VALSARTAN VIATRIS 320 mg FILM-COATED TABLETS

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 blood pressure medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Valsartan Viatris

• If you have liver disease.
• If you have severe kidney disease or are undergoing dialysis.
• If you have narrowing of the renal arteries.
• If you have recently had a kidney transplant (received a new kidney).
• 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 diuretics, and heparin. It may be necessary to check your potassium blood levels regularly.
• If you are under 18 years old and take Valsartan Viatris with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may periodically check your kidney function and potassium blood levels.
• 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 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 more than three months pregnant, as it can cause serious harm to your baby when administered from that time onwards (see section Pregnancy).
• If you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking another medicine (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 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.

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”.

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

If any of these conditions apply to you, inform 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 taken 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 to increase urine production).
• Medicines that increase the amount of potassiumin the blood. These include potassium supplements, salt substitutes containing potassium, potassium-sparing diuretics, and heparin.
• Certain pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs).
• Lithium,a medicine used to treat certain types of psychiatric disorders.
• Some antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsartan Viatris.

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 use Valsartan Viatris at the start of pregnancy, and in no case should it be administered from the third month of pregnancy onwards, as it can cause serious harm to your baby when administered from that time onwards.
• Tell your doctor if you are breastfeeding or about 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 machinery, or engaging in 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 can 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, so it 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, consult 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 attend your doctor's 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). You may also be given Valsartan Viatris in combination with another medicine (e.g., a diuretic).

Use in children and adolescents (6 to less than 18 years of age) 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.

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.

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 medicine and the amount ingested. Bring the package and the 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 usual 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Severe skin blisters (bullous dermatitis).

Other side 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 kidney impairment).

Uncommon(may affect up to 1 in 100 people)

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

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

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

Frequency not known(cannot be estimated from the available data)

• Allergic reactions with skin rash, itching, and hives; symptoms of fever, swelling, and joint pain, muscle pain, swelling of the lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness).
• Purple spots, fever, itching (signs of vasculitis, also known as inflammation of the blood vessels).
• Bleeding or bruising more often 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 and hematocrit levels in the blood (which, in severe cases, can lead to anemia).
• Increased potassium levels in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm).
• Elevated liver enzyme values (which may indicate liver damage), including an increase in bilirubin levels in the blood (which, in severe cases, can cause yellowing of the skin and eyes).
• Increased urea and creatinine levels in the blood (which may indicate kidney abnormalities).
• Low sodium levels in the blood (which can cause fatigue, confusion, muscle spasms, and/or convulsions 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 of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Valsartán Viatris

The active ingredient 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 Container Content

Valsartán Viatris 320 mg film-coated tablets are dark gray, oval, biconvex, beveled, marked with the inscription "VN 4" on one face and "M" on the other face of the tablet.

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

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanyValsartan dura 320 mg Filmtabletten

SpainValsartán Viatris 320 mg film-coated tablets EFG

IrelandValsartan Viatris 320 mg

ItalyValsartan Mylan Generics 320 mg

NetherlandsValsartan Viatris 320 mg film-coated tablets

PortugalValsartan Mylan

United Kingdom(Northern Ireland)Valsartan Film-coated Tablets 320 mg

Date of the last revision of this leaflet:January 2025

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