Leaflet: information for the user

Valsartán Stadafarma 160 mg film-coated tablets

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

1. What isValsartán Stadafarmaand what is it used for

2. What you need to know before starting to takeValsartán Stadafarma

3. How to takeValsartán Stadafarma

4. Possible side effects

5. Storage ofValsartán Stadafarma

6. Contents of the pack and additional information

Valsartán belongs to a class of medications known as angiotensin II receptor antagonists that help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in an increase in blood pressure. Valsartán acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Stadafarma 160 mg film-coated tabletscan be used to treat three different conditions:

• to treat high blood pressure in adults and in children and adolescents between 6 and 18 years old.High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and may cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values 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.Valsartán is used when it is not possible to use a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication to treat heart failure) or it can be used added 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 shortness of breath and swelling of feet and legs due to fluid retention. This is because the cardiac muscle cannot pump blood with sufficient force to provide all the blood needed by the body.

Do not take Valsartán Stadafarma:

• if you areallergic(hypersensitive) to valsartán or to any of the other components of Valsartán Stadafarma, (listed in section 6).
• if you have aserious liver disease,
• if you aremore than 3 months pregnant. (it is better to avoid taking valsartán during the first months of pregnancy - see the Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a medication to reduce blood pressure that contains aliskirén

If any of these situations affect you, inform your doctor and do not take valsartán.

Warnings and precautions

Consult your doctor or pharmacist before starting to take valsartán:

• if you have a liver disease,
• if you have a serious kidney disease or if you are undergoing dialysis,
• if you have a narrowing of the kidney artery,
• if you have recently undergone a kidney transplant (you received a new kidney),
• if you have a serious 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 valsartán, stop taking valsartán immediately and never take it again. See section 4, “Possible side effects”.
• if you are using medications that increase the amount of potassium in the blood. Among them are potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. You may need to control the amount of potassium in the blood regularly,
• if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, valsartán is not recommended,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications to increase urine elimination), inform your doctor.

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

• a renin-angiotensin-aldosterone system (RAAS) inhibitor (RAASi) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén

• if you are being treated with a RAASi along with other medications specifically for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone) or beta-blockers (for example, metoprolol)

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) regularly.

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

See also the information under the heading “Do not take Valsartán Stadafarma”.

You must inform your doctor if you think you are (or could be) pregnant. Valsartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it could cause serious harm to your baby if used during this period (see the Pregnancy section).

If any of these situations affect you, inform your doctor before taking valsartán

Taking Valsartán Stadafarma with other medications

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

The effect of valsartán treatment may be altered if taken with certain medications. You may need to change the dose, take other precautions, or, in some cases, stop taking one of the medications. This applies to both prescription and non-prescription medications, especially:

• other medications that lower blood pressure, especiallydiuretics(medications to increase urine elimination), RAASis (such as enalapril, lisinopril, etc.), or aliskirén.(see also the information under the headings “Do not take Valsartán Stadafarma” and “Warnings and precautions”).
• medications that increase the amount of potassiumin the blood. Among them are potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin,
• certain pain medicationscalled nonsteroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (in the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of valsartán
• lithium,a medication used to treat certain types of psychiatric disorders.

Additionally:

• if you are being treated aftera heart attack,it is not recommended to combine withACE inhibitors (a medication for treating a heart attack).
• if you are being treated forheart failure,it is not recommended to take a triple combination withACE inhibitorsand other medications specifically for the treatment of your heart failure, known asmineralocorticoid receptor antagonists (MRAs)(for example, spironolactone, eplerenone) orbeta-blockers(for example, metoprolol).

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

Taking Valsartán Stadafarma with food and drinks

You can take valsartán regardless of food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication

• You must inform your doctor if you are pregnant(or, if you suspect you may be).Generally, your doctor will advise you to stop taking valsartán before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it could cause serious harm to your baby if used during this period (see the Pregnancy section).

• Inform your doctor if you are planning to start or are breastfeedingsince valsartán is not recommended during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

Before driving a vehicle, using tools, or operating machines, or engaging in other activities that require concentration, make sure you know your reactions to the effects of valsartán. Like many other medications used to treat high blood pressure, valsartán may cause, in rare cases, dizziness and affect concentration.

Valsartán Stadafarma contains sorbitol.

This medication contains 18.5 mg of sorbitol in each tablet.

Valsartán Stadafarma contains sodium

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

Valsartán Stadafarma contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

To get the best results and reduce the risk of adverse effects, take valsartan exactly as your doctor tells you to. Consult your doctor or pharmacist if you have any doubts. 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 per day. In some cases, your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). You may also take valsartan with another medication (e.g. a diuretic).

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

In patients weighing less than 35 kg, the usual dose is 40 mg of valsartan once a day.

In patients weighing 35 kg or more, the recommended starting dose is 80 mg of valsartan once a day. 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 patients after a recent heart attack:

After a heart attack, treatment usually starts at 12 hours, typically with a low dose of 20 mg administered twice a day. Your doctor will gradually increase this dose over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance. Valsartan may be taken with other treatments for a heart attack, and your doctor will decide what treatment is suitable for you.

Adult patients with heart failure:Treatment usually starts with 40 mg twice a day. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

Valsartan may be taken with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

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

Take valsartan approximately at the same time every day.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

If you take more Valsartán Stadafarma than you should:

If you experience severe 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Valsartán 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, omit the missed dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Valsartán Stadafarma:

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

Like all medicines, valsartan may cause side effects, although not everyone will experience them.

Some side effects may 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 yourdoctor immediately (see also section 2 “Warnings and precautions”).

Other side 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,
• reduction in kidney function (signs of renal deterioration).

Rare:may affect up to 1 in 100 people

• angioedema (see section “Some side effects may be serious and may require immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of rotation, (vertigo)
• marked reduction in kidney function (signs of acute renal insufficiency),
• muscle spasms, abnormal heart rhythm (signs of hyperkalemia),
• shortness of breath, difficulty breathing while 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 that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Unknown frequency:(the frequency cannot be estimated from the available data):

• blistering on the skin (sign of dermatitis bullosa)
• may occurallergic reactions withskin rash, itching, and hives; symptoms of serum sickness, such as fever, swelling, and pain in the joints, muscle pain, swelling of the lymph nodes, and/or symptoms similar to the flu (signs of serum disease).
• red-purple spots, fever, itching (signs of inflammation of the blood vessels, also known as vasculitis).
• more frequent bleeding or bruising than usual (signs of thrombocytopenia),
• muscle pain (myalgia).
• fever, sore throat, or ulcers in the mouth due to infections (symptoms of low white blood cell count, also known as neutropenia).
• reduction in hemoglobin level and reduction in percentage of red blood cells in the blood (which, in severe cases, may cause anemia).
• increase in potassium level in the blood (which, in severe cases, may cause muscle spasms and abnormal heart rhythm).
• elevation of liver function values (which may indicate liver damage), including an increase in bilirubin level in the blood (which, in severe cases, may cause the skin and eyes to turn yellow).
• increase in urea nitrogen level in the blood and increase in serum creatinine level (which may indicate renal anomalies).
• low sodium level in the blood (which in severe cases may cause fatigue, confusion, muscle contraction, and/or convulsions).

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and kidney function reduction were observed less frequently in patients treated for hypertension than in patients treated for heart failure or after a recentheart attack.

Side effectsin children and adolescents are similar to those observed in adults

Reporting of side effects

If you experienceanytype ofside effect, consultyour doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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 out of the sight and reach of children

Do not store at a temperature above 86°F (30°C). Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines that you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Valsartán Stadafarma

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

Appearance of the product and content of the container

Valsartán Stadafarma 160 mg: are film-coated, cylindrical tablets, of ocre color and with a notch on one of the faces.

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

Only some container sizes may be commercially available.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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.

U. Kabelovny 130

10237 Praga, Republica Checa

You can request more information about this medication by contacting the marketing authorization holder.

Last review date of e this leaflet: 02/2025

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