VALSARTAN/HYDROCHLOROTHIAZIDE TECNIGEN 160 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan/Hydrochlorothiazide TecniGen 160mg/25mg 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/Hydrochlorothiazide TecniGen and what is it used for
2. What you need to know before you take Valsartan/Hydrochlorothiazide TecniGen
3. How to take Valsartan/Hydrochlorothiazide TecniGen
4. Possible side effects
5. Storage of Valsartan/Hydrochlorothiazide TecniGen
6. Contents of the pack and other information

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

Valsartan/Hydrochlorothiazide TecniGen film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartanbelongs to a class of medicines known as “angiotensin II receptor antagonists” that help 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, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also decreases blood pressure.

Valsartan/Hydrochlorothiazide TecniGen is used to treat high blood pressure that is not adequately controlled with the use of a single component.

Hypertension increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these disorders.

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

Do not take Valsartan/Hydrochlorothiazide TecniGen

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months.(In any case, it is best to avoid taking this medicine also at the start of your pregnancy – see section Pregnancy).
• if you have severe liver disease.
• if you have severe kidney disease.
• if you are unable to urinate.
• if you are undergoing dialysis.
• if you have low levels of potassium or sodium in your blood, or if your blood calcium levels are higher than normal despite treatment.
• if you have gout.
• if you have diabetes or kidney failure 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 this medicine and consult your doctor.

Warnings and precautions

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

• if you are using potassium-sparing medicines, potassium supplements, salt substitutes that contain potassium, or other medicines that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly check your potassium levels.
• if you have low levels of potassium in your blood.
• if you experience severe diarrhea or vomiting.
• if you are taking high doses of a diuretic.
• if you have severe heart disease.
• if you have narrowing of the kidney artery.
• if you have recently undergone a kidney transplant.
• if you have hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartan/Hydrochlorothiazide is not recommended.
• if you have kidney or liver disease.
• if you have fever, skin rash, and joint pain, which can be signs of systemic lupus erythematosus (a known autoimmune disease).
• if you have diabetes, gout, high cholesterol, or lipid levels in your blood.
• if you have previously had an allergic reaction with the use of another medicine in this class to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.
• may cause increased sensitivity of the skin to the sun.
• if you are taking any of the following medicines used to treat high blood pressure (high blood pressure):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking valsartan/hydrochlorothiazide on your own.

If you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a few hours to a week after taking valsartan/hydrochlorothiazide.

Your doctor may regularly check your kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood.

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

Valsartan/Hydrochlorothiazide is not recommended for use in children and adolescents (under 18 years of age).

If you are pregnant, think you may be pregnant, or are planning to have a baby, inform your doctor. Valsartan/Hydrochlorothiazide is not recommended during the first trimester of pregnancy (first 3 months) and should not be used from the second trimester of pregnancy onwards, as it may cause serious harm to your baby, see section Pregnancy.

Athletes:

This medicine contains hydrochlorothiazide, which may produce a positive result in doping tests (see references in section 4.4 of the technical sheet).

Use of Valsartan/Hydrochlorothiazide TecniGen with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

The effect of treatment with Valsartan/Hydrochlorothiazide TecniGen 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 is especially applicable to the following medicines:

• lithium, a medicine used to treat some types of psychiatric illnesses
• medicines that can affect or be affected by potassium levels, such as digoxin, a medicine to control heart rhythm, some antipsychotic medicines
• medicines that can increase the amount of potassium in the blood, such as potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines, heparin
• medicines that can decrease the amount of potassium in the blood, such as corticosteroids, some laxatives
• diuretics (medicines to urinate), medicines to treat gout, such as allopurinol, therapeutic vitamin D, and calcium supplements, medicines to treat diabetes (oral antidiabetics or insulin)

• other medicines to lower blood pressure, such as beta-blockers or methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under the headings “Do not take Valsartan/Hydrochlorothiazide TecniGen” and “Warnings and precautions”).

• medicines that narrow your blood vessels or stimulate your heart, such as noradrenaline or adrenaline
• medicines to increase blood sugar levels, such as diazoxide
• medicines to treat cancer, such as methotrexate or cyclophosphamide
• medicines for pain
• medicines for arthritis
• muscle relaxants, such as tubocurarine
• anticholinergic medicines, such as atropine or biperiden
• amantadine (a medicine to prevent flu)
• cholestyramine and colestipol (medicines used to treat high lipid levels in the blood)
• cyclosporine, a medicine used to prevent organ rejection after transplantation
• certain antibiotics (tetracyclines), anesthetics, and sedatives
• carbamazepine, a medicine used to treat seizures.

Taking Valsartan/Hydrochlorothiazide TecniGen with food, drinks, and alcohol

You can take Valsartan/Hydrochlorothiazide TecniGen with or without food.

Avoid drinking alcohol until you have consulted your doctor. Alcohol can further lower your blood pressure and/or increase the risk of dizziness and weakness.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

• You must inform your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.Your doctor will normally advise you to stop taking Valsartan/Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine to lower your blood pressure instead. Valsartan/Hydrochlorothiazide should not be used during the first trimester of pregnancy and should not be used from the second trimester of pregnancy onwards, as it may cause serious harm to your baby when administered from that time on.

• Tell your doctor if you are about to start or are breastfeeding, as Valsartan/Hydrochlorothiazide is not recommended for use in women during this period. Your doctor may decide to prescribe a treatment that is more suitable if you wish to breastfeed, especially newborns or premature babies.

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 you react to the effects of Valsartan/Hydrochlorothiazide. Like many other medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide can, in rare cases, cause dizziness and affect your ability to concentrate.

3. How to take Valsartan/Hydrochlorothiazide TecniGen

Always take this medicine exactly as your doctor has told you. This will help you to get the best results and reduce the risk of side effects. If you are not sure, ask your doctor or pharmacist.

People with high blood pressure often do not notice any symptoms of the disease; many feel normal. This makes it very important to attend your appointments with your doctor, even if you feel well.

Your doctor will tell you exactly how many Valsartan/Hydrochlorothiazide tablets to take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The usual dose of Valsartan/Hydrochlorothiazide is one tablet per day.
• Do not change the dose or stop treatment without consulting your doctor.
• This medicine should be taken at the same time every day, usually in the morning.
• You can take Valsartan/Hydrochlorothiazide with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide TecniGen than you should

If you notice a strong dizziness and/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/Hydrochlorothiazide TecniGen

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.

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

If you stop taking Valsartan/Hydrochlorothiazide TecniGen

If you stop your treatment with Valsartan/Hydrochlorothiazide, your hypertension 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 cause adverse effects, although not all people suffer from them.

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

• very frequent: may affect more than 1 in 10 people.
• frequent: may affect up to 1 in 10 people
• infrequent: 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: the frequency cannot be estimated from the available data

Some adverse effects can be serious and require immediate medical attention:

You should visit your doctor immediately if you notice symptoms of angioedema, such as:

• swelling in the face, tongue, or pharynx
• difficulty swallowing
• hives and difficulty breathing.

Other adverse effects include:

Infrequent

• cough
• low blood pressure
• dizziness
• dehydration (with symptoms of thirst, dry mouth and tongue, reduced urination frequency, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises (e.g., ringing or buzzing) in the ears

Very rare

• dizziness
• diarrhea
• joint pain

Frequency not known

• difficulty breathing
• severe decrease in diuresis
• low sodium level in the blood (sometimes with nausea, fatigue, confusion, discomfort, convulsions)
• low potassium level in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• low white blood cell count in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
• increased bilirubin level in the blood (which, in severe cases, can cause the skin and eyes to turn yellow)
• increased urea and creatinine levels in the blood (which may indicate abnormal kidney function)
• increased uric acid level in the blood (which, in severe cases, can trigger a gout attack)
• syncope (fainting)

Adverse effects observed with valsartan or hydrochlorothiazide separately, but not observed with Valsartan/Hydrochlorothiazide TecniGen:

Valsartan

Infrequent

• feeling of rotation
• abdominal pain

Very rare

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

Frequency not known

• skin rash with or without itching along with any of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or symptoms similar to those of the flu
• skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation
• low platelet count (sometimes with bleeding or bruising more frequently than usual)
• high potassium level in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling mainly of the face and throat; skin rash; itching
• elevation of liver function values
• decrease in hemoglobin level and reduction of red blood cell percentage in the blood (which, in severe cases, can cause anemia)
• renal failure

Hydrochlorothiazide

Frequent

• skin rash with itching and other types of rash
• decreased appetite
• vomiting and mild nausea
• dizziness, dizziness when standing up
• impotence

Rare

• swelling and blisters on the skin (due to increased sensitivity to the sun)
• constipation, stomach or intestinal discomfort, liver alterations (yellow skin or eyes)
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet count (sometimes with bleeding or bruising under the skin)

Very rare

• inflammation of the blood vessels with symptoms such as skin rash, red-purple spots, fever
• itching or redness of the skin
• blisters on the lips, eyes, or mouth
• skin peeling
• fever
• facial rash associated with joint pain
• muscle disorders
• fever (cutaneous lupus erythematosus)
• severe pain in the upper abdomen; absence or low levels of different types of blood cells
• severe allergic reactions
• difficulty breathing
• pulmonary infection; shortness of breath
• acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion)

Frequency not known

• Skin and lip cancer (non-melanoma skin cancer).
• Decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma]

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/Hydrochlorothiazide TecniGen

• Keep this medicine out of sight and reach of children.
• Do not use Valsartan/Hydrochlorothiazide TecniGen after the expiration date that appears on the packaging (CAD:). The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C. Store in the original packaging to protect from moisture.
• Do not use Valsartan/Hydrochlorothiazide TecniGen if you observe that the packaging is damaged or shows signs of deterioration.
• Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Valsartan/Hydrochlorothiazide TecniGen

• The active ingredients are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
• The other components (excipients) are in the core: microcrystalline cellulose, crospovidone, and magnesium stearate. The tablet coating contains hypromellose, titanium dioxide (E171), talc, macrogol PGE 8000, yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172)

Appearance of the Product and Packaging Contents

• The film-coated tablets of Valsartan/Hydrochlorothiazide TecniGen 160 mg/25 mg are film-coated, oval, biconvex tablets, orange in color, and scored on one side.
• The tablets are presented in blister packs with 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, 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, 2, Abrunheira, 2710 – 089 Sintra Portugal

Date of the Last Revision of this Prospectus: February 2025

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