Valsartan Tecnigen 160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valsartán TecniGen 160 mg film-coated tablets EFG

Valsartan

Read the 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, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Valsartán TecniGen belongs to a group 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. Valsartán TecniGen works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

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

• To treat high blood pressure in adults and 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 blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. 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.

Valsartán TecniGen is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a medication used to treat heart failure) cannot be used, or it may be used in addition to ACE inhibitors when other heart failure treatments are not suitable.

Symptoms of heart failure include difficulty breathing, and 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 supply needs.

2. What you need to know before taking Valsartán TecniGen

Do not take Valsartán TecniGen

• if you are allergic to the active substance or to any of the other components 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 in early 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 TecniGen.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Valsartán TecniGen

• if you have liver disease,

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

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

• if you have recently undergone a kidney transplant,

• if you are being treated for a heart attack or heart failure, your doctor may monitor your kidney function,

• 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 another medicine (including ACE inhibitors), inform your doctor. If you notice these symptoms while taking Valsartán TecniGen, stop treatment immediately and do not take it again. See also section 4 “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 are under 18 years of age and taking Valsartán TecniGen in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may regularly 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, taking Valsartán is not recommended.

• if you have lost a large amount of fluid (dehydration) due to diarrhoea, vomiting, or high doses of diuretics (medicines that increase urine output),

• You must inform your doctor if you suspect you are pregnant (or could be). Use of Valsartán is not recommended in early pregnancy, and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

• 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 certain specific medicines for heart failure known as mineralocorticoid receptor antagonists (MRA) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

Your doctor may need to monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

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

Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking valsartan. Your doctor will decide whether to continue treatment. Do not stop taking valsartan when used as monotherapy.

Taking Valsartán TecniGen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 information under “Do not take Valsartán TecniGen” and “Warnings and precautions”).

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

The effect of treatment with Valsartán may be altered if taken together with certain medicines. It may be necessary to change the dose, take other precautions, or in some cases, discontinue treatment with one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• other medicines that lower blood pressure, particularly diuretics (medicines that increase urine output),
• medicines that increase potassium levels in the blood. 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 (such as rifampicin), cyclosporine (a medicine used to prevent transplant rejection), or antiretrovirals used to treat HIV infection (AIDS) (ritonavir). These medicines may increase the effect of valsartan.
• lithium, a medicine used to treat certain psychiatric conditions.

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, triple combination with ACE inhibitors and beta-blockers (a medicine used to treat heart attack) is not recommended.

Taking Valsartán TecniGen with food, drinks and alcohol

You may take Valsartán TecniGen with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

• You must inform your doctor if you suspect you are pregnant or could be pregnant. Your doctor will usually advise you to stop taking Valsartán before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Use of Valsartán is not recommended in early pregnancy, and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.
• Inform your doctor if you are breast-feeding or about to start breast-feeding. Use of Valsartán is not recommended in breastfeeding mothers, and your doctor may choose an alternative treatment if you plan to breastfeed, especially if your baby is a newborn or was 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 you react to the effects of Valsartán. Like many other medicines used to treat high blood pressure, Valsartán may rarely cause dizziness and affect your ability to concentrate.

3. How to take Valsartán TecniGen

To achieve the best results and reduce the risk of adverse effects, always take this medicine 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 completely normal. Therefore, it is very important to keep your medical appointments even if you feel well.

Adult patients with high blood pressure: The recommended dose is one 80 mg tablet daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Valsartan may also be combined with another additional 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 recommended dose is 40 mg of valsartan once daily.

In patients weighing 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 after the heart attack, typically at a low starting dose of 20 mg given twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. 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 TecniGen may be administered together with other medications for heart attack, and your doctor will decide which treatment is most suitable for you.

Adult patients with heart failure: treatment is usually started at 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 TecniGen may be administered together with other treatments for heart failure, and your doctor will decide which treatment is most suitable for you.

Valsartan can be taken with or without food. Swallow the tablet with a glass of water.

Take valsartan at approximately the same time each day.

The tablet may be divided into two equal doses.

If you take more valsartan than you should

If you experience 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 at 91-562 04 20, indicating the medication and the amount taken.

If you forget to take valsartan

Do not take a double dose to make up for a missed dose.

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 discontinue treatment with valsartan, 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone gets them.

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

• very common: affects more than 1 in 10 patients,
• common: affects between 1 and 10 in 100 patients,
• uncommon: affects between 1 and 10 in 1,000 patients,
• rare: affects between 1 and 10 in 10,000 patients,
• very rare: affects fewer than 1 in 10,000 patients,
• frequency not known: frequency cannot be estimated from the available data.

Some symptoms requiring immediate medical attention:

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

• swelling of the face, lips, tongue or pharynx,
• difficulty breathing or swallowing,
• urticaria (itchy skin rash), pruritus.

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

Other adverse effects include:

Common

• dizziness,
• low blood pressure with or without symptoms such as dizziness and fainting upon standing,
• reduced kidney function (signs of renal 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, abnormal heart rhythm (signs of hyperkalaemia),
• shortness of breath, difficulty breathing when lying down, swelling of feet or legs (signs of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhoea,
• fatigue,
• weakness.

Very rare

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

Frequency not known

• skin blisters (sign of bullous dermatitis),
• allergic reactions with skin rash, itching and urticaria (itchy skin rash), fever symptoms, joint swelling, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness),
• red-purple spots, fever, itching (signs of blood vessel inflammation, also called vasculitis),
• bleeding or bruising more 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 haemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anaemia),
• increased potassium levels in blood (which, in severe cases, may cause muscle cramps and abnormal heart rhythm),
• elevation of liver function values (which may indicate liver damage), including increased bilirubin levels in blood (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 sodium levels in blood (which may cause fatigue, confusion, muscle fasciculations and/or seizures 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 kidney 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, talk to your doctor, pharmacist or nurse, 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. Website: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to 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 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 packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán TecniGen

The active substance is Valsartan. Each tablet contains 160 mg of Valsartan.

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

Appearance of the product and contents of the pack

Valsartán TecniGen 160 mg film-coated tablets are orange-yellow, oblong, film-coated tablets, scored on one side. The tablet can be divided into two equal halves.

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

Not all pack sizes 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 medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

Italy: Valsartan Tecnimede 160 mg compresse rivestite con film

Portugal: Valsartan Tecnimede

Romania: Valsartan Tecnimede 160 mg comprimate filmate

Spain: Valsartán Tecnigen 160 mg comprimidos recubiertos con película

Date of the most recent review of this leaflet: August 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es