Valsartan Sandoz 320 mg film-coated tablets EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Valsartan Sandoz 320 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, 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, as it could 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 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 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 the blood vessels in the brain, heart, and kidneys, and may lead 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 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 severe heart disease 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 experience 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 potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medications, and heparin. Regular monitoring of blood potassium levels may be necessary,
• if you are under 18 years of age and 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, valsartan is not recommended,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to 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 after the third month of pregnancy 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, known as mineralocorticoid receptor antagonists (MRA) (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”.

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 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 to 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 potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medications, and heparin,
• certain painkillers 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 (MRA) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Taking Valsartán Sandoz with food and drink

You may take valsartan regardless of meals.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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). Your doctor will generally 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. Use of 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 when administered from that point onward.

• Inform your doctor if you are breast-feeding or plan to start breast-feeding. Use of valsartan during breast-feeding is not recommended, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a 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 you react to the effects of valsartan. 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 perfectly normal. Therefore, it is very important to keep your medical 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). Valsartan may also be combined with another medication (e.g. a diuretic).

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

For patients weighing less than 35 kg, the usual starting dose is 40 mg of valsartan once daily. For 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 starting 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 administered 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 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 appropriate for you.

You may take valsartan 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 stop taking valsartan, your condition may worsen. Do not discontinue 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 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 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”).

Adverse effects include:

Common (may affect up to 1 in 10 people)

• dizziness,
• low blood pressure with 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 renal failure),
• muscle cramps, irregular heartbeat (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.

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

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

Not known (frequency cannot be estimated from available data)

• 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, 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),
• 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 levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anemia),
• increased potassium levels in blood (which, in severe cases, may cause muscle cramps and irregular heartbeat),
• 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 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 type of 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 Medicinal Products: 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 refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect 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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán Sandoz 320 mg

• The active substance is valsartan. Each tablet contains 320 mg of valsartan.
• The other components 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 contents of the pack

Valsartán Sandoz 320 mg film-coated tablets are dark greyish-violet, oval-shaped, bevelled-edge tablets, scored, with the mark "DC" on one side of the score and "DC" on the other side of the score, and "NVR" on the opposite side of the tablet.

The score line is intended only to assist in breaking the tablet if you have difficulty swallowing it whole, but it is not intended 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 Centre
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.
Verovska 57
1526 Ljubljana
Slovenia

OR

Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava
Slovenia

OR

LEK, S.A.
Ul Podlipie, 16
Strykow - PL95-010
Poland

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 under the following names:

Austria: Valsartan Sandoz 320 mg – Filmtabletten
Belgium: Valsartan Sandoz 320 mg filmomhulde tabletten
Cyprus: Valsartan Sandoz 320 mg
Greece: Valsartan/Sandoz επικαλυμμένα με λεπτό υμένιο δισκία 320 mg
Hungary: Valsartan Sandoz 320 mg filmtabletta
Lithuania: Suvartar 320 mg plevele dengtos tabletes
Netherlands: Valsartan Sandoz 320 mg, filmomhulde tabletten
Norway: Valsartan Sandoz 320 mg tabletter, filmdrasjerte
Poland: Axudan
Slovenia: Valsartan Lek 320 mg filmsko obložene tablete
Sweden: Valsartan Sandoz filmdragerade tabletter

Date of the most recent revision 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/