Package Insert: Information for the Patient

Valsartán Combix 160 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Valsartán Combix and how is it used

2. What you need to know before starting to take Valsartán Combix

3. How to take Valsartán Combix

4. Possible adverse effects

5. Storage of Valsartán Combix

6. Contents of the package and additional information

Valsartán belongs to a class of medications known as angiotensin II receptor antagonists that help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in increased blood pressure. Valsartán acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Combix 160 mg film-coated tabletscan be used to treat 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 cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders,

• to treat people 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 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 may 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 feet and legs due to fluid retention. This is because the heart muscle is not strong enough to pump blood with sufficient force to provide all the blood needed by the body.

Do not take Valsartán Combix:

• if you areallergicto valsartán or to any of the other components of this medication (listed in section 6),
• if you have aserious liver disease,
• if you aremore than 3 months pregnant(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 aliskirén.

If any of these situations affect 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 a serious kidney disease or if you are undergoing dialysis,
• if you have a narrowing of the renal artery,
• if you have recently undergone a kidney transplant (you received a new kidney),
• if you are being treated for a heart attack or heart failure, your doctor may check your renal function,
• if you have a 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. You may need to regularly check the amount of potassium in your blood,
• if you are under 18 years of age and take valsartán with other medications that inhibit the renin-angiotensin-aldosterone system (medications that lower blood pressure), your doctor may periodically check your renal function and the amount of potassium in your blood,
• 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 to increase urine production),
• if you are taking any of the following medications used to treat high blood pressure:

- an angiotensin-converting enzyme inhibitor (ACEI) (for example, enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.

- aliskirén

• if you are being treated with an ACEI along with other medications specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone) or beta-blockers (for example, metoprolol).

Your doctor may regularly check your renal function, blood pressure, and electrolyte levels (such as potassium) in the blood.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartán. Your doctor will decide whether to continue treatment. Do not stop taking valsartán on your own.

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

Inform your doctor if you are pregnant (or if you suspect you may be).

If any of these situations affect you, inform your doctor before taking Valsartán Combix.

Use of Valsartán Combix with other medications

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

The effect of valsartán treatment 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, discontinue one of the medications. This applies to both prescription and non-prescription medications, especially:

• other medications that lower blood pressure,especiallydiuretics(medications to increase urine production), an ACEI, or aliskirén (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 medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs),
• litium,a medication used to treat certain types of psychiatric disorders.

Additionally:

• if you are being treated aftera heart attack,it is not recommended to combine withACEIsa medication for heart attack treatment),
• if you are being treated forheart failure,it is not recommended to combine withACEIsand other medications specifically used to treat your heart failure, known as MRAs(for example, spironolactone, eplerenone)orbeta-blockers(for example, 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, or if you suspect you may be, consult your doctor or pharmacist before using this medication.

• Pregnancy

You must inform your doctor if you are pregnant(or if you suspect you may be).Your doctor will generally recommend that you stop taking valsartán 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 beginning of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious damage to your baby when administered from that moment on.

• Breastfeeding

Inform your doctor if you are breastfeeding or plan to start.It is not recommended to use valsartán 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 operating machines

Before driving a vehicle, using tools, or operating machines, 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 may cause, in rare cases, dizziness and affect concentration.

To get the best results and reduce the risk of adverse effects, take Valsartán Combix exactly as your doctor tells you to. Consult your doctor or pharmacist if you have any doubts. People with high blood pressure often do not notice any symptoms 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 combine valsartán with another medication (e.g. a diuretic).

Children and adolescents (6 to 18 years old) with high blood pressure:In patients weighing less than 35 kg, the usual dose is 40 mg of valsartán once a day.

In patients weighing 35 kg or more, the usual starting dose is 80 mg of valsartán 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 at 12 hours, typically with a low dose of 20 mg, administered 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 taken with other treatments for heart attack, and your doctor will decide what 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 taken with other treatments for heart failure, and your doctor will decide what 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 approximately at the same time every day.

If you take more Valsartán Combix than you should:

If you experience severe 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 Toxicological 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, omit the missed dose.

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

If you interrupt treatment with Valsartán Combix:

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

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

Like all medicines, Valsartán Combix can cause side effects, although not everyone will experience 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 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,
• Reduction in kidney function (signs of renal deterioration).

Uncommon

• Angioedema, (see section “Some symptoms require immediate medical attention”)
• Sudden loss of consciousness (syncope),
• Sensation of rotation (vertigo),
• Marked reduction in kidney function (signs of acute renal insufficiency),
• Muscle spasms, abnormal heart rhythm (signs of hyperkalemia),
• Shortness of breath, difficulty breathing while 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:

• May occur allergic reactions with skin rash, itching, and hives; symptoms of serum sickness, such as fever, swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or symptoms similar to the flu,
• Reddish-purple spots, fever, itching (signs of inflammation of blood vessels, also known as vasculitis),
• Bleeding or bruising more frequently than usual (signs of thrombocytopenia),
• Muscle pain (myalgia),
• Fever, sore throat, or ulcers in the mouth due to infections (symptoms of low white blood cell count, also known as neutropenia),
• Reduction in hemoglobin level and reduction in percentage of red blood cells in the blood (which, in severe cases, may cause anemia),
• Increased potassium level in the blood (which, in severe cases, may 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, may cause the skin and eyes to turn yellow),
• Increased urea nitrogen level in the blood and increased serum creatinine level (which may indicate renal anomalies),
• Low sodium level in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or convulsions)

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduction in 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.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store at a temperature above30ºC.

Store in the original packaging to protect it from moisture.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the packaging is damaged or shows signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172).

Appearance of the product and content of the packaging

Valsartán Combix 160 mg is presented in blister packaging containing 28 film-coated tabletsare yellow, oval, with beveled edges, scored on one face and smooth on the other.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet:February 2025

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