Valsartan Combix 160 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Valsartan Combix 160 mg Film-coated Tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Valsartan 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, leading to increased blood pressure. Valsartan works by blocking the effects of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Combix 160 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it may damage the blood vessels of the brain, heart, and kidneys, leading 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 people after a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.

• to treat symptomatic heart failure in adult patients. Valsartán Combix is used when a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (medicines used to treat heart failure) cannot be used, or it may be added to angiotensin-converting enzyme inhibitors when other heart failure treatments cannot be used.

Symptoms of heart failure include difficulty breathing and swelling of the feet and legs due to fluid retention. This occurs because the heart muscle cannot pump blood strongly enough to supply the body's needs.

2. What you need to know before taking Valsartán Combix

Do not take Valsartán Combix:

• if you are allergic to valsartan or to 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 advisable to avoid Valsartán Combix 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 these situations apply to you, do not take Valsartán Combix.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valsartán Combix:

• if you have liver disease,

• if you have severe kidney disease or are undergoing dialysis,

• if you have narrowing of the renal artery (the artery supplying the kidney),

• 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 severe heart disease other than heart failure or heart attack,

• 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 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, Valsartán Combix is not recommended,

• if you have lost a large amount of fluid (dehydration) due to diarrhea, 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 (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 treatment, 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 blood electrolyte levels (e.g., potassium) at regular intervals.

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.

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

Inform your doctor if you are pregnant (or suspect you may be pregnant). Valsartan is not recommended during early pregnancy, and must not be used after the third month of pregnancy, as it may cause serious harm to your baby when used from that stage onward (see Pregnancy section).

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

Taking Valsartán Combix 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 if 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 non-prescription medicines, especially:

• other medicines that lower blood pressure, particularly diuretics (medicines that increase urine output), 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”),
• 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),
• lithium, a medicine used to treat certain psychiatric disorders.

Additionally:

• if you are being treated after a heart attack, the 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 treatment, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol) is not recommended.

Taking Valsartán Combix with food and drink

You may 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 medicine.

• Pregnancy

You must inform your doctor if you are pregnant (or suspect you may be pregnant). 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 Valsartán Combix. Valsartán Combix is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that stage.

• Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Valsartan is not recommended during breastfeeding, and your doctor will choose an alternative treatment for you if you plan to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, operating machinery, or engaging in other activities requiring concentration, make sure you know how Valsartán Combix affects you. Like many other medicines used to treat high blood pressure, Valsartán Combix may rarely cause dizziness and affect your ability to concentrate.

3. How to take Valsartán Combix

To achieve the best results and reduce the risk of adverse effects, always take Valsartán Combix exactly as prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts. People with high blood pressure often do not experience any symptoms and may feel perfectly normal. This makes it very important to attend your medical appointments regularly, 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 may also be combined with another medicine (e.g., a diuretic).

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

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

Adult patients after a recent heart attack: Treatment is usually initiated 12 hours after the heart attack, typically starting 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 up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartán Combix 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.

Valsartán Combix may be administered together with other treatments for heart failure, and your doctor will decide which treatment is appropriate for you.

Valsartán Combix may be taken with or without food. Swallow the tablet with a glass of water. The tablet may 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 experience severe dizziness or fainting, lie down and contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 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 Combix

If you discontinue treatment with Valsartán Combix, your condition may worsen. Do not stop taking the 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, Valsartán Combix may cause adverse effects, although not everyone experiences them.

These adverse effects may occur with certain frequencies, defined as follows:

• very common: may affect more than 1 in 10 people,
• common: may affect between 1 and 10 in 1,000 people,
• uncommon: may affect between 1 and 10 in 1,000 people,
• rare: may affect between 1 and 10 in 10,000 people,
• very rare: may affect fewer than 1 in 10,000 people,
• 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 of the face, lips, tongue, or throat,
• difficulty breathing or swallowing,
• hives, itching.

If you experience any of these symptoms, consult a doctor immediately.

Adverse effects include:

Common

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

Uncommon

• 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.

Very rare:

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

Frequency not known:

• allergic reactions may occur, such as 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 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),
• 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 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 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 and 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 can also report them directly through 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 Valsartán Combix

Do not store above 30°C.

Keep in the original container to protect from moisture.

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

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.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán Combix

• The active substance 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 contents of the pack

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

The score line is intended only to facilitate breaking the tablet and swallowing, but not to divide the tablet 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 most recent revision of this leaflet: February 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/"