VALSARTAN COMBIX 80 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Valsartan Combix 80 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Valsartan Combix and what is it used for
2. What you need to know before taking Valsartan Combix
3. How to take Valsartan Combix
4. Possible side effects
5. Storage of Valsartan Combix
6. Package contents and additional information

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

Valsartan belongs to a class of medications 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 Combix 80 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in children and adolescents from6 to18 years of age.High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage 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 values reduces the risk of developing these disorders,

• to treat people after a recent heart attack(myocardial infarction). "Recent" here means between 12 hours and 10 days,

• to treat symptomatic heart failure in adult patients. Valsartan Combix is used when it is not possible to use a group of medications 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 treating 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 taking Valsartan Combix

Do not take Valsartán Combix:

• if you are allergicto valsartan or any of the other ingredients of this medication (listed in section 6),
• if you have a severe liver disease,
• if you are pregnant for more than 3 months(it is also recommended to avoid Valsartán Combix during the first months of pregnancy - see section Pregnancy).
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartán Combix:

• if you have liver disease,
• if you have severe kidney disease or are undergoing dialysis,
• if you have a 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 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 monitor the amount of potassium in the blood,
• if you are under 18 years of age and take valsartan along with other medications that inhibit the renin-angiotensin-aldosterone system (medications 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 Valsartán Combix,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications that increase urine production),
• 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).

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

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.

See also the information under the heading "Do not take Valsartán Combix".

Using Valsartán Combix with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

The effect of treatment with valsartan may be altered if taken with certain medications. Your doctor may need to modify your dose and/or take other precautions or, in some cases, stop treatment with one of the medications. This applies to both prescription and non-prescription medications, especially:

• other medications that lower blood pressure,especially diuretics(medications that increase urine production), an angiotensin-converting enzyme inhibitor (ACE inhibitor), or aliskiren (see also the information under the headings "Do not take Valsartán Combix" and "Warnings and precautions").
• medications that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin,
• certain pain medicationscalled non-steroidal anti-inflammatory drugs (NSAIDs),
• lithium,a medication used to treat certain types of psychiatric disorders.

In addition:

• if you are being treated after a heart attack,it is not recommended to combine with ACE inhibitors(a medication for treating a heart attack),
• if you are being treated for heart failure,it is not recommended to combine with ACE inhibitorsand 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).

Taking Valsartán Combix with food and drinks

You can take Valsartán Combix with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• Pregnancy

You must inform your doctor if you are pregnant(or if you think 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 that you take another medication instead of Valsartán Combix. It is not recommended to use Valsartán Combix at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on.

• Breastfeeding

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 start breastfeeding, especially if your baby is newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or performing other activities that require concentration, make sure you know how Valsartán Combix affects you. Like many other medications used to treat high blood pressure, Valsartán Combix can cause dizziness and affect your ability to concentrate.

3. How to take Valsartán Combix

To get the best results and reduce the risk of side effects, always take Valsartán Combix exactly as your doctor tells you. Consult your doctor or pharmacist if you have any questions. 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 usual dose is 80 mg per day. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). You may also be given Valsartán Combix in combination with another medication (e.g., a diuretic).

Children and adolescents (6 to18 years of age) with high blood pressure:in patients who weigh less than 35 kg, the usual dose is 40 mg of valsartan once a day.

In patients who weigh 35 kg or more, the usual starting dose is 80 mg of valsartan once a day.

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 usually starts within 12 hours, normally with a low dose of 20 mg, given twice a day. 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 a day. The final dose will depend on your individual tolerance.

Valsartán Combix can be given with other treatments for heart attack, and your doctor will decide which treatment is suitable for you.

Adult patients with heart failure:treatment usually starts with 40 mg twice a day. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

Valsartán Combix can be given with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

You can take Valsartán Combix with or without food. Swallow Valsartán Combix with a glass of water. The tablet can be divided into equal doses.

Take Valsartán Combix at approximately the same time each day.

If you take more Valsartán Combix than you should

If you notice a strong dizziness or fainting, lie down and contact your doctor immediately.

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 medication and the amount ingested.

If you forget to take Valsartán Combix

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to make up for missed doses.

If you stop taking Valsartán Combix

If you stop your treatment with Valsartán Combix, your condition may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Valsartán Combix can cause side effects, although not everyone gets them.

These side effects may occur with certain frequencies, which are defined below:

• very common: may affect more than 1 in 10 patients,
• common: may affect between 1 and 10 in 100 patients,
• uncommon: may affect between 1 and 10 in 1,000 patients,
• rare: may affect between 1 and 10 in 10,000 patients,
• very rare: may affect less than 1 in 10,000 patients,
• frequency not known: cannot be estimated from the available data.

Some symptoms require 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, consult a doctor immediately.

The side effects include:

Common

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

Uncommon

• angioedema (see section "Some symptoms require immediate medical attention"),
• sudden loss of consciousness (syncope),
• feeling of rotation (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.

Very rare:

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

Frequency not known:

• 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),
• purplish red spots, fever, itching (signs of vasculitis, also called inflammation of the blood vessels),
• bleeding or bruising more frequently 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 level and reduction in red blood cell percentage in the blood (which, in severe cases, can cause anemia),
• increase in potassium level in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm),
• elevation of liver function values (which may indicate liver damage), including an increase in bilirubin level in the blood (which, in severe cases, can cause yellowing of the skin and eyes),
• increase in blood urea nitrogen and increase in serum creatinine level (which may indicate kidney function abnormalities),
• low sodium level in the blood (which, in severe cases, can cause fatigue, confusion, muscle twitching, 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 and after a recent heart attack.

The side effects in children and adolescents are similar to those observed in adults.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them 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 medication.

5. Storage of Valsartán Combix

Do not store above 30°C.

Keep in the original package to protect from moisture.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartán Combix

• The active ingredient is valsartan. Each film-coated tablet contains 80 mg of valsartan.

• The other components are: crospovidone, microcrystalline cellulose, anhydrous colloidal silica, hypromellose, anhydrous calcium hydrogen phosphate, magnesium stearate.

• The tablet coating contains: hypromellose, polyethylene glycol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

Appearance of the Product and Package Contents

Valsartán Combix 80 mg is presented in blister packs containing 28 film-coated tablets of pink color, round, with beveled edges, scored on one side and smooth on the other.

The score line is only for fractionation and to facilitate swallowing, but not for dividing into equal doses.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Specialites Pharmaceutiques

ZAC du Suzot

35 rue de la Chapelle

63450 St Amant Tallende

France

Date of the Last Revision of this Leaflet: February 2025

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