Valsartan Cardio Stada 40 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Valsartán Cardio Stada 40 mg Film-coated Tablets

EFG

Read the entire 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Valsartán Cardio Stada is and what it is used for

Valsartán Cardio Stada 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. Valsartán works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Cardio Stada 40 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage 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 disorders.
• to treat adult patients after a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.
• to treat symptomatic heart failure in adult patients. Valsartán is used when a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication for treating heart failure) cannot be used, or may be used in addition to ACE inhibitors when other heart failure treatments are not possible. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. This is caused by the heart muscle being unable to pump blood strongly enough to supply the body's needs.

2. What you need to know before taking Valsartán Cardio Stada

Do not take Valsartán Cardio 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 failure and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you are more than 3 months pregnant. (It is also advisable to avoid valsartan during the first months of pregnancy – see section Pregnancy.)

If any of these situations apply to you, do not take valsartan.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take valsartan:

• if you have liver disease

• if you have severe kidney disease or are undergoing dialysis

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

• if you have recently had a kidney transplant (received a new kidney)

• if you are being treated for heart attack or heart failure, your doctor may monitor your kidney function

• if you have a serious heart condition other than heart failure or heart attack

• if you are taking medicines that increase blood potassium levels. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin. Regular monitoring of blood potassium levels may be necessary

• if you are under 18 years of age and are taking valsartan together with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor may periodically monitor your kidney function and blood potassium levels

• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, taking valsartan is not recommended

• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines that increase urine output)

• if you have previously experienced swelling, especially of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you develop these symptoms while taking this medicine, stop taking it immediately and contact your doctor without delay. You must not take this medicine again, nor any other medicine containing valsartan

• inform your doctor if you are pregnant (or suspect you might be). Valsartan is not recommended during early pregnancy, and must not be used after the third month of pregnancy, as it may cause serious harm to your baby from that stage onward (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), particularly if you have kidney problems related to diabetes
  • aliskiren

• if you are being treated with an ACE inhibitor together with other specific medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).

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

Talk to 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 Valsartán Cardio Stada with other medicines

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

The effect of treatment with valsartan may be altered if taken together with certain medicines. Your doctor may need to adjust your dose and/or take other precautions, or in some cases, discontinue treatment with one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• other medicines that lower blood pressure, particularly diuretics (medicines that increase urine output)
• medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
• certain pain medicines known as non-steroidal anti-inflammatory drugs (NSAIDs)
• lithium, a medicine used to treat certain psychiatric conditions
• some antibiotics (such as rifampicin), a drug used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used to treat HIV/AIDS (ritonavir). These drugs may increase the effect of valsartan
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Valsartán Cardio Stada” and “Warnings and precautions”)
• If you are being treated with an ACE inhibitor together with other specific medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenona) or beta-blockers (e.g., metoprolol)

In addition:

• if you are being treated after a heart attack, combination with ACE inhibitors (a medication used to treat heart attack) is not recommended

Taking Valsartán Cardio Stada with food and drinks

You may 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 become pregnant, consult your doctor or pharmacist before using this medicine.

• You must inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking valsartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of valsartan. Valsartan is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby from that stage.

• Inform your doctor if you are breast-feeding or plan to start breast-feeding. Valsartan is not recommended during breastfeeding, and your doctor will choose an alternative treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, operating machinery, or engaging in other activities requiring concentration, make sure you are aware of how valsartan affects you. Like many other medicines used to treat high blood pressure, valsartan may cause dizziness and affect your ability to concentrate.

Valsartán Cardio Stada contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him 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 Valsartán Cardio Stada

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

People with high blood pressure often do not experience any symptoms; many feel perfectly normal. Therefore, it is very important to attend your medical appointments regularly, even if you feel well.

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

In patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once daily.

In patients weighing 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).

Adult patients after a recent heart attack: treatment is usually started within 12 hours after the heart attack, 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 up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan may be administered together 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 at 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

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

Method of administration

Valsartán Cardio Stada may be taken regardless of meals. The tablet may be divided into equal doses. Swallow Valsartán Cardio Stada with a glass of water.

Take Valsartán Cardio Stada at approximately the same time each day.

If you take more Valsartán Cardio Stada than you should

If you experience severe 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 may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartán Cardio Stada

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 Valsartán Cardio Stada

If you discontinue treatment with valsartan, your condition may worsen. Do not stop taking this medicine unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, valsartan can cause adverse effects, although not everyone experiences 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 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 upon standing
• 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)
• sensation of spinning (vertigo)
• marked reduction in kidney function (signs of acute kidney failure)
• muscle cramps, irregular heartbeat (signs of hyperkalemia)
• shortness of breath, difficulty breathing when lying down, swelling of feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhea
• tiredness (fatigue)
• weakness (asthenia)

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

• intestinal angioedema: swelling in the intestine causing 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 may occur with skin rash, itching, and hives; symptoms of fever, swelling and joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms (signs of serum sickness)
• purplish red spots, fever, itching (signs of blood vessel inflammation, also called vasculitis)
• bleeding or bruising more easily 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 in hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anemia)
• increased potassium levels in the blood (which, in severe cases, may cause muscle cramps and irregular heartbeat)
• elevated liver function test values (which may indicate liver damage), including increased blood bilirubin levels (which, in severe cases, may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and increased serum creatinine levels (which may indicate kidney function abnormalities)
• low sodium levels in the blood (may cause tiredness, confusion, muscle twitching, and/or seizures in more severe cases)

The frequency of some adverse effects may vary depending on your condition. For example, certain adverse effects such as dizziness and reduced kidney function were observed less frequently in adult patients treated for hypertension than in adult 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 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 Valsartán Cardio Stada

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.
• 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán Cardio Stada

• The active substance is valsartan.

Each Valsartán Cardio Stada 40 mg film-coated tablet contains 40 mg of valsartan.

• The other components of the core are:

• Lactose monohydrate

• Cellulose, powdered

• Hypromellose

• Sodium croscarmellose

• Colloidal anhydrous silica

• Magnesium stearate

• The other components of the coating are:

• Hypromellose

• Macrogol 8000

• Titanium dioxide (E171)

• Talc

• Yellow iron oxide (E172)

Nature of the product and contents of the pack

Valsartán Cardio Stada 40 mg film-coated tablets are yellow, round, biconvex tablets with a score line on both sides. The tablet can be divided into equal doses.

Valsartán Cardio Stada 40 mg film-coated tablets are available in aluminum PVC/PVDC blisters containing 10, 14, 28, 30, 50, 56, 90 and 98 tablets.

Only certain 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

The 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 medicinal product is authorized in the European Economic Area member states under the following names:

Denmark: Valsavil 40 mg, filmovertrukne tabletter

Finland: Valsarstad 40 mg tabletti, kalvopäälllysteinen

Germany: Valsartan STADA 40 mg Filmtabletten

Ireland: Valtan 40 mg film-coated tablets

Portugal: Valsartan Ciclum

Spain: Valsartán Cardio Stada 40 mg comprimidos recubiertos con película EFG

Sweden: Valsartore 40 mg filmdragerade tabletter

Netherlands: Valsartan CF 40 mg, filmomhulde tabletten

Date of the most recent revision of this leaflet: May 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/