Package Insert: Information for the User

Valsartan/Hydrochlorothiazide TecniGen 320mg/12.5mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Valsartán/Hidroclorotiazida TecniGen film-coated tablets contain two active ingredients known as valsartán and hidroclorotiazida. These components help to control high blood pressure (hypertension).

• Valsartánbelongs to a class of medications known as “angiotensin II receptor antagonists” that help to control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in an increase in blood pressure. Valsartán acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hidroclorotiazidabelongs to a class of medications known as thiazide diuretics. Hidroclorotiazida increases diuresis, which also decreases blood pressure.

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

Hypertension increases the load on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and can cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not take Valsartán/Hidroclorotiazida TecniGen

• If you are allergic to valsartan, hidroclorotiazida, sulfonamide derivatives (chemically related substances to hidroclorotiazida) or any other component of this medication (listed in section 6).
• If you are more than 3 months pregnant.(In any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section).
• If you have a severe liver disease.
• If you have a severe kidney disease.
• If you cannot urinate.
• If you are undergoing dialysis.
• If you have lower than normal 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 insufficiency and are being treated with a medication to reduce blood pressure that contains aliskirén..

If any of these situations affect you, do not take this medication and consult your doctor.

Warnings and precautions

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

• If you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium or other medications that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to control your potassium levels regularly.
• 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 a severe heart disease.
• If you have a narrowing of the renal 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, Valsartán/Hidroclorotiazida is not recommended.
• If you have kidney or liver disease.
• If you have fever, skin rash and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease).
• If you have diabetes, gout, high levels of cholesterol or lipids in your blood.
• If you have previously experienced an allergic reaction with the use of another medication of this class to reduce blood pressure (angiotensin II receptor antagonists), or if you have any type of allergy or asthma.
• It may cause increased sensitivity of the skin to the sun.
• If you are taking any of the following medications used to treat high blood pressure:

- an angiotensin-converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskirén

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking this medication.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Valsartán/Hidroclorotiazida TecniGen, see your doctor immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhea after taking valsartán/hidroclorotiazida. Your doctor will decide whether to continue treatment. Do not stop taking valsartán/hidroclorotiazida in monotherapy.

If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking valsartán/hidroclorotiazida.

Your doctor may monitor 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/Hidroclorotiazida TecniGen”

Valsartán/Hidroclorotiazida is not recommended for use in children and adolescents (under 18 years old).

Inform your doctor if you are pregnant, suspect you may be pregnant or plan to become pregnant. Valsartán/Hidroclorotiazida is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy as it may cause serious harm to your baby, see Pregnancy section.

Use in athletes:

This medication contains hidroclorotiazida, which may produce a positive result in doping control tests (see references in section 4.4 of the technical data sheet).

Use of Valsartán/Hidroclorotiazida TecniGen with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

The effect of treatment with Valsartán/Hidroclorotiazida TecniGen may be altered if taken with certain medications. Your doctor may need to modify your dose and/or take other precautions or, in some cases, discontinue one of the medications. This is especially applicable to the following medications:

• lithium, a medication used to treat certain types of psychiatric disorders
• medications that may affect or be affected by potassium levels, such as digoxin, a medication to control heart rhythm, some antipsychotic medications
• medications that may increase the amount of potassium in the blood, such as potassium supplements, salt substitutes containing potassium, potassium-sparing medications, heparin
• medications that may decrease the amount of potassium in the blood, such as corticosteroids, some laxatives
• diuretics (medications to urinate), medications to treat gout, such as alopurinol, vitamin D therapy and calcium supplements, medications to treat diabetes (oral antidiabetic medications or insulin)

• other medications to reduce blood pressure, such as beta-blockers or metildopa, ACEIs (such as enalapril, lisinopril, etc.) or aliskirén (see also the information under the headings “Do not take Valsartán/Hidroclorotiazida TecniGen” and “Warnings and precautions”).

• medications that constrict blood vessels or stimulate the heart, such as norepinephrine or epinephrine
• medications to increase blood sugar levels, such as diazoxide
• medications to treat cancer, such as methotrexate or cyclophosphamide
• pain medications
• arthritis medications
• muscle relaxants, such as tubocurarine
• anticholinergic medications, such as atropine or biperiden
• amantadine (a medication to prevent flu)
• cholestyramine and colestipol (medications used to treat high levels of lipids in the blood)
• ciclosporina, a medication used to prevent organ rejection after transplantation
• some antibiotics (tetracyclines), anesthetics and sedatives
• carbamazepine, a medication used to treat seizures.

Taking Valsartán/Hidroclorotiazida TecniGen with food, drinks and alcohol

You can take Valsartán/Hidroclorotiazida TecniGen with or without food.

Avoid taking alcohol until you have consulted your doctor. Alcohol may 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 medication.

• You must inform your doctor if you are pregnant, suspect you may be pregnant or plan to become pregnant.Generally, your doctor will advise you to stop taking Valsartán/Hidroclorotiazida before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartán/Hidroclorotiazida is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point on.

• Inform your doctor if you are planning to start or are breastfeedingas Valsartán/Hidroclorotiazida is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machines

Before driving a vehicle, using tools or operating machines, or performing other activities that require concentration, make sure you know your reactions to the effects of Valsartán/Hidroclorotiazida. Like many other medications used to treat high blood pressure, Valsartán/Hidroclorotiazida may cause, in rare cases, dizziness and affect concentration.

Always take this medication exactly as your doctor tells you to. This will help you get the best results and reduce the risk of side effects. Ask your doctor or pharmacist if you have any questions.

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 tablets of Valsartán/Hidroclorotiazida you should take. Depending on how you respond to the treatment, your doctor may suggest increasing or decreasing the dose.

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

If you take more Valsartán/Hidroclorotiazida TecniGen than you should

If you experience severe 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 medication and the amount ingested).

If you forget to take Valsartán/Hidroclorotiazida TecniGen

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.

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

If you interrupt treatment with Valsartán/Hidroclorotiazida TecniGen

If you stop taking Valsartán/Hidroclorotiazida, your blood pressure may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other questions about using 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: 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
• Unknown frequency: the frequency cannot be estimated from available data

Some side effects may be severe 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
• Urticaria and difficulty breathing.

Other side effects include:

Uncommon

• Cough
• Low blood pressure
• Dizziness
• Dehydration (with symptoms of thirst, dry mouth and tongue, reduced urine output, dark urine, dry skin)
• Muscle pain
• Fatigue
• Prickling or numbness
• Blurred vision
• Ringing in the ears (e.g. tinnitus or buzzing)

Very rare

• Dizziness
• Diarrhea
• Joint pain

Unknown frequency

• Difficulty breathing
• Severe decrease in urine output
• Low sodium levels in the blood (sometimes with nausea, fatigue, confusion, discomfort, seizures)
• Low potassium levels 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 levels in the blood (which, in severe cases, can cause the skin and eyes to turn yellow)
• Increased levels of urea nitrogen and creatinine in the blood (which may indicate abnormal kidney function)
• Increased uric acid levels in the blood (which, in severe cases, can trigger a gout attack)
• Syncope (fainting)

Side effects observed with valsartan or hydrochlorothiazide separately, but not observed with Valsartán/Hidroclorotiazida TecniGen:

Valsartan

Uncommon

• Sensation of rotation
• Abdominal pain

Very rare

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

Unknown frequency

• Rash with or without itching, along with one or more of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or flu-like symptoms
• Rash, red-purple spots, fever, itching (signs of blood vessel inflammation)
• Low platelet count (sometimes with bleeding or bruising more frequently than usual)
• High potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• Allergic reactions (with symptoms such as rash, itching, urticaria, difficulty breathing or swallowing, dizziness)
• Swelling mainly of the face and throat; rash; itching
• Elevation of liver function values
• Decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, can cause anemia)
• Renal insufficiency

Hydrochlorothiazide

Common

• Rash with itching and other types of rash
• Loss of appetite
• Mild nausea and vomiting
• 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 changes (yellow skin or eyes)
• Irregular heartbeat
• Headache
• Sleep disturbances
• Depression (sadness)
• Low platelet count (sometimes with bleeding or bruising under the skin)

Very rare

• Inflammation of blood vessels with symptoms such as rash, red-purple spots, fever
• Itching or redness of the skin
• Blisters on the lips, eyes, or mouth
• Peeling of the skin
• Fever
• Facial rash associated with joint pain
• Muscle disorders
• Fever (cutaneous lupus erythematosus)
• Severe stomach pain; absence or low levels of different types of blood cells
• Severe allergic reactions
• Difficulty breathing
• Pulmonary infection; shortness of breath
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion)

Unknown frequency

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

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use. Website: 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 use Valsartán/Hidroclorotiazida 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 above 86°F (30°C). Store in the original packaging to protect from humidity.
• Do not use Valsartán/Hidroclorotiazida TecniGen 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 medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Valsartan/Hydrochlorothiazide TecniGen

• The active principles are valsartan and hydrochlorothiazide. Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other components (excipients) are: 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, and iron oxide red (E172).

Appearance of the product and content of the packaging

• The coated tablets of Valsartan/Hydrochlorothiazide TecniGen 320 mg/12.5 mg are coated tablets with a film coating, oblong, convex, and light pink in color.
• The tablets are presented in blister packaging with 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tecnimede España Industria farmacéutica, S.A

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

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, 2, Abrunheira, 2710 – 089 Sintra

Portugal

Date of the last review of this leaflet: February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/