VALSARTAN TECNIGEN 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan TecniGen 80 mg film-coated tablets EFG

Valsartan

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 or nurse.
• 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

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

Valsartan TecniGen belongs to a group 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, the blood vessels relax and blood pressure decreases.

Valsartan TecniGen 80 mg film-coated tablets EFG can be usedfor three different conditions:

• To treat high blood pressure in adults and in children and adolescents from 6 to 18 years.High blood pressure increases the strain on the heart and arteries. If not treated, it can lead to damage to the blood vessels in the brain, heart, and kidneys, and can result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering the blood pressure to normal reduces the risk of developing these disorders.
• To treat adult patients after a recent heart attack(myocardial infarction). “Recent” here means between 12 hours and 10 days.

To treat symptomatic heart failure in adult patients.

Valsartan TecniGen 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.

The symptoms of heart failure include difficulty breathing, swelling of the feet and legs due to fluid accumulation. This occurs when the heart muscle cannot pump blood strongly enough to meet the body's blood needs.

2. What you need to know before you take Valsartan TecniGen

Do not take Valsartan TecniGen

• if you are allergicto the active substance or to any of the other ingredients of the medicine (listed in section 6)
• if you have severe liver disease
• if you are pregnantof more than 3 months(it is also preferable to avoid Valsartan at the start of pregnancy; see the section on 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 TecniGen.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take Valsartan TecniGen

• if you have liver disease,
• if you have severe kidney disease or are undergoing dialysis,
• if you have narrowing of the kidney artery,
• if you have recently undergone a kidney transplant,
• 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 have inflammation of the tongue and face due to an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), inform your doctor. If you notice these symptoms while taking Valsartan TecniGen, stop treatment immediately and do not take it again. See also section 4 “Side Effects”.
• if you are taking medicines that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, 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 TecniGen in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may check your kidney function and the amount of potassium in your blood at regular intervals.
• 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.
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine elimination),
• You must inform your doctor if you suspect that you are pregnant (or could be). It is not recommended to use Valsartan at the start of pregnancy, and it should not be taken if you are pregnant for more than 3 months, because it can cause serious harm to your baby if used after the third month of pregnancy.
• if you are taking any of the following medicines 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 medicines 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.

See also the information under the heading “Do not take Valsartan TecniGen”

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.

Taking Valsartan TecniGen with other medicines

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

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information that says “Do not take Valsartan TecniGen” and “Warnings and precautions”).

If you are being treated with an ACE inhibitor along with certain medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

The effect of treatment with Valsartan may be altered if taken with certain medicines. It may be necessary to change the dose, 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 elimination),
• medicines that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin,
• certain pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (such as rifampicin),cyclosporin (a medicine used to prevent transplant rejection) or antiretrovirals used to treat HIV (AIDS) infection (e.g., ritonavir). These medicines may increase the effect of valsartan.
• lithium,a medicine used to treat certain types of psychiatric diseases.

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 inhibitors and beta-blockers (a medication to treat a heart attack).

Taking Valsartan TecniGen with food, drinks, and alcohol

You can take Valsartan TecniGen with or without food.

Pregnancy, breastfeeding, and fertility

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

• You must inform your doctor if you suspect that you are pregnant or could be.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. It is not recommended to use Valsartan at the start of pregnancy, and it should not be taken if you are pregnant for more than 3 months, because it can cause serious harm to your baby if used after the third month of pregnancy.
• Inform your doctor if you are breastfeeding or about to start breastfeeding.It is not recommended to use Valsartan in breastfeeding mothers, and your doctor may choose another 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, or operating machinery, or carrying out other activities that require concentration, make sure you know how Valsartan affects you. Like many other medicines used to treat high blood pressure, Valsartan can cause dizziness and affect your ability to concentrate.

3. How to take Valsartan TecniGen

To get the best results and reduce the risk of side effects, always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you have any questions. People with high blood pressure often do not notice any symptoms of the disease; many feel normal. This makes it very important to keep your appointments with your doctor even if you feel well.

Adult patients with high blood pressure:

The recommended dose is one 80 mg tablet per day. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Your doctor may also prescribe you to take an additional medicine, e.g., a diuretic.

Children and adolescents (6 to 18 years) with high blood pressure:

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

In patients who weigh 35 kg or more, the recommended 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 started within 12 hours of the heart attack, normally with a low dose of 20 mg twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase the dose over the next few weeks to a maximum of 160 mg twice daily.

The final dose will depend on your individual tolerance.

Valsartan TecniGen can be given with other medicines used to treat heart attack, and your doctor will decide which treatment is most 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 TecniGen can be given with other treatments for heart failure, and your doctor will decide which treatment is most suitable for you.

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

Take Valsartan at approximately the same time each day.

The tablet can be divided into two equal doses.

If you take more Valsartan than you should

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

If you forget to take Valsartan

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

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.

If you stop taking Valsartan

If you stop your treatment with Valsartan, your disease 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 product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

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

• very frequent: affect more than 1 in 10 patients,
• frequent: affect between 1 and 10 in 100 patients,
• infrequent: affect between 1 and 10 in 1000 patients,
• rare: affect between 1 and 10 in 10,000 patients,
• very rare: affect less than 1 in 10,000 patients,
• unknown frequency: the frequency cannot be estimated from the available data.

Some symptoms that require immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

• swelling in the face, lips, tongue, or pharynx
• difficulty breathing or swallowing
• Urticaria (skin rash with itching), pruritus

If you experience any of these symptoms, consult your doctor immediately (see Section 2 "Warnings and Precautions").

Other adverse effects include:

Frequent

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

Infrequent

• angioedema (see section "some symptoms require immediate medical attention")
• sudden loss of consciousness (syncope),
• sensation of rotation (vertigo),
• marked reduction of renal function (signs of acute renal failure),
• 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.

Unknown Frequency

• skin blisters (sign of bullous dermatitis)
• allergic reactions with skin rash, itching, and urticaria (itchy skin rash), symptoms of fever, joint inflammation, muscle pain, swelling of lymph nodes and/or may occur symptoms similar to those of the flu (signs of serum sickness),
• purple-red spots, fever, itching (signs of blood vessel inflammation, also called vasculitis),
• more frequent bleeding or bruising 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 of hemoglobin level and reduction of red blood cell percentage in blood (which, in severe cases, can cause anemia),
• increase in blood potassium level (which, in severe cases, can cause muscle spasms and abnormal heart rhythm),
• elevation of liver function values (which may indicate liver damage), including an increase in bilirubin level in blood (which, in severe cases, can cause yellowing of the skin and eyes),
• increase in blood urea nitrogen level and increase in serum creatinine level (which may indicate kidney function abnormalities).
• Low sodium level in blood (which can cause fatigue, confusion, muscle fasciculations, and/or convulsions in severe cases)

The frequency of some adverse effects may vary depending on your condition. For example, certain adverse effects such as dizziness and reduced renal function were observed less frequently in patients treated for hypertension than in patients treated for heart failure and after a recent heart attack.

Adverse effects in children and adolescents are similar to those seen in adults.

Reporting of Adverse Effects

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

5. Storage of Valsartan TecniGen

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

• Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

• Do not store above 30°C. Store in the original packaging to protect from light.

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

• Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Valsartan TecniGen

The active ingredient is Valsartan. Each tablet contains 80 mg of Valsartan.

The other components (excipients) are, in the core: microcrystalline cellulose, crospovidone (Type A), and magnesium stearate. The tablet coating contains hypromellose, titanium dioxide (E171), Macrogol PGE 8000, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the Product and Packaging Contents

The film-coated tablets of Valsartan TecniGen 80 mg are film-coated, pink, oblong, and scored on one side. The tablet can be divided into two equal halves.

They are available in packs of 14, 28, 30, 56, and 90 film-coated tablets.

Not all packs may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Tel: 91 383 51 66

Fax: 91 383 51 67

E-mail: [email protected]

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

This medicine is authorized in the Member States of the European Economic Area under the following names:

Italy: Valsartan Tecnimede 80 mg compresse rivestite con film

Portugal: Valsartan Tecnimede

Romania: Valsartan Tecnimede 80 mg comprimate filmate

Spain: Valsartán Tecnigen 80 mg comprimidos recubiertos con película

Date of the last revision of this prospectus: August 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es