Leaflet: information for the user

Valsartán Mabo 80mg film-coated tablets

valsartán

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

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

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

3.How to take Valsartán Mabo

4.Possible side effects

5.Storage of Valsartán Mabo

6.Contents of the pack and additional information

This medication contains the active ingredient: valsartán and 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 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 Mabo 80mg film-coated tabletscan be used to treat three different conditions:

• to treat high blood pressure in adults and in children and adolescents from6 toless than 18years 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 adult patients after a recent heart attack(myocardial infarction).“Recent” means here between 12hours and 10days.
• to treat symptomatic heart failure in adult patients.Valsartán 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 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 able to pump blood with sufficient force to provide all the blood needed by the body.

Do not take Valsartán Mabo:

• if you areallergic(hypersensitive) to valsartán or to any of the other components of this medication (listed in section 6).
• if you have a severe liver disease.
• if you arepregnantover 3 months(it is better to avoid this medication during the first months of pregnancy – see Pregnancy section).
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

If any of the above situations apply to you, inform your doctor and do not takethis medication.

Warnings and precautions:

Consult your doctor

• if you have liver disease.
• if you have a severe kidney disease or if you are undergoing dialysis.
• if you have a narrowing of the kidney artery.
• if you have recently undergone a kidney transplant (you received a new kidney).
• if you have a severe heart disease other than heart failure or heart attack.
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACEIs), inform your doctor. If you have these symptoms when taking this medication, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.
• 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 have your potassium levels checked regularly.
• 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 this medication.
• 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:
• • a medication that inhibits the angiotensin-converting enzyme (ACEI) (such as 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) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Your doctor may need to check your kidney function, blood pressure, and electrolyte levels (such as potassium) regularly.

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

You should inform your doctor if you think you are (or could be) pregnant. This medication is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant for more than3months, as it could cause serious harm to your baby if you use it 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.

Use of Valsartán Mabo with other medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to useany other medication.

The effect of treatment with this medication may be altered if taken with certain medications. Your doctor may need to adjust 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,especiallydiuretics(medications to increase urine production), ACEIs(such as enalapril, lisinopril, etc.,) or aliskirén(see also the information under the headings“Do not take Valsartán Mabo” 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).
• some antibiotics (in the rifampicin group), a medication used to prevent rejection in a transplant (ciclosporina) or a medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of this medication.
• lithium,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 withACEIs(a medication for treating a heart attack).
• if you are being treated forheart failure,it is not recommended to take a triple combination withACEIs and other medications specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) orbeta-blockers(such as metoprolol).

Pregnancy and breastfeeding

• You should inform your doctor if you are pregnant(or if you suspect you might be).Your doctor will usually recommend that you stop taking this medication before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of this medication. This medication is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant for more than3months, as it could cause serious harm to your baby if you use it during this period.

• Inform your doctor if you are breastfeeding or plan to start. This medication is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

Before driving a vehicle, using tools, or operating machines, or engaging in other activities that require concentration, make sure you know how this medication affects you. Like many other medications used to treat high blood pressure, Valsartán Mabo may cause dizziness and affect concentration.

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To get the best results and reduce the risk of side effects, take this medicine exactly as your doctor tells you to.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 appointments with your doctor, even if you feel well.

Adult patients with high blood pressure:The recommended dose is 80mg per day. In some cases, your doctor may prescribe higher doses (e.g. 160mg or 320mg). You may also combine valsartan with another medicine (e.g. a diuretic).

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

In patients weighing less than35kg, the recommended starting dose for valsartan is 40mg once a day.

In patients weighing35kgor more, the recommended starting dose for valsartan is 80mg once a day.

In some cases, your doctor may prescribe higher doses (the dose may be increased to 160mg and up to a maximum of 320mg).

Adult patients after a recent heart attack:After a heart attack, treatment usually starts at 12hours, typically with a low dose of 20mg, administered twice a day. The 20mg dose is obtained by dividing the 40mg tablet. Your doctor will gradually increase this dose over several weeks to a maximum of 160mg twice a day. The final dose will depend on your individual tolerance.

Valsartan can be taken with other treatments for a heart attack, and your doctor will decide what treatment is suitable for you.

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

Valsartan can be taken with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

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

Take this medicine approximately at the same time every day.

If you take more Valsartan Mabo than you should

If you notice a strong 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 can also call the Toxicological Information Service, phone 91 562 04 20 indicating the medicine and the amount taken.

If you forget to take Valsartan Mabo

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 compensate for the missed doses.

If you interrupt treatment withValsartan Mabo

If you stop taking this medicine, your condition may worsen. Do not stop taking the medicine unless your doctor tells you to.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects may be serious and may 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, stop taking this medicine and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other side effects include:

Frequent(may affect up to 1 in 10 people):

• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting when standing up
• reduction in kidney function (signs of renal deterioration)

Rare(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 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

Unknown frequency(cannot be estimated from available data):

• blistering on the skin (sign of dermatitis herpetiformis)
• 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
• red purpuric patches, fever, itching (signs of inflammation of blood vessels, also known as vasculitis)
• more frequent bleeding or bruising 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)
• increase in 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)
• increase in urea nitrogen level in the blood and increase in serum creatinine level (which may indicate renal function abnormalities)
• low sodium level in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or convulsions)

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

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

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 or 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano (www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

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

Do not store above 25°C. Store in the original packaging to protect it from humidity.

Medicines should not be thrown down the drains or in the trash.Deposit the packaging and medicines you no longer need at theSIGREpoint of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofValsartán Mabo

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

Appearance of the product and contents of the packaging

The film-coated Valsartán Mabo 80 mg tablets are of a light red color, biconvex, oval, scored on one face, with the mark “L” on one side and the mark “13” on the other face.. The score is only for breaking and facilitating swallowing but not for dividing into equal doses.

The tablets are presented in blister packaging (PVC/PE/PVDC/Alu) with 28 tablets.

Holder of the marketing authorization

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada (Madrid)

Spain

Responsible for manufacturing

NETPHARMALAB CONSULTING SERVICES

Carretera de Fuencarral, 22

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) htpp://www.aemps.gob.es/