Valsartan/hidroclorotiazida viatris 320/12,5 mg comprimidos recubiertos con pelicula efg

Package Insert: Information for the Patient

Valsartan/HydrochlorothiazideViatris320 mg/12.5 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medication, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See Section 4.

Valsartán/Hidroclorotiazida Viatris film-coated tablets contain two active ingredients known as valsartán and hidroclorotiazida. These medications help control high blood pressure (hypertension).

• Valsartánbelongs to a class of medications 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 constrict, resulting in increased blood pressure. Valsartán acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

• Hidroclorotiazidabelongs to a class of medications known as thiazide diuretics. Hidroclorotiazida increases urine production, which also reduces blood pressure.

Valsartán/Hidroclorotiazida Viatris is used to treat high blood pressure that is not adequately controlled with the use of a single medication.

Hypertension increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and could cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of suffering from heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not take Valsartán/Hidroclorotiazida Viatris

• If you areallergicto valsartán, hidroclorotiazida, sulfonamide derivatives, (chemically related substances to hidroclorotiazida) or to any of the other components of this medication (listed in section 6).
• If you aremore than 3 months pregnant. (In any case, it is better to avoid taking Valsartán/Hidroclorotiazida Viatris in the first months of pregnancy; see section "Pregnancy").
• If you have a severe liver disease.
• If you have a severe kidney disease.
• If you are unable to urinate (anuria).
• If you are undergoing dialysis.
• If you have low levels of potassium or sodium in your blood or if your calcium levels in the blood are higher than normal despite treatment.
• If you have gout.
• If you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskirén.

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

Warnings and precautions

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

• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience shortness of breath or severe difficulty breathing after takingvalsartán/hidroclorotiazida, see your doctor immediately.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking valsartán/hidroclorotiazida.
• If you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium, or other medications that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly monitor your potassium levels in the blood.
• If you have a history of allergy to sulfonamide or penicillin.
• If you have low levels of potassium in your blood.
• If you have severe diarrhea or vomiting.
• If you are taking high doses of diuretics (urine tablets).
• If you have a severe heart disease.
• If you have a narrowing of the renal artery.
• If you have recently undergone a kidney transplant.
• If you have primary aldosteronism. This is a disease in which your adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to use valsartán/hidroclorotiazida.
• If you have liver or kidney disease.
• If you have fever, skin rash, and joint pain, which may be symptoms of systemic lupus erythematosus (LES, a known autoimmune disease).
• If you have diabetes, gout, or high levels of cholesterol or triglycerides in your blood.
• If you have previously had an allergic reaction with the use of another medication of this class to reduce blood pressure (angiotensin II receptor antagonists), or if you have any type of allergy or asthma.
• It may cause increased sensitivity of the skin to the sun.
• You should inform your doctor if you suspect that you are (orcould be) pregnant. Valsartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and it should 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 medications used to treat high blood pressure:

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

- Aliskirén.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (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, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased pressure in the eye, which can occur within a few hours to weeks after takingValsartán/Hidroclorotiazida Viatris. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have had an allergy to penicillin or sulfonamides in the past.

Use in athletes

This medication contains hidroclorotiazida, which may produce a positive result in doping control tests.

Children and adolescents

Valsartán/hidroclorotiazida is not recommended for children and adolescents under 18 years old.

Other medications and Valsartán/Hidroclorotiazida Viatris

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

The effectiveness of this medication may be affected if taken with certain medications. You may need to change the dose, take other precautions, or, in some cases, discontinue treatment with one of the medications. This applies especially to the following medications:

• Lithium, a medication used to treat certain types of psychiatric disorders.
• Medications that affect or may be affected by potassium levels in the blood, such as digoxin, a medication to control heart rhythm, or some antipsychotics and antidepressants.
• Medications that may increase the amount of potassium in the blood, such as potassium supplements, salt substitutes containing potassium, potassium-sparing medications, heparin.
• Medications that may decrease the amount of potassium in the blood, such as corticosteroids, some laxatives.
• Diuretics (urine tablets), medications to treat gout, such as allopurinol, vitamin D, and therapeutic calcium supplements, medications to treat diabetes (oral agents or insulin).

• Other medications to reduce blood pressure, such as beta-blockers or metildopa, or medications that constrict blood vessels or stimulate the heart, such as norepinephrine or adrenaline.
• Medications to increase blood sugar levels, such as diazoxide.
• Medications to treat cancer, such as methotrexate or cyclophosphamide.
• Medications for pain.
• Medications for arthritis.
• Muscle relaxants, such as tubocurarine.
• Anticholinergic medications, such as atropine or biperiden.
• Amantadine (a medication to prevent flu).
• Colestiramine and colestipol (medications used to treat high levels of lipids in the blood).
• Ciclosporina, a medication used to prevent organ rejection.
• Barbiturates and narcotics (medications for sleep or analgesic use, for example, in surgery).
• Antiepileptics, such as carbamazepine, a medication used to treat convulsive disorders.
• Rifampicin, a medication used to treat tuberculosis.
• Ritonavir, a medication used to treat HIV infection.
• Medications that affect gastric motility, such as cisaprida.
• If you are taking an ACEI or aliskirén (see also the information under “Do not take Valsartán/Hidroclorotiazida Viatris” and “Warnings and precautions”).

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

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

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

Pregnancy and lactation

Pregnancy

If you are pregnant or breastfeeding, or if you suspect that you are (orcould be) pregnant, consult your doctor or pharmacist before using this medication.

Generally, your doctor will advise you to stop taking valsartán/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant and recommend taking another antihypertensive medication instead. Valsartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and it should 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”).

Lactation

If you are breastfeeding or plan to start breastfeeding, you should inform your doctor before taking this medication.

Valsartán/hidroclorotiazida is not recommended for use in women during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machines

Do not drive, operate tools or machines, or perform activities that require concentration until you know how this medication affects you. Like many other medications used to treat high blood pressure, valsartán/hidroclorotiazida may occasionally cause dizziness and affect concentration.

Valsartán/Hidroclorotiazida Viatris contains lactose and sodium

If your doctor has indicated that you have an intolerance to certain sugars (e.g., lactose), consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Use in children and adolescents

Valsartán/hidroclorotiazida is not recommended for children and adolescents under 18 years old.

Route and form of administration

This medication 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 appointments with your doctor, even if you feel well.

If you take more Valsartán/Hidroclorotiazida 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, or go to the emergency department of the nearest hospital.

If you forget to take Valsartán/Hidroclorotiazida Viatris

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

If you interrupt treatment with Valsartán/Hidroclorotiazida Viatris

If you stop taking valsartán/hidroclorotiazida, your high blood pressure may worsen. Do not stop taking the medication unless your doctor tells you to.

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

You may notice that this medication has an unusual color and/or taste. This is normal and characteristic of the active ingredient valsartán.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious and require immediate medical attention. Inform your doctor immediately or go to the hospital's emergency department if you experience symptoms of angioedema, such as the following:

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

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

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

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

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

• Dizziness.
• Diarrhea.
• Joint pain.

Unknown frequency (cannot be estimated from available data):

• Difficulty breathing.
• Intense decrease in urine production.
• Low sodium levels in the blood (sometimes with nausea, fatigue, confusion, general discomfort, and seizures).
• 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).
• Syncope (fainting).

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

Valsartan

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

• Sensation of rotation.
• Abdominal pain.

Unknown frequency (cannot be estimated from available data):

• Blisters on the skin (sign of a blistering dermatitis).
• Rash on the skin with or without itching, along with one or more 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, urticaria, difficulty breathing, or swallowing, dizziness).
• Swelling mainly of the face and throat, skin rash, itching.
• Elevation of liver function values.
• Decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, can cause anemia).
• Renal insufficiency.

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):

• Rash on the skin with itching and other types of rash.
• Low sodium levels in the blood, low magnesium levels in the blood.
• High uric acid levels.
• Reduced appetite.
• Mild nausea and vomiting.
• Sensation 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 sensitivity to the sun).
• Constipation, stomach or intestinal discomfort, diarrhea, liver damage (yellow skin or eyes).
• Irregular heart rhythm.
• High calcium levels, high blood sugar levels, sugar excretion in the urine, worsening of diabetic metabolic state.
• Headache, dizziness, sensation of prickling or numbness in the hands and feet.
• Sleep disturbances.
• Depression.
• Low platelet count (sometimes with bleeding or unusual bruising under the skin).
• Vision disturbances.

Very 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 the lips, eyes, or mouth.
• Peeling of the skin.
• Fever.
• Facial rash associated with joint pain.
• Muscle disorders.
• Lupus erythematosus cutaneous (fever).
• Severe abdominal pain; absence or low levels of different blood cells.
• Severe allergic reactions.
• Difficulty breathing.
• Pulmonary infection, difficulty breathing.
• Metabolic disorder that causes a loss of chloride from the body.
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency (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 increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].
• Renal dysfunction, acute renal insufficiency.
• Fever, weakness.
• Muscle spasms.
• Skin cancer and lip cancer (non-melanoma skin cancer).

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, label, blister pack, 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 medication does not require special storage conditions. Do not use Valsartán/Hidroclorotiazida Viatris if you observe damage to the packaging or signs of deterioration.

Medications should not be disposed of through drains or in the trash. Deposit the containers and unused medications at the SIGRE collection point of your pharmacy. Ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Valsartan/Hydrochlorothiazide Viatris

The active principles 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 cornstarch, 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),vanillinand iron oxide (E-172).

Appearance of the product and contents of the package

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

Valsartan/Hydrochlorothiazide Viatris is available in blister packs of 7, 10, 14, 28, 30, 56, 60, 84, 90, and 98 tablets; a calendar pack 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 that includes 2 cartons (each containing 49 tablets).

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

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

Luetticher Strasse 5

Troisdorf

Nordrhein-Westfalen, 53842

Germany

Further information on this medicinal product can be obtained by contacting 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 EEA under the following names:

GermanyValsartan/HCT Mylan

SpainValsartan/Hydrochlorothiazide Viatris

FranceVALSARTAN HYDROCHLOROTHIAZIDE VIATRIS

NetherlandsValsartan/Hydrochloorthiazide Mylan

PortugalValsartan + Hidroclorotiazida Mylan

Last review date of this leaflet: December 2021

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/