Valsartan Mabo 160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valsartan Mabo 160mg film-coated tablets EFG

valsartan

Read the entire leaflet carefully before you start taking this medicine because 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine contains the active substance: valsartan 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. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

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

• to treat high blood pressure in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure increases the workload of the heart and arteries. If left untreated, it may damage the blood vessels of 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. Valsartan is used when a group of medicines called Angiotensin-Converting Enzyme inhibitors (ACE inhibitors) (a medication used to treat heart failure) cannot be used, or may be used added to ACE inhibitors when other medicines for the treatment of heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. It is caused by the heart muscle being unable to pump blood strongly enough to supply the body with all the blood it needs.

2. What you need to know before taking Valsartán Mabo

Do not take Valsartán Mabo:

• if you are allergic (hypersensitive) 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 this medicine 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 situations apply to you, inform your doctor and do not take this medicine.

Warnings and precautions:

Consult your doctor

• 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 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 develop these symptoms while taking this medicine, 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 this medicine 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 elimination).
• if you are taking any of the following medicines used to treat hypertension (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).

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 Mabo”.

You must inform your doctor if you think you are (or could be) pregnant. This medicine is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

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

Taking Valsartán Mabo with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The effect of treatment with this medicine 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 elimination), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Valsartán Mabo” 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 (from the 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 this medicine.
• lithium, a medicine used to treat certain psychiatric disorders.

In addition:

• 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 treating heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenona) or beta-blockers (e.g., metoprolol) is not recommended.

Pregnancy and breastfeeding

• Inform your doctor if you are pregnant (or suspect you may be pregnant). Your doctor will usually advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. This medicine 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 breastfeeding or planning to breastfeed. Use of this medicine is not recommended during breastfeeding, and your doctor will choose an alternative treatment for you if you wish to breastfeed, especially if your baby is 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 are aware of how this medicine affects you. Like many other medicines used to treat high blood pressure, Valsartán Mabo may cause dizziness and affect your ability to concentrate.

3. How to take Valsartán Mabo

To achieve the best results and reduce the risk of adverse effects, always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. People with high blood pressure often do not experience any symptoms and may feel perfectly well. This makes it very important to attend your medical appointments regularly, even if you feel fine.

Adult patients with high blood pressure: the recommended 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).

Use in children and adolescents aged 6 to less than 18 years with high blood pressure:

In patients weighing less than 35 kg, the recommended starting dose of valsartan is 40 mg once daily.

In patients weighing 35 kg or more, the recommended starting dose of valsartan is 80 mg 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 started within 12 hours after the heart attack, typically with a low starting dose of 20 mg, administered 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.

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.

You may take this medicine with or without food. Swallow the tablet with a glass of water.

Take this medicine at approximately the same time each day.

If you take more Valsartán Mabo than you should

If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartán Mabo

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 forgotten doses.

If you stop taking Valsartán Mabo

If you discontinue treatment with this medicine, 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, this medicine can cause adverse effects, although not everyone gets 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 this medicine 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 kidney failure)
• muscle spasms, 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

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

• blisters on the skin (sign of blistering dermatitis)
• allergic reactions may occur with skin rash, itching and hives; 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 spasms 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)

Very rare (affects less than 1 in 10,000 patients):

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

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 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartan Mabo

Keep out of sight and reach of children.

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

Do not store above 25°C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán Mabo

• The active substance is valsartán. Each film-coated tablet contains 160 mg of valsartán.
• The other components are microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate. The tablet coating contains hypromellose 6 cp, hypromellose 5 cp, titanium dioxide (E-171), macrogol 8000, talc, iron oxide red (E-172), iron oxide yellow (E-172), and iron oxide black (E-172).

Appearance of the product and contents of the pack

The film-coated tablets of Valsartán Mabo 160 mg are light brown, biconvex, oval, scored on one side, marked with "L" on one side and "14" on the other. The score line is intended only to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.

The tablets are presented in blister packs (PVC/PE/PVDC/Alu) containing 28 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

NETPHARMALAB CONSULTING SERVICES

Carretera de Fuencarral, 22

28108 Alcobendas (Madrid)

Spain

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 Medical Devices (AEMPS) http://www.aemps.gob.es/