Valsartan/hydrochlorothiazide Tecnigen 160 mg/12.5 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Valsartan/Hydrochlorothiazide TecniGen 160 mg/12.5 mg Film-coated Tablets EFG

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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

Valsartán/Hidroclorotiazida TecniGen film-coated tablets contain two active substances known as valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartan belongs to a class 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. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also lowers blood pressure.

Valsartán/Hidroclorotiazida TecniGen is used to treat high blood pressure that is not adequately controlled with either component alone.

Hypertension increases the workload on 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 complications.

2. What you need to know before taking Valsartán/Hidroclorotiazida TecniGen

Do not take Valsartán/Hidroclorotiazida TecniGen

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide-derived substances (chemically related to hydrochlorothiazide), or any of the other components of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section).
• 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 abnormally 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 renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of these situations apply to you, do not take this medicine and consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Valsartán/Hidroclorotiazida TecniGen.

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may consider regular monitoring of potassium levels necessary.

• if you have low potassium levels 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 renal artery stenosis (narrowing of the artery to the kidney).

• if you have recently undergone a kidney transplant.

• if you have hyperaldosteronism, a condition 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 develop fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease).

• if you have diabetes, gout, or high cholesterol or lipid levels in the blood.

• if you have previously had an allergic reaction to another medicine of this class used to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.

• it may cause increased sensitivity of the skin to sunlight.

• if you are taking any of the following medicines used to treat hypertension (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

  • if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking this medicine.
  • if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Valsartán/Hidroclorotiazida TecniGen, seek medical attention immediately.

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 monotherapy without medical advice.

If you experience vision changes or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to a week after taking valsartan/hydrochlorothiazide.

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

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

Use of Valsartán/Hidroclorotiazida is not recommended in children and adolescents (under 18 years of age).

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of Valsartán/Hidroclorotiazida is not recommended during the first trimester of pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby – see Pregnancy section.

Use in athletes:

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

Taking Valsartán/Hidroclorotiazida TecniGen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

The effect of treatment with Valsartán/Hidroclorotiazida TecniGen may be altered if 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 is especially important for the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders

• medicines that may affect or be affected by potassium levels, such as digoxin (a medicine to control heart rhythm), some antipsychotics

• medicines that may increase blood potassium levels, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, heparin

• medicines that may decrease blood potassium levels, such as corticosteroids, some laxatives

• diuretics (medicines to increase urine output), medicines used to treat gout such as allopurinol, therapeutic vitamin D and calcium supplements, medicines for diabetes (oral antidiabetics or insulin)

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

• medicines that constrict your blood vessels or stimulate your heart, such as noradrenaline or adrenaline

• medicines to increase blood sugar levels, such as diazoxide

• medicines for cancer, such as methotrexate or cyclophosphamide

• pain medicines

• medicines for arthritis

• muscle relaxants, such as tubocurarine

• anticholinergic medicines, such as atropine or biperidene

• amantadine (a medicine to prevent influenza)

• cholestyramine and colestipol (medicines used to treat high blood lipid levels)

• cyclosporine, a medicine used to prevent rejection of transplanted organs

• certain antibiotics (tetracyclines), anesthetics, and sedatives

• carbamazepine, a medicine used to treat seizures.

Taking Valsartán/Hidroclorotiazida TecniGen with food, drinks, and alcohol

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

Avoid alcohol until you have discussed it with your doctor. Alcohol may further lower your blood pressure and/or increase the likelihood of dizziness and weakness.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

• 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 pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Use of Valsartán/Hidroclorotiazida is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that point.

• Inform your doctor if you are planning to start or are currently breastfeeding, as administration of Valsartán/Hidroclorotiazida to women during this period is not recommended. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if the infant is a newborn or premature.

Driving and using machines

Before driving, operating tools, or handling machinery, or engaging in other activities requiring concentration, ensure you are aware of how you react to the effects of Valsartán/Hidroclorotiazida. Like many other medicines used to treat high blood pressure, Valsartán/Hidroclorotiazida may rarely cause dizziness and affect your ability to concentrate.

3. How to take Valsartán/Hidroclorotiazida TecniGen

Always take this medicine exactly as your doctor has told you. This will help you achieve the best results and reduce the risk of adverse effects. Consult your doctor or pharmacist if you have any doubts.

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

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

• The usual dose of Valsartán/Hidroclorotiazida TecniGen 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 may take Valsartán/Hidroclorotiazida TecniGen 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 at: 91 562 04 20 (indicating the medicine 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 your next dose, skip the missed dose.

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

If you stop taking Valsartán/Hidroclorotiazida TecniGen

If you stop treatment with Valsartán/Hidroclorotiazida TecniGen, your high blood pressure 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: 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
• frequency not known: frequency cannot be estimated from available data

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

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

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

Other adverse effects include:

Uncommon

• cough
• low blood pressure
• dizziness
• dehydration (with symptoms of thirst, dry mouth and tongue, reduced frequency of urination, dark-colored 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 urine output
• low sodium levels in the blood (sometimes with nausea, fatigue, confusion, malaise, seizures)
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, irregular heartbeat)
• low white blood cell count (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, may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and creatinine levels (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which, in severe cases, may trigger a gout attack)
• syncope (fainting)

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

Valsartan

Uncommon

• sensation of spinning
• abdominal pain

Very rare

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

Frequency not known

• skin rash with or without 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
• 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 levels in the blood (sometimes with muscle cramps, irregular heartbeat)
• 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
• elevated liver function test values
• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anemia)
• renal failure

Hydrochlorothiazide

Common

• itchy skin rash and other types of rashes
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness upon standing
• impotence

Rare

• skin swelling and blisters (due to increased sensitivity to sunlight)
• constipation, stomach or intestinal discomfort, liver disorders (yellowing of the 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 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 upper stomach pain; absence or low levels of different types of blood cells
• severe allergic reactions
• difficulty breathing
• lung infection; shortness of breath
• acute breathing difficulty (symptoms include severe breathlessness, fever, weakness, and confusion)

Frequency not known

• Skin and lip cancer (non-melanoma skin cancer)
• Decreased vision or eye pain due to elevated 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 they are possible adverse effects not listed in this leaflet. You may 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 Valsartán/Hidroclorotiazida TecniGen

• Keep this medicine out of the sight and reach of children.
• Do not use Valsartán/Hidroclorotiazida TecniGen after the expiry date stated on the container (EXP:). The expiry date refers to the last day of the month indicated.
• Do not store above 30°C. Keep in the original packaging to protect from moisture.
• Do not use Valsartán/Hidroclorotiazida TecniGen 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 containers and medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán/Hidroclorotiazida TecniGen

• The active substances are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other components (excipients) in the core are: microcrystalline cellulose, crospovidone, and magnesium stearate. The tablet coating contains hypromellose, titanium dioxide (E171), talc, polyethylene glycol PEG 8000, and red iron oxide (E172).

Appearance of the product and contents of the pack

• Valsartán/Hidroclorotiazida TecniGen 160 mg/12.5 mg coated tablets are film-coated, oval-shaped, red tablets, scored on one side.
• The tablets are supplied in blister packs containing 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, Spain

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

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

Portugal

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

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