VALSARTAN/HYDROCHLOROTHIAZIDE VIATRIS 320/12.5 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Valsartan/HydrochlorothiazideViatris320 mg/12.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Valsartan/Hydrochlorothiazide Viatris film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. These medicines help to control high blood pressure (hypertension).

• Valsartanbelongs to a class of medicines known as "angiotensin II receptor antagonists", which help to control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, leading to an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, the blood vessels relax and blood pressure decreases.

• Hydrochlorothiazidebelongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also reduces blood pressure.

Valsartan/Hydrochlorothiazide Viatris is used to treat high blood pressure that is not adequately controlled with a single medicine.

High blood pressure increases the workload of the heart and arteries. If not treated, it can damage the blood vessels in the brain, heart, and kidneys, and may lead to a 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.

2. What you need to know before you take Valsartan/Hydrochlorothiazide Viatris

Do not take Valsartan/Hydrochlorothiazide Viatris

• If you are allergicto valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant more than 3 months. (In any case, it is better to avoid taking Valsartan/Hydrochlorothiazide Viatris in the first months of pregnancy; see section "Pregnancy").
• If you have severe liver disease.
• If you have severe kidney disease.
• If you are unable to urinate (anuria).
• If you are undergoing dialysis.
• If you have low potassium or sodium levels in your blood or if your calcium levels in your blood are higher than normal despite treatment.
• If you have gout.
• If you have diabetes or kidney problems and are being treated with a medicine to reduce blood pressure that contains aliskiren.

If any of these situations apply to you, do not take this medicine and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartan/Hydrochlorothiazide Viatris:

• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking valsartan/hydrochlorothiazide, seek medical attention immediately.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking valsartan/hydrochlorothiazide.
• If you are using potassium-sparing medicines, potassium supplements, salt substitutes that contain potassium, or other medicines that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly check your potassium levels in your blood.
• If you have a history of allergy to sulfonamide or penicillin.
• If your potassium levels in your blood are low.
• If you have severe diarrhea or vomiting.
• If you are taking high doses of diuretics (water pills).
• If you have severe heart disease.
• If you have narrowing of the kidney artery.
• If you have recently undergone a kidney transplant.
• If you have hyperaldosteronism. This is a disease in which your adrenal glands produce too much aldosterone hormone. In this case, the use of valsartan/hydrochlorothiazide is not recommended.
• If you have kidney or liver disease.
• If you have fever, rash, and joint pain, which can be signs of systemic lupus erythematosus (SLE, a known autoimmune disease).
• If you have diabetes, gout, or high cholesterol or triglyceride levels in your blood.
• If you have previously had an allergic reaction with the use of another medicine of this class to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.
• It may cause increased sensitivity of the skin to the sun.
• You must inform your doctor if you suspect that you are (or may be) pregnant. The use of valsartan/hydrochlorothiazide is not recommended at the start of pregnancy, and it should not be taken if you are pregnant more than 3 months, as it may cause serious harm to your baby if used during this period (see section “Pregnancy”).
• If you are taking any of the following medicines used to treat high blood pressure:

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

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 Valsartan/Hydrochlorothiazide Viatris”.

• If you experience vision loss or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, and can occur within hours to weeks after taking Valsartan/Hydrochlorothiazide Viatris. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have previously had an allergy to penicillin or sulfonamides.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking valsartan/hydrochlorothiazide on your own.

Use in athletes

This medicine contains hydrochlorothiazide, which may produce a positive result in doping tests.

Children and adolescents

Valsartan/hydrochlorothiazide is not recommended in children and adolescents under 18 years of age.

Other medicines and Valsartan/Hydrochlorothiazide Viatris

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

The effectiveness of this medicine 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 especially to the following medicines:

• Lithium, a medicine used to treat certain psychiatric disorders.
• Medicines that affect or may be affected by potassium levels in the blood, such as digoxin, a medicine to control heart rhythm, or some antipsychotic and antidepressant medicines.
• Medicines that can increase the amount of potassium in the blood, such as potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines, heparin.
• Medicines that can decrease the amount of potassium in the blood, such as corticosteroids, some laxatives.
• Diuretics (water pills), medicines to treat gout, such as allopurinol, vitamin D, and calcium supplements, medicines to treat diabetes (oral or insulin).

• Other medicines to lower blood pressure, such as beta-blockers or methyldopa, or medicines that narrow blood vessels or stimulate the heart, such as noradrenaline or adrenaline.
• Medicines to increase blood sugar levels, such as diazoxide.
• Medicines to treat cancer, such as methotrexate or cyclophosphamide.
• Pain medicines.
• Medicines for arthritis.
• Muscle relaxants, such as tubocurarine.
• Anticholinergic medicines, such as atropine or biperiden.
• Amantadine (a medicine to prevent flu).
• Colestyramine and colestipol (medicines used to treat high lipid levels in the blood).
• Cyclosporine, a medicine used to prevent organ rejection after transplantation.
• Barbiturates and narcotics (sleeping or pain-relieving medicines used, for example, during surgery).
• Antiepileptics, such as carbamazepine, a medicine used to treat seizure disorders.
• Rifampicin, a medicine used to treat tuberculosis.
• Ritonavir, a medicine used to treat HIV infection.
• Medicines that affect gastric motility, such as cisapride.
• If you are taking an ACE inhibitor or aliskiren (see also the information under “Do not take Valsartan/Hydrochlorothiazide Viatris” and “Warnings and precautions”.

Taking Valsartan/Hydrochlorothiazide Viatris with food, drinks, and alcohol

You can take Valsartan/Hydrochlorothiazide Viatris with or without food.

Avoid drinking alcohol until you have consulted your doctor. Alcohol can further lower your blood pressure and/or increase the risk of dizziness and weakness.

Pregnancy and breastfeeding

Pregnancy

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. In general, your doctor will advise you to stop taking valsartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will recommend that you take another blood pressure-lowering medicine instead. The use of valsartan/hydrochlorothiazide is not recommended at the start of pregnancy, and it should not be taken if you are pregnant more than 3 months, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

If you are breastfeeding or about to start breastfeeding, inform your doctor before taking this medicine. The use of valsartan/hydrochlorothiazide is not recommended in women during this period. Your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

Driving and using machines

Do not drive or use tools or machines or perform activities that require concentration until you know how this medicine affects you. Like many other medicines used to treat high blood pressure, valsartan/hydrochlorothiazide may occasionally cause dizziness and affect your ability to concentrate.

Valsartan/Hydrochlorothiazide Viatris contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars (e.g., lactose), consult your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Valsartan/Hydrochlorothiazide Viatris

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of Valsartan/Hydrochlorothiazide Viatris is one tablet once a day. This medicine should be taken at the same time every day, usually in the morning. Your doctor will tell you exactly how many Valsartan/Hydrochlorothiazide Viatris tablets you should take. Depending on how you respond to treatment, your doctor may ask you to increase or decrease the dose.

Use in children and adolescents

Valsartan/hydrochlorothiazide is not recommended in children and adolescents under 18 years of age.

Route and method of administration

This medicine can be taken with or without food. Swallow the tablet with a glass of water.

Duration of treatment

Do not change the dose or stop taking the tablets without consulting your doctor. Often, people with high blood pressure 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.

If you take more Valsartan/Hydrochlorothiazide Viatris than you should

If you notice a strong dizziness and/or faint, lie down and contact your doctor immediately.

If you have accidentally taken too many tablets, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested, or go to the emergency department of the nearest hospital.

If you forget to take Valsartan/Hydrochlorothiazide Viatris

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Valsartan/Hydrochlorothiazide Viatris

If you stop your treatment with valsartan/hydrochlorothiazide, your high blood pressure may worsen. Do not stop taking the medicine unless your doctor tells you to.

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

You may notice that this medicine has an unusual color and/or taste. This is normal and characteristic of the active substance valsartan.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects may be serious and require immediate medical attention. Inform your doctor immediately or go to the hospital emergency service if you experience symptoms of angioedema, such as the following:

• Swelling in the face, tongue, or pharynx.
• Difficulty swallowing.
• Hives and difficulty breathing.
• Skin rash, which can form blisters and appears as small targets (dark central spot surrounded by a paler area, with a dark ring around the edge) (erythema multiforme).

The following adverse effects have been observed during treatment with valsartan/hydrochlorothiazide, with the following frequencies:

Uncommon (may affect up to 1 in 100 people):

• Cough.
• Low blood pressure.
• Dizziness.
• Dehydration (with symptoms of thirst, dry mouth and tongue, reduced urination frequency, dark-colored urine, or dry skin).
• Muscle pain.
• Fatigue.
• Numbness or tingling.
• Blurred vision.
• Noises in the ears, such as ringing or buzzing.

Very rare (may affect up to 1 in 10,000 people):

• Dizziness.
• Diarrhea.
• Joint pain.

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

• Difficulty breathing.
• Sharp decrease in urine production.
• Low sodium levels in the blood (sometimes with nausea, fatigue, confusion, general malaise, and convulsions).
• Low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm).
• Low white blood cell count in the blood (with symptoms such as fever, skin infections, sore throat, or mouth ulcers due to infections, weakness).
• Increased bilirubin levels in the blood (which, in severe cases, can cause the skin and eyes to turn yellow).
• Increased urea and creatinine levels in the blood (which may indicate abnormal kidney function).
• Increased uric acid levels in the blood (which, in severe cases, can trigger a gout attack).
• Fainting (syncope).

Adverse effects of valsartan or hydrochlorothiazide in monotherapy that have not been observed with valsartan/hydrochlorothiazide

Valsartan

Uncommon (may affect up to 1 in 100 people):

• Feeling of rotation.
• Abdominal pain.

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):

• Blisters on the skin (sign of blistering dermatitis).
• Skin rash with or without itching along with some of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or flu-like symptoms.
• Rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation).
• Low platelet count in the blood (sometimes with bleeding or unusual bruising).
• High potassium levels in the blood (sometimes with muscle spasms or abnormal heart rhythm).
• Allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness).
• Swelling mainly of the face and throat, skin rash, itching.
• Elevation of liver function values.
• Decrease in hemoglobin levels and reduction of red blood cell percentage in the blood (which, in severe cases, can cause anemia).
• Kidney failure.

Hydrochlorothiazide

Very common (may affect more than 1 in 10 people):

• Low potassium levels in the blood, increased lipids in the blood (mainly at high doses).

Common (may affect up to 1 in 10 people):

• Skin rash with itching and other types of rash.
• Low sodium levels in the blood, low magnesium levels in the blood.
• High uric acid levels.
• Decreased appetite.
• Mild nausea and vomiting.
• Feeling of fainting, fainting when standing up.
• Impotence.

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

• Swelling and blisters on the skin (due to increased sun sensitivity).
• Constipation, stomach or intestinal discomfort, diarrhea, liver disorders (yellowing of the skin or eyes).
• Irregular heartbeat.
• High calcium levels, high blood sugar levels, sugar excretion in the urine, worsening of diabetic metabolic status.
• Headache, dizziness, feeling of tingling or numbness in the hands and feet.
• Sleep disorders.
• Sadness (depression).
• Low platelet count (sometimes with bleeding or bruising under the skin).
• Visual disturbances.

Very rare (may affect up to 1 in 10,000 people):

• Vasculitis with symptoms such as skin rash, red-purple spots, fever.
• Itching or redness of the skin.
• Blisters on the lips, eyes, or mouth.
• Peeling of the skin.
• Fever.
• Facial rash associated with joint pain.
• Muscle disorders.
• Fever (cutaneous lupus erythematosus).
• Severe pain in the upper abdomen; absence or low levels of different blood cells.
• Severe allergic reactions.
• Difficulty breathing.
• Lung infection, difficulty breathing.
• Metabolic disorder that causes loss of chloride from the body.
• Acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion).

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

• Significant decrease in blood cells that can cause weakness, bruising, and frequent infections.
• Decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].
• Kidney dysfunction, acute kidney failure.
• Fever, weakness.
• Muscle spasms.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any type of adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear 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/Hydrochlorothiazide 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 packaging, label, blister, or bottle, after CAD or EXP. The expiration date is the last day of the month indicated.

Use before 100 days have passed since the bottle was opened. Once opened, keep the bottle perfectly closed.

This medicine does not require special storage conditions. Do not use Valsartan/Hydrochlorothiazide Viatris if you observe damage to the packaging or signs of deterioration.

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 your pharmacy. 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/Hydrochlorothiazide Viatris

The active ingredients are valsartan and hydrochlorothiazide.

Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.

The other components are: anhydrous colloidal silica (E-551), sodium lauryl sulfate (E-487), microcrystalline cellulose (E-460), pregelatinized corn starch, lactose monohydrate, crospovidone (E-1202), povidone (E-1201), and magnesium stearate (E-572).

The film coating contains hypromellose (E-464), titanium dioxide (E-171), macrogol, talc (E-553b), vanillin, and iron oxide (E-172).

Appearance of the product and package contents

Valsartan/Hydrochlorothiazide Viatris are pink, oval, film-coated tablets, marked with "VH4" on one side of the tablet and an "M" on the other side.

Valsartan/Hydrochlorothiazide Viatris is available in blisters of 7, 10, 14, 28, 30, 56, 60, 84, 90, and 98 tablets; calendar blister of 28 tablets and bottles of 56, 98, 100, 200, 250, and 500 tablets.

It is also available in a multiple package of 98 tablets, which includes 2 boxes (each containing 49 tablets).

Only some package sizes may be marketed.

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Hungary Kft

H-2900 Komárom, Mylan utca 1

Hungary

or

Mylan Germany GmbH

Luetticher Strasse 5

Troisdorf

Nordrhein-Westfalen, 53842

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 pharmaceutical product is authorized in EEA member states under the following names:

Germany Valsartan/HCT Mylan

Spain Valsartán/Hidroclorotiazida Viatris

France VALSARTAN HYDROCHLOROTHIAZIDE VIATRIS

Netherlands Valsartan/Hydrochloorthiazide Viatris

Portugal Valsartan + Hidroclorotiazida Mylan

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/