VALSARTAN STADA 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

Valsartan Stada 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, blood vessels relax and blood pressure decreases.

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

• to treat high blood pressure in adults and in children and adolescents from6 to18 years of age. 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 increases the risk of heart attacks. Lowering blood pressure to normal levels 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 it can be used in addition to ACE inhibitors when it is not possible to use other medications for the treatment of heart failure. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. This is because the heart muscle cannot pump blood with enough force to supply the body with the blood it needs.

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

Do not take Valsartan Stada

• if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease
• if you have diabetes or kidney impairment and you are treated with a blood pressure lowering medicine containing aliskiren
• if you are more than 3 months pregnant. (It is also better to avoid valsartan during the first months of pregnancy - see section Pregnancy).

If any of these conditions apply to you, do not takevalsartan.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with 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 are being treated for a heart attack or heart failure, your doctor may check your kidney function
• if you have severe heart disease other than heart failure or heart attack
• if you are taking medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin. It may be necessary to regularly check the amount of potassium in your blood
• if you are under 18 years of age and taking valsartan with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may periodically check your kidney function and the amount of potassium in your 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 output)
• if you have experienced swelling, especially of the face and throat, while taking other medicines (including ACE inhibitors). If you develop these symptoms while taking this medicine, stop taking it and contact your doctor immediately. You should not take this medicine or any other medicine containing valsartan again
• tell your doctor if you are pregnant (or if you think you might be pregnant). Valsartan should not be used during pregnancy, and in particular, it should not be used after the third month of pregnancy, as it can cause serious harm to your baby when administered from that time on (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), especially if you have kidney problems related to diabetes
• aliskiren
  • if you are being treated with an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may check 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 Stada”.

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.

Taking Valsartan Stada 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 it is taken with certain other medicines. Your doctor may need to change your dose and/or 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 output)
• medicines that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin
• certain pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs)
• lithium, a medicine used to treat certain types of psychiatric diseases
• some 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 infection (ritonavir). These medicines may increase the effect of valsartan.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Valsartan Stada” and “Warnings and precautions”).
• If you are being treated with an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

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)

Taking Valsartan Stada with food and drink

You can take valsartan with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• You should inform your doctor if you are pregnant (or if you think you might be pregnant). Your doctor will normally advise you to stop taking valsartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of valsartan. Valsartan should not be used during pregnancy, and in particular, it should not be used after the third month of pregnancy, as it can cause serious harm to your baby when administered from that time on.

• Tell your doctor if you are breast-feeding or will start breast-feeding. Valsartan is not recommended for use while breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed, especially if your baby is newborn or premature.

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 valsartan affects you. Like many other medicines used to treat high blood pressure, valsartan may cause dizziness and affect your ability to concentrate.

Valsartan Stada contains lactose and sodium

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

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

3. How to take Valsartan Stada

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. 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 recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Valsartan can also be combined with another medicine (e.g., a diuretic).

Children and adolescents (6 to18 years of age) with high blood pressure

In patients who weigh less than 35 kg, the recommended 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 can be increased to 160 mg and up to a maximum of 320 mg).

Adult patients after a recent heart attack: treatment is usually started at 12 hours, normally at a low dose of 20 mg given twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. 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 patients with 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.

Method of administration

You can take Valsartan Stada with or without food. The tablet can be divided into equal doses. Swallow Valsartan Stada with a glass of water.

Take Valsartan Stada at approximately the same time each day.

If you take moreValsartan Stadathan you should

If you notice a strong dizziness or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital. You can also call the Toxicological Information Service, telephone 91-562 04 20, indicating the medicine and the amount taken.

If you forget to takeValsartan Stada

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 forgotten doses.

If you stop takingValsartan Stada

If you stop taking valsartan, your disease 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 side effects

Like all medicines, valsartan can cause side effects, although not everybody gets them.

Some symptoms require immediate medical attention:

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

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

If you experience any of these symptoms, consult a doctor immediately.

Other side effects include:

Common (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 kidney function (signs of kidney impairment)

Uncommon (may affect up to 1 in 100 people)

• angioedema (see section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling of spinning (vertigo)
• marked reduction of kidney function (signs of acute kidney 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 (tiredness)
• weakness (asthenia)

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

• intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• blistering of the skin (sign of bullous dermatitis)
• allergic reactions with skin rash, itching, and hives; symptoms of fever, swelling, and pain in the joints, muscle pain, swelling of the lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness)
• red purple spots, fever, itching (signs of vasculitis)
• bleeding or bruising more often 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 and reduction of the percentage of red blood cells in the blood (which, in severe cases, can cause anemia)
• increase in blood potassium levels (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 bilirubin levels in the blood (which, in severe cases, can cause yellowing of the skin and eyes)
• increase in blood urea nitrogen and increase in serum creatinine levels (which may indicate kidney function abnormalities)
• low sodium levels in the blood (which can cause fatigue, confusion, muscle contractions, and/or convulsions in severe cases)

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduced kidney function are observed less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

Side effects in children and adolescents are similar to those observed in adults.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartán Stada

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of deterioration.
• Do not store above 30°C.
• Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Valsartán Stada

• The active substance is valsartan.

Each Valsartán Stada 160 mg film-coated tablet contains 160 mg of valsartan.

• The other ingredients of the core are:

• Lactose monohydrate
• Cellulose powder
• Hypromellose
• Sodium croscarmellose
• Colloidal anhydrous silica
• Magnesium stearate

• The other ingredients of the coating are:

• Hypromellose
• Macrogol 8000
• Titanium dioxide (E171)
• Talc
• Yellow iron oxide (E172)

Appearance and package contents of the product

Valsartán Stada 160 mg film-coated tablets are yellow, oval, and biconvex tablets. They have a score line on both sides. The tablet can be divided into equal doses.

Valsartán Stada 160 mg film-coated tablets are available in aluminum PVC/PVDC blister packs of 10, 14, 28, 30, 50, 56, 90, 98, and 100 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer:

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Eurogenerics N.V.

Heizel Esplanade B22

1020 Brussels

Belgium

or

Lamp S. Prospero S.p.A.

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

or

STADA Arzneimittel AG

Stadastraße 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Valsartan EG 160 mg filmomhulde tabletten

Bulgaria: Valsavil 160 mg ????????? ????????

Denmark: Valsavil 160 mg, filmovertrukne tabletter

Finland: Valsarstad 160 mg tabletti, kalvopäälllysteinen

Germany: Valsartan STADA 160 mg Filmtabletten

Ireland: Valtan 160 mg film-coated tablets

Italy: Valsartan EG 160 mg compresse rivestite con film

Luxembourg: Valsartan EG 160 mg comprimés pelliculés

Portugal: Valsartan Ciclum

Spain: Valsartán Stada 160 mg comprimidos recubiertos con película EFG

Sweden: Valsartore 160 mg filmdragerade tabletter

Netherlands: Valsartan CF 160 mg, filmomhulde tabletten

Date of last revision of this prospectus:May 2025

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