Leaflet: information for the user

valsartán/hidroclorotiazida cinfa 160 mg/25 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isvalsartán/hidroclorotiazida cinfaand what it is used for

2. What you need to know before takingvalsartán/hidroclorotiazida cinfa

3. How to takevalsartán/hidroclorotiazida cinfa

4. Possible side effects

5. Storage ofvalsartán/hidroclorotiazida cinfa

6. Contents of the pack and additional information

valsartán/hidroclorotiazida film-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 increased 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 is 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 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 valsartan/hidroclorotiazida cinfa

• if you are allergic to valsartan, hidroclorotiazida, sulfonamide derivatives (chemicals related to hidroclorotiazida) or any of the other components 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 severe liver disease, small bile duct destruction in the liver (biliary cirrhosis) that leads to bile accumulation in the liver (cholestasis)

• if you have severe kidney disease
• if you are unable to produce urine (anuria)
• 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, inform your doctor and do not take valsartan/hidroclorotiazida

Warnings and precautions

Consult your doctor or pharmacist before starting to take valsartan/hidroclorotiazida cinfa

• 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 regularly control your potassium levels.
• 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 severe heart disease
• if you have heart failure or have had a heart attack. Follow your doctor's instructions carefully to start treatment. Your doctor may also monitor your renal function.
• if you have renal artery stenosis
• 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/hidroclorotiazida is not recommended.
• if you have kidney or liver disease
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking valsartan/hidroclorotiazida, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.
• 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 triglycerides in your blood
• if you have previously had 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
• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a period of time ranging from several hours to a week after taking valsartán/hidroclorotiazida. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have previously had an allergy to penicillin or sulfonamides.
• if you are taking any of the following medications used to treat high blood pressure:
• • a converting enzyme inhibitor (ACE inhibitor) (e.g. 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 valsartan/hidroclorotiazida cinfa.
• 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 valsartan/hidroclorotiazida cinfa, see your doctor immediately.

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

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 valsartan/hidroclorotiazida cinfa”.

Valsartan/hidroclorotiazida may cause increased sensitivity to the sun.

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/hidroclorotiazida before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartan/hidroclorotiazida is not recommended at the beginning of pregnancy (first 3 months) and should not be administered at all from the third month of pregnancy, as it may cause serious harm to your baby, see Pregnancy section.

Children and adolescents

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

Taking valsartan/hidroclorotiazida cinfa with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication

The effect of treatment with valsartan/hidroclorotiazida 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 treatment with one of the medications. This is especially applicable to the following medications:

• lithium, a medication used to treat certain types of psychiatric disorders
• medications or substances that may increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications and heparin
• medications that may decrease the amount of potassium in the blood, such as diuretics (urine-producing medications), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G
• some antibiotics (of the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of valsartan/hidroclorotiazida
• medications that may induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (heart problem medications) and some antipsychotics
• medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics
• medications to treat gout, such as allopurinol, probenecid, sulfinpirazona
• vitamin D therapy and calcium supplements
• medications to treat diabetes (insulin or oral antidiabetic medications such as metformin)
• other medications to reduce blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskirén (see also the information under the headings “Do not take valsartan/hidroclorotiazida cinfa” and “Warnings and precautions”).
• medications that increase blood pressure, such as norepinephrine or adrenaline
• digoxin or other digitalis glycosides (medications used to treat heart problems)
• medications that may increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide
• pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and aspirin in doses above 3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medications (medications used to treat a wide range of disorders such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease and as an aid to anesthesia)
• amantadine (a medication used to treat Parkinson's disease and also to treat or prevent certain viral diseases)
• colestiramine and colestipol (medications primarily used to treat high levels of lipids in the blood)
• ciclosporina, a medication used to prevent organ rejection after transplant
• alcohol, sleep medications and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgery)
• iodinated contrast media (used for diagnostic imaging tests)

Taking valsartan/hidroclorotiazida cinfa with food, drinks and alcohol

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

• 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 valsartan/hidroclorotiazida before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartan/hidroclorotiazida is not recommended at the beginning of pregnancy (first 3 months) and should not be administered at all from the third month of pregnancy, as it may cause serious harm to your baby, see Pregnancy section.

• Inform your doctor if you plan to start or are breastfeeding, as valsartan/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 valsartan/hidroclorotiazida. Like many other medications used to treat high blood pressure, valsartan/hidroclorotiazida may cause, in rare cases, dizziness and affect concentration.

Valsartan/hidroclorotiazida cinfa contains lactose.

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

Valsartan/hidroclorotiazida cinfa contains sorbitol.

This medication contains 18.5 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a certain sugar intolerance, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult with your doctor (or your child) before taking this medication.

Valsartan/hidroclorotiazida cinfa contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

People with high blood pressure often do not notice any signs 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 indicate exactly how many tablets ofvalsartan/hydrochlorothiazideyou should take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose ofvalsartan/hydrochlorothiazideis one tablet per day.
• Do not change the dose or interrupt treatment without consulting your doctor.
• This medication should be taken at the same time every day, usually in the morning.
• You can takevalsartan/hydrochlorothiazidewith or without food.
• Swallow the tablet with a glass of water.

If you take more valsartan/hydrochlorothiazide cinfa 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 Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take valsartan/hydrochlorothiazide cinfa

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 compensate for the missed doses.

If you interrupt treatment with valsartan/hydrochlorothiazide cinfa

If you stop takingvalsartan/hydrochlorothiazideyour blood pressure may worsen. Do not stop taking the medication unless your doctor tells you to.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side 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 throat
• difficulty swallowing
• hives and difficulty breathing.
• Severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Decreased vision or eye pain due to high blood pressure (possible signs of acute angle-closure glaucoma)
• Fever, sore throat, increased frequency of infections (agranulocytosis)

These side effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking valsartan/hydrochlorothiazide and contact your doctor immediately (see also section 2 "Warnings and precautions").

Other side effects include:

Rare (may affect up to 1 in 100 patients):

• cough
• low blood pressure
• dizziness
• dehydration (with symptoms of thirst, dry mouth and tongue, reduced urine frequency, dark-colored urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• ringing in the ears (e.g. tinnitus or buzzing)

Very rare (may affect up to 1 in 10,000 patients):

• dizziness
• diarrhea
• joint pain

Unknown frequency (cannot be estimated from available data):

• difficulty breathing
• severe decrease in urine production
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or convulsions)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• 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 the skin and eyes to turn yellow)
• increased levels of urea nitrogen and creatinine in the blood (which may indicate abnormal kidney function)
• increased levels of uric acid in the blood (which, in severe cases, may trigger a gout attack)
• syncope (fainting)

The following side effects have been observed with valsartan or hydrochlorothiazide-containing medicines separately:

Valsartan

Rare (may affect up to 1 in 100 patients):

• vertigo
• abdominal pain

Very rare (may affect up to 1 in 10,000 patients) :

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

Unknown frequency (cannot be estimated from available data):

• blistering skin (sign of dermatitis bullosa)

• skin 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 symptoms similar to the flu
• skin rash, red-purple spots, fever, itching (symptoms of vasculitis)
• 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
• increased liver function values
• low hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anemia)
• renal insufficiency
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or convulsions)

Hydrochlorothiazide

Very common (may affect more than 1 in 10 patients):

• low potassium levels in the blood
• increased levels of lipids in the blood

Common (may affect up to 1 in 10 patients):

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood

• skin rash with itching and other types of rash
• loss of appetite
• light vomiting and nausea
• dizziness, dizziness when standing up
• difficulty achieving or maintaining an erection

Rare (may affect up to 1 in 1,000 patients):

• swelling and blisters on the skin (due to increased sensitivity to the sun)
• high calcium levels in the blood
• high blood sugar levels
• glucose in the urine
• emergence of diabetic metabolic state
• constipation, diarrhea, stomach or intestinal discomfort, liver alterations that may appear with the skin and eyes turning yellow
• irregular heartbeat
• headache
• sleep disturbances
• depression
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• visual disturbances

Very rare (may affect up to 1 in 10,000 patients):

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• skin rash, joint pain, muscle pain,
• fever (lupus erythematosus)
• severe stomach pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (difficulty breathing that includes pneumonitis and pulmonary edema)
• paleness, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat, or mouth ulcers due to infections (leucopenia)
• confusion, fatigue, muscle fasciculations, and spasms, rapid breathing (hypochloremic alkalosis)
• acute respiratory distress (the signs include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency (cannot be estimated from available data):

• skin cancer and lip cancer (non-melanoma skin cancer)
• weakness, bruises, and frequent infections (aplastic anemia)
• significant decrease in urine production (possible signs of renal impairment or renal failure)
• skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle spasms
• fever (pyrexia)
• weakness (asthenia)
• decreased vision or eye pain due to high blood 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 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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Maintainthis medication out of sight and reach of children.
• Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C.
• Do not usethis medicationif you observe that the packaging is damaged or shows signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications that you no longer need. In this way, you will help protect the environment.

Composition of valsartan/hydrochlorothiazide cinfa

• The active principles are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 25 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), Stearate fumarate and sodium, Sodium lauryl sulfate, Crospovidone, Anhydrous colloidal silica.

Appearance of the product and contents of the packaging

Biconvex, cylindrical, coated tablets, brown in color, and marked with the code “VH3”.

The tablets are presented in packaging of 28 and 280 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) – Spain

Date of the last review of this leaflet: February 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73017/P_73017.html

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