VALSARTAN COMBIX 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valsartan Combix 160 mg Film-Coated Tablets EFG

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

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

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

Valsartan 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 Combix 160 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 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 adults 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 Combix is used when it is not possible to use a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication to treat 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 Combix

Do not take Valsartan Combix:

• if you are allergicto valsartan or any of the other ingredients of this medicine (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 Valsartan Combix 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 these situations apply to you, do not take Valsartan Combix.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartan 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 using 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 Combix,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to 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 check 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 Valsartan Combix".

Inform your doctor if you are pregnant (or if you think you might be pregnant). 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 3 months, as it can cause serious harm to your baby when administered from that time on (see section Pregnancy).

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

Using Valsartan Combix with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use 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 production), an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings "Do not take Valsartan Combix" and "Warnings and precautions").
• medicines 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-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),
• lithium,a medicine used to treat certain types of psychiatric illnesses.

In addition:

• if you are being treated after a heart attack,it is not recommended to combine with ACE inhibitors(a medication to treat 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) orbeta-blockers(e.g., metoprolol).

Taking Valsartan Combix with food and drinks

You can take Valsartan Combix with or without food.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Pregnancy

You must inform your doctor if you are pregnant(or if you think you might be pregnant).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 Combix. It is not recommended to take Valsartan Combix 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.

• Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding.It is not recommended to use valsartan during breast-feeding, and your doctor will choose another treatment for you if you want to start breast-feeding, 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 Combix affects you. Like many other medicines used to treat high blood pressure, Valsartan Combix can cause, in rare cases, dizziness and affect your ability to concentrate.

3. How to take Valsartan Combix

To get the best results and reduce the risk of side effects, always take Valsartan Combix exactly as your doctor tells you. Ask your doctor or pharmacist if you are unsure. 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 once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Valsartan can also be combined with another medicine (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 daily.

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

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

Take Valsartan Combix at approximately the same time each day.

If you take more Valsartan 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, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valsartan 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 Valsartan Combix

If you stop taking Valsartan Combix, 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 Combix can cause side effects, although not everybody gets them.

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

• very common: may affect more than 1 in 10 people,
• common: may affect up to 1 in 10 people,
• uncommon: may affect up to 1 in 100 people,
• rare: may affect up to 1 in 1,000 people,
• very rare: may affect up to 1 in 10,000 people,
• 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 of 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 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.

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),
• purple spots, fever, itching (signs of vasculitis, also known as inflammation of blood vessels),
• 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 known as neutropenia),
• reduction in hemoglobin and reduction in the percentage of red blood cells in the blood (which, in severe cases, can cause anemia),
• increase in blood potassium levels (which, in severe cases, can cause muscle spasms and an 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 increase in serum creatinine levels (which may indicate kidney function abnormalities),
• low sodium levels 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 were 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to 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 Combix

Do not store at a temperature above 30°C.

Keep in the original package to protect it from moisture.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date shown 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 pharmacy's SIGRE Point. In case of doubt, ask your pharmacist how to dispose of the 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 160 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), and black iron oxide (E172).

Appearance of the Product and Package Contents

Valsartán Combix 160 mg is presented in blister packs containing 28 film-coated tablets, which are yellow, oval, with beveled edges, scored on one side and smooth on the other.

The score line is only for fracturing and facilitating 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/”.