Package Leaflet: Information for the User

Valsartan/hydrochlorothiazide pensa160mg/12,5mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine.

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

1. What Valsartan/hydrochlorothiazide Pensa is and what it is 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

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

• Valsartánbelongs to a class of medications 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 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/hidroclorotiazidaPensais 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 cause a stroke, heart failure, or renal insufficiency. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

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 ofvalsartan/hydrochlorothiazide.

• 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 are unable to urinate.
• if you are undergoing dialysis.
• if you have low levels of potassium or sodium in your blood, or if your calcium levels in the blood 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 aliskiren.

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

Be especially careful withValsartan/hydrochlorothiazide Pensa

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

• if you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium or other medications that increase the amount of potassium in the blood, such as heparin. Your doctor may consider it necessary to control your potassium levels regularly.
• if you have low levels of potassium in the 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 a narrowing of the renal artery.
• if you have recently undergone a kidney transplant.
• if you have primary aldosteronism, 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 may be signs of systemic lupus erythematosus (a known autoimmune disease).
• if you have diabetes, gout, high levels of cholesterol or lipids in the blood.
• if you have previously experienced an allergic reaction with the use of another medication of this class to lower blood pressure (angiotensin II receptor antagonists), or if you have any type of allergy or asthma.
• it may cause an increase in skin sensitivity to the sun.

• if you are taking any of the following medications used to treat high blood pressure:

• a converting enzyme inhibitor (ACEI) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
• aliskiren

• if you have hadskin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, 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 exposure to the sun and UV rays while taking Valsartan/Hydrochlorothiazide Pensa.

• if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and may 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 present with severe shortness of breath or difficulty breathing after taking Valsartan/hydrochlorothiazide Pensa, go to the doctor immediately.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (e.g. potassium) 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”.

Valsartan/hydrochlorothiazide Pensa is not recommended for use in children and adolescents (under 18 years old).

If you are pregnant, if you suspect you may be, or if you plan to become pregnant, you must inform your doctor. Valsartan/hydrochlorothiazide Pensa 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 of other medications

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

The effect of treatment withValsartan/hydrochlorothiazide Pensamay be altered if taken with certain medications. You may need to change the dose, 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 diseases
• 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 allopurinol, vitamin D therapy, and calcium supplements, medications to treat diabetes (oral antidiabetic medications or insulin)
• other medications to lower blood pressure, such as beta-blockers or methyldopa, or 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)
• ciclosporin, a medication used to prevent organ rejection after transplantation
• some antibiotics (tetracyclines), anesthetics, and sedatives
• carbamazepine, a medication used to treat seizures.

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

• if you are taking an ACEI or aliskiren (see also the information under the headings “Do not take Valsartan/hydrochlorothiazide” and “Be especially careful with Valsartan/hydrochlorothiazide Pensa”.

TakingValsartan/hydrochlorothiazide Pensawith food and drinks

You can take Valsartan/hydrochlorothiazide Pensawith 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 and breastfeeding

Consult your doctor or pharmacist before using any medication.

• You must inform your doctor if you are pregnant, if you suspect you may be, or if you plan to become pregnant.Generally, your doctor will advise you to stop taking Valsartan/hydrochlorothiazide Pensabefore becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartan/hydrochlorothiazide Pensa 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 initiate or are in the lactation periodas Valsartan/hydrochlorothiazide Pensais not recommended for use during this period. Your doctor may decide to administer a treatment that is more suitable 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 Valsartan/hydrochlorothiazide Pensa. Like many other medications used to treat high blood pressure, Valsartan/hydrochlorothiazide Pensamay cause, in rare cases, dizziness and affect concentration.

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

This medication contains hydrochlorothiazide, which may result in a positive analytical control for doping.

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

Always take Valsartán/hidroclorotiazida Pensa exactly as your doctor tells you to.This will help you get the best results and reduce the risk of side effects.Consult your doctor or pharmacist if you have any doubts.

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 Pensa 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 Pensa is one tablet a 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 Pensa with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartán/hidroclorotiazida Pensa 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 Pensa

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..

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

If you interrupt treatment with Valsartán/hidroclorotiazida Pensa

If you stop taking Valsartán/hidroclorotiazida Pensa, your high 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, Valsartán/hidroclorotiazida Pensamay 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 10patients
• Common: affects between 1 and 10 in 100patients
• Uncommon: affects between 1 and 10 in 1,000patients
• Rare: affects between 1 and 10 in 10,000patients
• Very rare: affects less than 1 in 10,000patients
• 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 or buzzing in the ears

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

Valsartán

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
• Elevated 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

Hidroclorotiazida

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
• 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
• Lupus erythematosus (fever)
• 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 or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Maintain out of 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 disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Valsartan/Hydrochlorothiazide Pensa 160 mg/12.5 mg

• The active principles are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan 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 cornstarch, Pregelatinized cornstarch, Povidone (E-1201), Stearic acid fumarate and sodium, 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), Brown iron oxide (E-172).

Appearance of the product and contents of the package

• The coated valsartan/hydrochlorothiazide Pensa 160 mg/12.5 mg tablets are round, biconvex, coated tablets, red in color, and marked with the code “VH2”.
• The tablets are presented in packages of 28 and 280 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for Manufacturing

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 – Industrial Estate Areta

31620 Huarte – Pamplona (Navarra) – Spain

Last review date of this leaflet : January 2025

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