsartánViatrisis used when an ACE inhibitor (a medication for treating heart failure) cannot be used or 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 feet and legs due to fluid retention. This is because the heart muscle cannot pump blood with sufficient force to provide all the blood needed by the body.

Do not take ValsartánViatris

• If you areallergicto valsartán or any of the other components of this medication (listed in section 6).

• If you have aserious liver disease.
• If you aremore than 3 months pregnant(it is better to avoid Valsartán Viatris during the first months of pregnancy – see Pregnancy section).
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take ValsartánViatris

• If you have liver disease.
• If you have a serious kidney disease or are being treated with 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 a severe heart disease other than heart failure or heart attack.
• If you are taking medications that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. You may need to regularly check your potassium levels.
• If you are under 18 years old and taking Valsartán Viatris with other medications that inhibit the renin-angiotensin-aldosterone system (blood pressure medications), your doctor may regularly check your kidney function and potassium levels.
• If you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartán Viatris is not recommended.
• If you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications to increase urine production).
• Inform your doctor if you are pregnant (or suspect you may be). Valsartán Viatris is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point onwards (see 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 ValsartánViatris, stop taking ValsartánViatrisimmediately and do not take it again. See also thesection 4 “Possible side effects”.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):

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

• 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 valsartán. Your doctor will decide whether to continue treatment. Do not stop taking valsartán on your own.

Your doctor may regularly check your kidney function, blood pressure, and electrolyte levels in your blood (e.g., potassium).

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

Patients may perceive that this medication has an unusual odor and/or taste. This is normal and characteristic of the active ingredient valsartán.

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

Other medications andValsartánViatris

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

The effect of treatment with Valsartán Viatris may be altered if taken with certain medications. You may need to change the dose, take other precautions, or, in some cases, discontinue treatment with one of the medications. This applies to both prescription and over-the-counter medications, especially:

• Other medications that lower blood pressure,especiallydiuretics(medications to increase urine production).
• Medications that increase the amount of potassiumin your blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.
• Certain medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs).
• Lithium,a medication used to treat certain types of psychiatric disorders.
• Some antibiotics (rifampicin group), a medication used to protect against transplant rejection (ciclosporin), or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of ValsartánViatris.

Additionally:

• If you are being treated aftera heart attack,it is not recommended to combine withACE inhibitors(a medication for treating a heart attack).
• If you are being treated forheart failure,it is not recommended to take a triple combination withACE 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 aliskirén (see also the headings “Do not take Valsartán 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, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

• Inform your doctor if you think you are (or may be) pregnant.Your doctor will usually recommend that you stop taking Valsartán Viatris before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Valsartán Viatris. Valsartán Viatris is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point onwards.
• Inform your doctor if you are breastfeeding or plan to start breastfeeding.Valsartán Viatris is not recommended for use 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 operating machinery

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

Valsartán Viatris contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially “sodium-free”.

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 appointments with the doctor, 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). You may also combine Valsartán Viatris with another medication (e.g. a diuretic).

Use in children and adolescents (6 to less than 18 years) with high blood pressure:In patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once a day. In patients weighing 35 kg or more, the initial usual dose is 80 mg of valsartan once a day. In some cases, your doctor may prescribe higher doses (the dose may 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 at 12 hours, 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 individual tolerance.

Valsartán Viatris can be taken with other treatments for heart attack and your doctor will decide what 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 individual tolerance.

Valsartán Viatris can be taken with other treatments for heart failure and your doctor will decide what treatment is suitable for you.

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

Take Valsartán Viatris approximately at the same time every day.

The tablet can be divided into equal doses.

If you take more Valsartán 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the packaging and remaining tablets with you.

If you forgot to take Valsartán Viatris:

Try to take Valsartán Viatris daily as prescribed. However, if you forget a dose, do not take a double dose to compensate for the missed doses. Simply return to your usual routine.

If you interrupt treatment with Valsartán Viatris:

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

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.

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

Rare(may affect up to 1 in 100 people)

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

Frequency unknown(cannot be estimated from available data)

• Severe blisters on the skin. (Dermatitis bullosa).

Otherside 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 deterioration).

Rare(may affect up to 1 in 100 people)

• Sudden loss of consciousness (syncope).
• Sensation of rotation (vertigo).
• Marked reduction in 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 with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency unknown(cannot be estimated from available data)

• Allergic reactions with skin rash, itching, and urticaria; symptoms of fever, swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or symptoms similar to the flu (signs of serum sickness).
• Reddish purple spots, fever, itching (signs of inflammation of blood vessels, also known as vasculitis).
• Bleeding or bruising more frequently than usual (signs of thrombocytopenia).
• Muscle pain (myalgia).
• Fever, sore throat, or ulcers in the mouth due to infections (symptoms of low white blood cell count, also known as neutropenia).
• Reduced hemoglobin level and reduced 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 abnormal heart rhythm).
• Elevation of liver function values (which may indicate liver damage), including an increase in bilirubin levels in the blood (which, in severe cases, can cause the skin and eyes to turn yellow).
• Increased levels of urea nitrogen in the blood and increased serum creatinine levels (which may indicate renal anomalies).
• Low sodium level in the blood (which can cause fatigue, confusion, muscle spasms, and/or seizures in severe cases).

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

Side effects in children and adolescents are similar to those observed 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 theSpanish 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 this medication out of the sight and reach of children.

Do not use this medication 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 medication does not require special storage conditions.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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 contents of the package

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

The groove 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 a multiple package of 98 tablets that includes 2 boxes (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 commercially available.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturers responsible

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

For more information about this medicine, please contact 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 Area and in the United Kingdom (Northern Ireland) with the following names:

Germany Valsartan dura 160 mg Filmtabletten

Spain Valsartán Viatris 160 mg comprimidos recubiertos con película EFG

France Valsartan Viatris 160 mg, comprimé pelliculé sécable

Ireland Valsartan Viatris 160 mg

Italy Valsartan Mylan Generics 160 mg

Netherlands Valsartan Viatris 160 mg filmomhulde tabletten

Portugal Valsartan Mylan

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

Last review date of this leaflet: January 2025

For more detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es /