VALSARTAN SANDOZ 160 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Valsartan Sandoz 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 and other information

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

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

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

• 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 stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal reduces the risk of developing these disorders,
• to treat adult patients after a recent heart attack(myocardial infarction). “Recent” here means between 12 hours and 10 days,
• to treat symptomatic heart failure in adult patients.Valsartan Sandoz can be used 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 medicine for treating heart failure), or it can be used in addition to ACE inhibitors when it is not possible to use other medicines for treating heart failure.

Among the symptoms of heart failure are 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.

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

Do not take Valsartan Sandoz:

• if you are allergicto valsartan or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver disease,
• if you are pregnantfor more than 3 months(in any case, it is better to avoid taking valsartan at the start of your pregnancy - see section Pregnancy),
• if you have diabetes or kidney problems and are being treated with a medicine to reduce blood pressure that contains aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartan Sandoz:

• if you have liver disease,
• if you have severe kidney disease or 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 have ever had swelling mainly of the face and tongue due to an allergic reaction while taking other medicines (including ACE inhibitors). If you have these symptoms, stop taking valsartan and contact your doctor immediately. Do not take valsartan again. See also section 4 “Possible side effects”,
• if you are taking medicines that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin. It may be necessary to regularly check the amount of potassium in the blood,
• if you are under 18 years of age and take 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 production),
• if you are pregnant, if you think you may be pregnant (or if you plan to become pregnant), you must inform your doctor. It is not recommended to use valsartan at the start of pregnancy and in no case should it be administered from the third month of pregnancy because it can cause serious harm to your baby (see section Pregnancy),
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• 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 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).

If any of these situations apply to you, inform your doctor before taking Valsartan Sandoz.

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 Sandoz”.

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 Sandoz 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 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 production) ACE inhibitors(such as enalapril, lisinopril, etc.) or aliskiren(see also the information under the headings “Do not take Valsartan Sandoz” and “Warnings and precautions”),
• medicines that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin,
• certain pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),
• certain antibiotics (rifampicin group), a medicine used to protect against rejection in a transplant (cyclosporin), or antiretroviral medicines used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of valsartan,
• lithium,a medicine used to treat certain types of psychiatric diseases.

Additionally:

• if you are being treatedafter a heart attack,it is not recommended to combine with ACE inhibitors(a medicine for treating heart attack),
• if you are being treated with an ACE inhibitoralong 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).

Taking Valsartan Sandoz 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 must inform your doctor if you are pregnant (or if you think you may 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. It is not recommended to use valsartan at the start of pregnancy and in no case should it be administered from the third month of pregnancy as it can cause serious harm to your baby.

• Inform your doctor if you are breast-feeding or about to start breast-feeding.It is not recommended to use valsartan during breast-feeding, and your doctor may choose another treatment for you if you want to breast-feed, especially if your baby is a 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 can cause dizziness and affect your ability to concentrate.

3. How to take Valsartan Sandoz

To get the best results and reduce the risk of side effects, always take this medicine exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist. People with high blood pressure often do not notice any signs of the disease. Many feel normal. This makes it very important to go to your doctor's appointments, even if you feel well.

Adult patients with high blood pressure

The usual 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 usual dose is 40 mg of valsartan once daily. In patients who weigh 35 kg or more, the usual 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

After a heart attack, treatment is usually started at 12 hours, normally at a low dose of 20 mg 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 what 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 what treatment is suitable for you.

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

Take valsartan at about the same time each day.

If you take more Valsartan Sandoz than you should

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

If you forget to take Valsartan Sandoz

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 taking Valsartan Sandoz

If you stop taking valsartan, your disease may get worse. Do not stop taking the medicine unless your doctor tells you to.

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

4. Possible side effects

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

Some symptoms need immediate medical attention:

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

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

If you experience any of these symptoms, stop taking Valsartan Sandoz and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Side effects include:

Common(may affect up to 1 in 10 people)

• dizziness,
• low blood pressure with 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 need 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,
• weakness.

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.

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

• blisters on the skin (symptom of bullous dermatitis),
• skin rash, itching, along with some of the following signs or symptoms: fever, joint pain, 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),
• unusual bleeding or bruising (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 lead to anemia),
• increase in potassium levels in the blood (which, in severe cases, can lead to 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 the skin and eyes to turn yellow),
• increase in blood urea nitrogen and increase in serum creatinine levels (which may indicate kidney function abnormalities),
• low sodium levels in the blood (which, in severe cases, can lead to fatigue, confusion, muscle cramps, and/or convulsions).

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 patients treated for hypertension than in patients treated for heart failure or after a recent heart attack.

Side effects in children and adolescents are similar to those detected 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 via 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 Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from moisture.

Do not use Valsartán Sandoz if you notice that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartán Sandoz 160 mg

• The active ingredient is valsartan. Each tablet contains 160 mg of valsartan.
• The other ingredients are:

Core: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172).

Appearance of the Product and Package Contents

Valsartán Sandoz 160 mg film-coated tablets are orange-gray, oval, slightly convex, scored, and marked with "DX" on one side of the score and "DX" on the other side of the score, and "NVR" on the opposite side of the tablet.

The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole, but not to divide it into equal doses.

The tablets are packaged in blister packs containing 7, 10, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 84, 90, 98, 100, or 280 film-coated tablets.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Ott-von-Guericke-allee 1,

39179 Barleben,

Germany

Or

S.C. Sandoz S.R.L.

Str. Livezeni nr. 7A,

540472 Targu-Mures

Romania

Or

LEK S.A.

Ul. Domaniewska 50 C

02-672 Warszawa

Poland

Or

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana,

Slovenia

Or

Lek Pharmaceuticals d.d.

Trimlini 2D9220 Lendava

Slovenia

Or

Novartis Farmacéutica S.A.

Gran Vía de les Corts Catalanes, 764,

08013

Barcelona

Spain

Or

Novartis Farma S.p.A

Via Provinciale Schito 131

80058 Torre Annunziata

Italy

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

Austria: Valsartan Sandoz 160 mg – Filmtabletten

Belgium: Valsartan Sandoz 160 mg filmomhulde tabletten

Bulgaria: Suvartar 160 mg film coated tablets

Cyprus: Valsartan Sandoz 160 mg

Slovenia: Valsartan Lek 160 mg filmsko obložene tablete

Finland: Valsartan Sandoz 160 mg kalvopäällysteinen tabletti

France: Valsartan Sandoz 160 mg, comprimé pelliculé

Greece: Valsartan/Sandoz επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α 160 mg

Netherlands: Valsartan Sandoz 160 mg, filmomhulde tabletten

Hungary: Valsartan Sandoz 160 mg filmtabletta

Lithuania: Suvartar 160mg plevele dengtos tablets

Norway: Valsartan Sandoz 160 mg tabletter, filmdrasjerte

Poland: Axudan 160 mg tabletki powlekane

Portugal: Valsartan Sandoz 160 mg Comprimidos

Sweden: Valsartan Sandoz 160 mg filmdragerade tabletter

Date of the last revision of this leaflet: February 2025

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