Valsartan Stada 320 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Valsartán Stada 320 mg Film-coated Tablets EFG

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

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

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

Valsartán Stada 320 mg film-coated tablets can be used to:

• treat high blood pressure in adults and 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, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. What you need to know before taking Valsartán Stada

Do not take Valsartán Stada:

• if you are allergic to valsartan or to 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 better to avoid valsartan during the first months of pregnancy – see Pregnancy section.)

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

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 undergone 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 severe heart disease other than heart failure or heart attack

• if you are taking medicines that increase potassium levels in the blood. 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 take 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 right away. You must not take this medicine or any other medicine containing valsartan again

• inform your doctor if you are pregnant (or suspect you might be). Use of valsartan is not recommended in early pregnancy, and it must not be used after the third month of pregnancy, as it may cause serious harm to your baby when used from that point onward (see Pregnancy section)

• 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

Your doctor may monitor 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 Valsartán Stada”.

Contact 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 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 when 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 salt substitutes containing potassium, 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
• certain antibiotics (rifampicin group), 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 Stada” and “Warnings and precautions”).

Taking Valsartán Stada with food and drinks

You may take valsartan with or without food.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan 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. Use of valsartan is not recommended in early pregnancy, and it must not be used after the third month of pregnancy, as it may cause serious harm to your baby from that stage onward.

• Inform your doctor if you are breastfeeding or plan to start breastfeeding. Use of valsartan is not recommended during breastfeeding. Your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Before driving, using tools, operating machinery, or engaging in any activity requiring 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.

Valsartán Stada contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor 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 Stada

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

People with high blood pressure often do not notice any symptoms of the condition; many feel perfectly normal. This makes it very important to attend your medical appointments regularly, even if you feel well.

Patients with high blood pressure: The recommended dose is 80 mg 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 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).

Method of administration

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

Take Valsartán Stada approximately at the same time each day.

If you take more Valsartán 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 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 missed doses.

If you stop taking Valsartán Stada

If you stop 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 may cause adverse effects, although not everyone 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 adverse 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)
• sensation of spinning (vertigo)
• marked reduction in kidney function (signs of acute renal failure)
• muscle cramps, irregular heartbeat (signs of hyperkalaemia)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• tiredness (fatigue)
• weakness (asthenia)

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 diarrhoea

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

• blistering of 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 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 haemoglobin levels and reduction in the proportion of red blood cells in the blood (which, in severe cases, may lead to anaemia)
• increased blood potassium levels (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 blood (may cause tiredness, confusion, muscle cramps 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Valsartan 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 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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán Stada

• The active substance is valsartan.

Each Valsartán Stada 320 mg film-coated tablet contains 320 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)

• Red iron oxide (E172)

• Black iron oxide (E172)

Nature of the product and contents of the pack

Valsartán Stada 320 mg film-coated tablets are brown, oval-shaped, biconvex tablets with a score line on one side. The tablet can be divided into equal doses.

Valsartán Stada 320 mg film-coated tablets are available in PVC/PVDC aluminium blister packs containing 10, 14, 28, 30, 50, 56, 90, 98, 100, 112, 126, 154, 168, 182 and 196 tablets.

Only certain pack sizes may be commercially available.

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 (EEA) Member States under the following names:

Belgium: Valsartan EG 320 mg filmomhulde tabletten

Denmark: Valsavil 320 mg, filmovertrukne tabletter

Finland: Valsarstad 320 mg tabletti, kalvopäälllysteinen

Germany: Valsartan STADA 320 mg Filmtabletten

Italy: Valsartan EG 320 mg compresse rivestite con film

Luxembourg: Valsartan EG 320 mg comprimés pelliculés

Portugal: Valsartan Ciclum

Spain: Valsartán Stada 320 mg comprimidos recubiertos con película EFG

Sweden: Valsartore 320 mg filmdragerade tabletter

Netherlands: Valsartan CF 320 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 Health Products (AEMPS) http://www.aemps.gob.es/