Leaflet: information for the user

Valsartán TecniGen 320 mg film-coated tablets

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

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

Valsartán TecniGenmay be used to treat high blood pressure in adults and in children and adolescents aged6 to18years old.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 also increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these conditions.

.

Do not take Valsartán TecniGen

• if you areallergicto the active ingredient or to any of the other components of this medication (listed in section 6),
• if you have asevere liver disease,
• if you arepregnantover 3 months(it is also recommended to avoid Valsartán at the beginning of pregnancy; see the pregnancy section),
• if you havediabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

If any of these situations apply to you, do not take Valsartán.

Warnings and precautions:

Consult your doctor or pharmacist or nurse before starting to take Valsartán TecniGen:

• 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 renal artery,
• if you have recently undergone a kidney transplant (you received a new kidney),
• if you are being treated for a heart attack or heart failure, your doctor may check your renal function,
• if you have a severe heart disease other than heart failure or heart attack,
• if you are using medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin. You may need to have your potassium levels checked regularly,
• if you are under 18 years of age and takeValsartán with other medications that inhibit the renin-angiotensin-aldosterone system (medications that lower blood pressure), your doctor may check your renal function and potassium levels periodically,
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take Valsartán.
• If you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications to increase urine production),
• inform your doctor if you are pregnant (or if you suspect you may be). Valsartán TecniGen is not recommended to be used at the beginning of pregnancy, and in no case should it be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point onwards (see the pregnancy section).
• ifyou are taking any of the following medications used to treat high blood pressure:
• aconverting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén

Your doctor may check your renal function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

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

Consult 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 in monotherapy.

Use of Valsartán TecniGen with other medications

Inform your doctor or pharmacist if you are using, have used recently other medications or may need to use any other medication.

The effect of treatment with Valsartán 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, discontinue 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),
• if you are taking an ACE inhibitororaliskirén(see also the information under the headings “Do not take Valsartán TecniGen” and “Warnings and precautions”)
• medications that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin,
• certain medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs),
• litium,a medication used to treat certain types of psychiatric disorders.

Taking Valsartán TecniGen with food, drinks, and alcohol

You can take Valsartán with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consultyour doctor or pharmacist before using this medication:

You must inform your doctor if you are pregnant(or if you suspect you may be).Your doctor will generally recommend that you stop taking Valsartán TecniGenbefore becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Valsartán TecniGen. Valsartán TecniGen is not recommended to be used at the beginning 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 point onwards.

.

Breastfeeding:

Inform your doctor if you are breastfeeding or plan to start. Valsartán TecniGen is not recommended to be used during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. People with high blood pressure often do not notice any signs of the disease, 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 per day. In some cases, your doctor may prescribe higher doses (e.g. 160 mg or 320 mg).

You may also combine Valsartán with another medication (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 valsartán once a day.

In patients weighing 35 kg or more, the initial usual dose is 80 mg of valsartán once a day.

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 can take Valsartán regardless of meals. Swallow Valsartán with a glass of water.

Take Valsartán approximately at the same time every 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Valsartán TecniGen

Do not take a double dose to compensate for the missed 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, omit the missed dose.

If you interrupt treatment with Valsartán TecniGen

If you stop taking Valsartán, your disease may worsen. Do not stop taking the medication unless your doctor tells you to.

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

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

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

• 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,
• 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 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,
• Reduction in kidney function (signs of renal deterioration).

Uncommon:

• Angioedema (see section “Some symptoms require immediate medical attention”)
• Sudden loss of consciousness (syncope),
• Sensation of rotation (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.

Very rare:

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

Unknown frequency:

• may occur 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 the flu (signs of serum disease),
• red spots, fever, itching (signs of inflammation of blood vessels, also called vasculitis),
• bleeding or bruising more frequently 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 called neutropenia),
• reduction of hemoglobin levels and reduction of 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 abnormal heart rhythm),
• elevation of liver function values (which can 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 urea nitrogen levels in the blood and increase in serum creatinine levels (which can indicate renal anomalies).

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

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

Do not store at a temperature above 30°C. Store in the original packaging.

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

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Valsartán TecniGen

The active ingredient is Valsartán. Each tablet contains 320 mg of valsartán.

The other components (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 contents of the packaging

The film-coated Valsartán 320 mg tabletsarefilm-coated, brown-colored, oblong, convex, and scored on one face. The score is intended to facilitate division to aid swallowing, but not to divide into two equal doses.

They are presented in packs of 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

TECNIMEDE ESPAÑA INDUSTRIA FARMACÉUTICA, S.A.

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

28108 Alcobendas. SPAIN

Responsible manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

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

Date of the last review of this leaflet:February 2025