VALSARTAN STADAFARMA 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan Stadafarma 160 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

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

1. What is Valsartan Stadafarma and what is it used for

Valsartan belongs 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.

Valsartan Stadafarma 160 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in adults and in children and adolescents from 6 to 18 years of age.High blood pressure increases the workload of the heart and arteries. If not treated, it can damage the blood vessels of the brain, heart, and kidneys, and can cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal reduces the risk of developing these disorders,
• to treat adult patients after a recent heart attack(myocardial infarction). "Recent" means here between 12 hours and 10 days,
• to treat symptomatic heart failure in adult patients.Valsartan is used when it is not possible to use a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication for treating heart failure) or may be used in addition to ACE inhibitors when it is not possible to use other medications for the treatment of heart failure.

Among the symptoms of heart failure are difficulty breathing and swelling of the feet and legs due to fluid retention. This is because the heart muscle cannot pump blood with enough force to provide all the blood needed for the body.

2. What you need to know before you take Valsartan Stadafarma

Do not take Valsartan Stadafarma:

• if you are allergic(hypersensitive) to valsartan or any of the other ingredients of Valsartan Stadafarma, (listed in section 6.)
• if you have severe liver disease,
• if you are pregnant for more than 3 months. (it is better to avoid taking valsartan during the first months of pregnancy - see section Pregnancy).
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren

If any of these situations apply to you, inform your doctor and do not take valsartan.

Warnings and precautions

Consult your doctor or pharmacist before starting to take valsartan:

• if you have liver disease,
• if you have severe kidney disease or if you are undergoing dialysis,
• if you have narrowing of the kidney artery,
• if you have recently undergone a kidney transplant (received a new kidney),
• if you have severe heart disease other than heart failure or heart attack,
• if you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking valsartan, stop taking valsartan immediately and never take it again. See section 4, "Possible side effects".
• if you are taking medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. It may be necessary to regularly check the amount of potassium in the blood,
• if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take valsartan,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine elimination), inform your doctor.

• if you are taking any of the following medications used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, etc.), especially if you have kidney problems related to diabetes.
• aliskiren

• if you are being treated with an ACE inhibitor along with other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol)

Your doctor may check your kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood at regular intervals.

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.

See also the information under the heading "Do not take Valsartan Stadafarma".

You must inform your doctor if you think you are (or might become) pregnant. Valsartan is not recommended at the start 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 the section on pregnancy).

If any of these situations apply to you, inform your doctor before taking valsartan

Taking Valsartan Stadafarma with other medicines

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

The effect of treatment with valsartan may be altered if taken with certain 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 elimination), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren. (see also the information under the headings "Do not take Valsartan Stadafarma" and "Warnings and precautions") .
• medicines that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin,
• certain pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),
• certain antibiotics (of the rifampicin group), a medicine used to protect against rejection in a transplant (ciclosporin) or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of valsartan
• lithium,a medicine used to treat certain types of psychiatric illnesses.

In addition:

• if you are being treated after a heart attack,it is not recommended to combine with ACE inhibitors(a medication for treating a heart attack).
• if you are being treated for heart failure,it is not recommended to combine with ACE inhibitorsand other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs)(such as spironolactone, eplerenone) or beta-blockers(such as metoprolol).

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

Taking Valsartan Stadafarma with food and drinks

You can take valsartan with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

• You must inform your doctor if you are pregnant(or, if you think you may be pregnant).Normally, your doctor will advise you to stop taking valsartan before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take another blood pressure-lowering medicine instead. Valsartan is not recommended during the first trimester of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after this time.

• Tell your doctor if you are about to start or are breastfeeding, as it is not recommended to take valsartan 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

Before driving a vehicle, using tools, or operating machinery, or carrying out other activities that require concentration, make sure you know how you react to the effects of valsartan. Like many other medicines used to treat high blood pressure, valsartan can cause dizziness and affect your ability to concentrate.

Valsartan Stadafarma contains sorbitol.

This medicine contains 18.5 mg of sorbitol in each tablet.

Valsartan Stadafarma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol); this is, essentially "sodium-free".

Valsartan Stadafarma contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Valsartan Stadafarma

To get the best results and reduce the risk of side effects, always take valsartan exactly as your doctor tells you. Consult your doctor or pharmacist if you have any doubts. People with high blood pressure often 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.

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). Valsartan may also be combined with another medicine (e.g., a diuretic).

Children and adolescents (6 to 18 years of age) with high blood pressure:

In patients who weigh less than 35 kg, the usual dose is 40 mg of valsartan once daily.

In patients who weigh 35 kg or more, the recommended 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, it is recommended to administer valsartan oral solution.

Adult patientsafter a recent heart attack:

After a heart attack, treatment is usually started at 12 hours, normally with a low dose of 20 mg given twice daily. Your doctor will gradually increase this dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance. Valsartan can be given with other treatments for heart attack, and your doctor will decide which treatment is suitable for you.

Adult patientswith heart failure:treatment is usually started with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan can be given with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

You can take valsartan with or without food. Swallow valsartan with a glass of water.

Take valsartan at approximately the same time each day.

The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

If you take more Valsartan Stadafarmathan you should

If you notice a strong dizziness or fainting, lie down and contact your doctor immediately. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartan Stadafarma

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to make up for missed doses

If you stop taking Valsartan Stadafarma

If you stop taking valsartan, 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 product, ask your doctor or pharmacist.

4. Possible Adverse Effects

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

Some adverse effects can be serious and may require immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

• swelling in the face, lips, tongue, or throat,
• difficulty breathing or swallowing,
• hives, itching

If you experience any of these symptoms, stop taking valsartan and contact your doctor immediately (see also section 2 "Warnings and Precautions").

Other adverse effects include:

Frequent: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 renal function (signs of renal impairment).

Infrequent:may affect up to 1 in 100 people

• angioedema (see section "Some adverse effects can be serious and may require immediate medical attention")
• sudden loss of consciousness (syncope)
• feeling of rotation (vertigo)
• marked reduction of renal function (signs of acute renal failure),
• muscle spasms, abnormal heart rhythm (signs of hyperkalemia),
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure),
• 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 with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• blisters on the skin (sign of bullous dermatitis)
• 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).
• purplish red spots, fever, itching (signs of inflammation of the blood vessels, also called vasculitis).
• more frequent bleeding or bruising 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 of hemoglobin level and reduction of red blood cell percentage in the blood (which, in severe cases, can cause anemia).
• increase in blood potassium level (which, in severe cases, can cause muscle spasms and abnormal heart rhythm).
• elevation of liver function values (which may indicate liver damage), including an increase in blood bilirubin level (which, in severe cases, can cause the skin and eyes to turn yellow).
• increase in blood urea nitrogen level and increase in serum creatinine level (which may indicate renal function abnormalities).
• low sodium level in the blood (which, in severe cases, can cause fatigue, confusion, muscle contraction, and/or convulsions).

The frequency of some adverse effects may vary depending on your condition. For example, certain adverse effects such as dizziness and reduced renal function were observed less frequently in patients treated for hypertension than in 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, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. 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 Valsartán Stadafarma

Keep out of sight and reach of children

Do not store above 30°C. Store in the original package to protect from moisture.

Do not use this medicine after the expiration date stated on the package. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice that the package is damaged or shows signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartán Stadafarma

• The active ingredient is valsartan. One tablet of Valsartán Stadafarma 160 mg contains 160 mg of valsartan;
• The other components are: microcrystalline cellulose (E 460), anhydrous colloidal silica (E 551), sorbitol (E 420), magnesium carbonate (E 504), pregelatinized corn starch, povidone K-25 (E 1201), sodium stearyl fumarate, and sodium lauryl sulfate, crospovidone Type A (E 1202). Coating: lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), macrogol.
• Valsartán Stadafarma 160 mg contains the colorant yellow iron oxide (E 172) and brown iron oxide (E 172).

Appearance of the Product and Package Contents

Valsartán Stadafarma 160 mg: are cylindrical, film-coated tablets, ochre in color, and scored on one side.

The tablets are presented in packages of 7, 14, 28, 56, 98, and 280 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10. Polig. Areta

31620 Huarte (Pamplona)

Spain

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

ZENTIVA K.S.

• Kabelovny 130

10237 Prague, Czech Republic

You can request more information about this medicine from the marketing authorization holder.

Date of the Last Revision of this Prospectus:02/2025

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