Valsartan Sandoz 160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Valsartan Sandoz 160 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 must not be given 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 such effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

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

Valsartán 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 aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, 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 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. Valsartán Sandoz can be used for the treatment of symptomatic heart failure in adult patients. Valsartan is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a medicine for treating heart failure) cannot be used, or may be used in addition to angiotensin-converting enzyme inhibitors when other medicines for treating heart failure cannot be used.

Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. This is due to 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 Sandoz

Do not take Valsartán Sandoz:

• 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 are more than 3 months pregnant (in any case, it is better to avoid taking valsartan during early pregnancy – see Pregnancy section),
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Valsartán Sandoz:

• 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 a 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 have ever experienced swelling, mainly of the face and tongue, due to an allergic reaction while taking other medicines (including ACE inhibitors). If you develop 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 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 are pregnant, suspect you may be pregnant (or plan to become pregnant), you must inform your doctor. Use of valsartan is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby (see Pregnancy section),
• 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 together with other specific medicines for heart failure treatment, 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 Valsartán Sandoz.

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 Sandoz”.

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 Sandoz 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), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take Valsartán Sandoz” and “Warnings and precautions”),
• medicines that increase blood potassium levels. 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),
• some antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or antiretroviral medicines used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of valsartan,
• lithium, a medicine used to treat certain psychiatric conditions.

In addition:

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

Taking Valsartán Sandoz with food and drinks

You may take valsartan with or without food.

Pregnancy and breastfeeding

If you are pregnant or 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 may be pregnant). Generally, your doctor will 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 onwards, as it may cause serious harm to your baby when used from that time.

• Inform your doctor if you are breastfeeding or plan to breastfeed. Use of valsartan during breastfeeding is not recommended, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Before driving, operating tools, handling 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 rarely cause dizziness and affect your ability to concentrate.

3. How to take Valsartán Sandoz

To achieve the best results and reduce the risk of adverse effects, always take this medicine exactly as prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts. People with high blood pressure often do not experience any symptoms of the condition and may feel completely normal. This makes it very important to attend your medical appointments regularly, 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 (for example, 160 mg or 320 mg). Valsartan may also be combined with another medicine (for example, a diuretic).

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

In patients weighing less than 35 kg, the usual dose is 40 mg of valsartan once daily. In patients weighing 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 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 a heart attack, typically at a low dose of 20 mg administered 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 given together with other treatments for heart attack, and your doctor will decide which treatment is appropriate for you.

Adult patients with heart failure

Treatment is usually initiated with 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 given together with other treatments for heart failure, and your doctor will decide which treatment is appropriate for you.

Valsartan can be taken with or without food. Swallow the tablet with a glass of water.

Take valsartan approximately at the same time each day.

If you take more Valsartán Sandoz than you should

If you experience severe 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 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 Sandoz

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 forgotten dose.

If you stop taking Valsartán Sandoz

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, this medicine can 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 swallowing,
• hives, itching.

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

Adverse 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 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, abnormal heart rhythm (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,
• fatigue,
• weakness.

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

• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Not known (frequency cannot be estimated from the available data)

• blisters on the skin (symptom of bullous dermatitis),
• skin rash, itching, together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness),
• purplish red spots, fever, itching (signs of inflammation of blood vessels, also called 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),
• reduced haemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anaemia),
• increased potassium levels in blood (which, in severe cases, may cause muscle cramps and abnormal heart rhythm),
• elevation of liver function test values (which may indicate liver injury), including increased blood bilirubin levels (which, in severe cases, may cause yellowing of the skin and eyes),
• increased blood urea nitrogen levels and increased serum creatinine levels (which may indicate kidney function abnormalities),
• low sodium levels in blood (which, in severe cases, may cause fatigue, confusion, muscle cramps and/or seizures).

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 patients treated for hypertension than in 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 Valsartán Sandoz

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

Do not use this medicine after the expiry date stated on the blister after EXP. The expiry date is the last day of the month indicated.

Do not store 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán Sandoz 160 mg

• The active substance is valsartan. Each tablet contains 160 mg of valsartan.
• The other components are:

Core: microcrystalline cellulose, crospovidone, colloidal anhydrous 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 medicine and contents of the pack

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

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

The tablets are available 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 pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Salutas Pharma GmbH
Ott-von-Guericke-Allee 1
39179 Barleben
Germany

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 2D
9220 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 medicinal product is authorized in the Member States of the European Economic Area (EEA) 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 επικαλυμμένα με λεπτό υμένιο δισκία 160 mg
Netherlands: Valsartan Sandoz 160 mg, filmomhulde tabletten
Hungary: Valsartan Sandoz 160 mg filmtabletta
Lithuania: Suvartar 160mg plėvele dengtos tabletės
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 most recent review of this leaflet: February 2025

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