Valsartan Viatris 160 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Valsartan Viatris 160 mg film-coated tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Valsartán Viatris belongs to a class of medicines 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, leading to increased blood pressure. Valsartán Viatris works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Viatris film-coated tablets can be used for 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 on the heart and arteries. If left untreated, it may damage blood vessels in the brain, heart, and kidneys, potentially leading to stroke, heart failure, or kidney failure. High blood pressure also 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 within 12 hours to 10 days.
• To treat symptomatic heart failure in adult patients. Valsartán Viatris is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a medication for treating heart failure) cannot be used, or it may be used in combination with ACE inhibitors when other heart failure treatments are not suitable.

Symptoms of heart failure include difficulty breathing and swelling of the feet and legs due to fluid retention. This occurs because the heart muscle cannot pump blood strongly enough to supply the body's needs.

2. What you need to know before taking Valsartán Viatris

Do not take Valsartán Viatris

• If you are allergic to valsartan or to 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 best 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 blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Valsartán Viatris

• If you have liver disease.

• If you have severe kidney disease or are undergoing dialysis.

• If you have narrowing of the artery to the kidney (renal artery stenosis).

• If you have recently undergone a kidney transplant (received a new kidney).

• If you are being treated for heart attack or heart failure, your doctor may monitor your kidney function.

• If you have a serious heart condition other than heart failure or heart attack.

• If you are taking medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin. Regular monitoring of blood potassium levels may be necessary.

• If you are under 18 years of age and taking Valsartán Viatris together with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may periodically monitor your kidney function and blood potassium levels.

• If you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, taking Valsartán Viatris is not recommended.

• If you have lost a large amount of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines that increase urine output).

• Inform your doctor if you are pregnant (or suspect you may be pregnant). The use of Valsartán Viatris is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause severe harm to your baby when taken from that point onward (see Pregnancy section).

• If you have ever experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartán Viatris, stop taking it 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), particularly 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 monitor 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 Valsartán 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 situations apply to you, inform your doctor before taking Valsartán Viatris.

Other medicines and Valsartán Viatris

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

The effect of treatment with Valsartán Viatris may be altered if taken together with certain medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases, discontinue treatment with one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• Other medicines that lower blood pressure, particularly diuretics (medicines that increase urine output).
• Medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• Certain pain medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
• Lithium, a medicine used to treat certain psychiatric disorders.
• Some antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartán Viatris.

Additionally:

• If you are being treated after a heart attack, combination with ACE inhibitors (a medicine used to treat heart attack) is not recommended.
• If you are being treated for heart failure, the triple combination with ACE inhibitors and beta-blockers (medicines used to treat heart failure) is not recommended.

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

• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Valsartán 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 breastfeeding

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

• Inform your doctor if you think you are (or might be) pregnant. Your doctor will usually advise you to stop taking Valsartán Viatris before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartán Viatris is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause severe harm to your baby when taken from that point.
• Inform your doctor if you are breastfeeding or planning to breastfeed. The use of Valsartán Viatris during breastfeeding is not recommended, and your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Before driving, operating tools, handling machinery, or engaging in other activities requiring concentration, make sure you know how Valsartán Viatris affects you. Like many other medicines used to treat high blood pressure, Valsartán Viatris may rarely cause dizziness and affect your ability to concentrate.

Valsartán Viatris contains sodium

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

3. How to take Valsartán Viatris

To achieve the best results and reduce the risk of adverse effects, follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. People with high blood pressure often do not notice any signs of the condition and frequently feel completely normal. This makes it very important to attend your medical appointments regularly, 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). Valsartán Viatris may also be combined with another medicine (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 daily. In patients weighing 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 may be increased to 160 mg and up to a maximum of 320 mg).

In children who have difficulty swallowing tablets, administration of valsartan oral solution is recommended.

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

Valsartán Viatris may be administered together with other treatments for heart attack, and your doctor will decide which treatment is appropriate for you.

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

Valsartán Viatris may be administered together with other treatments for heart failure, and your doctor will decide which treatment is appropriate for you.

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

Take Valsartán Viatris approximately at the same time each day.

The tablet may be divided into equal doses.

If you take more Valsartán Viatris than you should

If you experience severe 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Bring the packaging and any remaining tablets with you.

If you forget to take Valsartán Viatris

Try to take Valsartán Viatris daily as prescribed. However, if you miss a dose, do not take a double dose to make up for the missed dose. Simply resume your regular dosing schedule.

If you stop taking Valsartán Viatris

If you discontinue treatment with Valsartán Viatris, your condition may worsen. Do not stop taking the medicine unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Stop taking this medicine and consult your doctor or go to the nearest hospital emergency department 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 when lying down, swelling of the feet or legs (signs of heart failure).

Frequency not known (cannot be estimated from available data)

• Severe blistering of 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 upon standing.
• Reduced kidney function (signs of renal impairment).

Uncommon (may affect up to 1 in 100 people)

• Sudden loss of consciousness (syncope).
• Sensation of spinning (vertigo).
• Marked reduction in kidney function (signs of acute renal failure).
• Muscle cramps, irregular heartbeat (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 causing 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, joint swelling and pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms (signs of serum sickness).
• Purple-red spots, fever, itching (signs of blood vessel inflammation, also called vasculitis).
• Unusual bleeding or bruising (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).
• Reduction in hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anemia).
• Increased potassium levels in the blood (which, in severe cases, may cause muscle cramps and irregular heartbeat).
• Elevated liver function test values (which may indicate liver injury), including increased blood bilirubin levels (which, in severe cases, may cause yellowing of the skin and eyes).
• Increased blood urea nitrogen and increased serum creatinine levels (which may indicate kidney dysfunction).
• Low sodium levels in the blood (which may cause fatigue, confusion, muscle cramps, and/or seizures 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 for 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the carton after CAD or EXP. The expiry date is the last day of the month indicated.

This medicine does not require any 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 disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán Viatris

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

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

The coating contains 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 pack

Valsartán Viatris 160 mg film-coated tablets are yellow/light brownish-yellow, oval, biconvex, bevelled tablets, marked with the inscription “M” on the left side of the breakline on one side and “VN 3” on the other side of the tablet.

The breakline is intended to facilitate breaking the tablet into two equal parts.

Valsartán Viatris tablets are supplied in blister packs of 7, 10, 14, 28, 30, 56, 90, 98, 100 tablets, in a multiple pack of 98 tablets comprising 2 cartons (each containing 49 tablets), in HDPE bottles containing 56, 98, 500 and 1000 tablets, and in HDPE bottles with desiccant containing 28 and 30 tablets.

Only some pack 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

For further information regarding this medicinal product, please contact 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 and in the United Kingdom (Northern Ireland) under the following names:

Germany Valsartan dura 160 mg Filmtabletten
Spain Valsartán Viatris 160 mg film-coated tablets 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

Date of the most recent revision of this leaflet: January 2025

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