VALSARTAN/HYDROCHLOROTHIAZIDE PENSA 80 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan/Hydrochlorothiazide Pensa 80mg/12.5mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

1. What is Valsartan/Hydrochlorothiazide Pensa and what is it used for
2. Before taking Valsartan/Hydrochlorothiazide Pensa
3. How to take Valsartan/Hydrochlorothiazide Pensa
4. Possible side effects
5. Storage of Valsartan/Hydrochlorothiazide Pensa
6. Further information

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

Valsartan/Hydrochlorothiazide Pensa contains 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, resulting in increased 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 Pensa is used to treat high blood pressure that is not adequately controlled with the use of a single component.

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 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. Before taking Valsartan/Hydrochlorothiazide Pensa

Do not takeValsartan/Hydrochlorothiazide Pensa

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), or any of the other components of valsartan/hydrochlorothiazide.

• if you are pregnant for more than 3 months. (In any case, it is best to avoid taking this medicine also at the beginning 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 potassium or sodium levels 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.

Be particularly careful withValsartan/Hydrochlorothiazide Pensa

Consult your doctor or pharmacist before starting to take Valsartan/Hydrochlorothiazide Pensa:

• 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 monitor your potassium levels.
• 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 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 of 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:

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

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Valsartan/Hydrochlorothiazide Pensa.
• 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 eye pressure and can occur within a few hours to a week after taking Valsartan/hydrochlorothiazide Pensa.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Valsartan/hydrochlorothiazide Pensa, see your doctor immediately.

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

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

See also the information under the heading “Do not take Valsartan/hydrochlorothiazide Pensa”.

Use of Valsartan/hydrochlorothiazide Pensa is not recommended in children and adolescents (under 18 years of age).

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Valsartan/hydrochlorothiazide Pensa is not recommended during the first trimester of pregnancy (first 3 months) and should not be taken after the third month of pregnancy as it may cause serious harm to your baby, see section Pregnancy.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicines.

The effect of treatment with Valsartan/hydrochlorothiazide Pensa may be altered if taken with certain medicines. It may be necessary to change the dose, 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 disorders
• medicines that may affect or be affected by potassium levels, such as digoxin, a medicine to control heart rhythm, some antipsychotic medicines
• medicines that may increase potassium levels in the blood, such as potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines, heparin
• medicines that may decrease potassium levels 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, or 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
• pain medicines
• 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.

Your doctor may need to modify your dose and/or take other precautions:

• if you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Valsartan/hydrochlorothiazide Pensa” and “Be particularly careful with Valsartan/hydrochlorothiazide Pensa”.

Taking Valsartan/Hydrochlorothiazide Pensa with food and drink

You can take Valsartan/Hydrochlorothiazide Pensa 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 and breastfeeding

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 become pregnant.Your doctor will normally advise you to stop taking Valsartan/Hydrochlorothiazide Pensa before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take another medicine to lower your blood pressure instead. Valsartan/Hydrochlorothiazide Pensa is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby when taken after this time.

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

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or performing other activities that require concentration, make sure you know how you react to the effects of Valsartan/Hydrochlorothiazide Pensa. Like many other medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide Pensa can cause, in rare cases, dizziness and affect your ability to concentrate.

Important information about some of the components of Valsartan/Hydrochlorothiazide Pensa

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

This medicine contains sorbitol and lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Valsartan/Hydrochlorothiazide Pensa

Always take Valsartan/Hydrochlorothiazide Pensa exactly as your doctor has told you. This will help you get the best results and reduce the risk of side effects. If you are unsure, 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 Pensa 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 Pensa is one tablet a 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 Pensa with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide Pensa than you should

If you notice 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 medicine and the amount taken).

If you forget to take Valsartan/Hydrochlorothiazide Pensa

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 missed doses.

If you stop taking Valsartan/Hydrochlorothiazide Pensa

If you stop your treatment with Valsartan/Hydrochlorothiazide Pensa, your high blood pressure may worsen. Do not stop taking the medicine unless your doctor tells you to.

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

4. Possible Adverse Effects

Like all medicines, Valsartán/hidroclorotiazida Pensa 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: affect more than 1 in 10 patients
• frequent: affect between 1 and 10 in 100 patients
• infrequent: affect between 1 and 10 in 1,000 patients
• rare: affect between 1 and 10 in 10,000 patients
• very rare: affect less than 1 in 10,000 patients
• 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 levels in the blood (sometimes with nausea, fatigue, confusion, discomfort, convulsions)
• 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 urea and creatinine levels 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)

Adverse effects observed with valsartán or hydrochlorothiazide separately, but not observed with Valsartán/hidroclorotiazida Pensa:

Valsartán

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 some 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, purple-red 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 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 levels 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 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 the blood vessels with symptoms such as skin rash, purple-red 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 unknown

• 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 or pharmacist, even if it is an adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Valsartán/Hidroclorotiazida Pensa

• Keep out of the reach and sight of children.
• Do not use Valsartán/hidroclorotiazida Pensa after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C.
• Do not use Valsartán/hidroclorotiazida Pensa 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 that you no longer need in the SIGRE point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of Valsartán/hidroclorotiazida Pensa 80 mg/12.5 mg EFG

• The active ingredients are valsartán and hydrochlorothiazide. Each tablet contains 80 mg of valsartán and 12.5 mg of hydrochlorothiazide.

• The other components are: microcrystalline cellulose (E-460) + anhydrous colloidal silica, sorbitol (E-420i), magnesium carbonate (E-504) + pregelatinized corn starch, pregelatinized corn starch, povidone (E-1201), sodium stearyl fumarate, and sodium lauryl sulfate, crospovidone, anhydrous colloidal silica.
• The tablet coating contains: lactose monohydrate, hypromellose (E-464), titanium dioxide (E-171), macrogol 4000, red iron oxide (E-172).

Appearance of the Product and Packaging Content

• The film-coated tablets of Valsartan/hidroclorotiazida Pensa 80 mg/12.5 mg are cylindrical, biconvex, film-coated tablets, pink in color, and marked with the code "VH1".

• The tablets are presented in packages of 28 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 – Polígono Industrial Areta

31620 Huarte – Pamplona (Navarra) – Spain

Date of the Last Revision of this Prospectus:January 2025

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