Valsartan Viatris 320 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Valsartan Viatris 320 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 disease symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such 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, resulting in 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:

• 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 the blood vessels in the brain, heart, and kidneys, 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 conditions.

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 a severe liver disease.

• If you are more than 3 months pregnant (it is also 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 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 a narrowing of the renal artery (the artery supplying the kidney).

• 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 salt substitutes containing potassium, potassium-sparing medications, 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, 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 might be). Use of Valsartán Viatris is not recommended at the beginning of pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to your baby when used 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 (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

• Aliskiren.

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 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 when taken 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 potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin.
• Certain pain-relief 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.

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

• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Valsartán Viatris” and “Warnings and precautions”).

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 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. Use of Valsartán Viatris is not recommended during early pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby from that time onward.
• Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Valsartán Viatris is not recommended during breastfeeding, and your doctor will choose another treatment for you 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 and is therefore 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 provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. People with high blood pressure often do not experience any symptoms of the disease and may feel perfectly normal. Therefore, it is very important to keep your medical appointments, 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 oral valsartan solution is recommended.

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

Take Valsartán Viatris at approximately the same time each day.

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 this 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 can cause adverse effects, although not everyone will experience 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 kidney 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 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 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 skin spots, fever, itching (signs of blood vessel inflammation, also called vasculitis).
• Bleeding or bruising more easily 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).
• Reduction in hemoglobin levels and reduction in the proportion 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 spasms and abnormal heart rhythm).
• Increased liver function test values (which may indicate liver damage), 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 function abnormalities).
• Low sodium levels in the blood (which may cause fatigue, confusion, muscle spasms 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, talk to 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 Medicines: 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 refers to 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartan Viatris

The active substance is valsartan. Each tablet contains 320 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 pack

Valsartan Viatris 320 mg film-coated tablets are dark grey, oval, biconvex, bevelled tablets, marked with the inscription "VN 4" on one side and "M" on the other side of the tablet.

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

Only certain pack sizes may be marketed.

Marketing Authorisation 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 about this medicine, contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany Valsartan dura 320 mg Filmtabletten
Spain Valsartán Viatris 320 mg film-coated tablets EFG
Ireland Valsartan Viatris 320 mg
Italy Valsartan Mylan Generics 320 mg
Netherlands Valsartan Viatris 320 mg filmomhulde tabletten
Portugal Valsartan Mylan
United Kingdom (Northern Ireland) Valsartan Film-coated Tablets 320 mg

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

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