Valsartan Sun 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

VALSARTAN SUN 80 mg FILM-COATED TABLETS EFG

valsartan

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 you should not give it to others, even if they have the same symptoms as you, because 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 SUN is and what it is used for
2. What you need to know before taking Valsartan SUN
3. How to take Valsartan SUN
4. Possible side effects
5. How to store Valsartan SUN
6. Contents of the pack and other information

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

Valsartán SUN contains the active substance: valsartan and 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.

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 aged 6 to under 18 years. High blood pressure increases the workload of 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. Valsartan is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a medication for treating heart failure) cannot be used, or may be used in addition to ACE inhibitors when other medications for treating heart failure cannot be used.

Symptoms of heart failure include difficulty breathing 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 all the blood needed by the body.

2. What you need to know before taking Valsartan

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 more than 3 months pregnant (it is also better to avoid valsartan during the first months of 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 the above situations apply to you, inform your doctor and do not take valsartan.

Warnings and precautions:

Talk to your doctor or pharmacist before taking valsartan:

• 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 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 previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If you develop these symptoms while taking valsartan, stop treatment immediately and never 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 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, 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).
• inform your doctor if you are pregnant (or suspect you might be). Valsartan is not recommended during early pregnancy, and must not be used after the third month of pregnancy as it may cause severe harm to your baby when used from that stage onward (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 (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Talk to 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 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 Valsartan”.

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

Taking valsartan 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).
• medicines that increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin.
• certain pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (such as rifampicin), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of valsartan.
• lithium, a medicine used to treat certain psychiatric conditions.
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Valsartan” and “Warnings and precautions”).
• If you are being treated for heart failure, the triple combination of ACE inhibitors and other specific medicines for heart failure treatment, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol), is not recommended.

Additionally:

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

Taking valsartan with food and drink

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 might be). Your doctor will usually 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 administered after the third month of pregnancy, as it may cause severe harm to your baby when used from that stage onward.

Inform your doctor if you are breastfeeding or plan to breastfeed. The use of valsartan during breastfeeding is not recommended, and your doctor will choose another treatment for you if you intend to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Before driving, operating tools, handling machinery, or engaging in any activity requiring concentration, make sure you know 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 SUN

To achieve the best results and reduce the risk of adverse effects, follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist.

People with high blood pressure often do not notice any signs of the condition; many feel completely normal. Therefore, it is very important to attend your medical appointments regularly, 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 may also be combined with another medicine (e.g. a diuretic).

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

In patients weighing less than 35 kg, the recommended starting dose is 40 mg of valsartan once daily.

In patients weighing 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 may be increased to 160 mg and up to a maximum of 320 mg).

For children who have difficulty swallowing tablets, administration of valsartan oral solution is recommended.

Adult patients after a recent heart attack: Treatment is usually started within 12 hours after a heart attack, normally beginning with a low dose of 20 mg, administered twice daily. The 20 mg dose is obtained by splitting 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 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 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 valsartan with a glass of water.

Take valsartan approximately at the same time each day.

If you take more Valsartán SUN than you should

If you experience severe 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valsartán 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 forgotten doses.

If you stop taking Valsartán SUN

If you stop 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, valsartan may cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious and may 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, stop taking Valsartán SUN immediately and contact your doctor straight away (see also section 2 “Warnings and precautions”).

Other adverse effects include:

Common (may affect up to 1 in 10 patients)

• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting upon standing
• reduced kidney function (signs of kidney impairment)

Uncommon (may affect up to 1 in 100 patients)

• 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 patients)

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

Frequency not known (cannot be estimated from available data)

• blisters on the skin (sign of bullous dermatitis)
• allergic reactions may occur with skin rash, itching, and hives; symptoms of fever, swelling and 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)
• bleeding or bruising more easily 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 haemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anaemia)
• increased potassium levels in the blood (which, in severe cases, may cause muscle cramps and irregular heartbeat)
• elevated liver function test values (which may indicate liver damage), 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)
• reduced sodium levels in the blood (which may cause fatigue, confusion, muscle cramps and/or seizures in severe cases)

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 adult patients treated for high blood pressure than in adult 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 Valsartan SUN

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán SUN

The active substance is valsartan.

One film-coated tablet contains 80 mg of valsartan.

The other components are: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, pregelatinized maize 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 contents of the pack

Valsartán SUN 80 mg film-coated tablets are orange-colored, oval-shaped, 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 intended to facilitate breaking the tablet for ease of swallowing, but not to divide the tablet into equal doses.

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Holder

Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87,
2132JH Hoofddorp,
The 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 medicinal product 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 most recent review of this summary: January 2025

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