Valsartan CINFA 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

valsartán cinfa 40 mg film-coated tablets EFG

Read this entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What valsartán cinfa is and what it is used for

valsartán cinfa contains the active substance: valsartán 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. Valsartán works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

valsartán cinfa can be used for three different conditions:

• to treat high blood pressure in children and adolescents aged 6 to less than 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 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 is used when a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication for treating heart failure) cannot be used, or may be used in addition to ACE inhibitors when other heart failure treatments are not possible. 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 the body's needs.

2. What you need to know before taking valsartán cinfa

Do not take valsartán cinfa

• 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 best 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 apply to you, inform your doctor and do not take valsartán

Warnings and precautions

Talk to your doctor or pharmacist before taking valsartán cinfa

• 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 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 experience these symptoms while taking valsartán, stop treatment immediately and never take it again. See also section 4 “Possible side effects”.

• if you are taking medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin. Regular monitoring of blood potassium levels may be necessary.

• 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 large amount of fluid (dehydration) due to diarrhoea, vomiting, or high doses of diuretics (medicines that increase urine output).

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

• 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 diarrhoea 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 valsartán cinfa”.

You must inform your doctor if you think you are (or might be) pregnant. Valsartan is not recommended in early pregnancy, and must not be taken after the third month of pregnancy as it may cause serious harm to your baby if taken during this period (see Pregnancy section).

Other medicines and valsartán cinfa

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 cinfa” and “Warnings and precautions”).
• medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, 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 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.

Additionally:

• 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 for heart failure, the triple combination with ACE inhibitors and other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol) is not recommended.

Taking valsartán cinfa with food and drink

You may take valsartan with or without food.

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 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. 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 stage.
• Inform your doctor if you are breast-feeding or plan to start. Use of valsartan during breast-feeding is not recommended, and your doctor will choose an alternative treatment if you wish to breast-feed, especially if your baby is newborn or premature.

Driving and using machines

Before driving, using tools, operating machinery, or engaging in other activities 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.

valsartán cinfa contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

valsartán cinfa contains sorbitol.

This medicine contains 4.6 mg of sorbitol per tablet.

valsartán cinfa contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take valsartan cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

People with high blood pressure often do not notice any symptoms; many feel perfectly normal. This makes it very important to attend your medical appointments regularly, even if you feel well.

Use in children and adolescents (6 to 18 years of age) with high blood pressure

In patients weighing less than 35 kg, the recommended 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).

Adult patients after a recent heart attack: after a heart attack, treatment is usually started within 12 hours, typically 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.

Valsartan can be taken with or without food. Swallow valsartan with a glass of water. Take valsartán cinfa approximately at the same time each day.

The tablet may be divided into equal doses.

If you take more valsartán cinfa than you should

If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. In case of overdose or accidental ingestion, consult 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 cinfa

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 missed dose.

If you stop taking valsartán cinfa

If you stop your 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 will experience 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 valsartan and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other adverse effects include:

Common (may affect up to 1 in 10 people):

• 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 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 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 with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from available data):

• blisters on the skin (signs 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)
• purple-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 hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anemia)
• increased blood potassium levels (which, in severe cases, may cause muscle cramps and irregular heartbeat)
• elevation of 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 and increased serum creatinine levels (which may indicate kidney function abnormalities)
• low blood sodium levels (which, in severe cases, may cause fatigue, confusion, muscle twitching, and/or seizures)

The frequency of certain 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 type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of valsartan cinfa

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

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

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

6. Contents of the pack and other information

Composition of valsartán cinfa

• The active substance is valsartan. Each tablet contains 40 mg of valsartan.
• The other components are:

Tablet core: microcrystalline cellulose (E-460), colloidal anhydrous silica, sorbitol (E-420), magnesium carbonate (E-504), pregelatinized corn starch, povidone (E-1201), sodium stearyl fumarate, sodium lauryl sulfate and crospovidone.

Coating: Opadry OY-L-28900 (monohydrate lactose, hypromellose (E-464), titanium dioxide (E-171) and macrogol) and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

valsartán cinfa 40 mg are yellow, film-coated, cylindrical tablets, scored and marked with the code “V”.

Packs of PVC/PVDC-Aluminum blisters are available, containing 14, 28 or 280 tablets (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) Spain

Date of the most recent revision of this leaflet: February 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70322/P_70322.html

QR code to: https://cima.aemps.es/cima/dochtml/p/70322/P_70322.html