Valsartan/hydrochlorothiazide Viatris 160 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Valsartan/Hydrochlorothiazide Viatris 160 mg/12.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, as 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Valsartan/Hydrochlorothiazide Viatris is and what it is used for
2. What you need to know before taking 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 known as valsartan and hydrochlorothiazide. These medicines help control high blood pressure (hypertension).

• Valsartan 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. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

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

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

Hypertension increases the workload on the heart and arteries. If left untreated, it can damage the blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure 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 starting Valsartán/Hidroclorotiazida Viatris

Do not take Valsartán/Hidroclorotiazida Viatris

• If you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide), or to any of the other components of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (In any case, it is better to avoid taking Valsartán/Hidroclorotiazida Viatris during 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 abnormally low levels of potassium or sodium in the blood, or if your blood calcium levels are higher than normal despite treatment.
• If you have gout.
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Valsartán/Hidroclorotiazida Viatris:

• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking valsartan/hydrochlorothiazide, seek medical attention immediately.

• If you have had skin cancer or 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 exposure to sunlight and UV rays while taking valsartan/hydrochlorothiazide.

• If you are using potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase blood potassium levels such as heparin. Your doctor may consider regular monitoring of blood potassium levels.

• If you have a history of allergy to sulphonamides or penicillin.

• If your blood potassium levels are low.

• If you have severe diarrhea or vomiting.

• If you are taking high doses of diuretic tablets ("water pills").

• If you have severe heart disease.

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

• If you have recently undergone a kidney transplant.

• If you have hyperaldosteronism—a condition in which your adrenal glands produce too much aldosterone hormone. In this case, valsartan/hydrochlorothiazide is not recommended.

• If you have kidney or liver disease.

• If you develop fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (SLE, a known autoimmune disease).

• If you have diabetes, gout, or high cholesterol or triglyceride levels in the blood.

• If you have previously had an allergic reaction to another medicine of this class used to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.

• It may cause increased skin sensitivity to sunlight.

• You must inform your doctor if you suspect you are (or might be) pregnant. Use of valsartan/hydrochlorothiazide is not recommended at the beginning of pregnancy, and must not be taken if you are more than 3 months pregnant, 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 (hypertension):

• 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 Valsartán/Hidroclorotiazida Viatris”.

• If you experience vision loss or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to weeks after taking Valsartán/Hidroclorotiazida Viatris. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulphonamides.

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 control tests.

Children and adolescents

Valsartán/hydrochlorothiazida is not recommended for children and adolescents under 18 years of age.

Other medicines and Valsartán/Hidroclorotiazida Viatris

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

The effectiveness of this medicine may be affected 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 particularly applies to the following medicines:

• Lithium, a medicine used to treat certain psychiatric conditions.

• Medicines that affect or may be affected by blood potassium levels, such as digoxin (a medicine to control heart rhythm), or certain antipsychotics and antidepressants.

• Medicines that may increase blood potassium levels, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, heparin.

• Medicines that may decrease blood potassium levels, such as corticosteroids, certain laxatives.

• Diuretics ("water pills"), medicines used to treat gout such as allopurinol, vitamin D, therapeutic calcium supplements, and medicines used to treat diabetes (oral agents or insulin).

• Other blood pressure-lowering medicines such as beta-blockers or methyldopa, or medicines that constrict blood vessels or stimulate the heart, such as noradrenaline or adrenaline.

• Medicines that increase blood sugar levels, such as diazoxide.

• Medicines used to treat cancer, such as methotrexate or cyclophosphamide.

• Painkillers.

• Medicines for arthritis.

• Muscle relaxants such as tubocurarine.

• Anticholinergic medicines such as atropine or biperiden.

• Amantadine (a medicine used to prevent influenza).

• Cholestyramine and colestipol (medicines used to treat high blood lipid levels).

• Cyclosporine, a medicine used to prevent rejection of transplanted organs.

• Barbiturates and narcotics (medicines used for sleep or analgesia, e.g., 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 affecting gastric motility, such as cisapride.

• If you are taking an ACE inhibitor or aliskiren (see also information under “Do not take Valsartán/Hidroclorotiazida Viatris” and “Warnings and precautions”).

Taking Valsartán/Hidroclorotiazida Viatris with food, drinks, and alcohol

You may take Valsartán/Hidroclorotiazida Viatris with or without food.

Avoid drinking alcohol until you have discussed it with your doctor. Alcohol may further lower your blood pressure and/or increase the likelihood of dizziness and weakness.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Generally, your doctor will advise you to stop taking valsartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative antihypertensive medicine. Use of valsartan/hydrochlorothiazide is not recommended in early pregnancy, and must not be used if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that point onward.

Breastfeeding

If you are breastfeeding or about to start breastfeeding, inform your doctor before taking this medicine. Use of valsartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breastfeed, especially if the infant is newborn or premature.

Driving and using machines

Do not drive or operate tools or machinery, or perform activities requiring 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.

Valsartán/Hidroclorotiazida Viatris contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars (e.g., lactose), consult him 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 as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Valsartan/Hydrochlorothiazide Viatris is one tablet once daily. This medicine should be taken at the same time every day, usually in the morning. Your doctor will tell you exactly how many tablets of Valsartan/Hydrochlorothiazide Viatris you should take. Depending on how you respond to treatment, your doctor may instruct 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 condition and feel completely normal. For this reason, it is very important to attend your doctor's appointments regularly, even if you feel well.

If you take more Valsartan/Hydrochlorothiazide Viatris than you should

If you experience severe dizziness and/or fainting, 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 at 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital emergency department.

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 a missed dose.

If you stop taking Valsartan/Hydrochlorothiazide Viatris

If you discontinue treatment with valsartan/hydrochlorothiazide, your hypertension 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.

You may notice that this medicine has an unusual colour 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 everyone will experience them.

Some adverse effects may be serious and require immediate medical attention. Immediately inform your doctor or go to the nearest hospital emergency department if you experience symptoms of angioedema such as:

• Swelling of the face, tongue, or pharynx.
• Difficulty swallowing.
• Hives and difficulty breathing.
• Skin rash, which may blister and appear as target-like lesions (a 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 such as thirst, dry mouth and tongue, reduced frequency of urination, dark-colored urine, or dry skin).
• Muscle pain.
• Fatigue.
• Tingling or numbness.
• Blurred vision.
• Ringing in the ears, such as tinnitus or buzzing.

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.
• Marked decrease in urine production.
• Low sodium levels in blood (sometimes with nausea, fatigue, confusion, malaise, and seizures).
• Low potassium levels in blood (sometimes with muscle weakness, muscle cramps, or irregular heartbeat).
• Low white blood cell count in blood (symptoms such as fever, skin infections, sore throat, or mouth ulcers due to infections, weakness).
• Increased bilirubin levels in blood (which, in severe cases, may cause yellowing of the skin and eyes).
• Increased blood urea nitrogen and creatinine levels in blood (which may indicate abnormal kidney function).
• Increased uric acid levels in blood (which, in severe cases, may trigger a gout attack).
• Syncope (fainting).

Adverse effects of valsartan or hydrochlorothiazide in monotherapy not observed with valsartan/hydrochlorothiazida

Valsartan

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

• Sensation of spinning.
• Abdominal pain.

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

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

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

• Skin blisters (a sign of blistering dermatitis).
• Skin rash with or without itching, together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms.
• Rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation).
• Low platelet count in blood (sometimes with unusual bleeding or bruising).
• High potassium levels in blood (sometimes with muscle cramps or irregular heartbeat).
• 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.
• Elevated liver function test values.
• Decreased hemoglobin levels and reduced percentage of red blood cells in blood (which, in severe cases, may lead to anemia).
• Renal failure.

Hydrochlorothiazide

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

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

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

• Itchy rash and other types of skin rash.
• Low sodium levels in blood, low magnesium levels in blood.
• High uric acid levels.
• Decreased appetite.
• Mild nausea and vomiting.
• Feeling faint, fainting upon standing.
• Impotence.

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

• Skin swelling and blistering (due to increased sensitivity to sunlight).
• Constipation, stomach or intestinal discomfort, diarrhea, liver disorders (yellowing of the skin or eyes).
• Irregular heartbeat.
• Elevated calcium levels, elevated blood sugar levels, sugar in urine, worsening of diabetic metabolic state.
• Headache, dizziness, tingling or numbness in hands and feet.
• Sleep disorders.
• Sadness (depression).
• Low platelet count (sometimes with bleeding or bruising under the skin).
• Vision disturbances.

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

• Inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever.
• Itching or redness of the skin.
• Blisters on lips, eyes, or mouth.
• Skin peeling.
• 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 causing loss of chloride from the body.
• Acute respiratory difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

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

• Significant decrease in blood cells which may cause weakness, bruising, and frequent infections.
• Decreased vision or eye pain due to elevated 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 cramps.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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/Hydrochlorothiazide Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, label, blister, or bottle, indicated as CAD or EXP. The expiry date refers to the last day of the month shown.

Use within 100 days after opening the bottle. After opening, keep the bottle tightly closed.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartan/Hydrochlorothiazide Viatris

The active substances are valsartan and hydrochlorothiazide.

Each tablet contains 160 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 contents of the pack

Valsartan/Hydrochlorothiazide Viatris are reddish, oval, film-coated tablets, marked with "VH2" on one side 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 packs of 28 tablets; and bottles of 56, 98, 100, 200, 250, and 500 tablets.

It is also available in a multiple pack of 98 tablets consisting of 2 boxes (each containing 49 tablets).

Only certain pack 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

Further information on this medicinal product is available from 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 EEA Member States under the following names:

Germany Valsartan/HCT Mylan
Spain Valsartan/Hydrochlorothiazide Viatris
France VALSARTAN HYDROCHLOROTHIAZIDE VIATRIS
Netherlands Valsartan/Hydrochlorothiazide Viatris
Portugal Valsartan + Hydrochlorothiazide Mylan

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 Health Products (AEMPS): https://www.aemps.gob.es/