VALSARTAN STADA 320 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valsartan Stada 320 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 Stada works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartan Stada 320 mg film-coated tablets can be used for:

• 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 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.

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 disease 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 apply to you, do not take valsartan.

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 renal arteries
• 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 check your kidney function
• if you have severe heart disease other than heart failure or heart attack
• if you are using medicines that increase the amount of potassium in your blood. These include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparin. It may be necessary to check your potassium blood levels regularly
• if you are under 18 years of age and taking valsartan in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may check your kidney function and potassium blood levels periodically
• if you have aldosteronism, a condition where 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 that increase urine production)
• if you have 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. Do not take this medicine or any other medicine containing valsartan again
• tell your doctor if you are pregnant (or think you might be). It is not recommended to use valsartan at the start of pregnancy, and in no case should it be administered if you are more than three months pregnant, as it can cause serious harm to your baby when administered from that time onwards (see section Pregnancy)
• if you are taking any of the following medicines used to treat high blood pressure:

• a medicine called an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
• aliskiren

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 affected if 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 that increase urine production)
• medicines that increase the amount of potassium in your blood. These include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparin
• certain pain relievers called non-steroidal anti-inflammatory drugs (NSAIDs)
• lithium, a medicine used to treat certain types of psychiatric illnesses
• 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.
• 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”).

Taking Valsartan Stada with food and drink

You can take valsartan with or without food.

Pregnancy and breastfeeding

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

• You must tell your doctor if you are pregnant (or think you might be). 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. It is not recommended to take valsartan during the first months of pregnancy, and in no case should it be administered after the third month of pregnancy, as it can cause serious harm to your baby when administered from that time onwards.

• Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use valsartan during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or engaging in 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 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 your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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.

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). Your doctor may also combine valsartan 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 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).

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 more Valsartan Stada than 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 Toxicology Information Service, phone 91-562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartan 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 forgotten doses.

If you stop taking Valsartan Stada

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 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, see 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 in 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)

Very 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 spots on the skin, 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 in hemoglobin and reduction in the percentage of red blood cells in the blood (which, in severe cases, can cause anemia)
• increase in potassium levels in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm)
• increase in liver function test 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 disorders)
• low sodium levels in the blood (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 were 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
• 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Valsartan Stada

• The active ingredient is valsartan.

Each Valsartan Stada 320 mg film-coated tablet contains 320 mg of valsartan.

• The other components of the core are:

• Lactose monohydrate
• Cellulose, powder
• Hypromellose
• Croscarmellose sodium
• 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)

Appearance of the Product and Container Content

Valsartan Stada 320 mg film-coated tablets are brown, oval, and biconvex tablets. They have a notch on one side. The tablet can be divided into equal doses.

Valsartan Stada 320 mg film-coated tablets are presented in aluminum PVC/PVDC blister packs of 10, 14, 28, 30, 50, 56, 90, 98, 100, 112, 126, 154, 168, 182, and 196 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium: Valsartan EG 320 mg film-coated tablets

Denmark: Valsavil 320 mg, film-coated tablets

Finland: Valsarstad 320 mg tablet, film-coated

Germany: Valsartan STADA 320 mg film-coated tablets

Italy: Valsartan EG 320 mg film-coated tablets

Luxembourg: Valsartan EG 320 mg film-coated tablets

Portugal: Valsartan Ciclum

Spain: Valsartán Stada 320 mg film-coated tablets EFG

Sweden: Valsartore 320 mg film-coated tablets

Netherlands: Valsartan CF 320 mg, film-coated tablets

Date of the Last Revision of this Leaflet:May 2025

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