Valsartan Tecnigen 320 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valsartan TecniGen 320 mg film-coated tablets EFG

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

Contents of the leaflet:

1. What Valsartan TecniGen is and what it is used for.
2. Before you take Valsartan TecniGen.
3. How to take Valsartan TecniGen.
4. Possible side effects.
5. How to store Valsartan TecniGen.
6. Further 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 can be used 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 the blood vessels of the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

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 at the beginning 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 these situations apply to you, do not take Valsartán.

Warnings and precautions:

Talk to your doctor, 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 renal artery stenosis (narrowing of the artery to the kidney),
• if you have recently undergone a kidney transplant (received a new kidney),
• if you are being treated for 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 are taking medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medications, and heparin. Regular monitoring of blood potassium levels may be necessary,
• if you are under 18 years of age and taking Valsartán together with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may periodically 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 significant amount of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine output),
• inform your doctor if you are pregnant (or suspect you might be). Use of Valsartán TecniGen is not recommended at the beginning of pregnancy, and must not be given after the third month of pregnancy, as it may cause serious harm to your baby when used from that stage onward (see pregnancy section).
• 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), particularly if you have kidney problems related to diabetes,
• aliskiren.

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

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

Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartán. Your doctor will decide whether to continue treatment. Do not stop taking valsartán used as monotherapy without medical advice.

Use of 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.

The effect of treatment with Valsartán may be altered when 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 over-the-counter medicines, especially:

• other medicines that lower blood pressure, particularly diuretics (medicines to increase urine output),
• if you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Valsartán TecniGen” and “Warnings and precautions”),
• medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medications, and heparin,
• certain pain medicines known as non-steroidal anti-inflammatory drugs (NSAIDs),
• lithium, a medicine used to treat certain psychiatric conditions.

Taking Valsartán TecniGen with food, drinks, and alcohol

You may take Valsartán 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 become pregnant, consult your doctor or pharmacist before using this medicine.

You must inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking Valsartán TecniGen before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Valsartán TecniGen. Use of Valsartán TecniGen is not recommended at the beginning of pregnancy, and must not be administered after the third month of pregnancy, as it may cause serious harm to your baby from that point onward.

Breastfeeding:

Inform your doctor if you are breastfeeding or intend to start breastfeeding. Use of Valsartán TecniGen is not recommended during breastfeeding. Your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and use of machines

Before driving, operating tools, or handling machinery, or engaging in other activities requiring concentration, make sure you know 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

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. People with high blood pressure often do not experience any symptoms of the condition and many feel perfectly normal. This makes it very important to keep your medical appointments 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).

Valsartán may also be combined with another 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 usual dose is 40 mg of valsartan once daily.

In patients weighing 35 kg or more, the usual 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).

You may take Valsartán independently of food. Swallow Valsartán with a glass of water.

Take Valsartán approximately at the same time each day.

If you take more Valsartán TecniGen than you should

If you experience severe dizziness or fainting, lie down and contact your doctor immediately. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valsartán 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 your next dose, skip the missed dose.

If you stop taking Valsartán TecniGen

If you discontinue treatment with Valsartán, 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 cause adverse effects, although not everyone experiences them.

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

• very common: affects 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 requiring 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 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 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.

Very rare:

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

Frequency not known:

• allergic reactions may occur, with skin rash, itching, together with one or more of the following signs or symptoms: fever, 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 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 cramps and abnormal heart rhythm),
• elevation of liver function test values (which may indicate liver injury), 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).

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 observed 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: http://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 store above 30°C. Store in the original packaging.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartan TecniGen

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

The other components (excipients) are, in the core: microcrystalline cellulose, crospovidone, 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

Valsartan 320 mg film-coated tablets are film-coated, brown-colored, oblong, biconvex tablets, scored on one side. The score line is intended to facilitate breaking the tablet for ease of swallowing, but not to divide it into two equal doses.

Presented 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. SPAIN

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

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

Date of the most recent revision of this leaflet: February 2025