VALSARTAN SUN 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

VALSARTAN SUN 80 mg FILM-COATED TABLETS EFG

valsartan

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

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

Valsartan SUN contains the active substance: valsartan and 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 80 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 less than 18 years of age. High blood pressure increases the workload of the heart and arteries. If not treated, it can damage the blood vessels in 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 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. Valsartan is used when it is not possible to use a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication for treating heart failure), or it can be used in addition to ACE inhibitors when it is not possible to use other medications for the treatment of heart failure.

Among the symptoms of heart failure are difficulty breathing and swelling of the feet and legs due to fluid retention. This is because the heart muscle cannot pump blood with enough force to provide all the blood needed for the body.

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

Do not take valsartan:

• 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 are pregnant for more than 3 months (it is also better to avoid valsartan during the first months of 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 the above applies to you, tell your doctor and do not take valsartan.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take valsartan:

• 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 experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking valsartan, stop taking valsartan immediately and never take it again. See also section 4 "Possible side effects".
• if you are taking medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, 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 medications that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may periodically check your kidney function and blood potassium levels.

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 elimination),
• tell your doctor if you are pregnant (or if you 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 pregnant for more than three months, as it can cause serious harm to your baby when administered from that time on (see section Pregnancy).

if you are taking any of the following medications used to treat high blood pressure:

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

if you are being treated with an ACE inhibitor along with other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

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.

Your doctor may check your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.

See also the information under the heading "Do not take Valsartan".

If any of these situations apply to you, tell your doctor before taking valsartan.

Taking valsartan with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

The effect of treatment with valsartan may be altered if taken with certain medicines. Your doctor may need to modify 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 elimination).
• medicines that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.
• certain pain-relieving medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• some 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.
• lithium, a medicine used to treat certain types of psychiatric diseases.
• if you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Valsartan" and "Warnings and precautions")
• if you are being treated for heart failure, it is not recommended to take a triple combination of ACE inhibitors and other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Additionally:

• if you are being treated after a heart attack, it is not recommended to take valsartan in combination with ACE inhibitors (a medication for treating a heart attack),

Taking valsartan with food and drinks

You can 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 tell your doctor if you are pregnant (or if you 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 use valsartan at the start 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 on.

Tell your doctor if you are breastfeeding or plan 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 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, in rare cases, cause dizziness and affect your ability to concentrate.

3. How to take Valsartan SUN

To get the best results and reduce the risk of side effects, follow exactly the instructions for taking this medicine as indicated by your doctor. In case of doubt, consult 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 attend your doctor's appointments, even if you feel well.

Adult 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). Valsartan can also be taken in combination with another medicine (e.g., a diuretic).

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

In patients who weigh less than 35 kg, the recommended initial dose is 40 mg of valsartan once daily.

In patients who weigh 35 kg or more, the recommended initial 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).

In children who have difficulty swallowing tablets, it is recommended to administer valsartan oral solution.

Adult patients after a recent heart attack:after a heart attack, treatment is usually started at 12 hours, normally with a low dose of 20 mg, given 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 taken with other treatments for heart attack, and your doctor will decide which 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 taken with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

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

Take valsartan approximately at the same time each day.

If you take more Valsartan SUN than you should

If you notice a strong dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valsartan SUN

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 Valsartan SUN

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Some side effects can be serious and may need immediate medical attention:

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

• swelling in the face, lips, tongue, or throat
• difficulty breathing or swallowing
• hives, itching

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

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 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

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

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (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 joint pain, muscle pain, swelling of the lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness)
• red spots, 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 red blood cell percentage in the blood (which, in severe cases, can lead to anemia)
• increase in blood potassium levels (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 serum creatinine levels (which may indicate kidney function abnormalities).
• reduction in blood sodium levels (which, in severe cases, can cause 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 are 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, even if it is possible side effects not listed in this leaflet.

You can also report side effects directly through 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 SUN

Keep out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

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 SUN

The active ingredient is valsartan.

One film-coated tablet contains 80 mg of valsartan.

The other ingredients are: microcrystalline cellulose, crospovidone, anhydrous colloidal silica,

magnesium stearate, pregelatinized corn starch, talc.

The tablet coating contains hypromellose, titanium dioxide (E171), macrogol 400, macrogol 4000, talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the Product and Package Contents

Valsartán SUN 80 mg film-coated tablets are orange, oval, scored on one side with the mark "V" on one side of the score and "2" on the other side of the score, and scored on the other side.

The score line is to facilitate breaking and swallowing, but not to divide into equal doses.

Valsartán SUN 80 mg is available in packs containing 14, 28, 30, 56, 84, 90, or 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH, Hoofddorp

Or

TERAPIA S.A.

124 Fabricii Street, 400 632 Cluj Napoca

Romania

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona.

Spain

Tel.:+34 93 342 78 90

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

Germany: VALSARTAN BASICS 80 mg/160 mg Filmtabletten

Italy: Valsartan SUN 80 mg/160 mg compresse rivestite con film

Spain: Valsartán SUN 80 mg/160 mg comprimidos recubiertos con película EFG

For more information on this product, please contact the marketing authorization holder.

Date of the last revision of this leaflet: January 2025

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