Valsartan/hydrochlorothiazide Pensa 80 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Valsartan/hydrochlorothiazide Pensa 80 mg/12.5 mg film-coated tablets EFG

Read the entire 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 personally. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Valsartan/hydrochlorothiazide Pensa is and what it is used for
2. Before you take Valsartan/hydrochlorothiazide Pensa
3. How to take Valsartan/hydrochlorothiazide Pensa
4. Possible side effects
5. How to store Valsartan/hydrochlorothiazide Pensa
6. Further information

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

Valsartán/hidroclorotiazida Pensa contains 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 Pensa is used to treat high blood pressure that is not adequately controlled with either component used alone.

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

2. Before taking Valsartan/Hydrochlorothiazide Pensa

Do not take Valsartan/Hydrochlorothiazide Pensa

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide), or to any of the other components of valsartan/hydrochlorothiazide.
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see section Pregnancy.)
• if you have severe liver disease.
• if you have severe kidney disease.
• if you are unable to pass urine.
• 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.

Take special care with Valsartan/Hydrochlorothiazide Pensa

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

• 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 it necessary to monitor your potassium levels regularly.

• if you have low potassium levels in your blood.

• if you experience severe diarrhoea or vomiting.

• if you are taking high doses of a diuretic.

• if you have severe heart disease.

• if you have narrowing of the renal artery.

• 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, valsartan/hydrochlorothiazide 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 experienced an allergic reaction when using another medicine of this class 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 (ACE) inhibitor (for example 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, particularly 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 Valsartan/Hydrochlorothiazide Pensa.

• if you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within hours to a week after taking Valsartan/Hydrochlorothiazide Pensa.

• if you have previously had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnoea or severe difficulty breathing after taking Valsartan/Hydrochlorothiazide Pensa, seek medical attention 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 diarrhoea 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”.

The use of Valsartan/Hydrochlorothiazide Pensa 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. The use of Valsartan/Hydrochlorothiazide Pensa is not recommended during early pregnancy (first 3 months) and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby – see section Pregnancy.

Use of other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

The effect of treatment with Valsartan/Hydrochlorothiazide Pensa may be altered if taken together with certain medicines. It may be necessary to adjust the dose, 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, and some antipsychotic medicines
• medicines that may increase potassium levels in the blood, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, heparin
• medicines that may decrease potassium levels in the blood, such as corticosteroids, some laxatives
• diuretics (medicines to increase urine output), medicines to treat gout such as allopurinol, therapeutic vitamin D and calcium supplements, medicines to treat diabetes (oral antidiabetics or insulin)
• other blood pressure-lowering medicines such as beta-blockers or methyldopa, or 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
• painkillers
• medicines for arthritis
• muscle relaxants such as tubocurarine
• anticholinergic medicines such as atropine or biperiden
• amantadine (a medicine to prevent influenza)
• cholestyramine and colestipol (medicines used to treat high lipid levels in the blood)
• cyclosporine, a medicine used to prevent rejection of transplanted organs
• certain antibiotics (tetracyclines), anaesthetics, and sedatives
• carbamazepine, a medicine used to treat seizures.

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

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

Taking Valsartan/Hydrochlorothiazide Pensa with food and drinks

You may take Valsartan/Hydrochlorothiazide Pensa 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 and breast-feeding

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 Valsartan/Hydrochlorothiazide Pensa before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Valsartan/Hydrochlorothiazide Pensa is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

• Inform your doctor if you are planning to breast-feed or are currently breast-feeding, as Valsartan/Hydrochlorothiazide Pensa is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you intend to breast-feed, especially if the infant is a newborn or premature.

Driving and using machines

Before driving a vehicle, operating tools, handling machinery, or engaging in other activities requiring concentration, make sure you are aware of how Valsartan/Hydrochlorothiazide Pensa affects you. Like many other medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide Pensa may rarely cause dizziness and affect your ability to concentrate.

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

This medicine contains hydrochlorothiazide, which may lead to a positive analytical finding in doping controls.

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

3. How to take Valsartán/Hidroclorotiazida Pensa

Always take Valsartán/Hidroclorotiazida Pensa exactly as your doctor has instructed 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 experience any symptoms and may feel perfectly well. For this reason, it is very important to keep your doctor's appointments, even if you feel fine.

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

• The usual dose of Valsartán/Hidroclorotiazida Pensa is one tablet daily.
• 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 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 at: 91 562 04 20 (indicating the medicine 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 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 Pensa

If you discontinue treatment with Valsartán/Hidroclorotiazida Pensa, your hypertension may worsen. Do not stop taking this medicine unless your doctor tells you to.

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

4. Possible adverse effects

Like all medicines, Valsartan/hydrochlorothiazide Pensa may cause adverse effects, although not everyone experiences them.

These adverse effects may occur with certain frequencies defined as follows:

• very common: affects more than 1 in 10 patients
• common: affects 1 to 10 in every 100 patients
• uncommon: affects 1 to 10 in every 1,000 patients
• rare: affects 1 to 10 in every 10,000 patients
• very rare: affects fewer than 1 in 10,000 patients
• 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 experience 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 such as 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 separately, but not observed with Valsartan/hydrochlorothiazide Pensa:

Valsartan

Uncommon

• sensation of spinning
• abdominal pain

Very rare

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

Frequency not known

• skin rash with or without itching, accompanied by 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

• swelling and blistering of the skin (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 abdominal pain; absence or low levels of different types of blood cells
• severe allergic reactions
• difficulty breathing
• lung infection; shortness of breath
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion)

Frequency unknown

• skin 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 effusion) or acute angle-closure glaucoma]

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartan/Hydrochlorothiazide Pensa

• Keep out of the reach and sight of children.
• Do not use Valsartan/Hydrochlorothiazide Pensa after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C.
• Do not use Valsartan/Hydrochlorothiazide Pensa 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 unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. Additional information

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

• The active substances are valsartan and hydrochlorothiazide. Each tablet contains 80 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 corn starch, pregelatinized corn starch, povidone (E-1201), sodium stearyl fumarate, sodium lauryl sulfate, crospovidone, anhydrous colloidal silica.

• The tablet coating contains: monohydrate lactose, hypromellose (E-464), titanium dioxide (E-171), macrogol 4000, iron oxide red (E-172).

Appearance of the product and contents of the pack

• Valsartán/hidroclorotiazida Pensa 80 mg/12.5 mg coated tablets are cylindrical, biconvex, coated tablets, pink in colour, marked with the code "VH1".

• The tablets are supplied in packs 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 – Areta Industrial Estate

31620 Huarte – Pamplona (Navarra) – Spain

Date of latest review of this leaflet: January 2025

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