VALSARTAN TECNIGEN 320 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan TecniGen 320 mg film-coated tablets EFG

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, 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, 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. Before you take Valsartan TecniGen.
3. How to take Valsartan TecniGen.
4. Possible side effects.
5. Storing Valsartan TecniGen.
6. Further 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 TecniGen works by blocking the effect of angiotensin II. As a result, the blood vessels relax and blood pressure decreases.

Valsartan TecniGen can be used to treat high blood pressure in adults and in children and adolescents from6 to18years of age.High blood pressure increases the strain on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal reduces the risk of developing these disorders.

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

Do not take Valsartan TecniGen

• if you are allergicto the active substance or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver disease,
• if you are pregnantfor more than 3 months(it is also recommended 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 conditions apply to you, do not take Valsartan.

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 had a kidney transplant (received a new kidney),
• 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 are taking medicines that increase the amount of potassium in your 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 your blood,
• if you are under 18 years of age and are taking Valsartan with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may periodically check your kidney 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 Valsartan,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine production),
• tell your doctor if you are pregnant (or think you might be). It is not recommended to use Valsartan TecniGen at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time onwards (see the section on pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• a medicine to inhibit the enzyme that converts angiotensin (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

Your doctor may check 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 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.

Using Valsartan TecniGen with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

The effect of treatment with Valsartan may be altered if taken with certain medicines. Your doctor may need to change your dose and/or 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 production),
• if you are taking an ACE inhibitoror aliskiren(see also the information under the headings “Do not take Valsartan TecniGen” and “Warnings and precautions”)
• 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),
• lithium, a medicine used to treat certain types of psychiatric diseases.

Taking Valsartan TecniGen with food, drinks, and alcohol

You can take Valsartan with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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 tell your doctor if you are pregnant(or think you might be). Your doctor will normally advise you to stop taking Valsartan TecniGen before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan TecniGen. It is not recommended to use Valsartan TecniGen at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time onwards.

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Breastfeeding:

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use Valsartan TecniGen 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 using machines

Before driving a vehicle, using tools, or operating machinery, or performing 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

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. People with high blood pressure often do not notice any symptoms, and 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 usual dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg).

Valsartan can also be taken with another medicine (e.g., a diuretic).

Children and adolescents (6 to18years of age) with high blood pressure

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

In patients who weigh 35 kg or more, the starting dose is 80 mg of valsartan once daily.

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

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

Take Valsartan at approximately the same time each day.

If you take more Valsartan TecniGen than you should

If you notice a strong 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valsartan TecniGen

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 the next dose, skip the missed dose.

If you stop taking Valsartan TecniGen

If you stop your treatment with Valsartan, your condition 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• very common: may affect more than 1 in 10 people,
• common: may affect up to 1 in 10 people,
• uncommon: may affect up to 1 in 100 people,
• rare: may affect up to 1 in 1,000 people,
• very rare: may affect up to 1 in 10,000 people,
• frequency not known: 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 of the face, lips, tongue, or throat,
• difficulty breathing or swallowing,
• hives, itching.

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

Other side effects include:

Common:

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

Uncommon:

• angioedema (see the section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope),
• feeling of spinning (vertigo),
• marked reduction in kidney function (signs of acute kidney failure),
• muscle spasms, abnormal heart rhythm (signs of hyperkalemia),
• shortness of breath, difficulty breathing when 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 with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known:

• allergic reactions with skin rash, itching, along with some of the following signs or symptoms: fever, joint pain, muscle pain, swelling of the lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness),
• red purple spots, fever, itching (signs of vasculitis),
• bleeding or bruising more often 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 and reduction in the percentage of red blood cells in the blood (which, in severe cases, can cause anemia),
• increase in potassium levels in the blood (which, in severe cases, can cause muscle spasms and an abnormal heart rhythm),
• elevation of liver function values (which may indicate liver damage), including an increase in bilirubin levels in the blood (which, in severe cases, can cause the skin and eyes to turn yellow),
• increase in blood urea nitrogen and increase in serum creatinine levels (which may indicate kidney function abnormalities).

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduced kidney function were observed less frequently in patients treated for hypertension than in 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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Valsartan TecniGen

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

Do not store above 30°C. Store in the original package.

Do not use Valsartan after the expiry date stated on the package after EXP. The expiry date is the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Valsartan TecniGen

The active substance is Valsartan. Each tablet contains 320 mg of valsartan.

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

Appearance of the product and pack contents

The 320 mg Valsartan film-coated tablets are film-coated tablets, brown in color, oblong, convex, and scored on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

They are available in packs of 28 tablets.

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. ESPAÑA

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

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

Date of last revision of this leaflet:February 2025