Leaflet: information for the user

valsartán/hidroclorotiazida cinfa 80 mg/12.5 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, do 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 is valsartán/hidroclorotiazida cinfa and what is it used for

2. What you need to know before you start taking valsartán/hidroclorotiazida cinfa

3. How to take valsartán/hidroclorotiazida cinfa

4. Possible side effects

5. Storage of valsartán/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 to control high blood pressure (hypertension).

• Valsartánbelongs to a class of medications known as “angiotensin II receptor antagonists” that help to 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/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 (substances chemically related to hidroclorotiazida) or to any of the other components ofthis 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 at the beginning of your pregnancy – see Pregnancy section).
• if you have a severe liver disease,severe liver damage,small bile duct destruction in the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).

• if you have a severe kidney disease.
• if you are unable to produce urine (anuria).
• if you are undergoing dialysis.
• if you have 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 kidney insufficiency and are being treated with a blood pressure-lowering medicine containing aliskirén

If any of these situations apply to you, inform your doctor and do not take valsartan/hidroclorotiazida

Warnings and precautions

Consult your doctor or pharmacist before starting to takevalsartan/hidroclorotiazida cinfa

• if you are using potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines 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 a 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 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/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 medicines (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 experienced an allergic reaction with the use of another medicine of this class to lower 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 offluid accumulation in the vascular layer of the eye (choroidal effusion) orincreased pressure in the eye and may occur during a period of time ranging from several hours to a week after taking valsartan/hidroclorotiazida. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have previously been allergic to penicillin or sulfonamides.
• if you are taking any of the following medicines used to treat high blood pressure:
• • an ACE inhibitor (such as 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 exposure to the sun 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/hidroclorotiazidamay cause increased sensitivity of the skin to the sun.

If you are pregnant, if you suspect you may be pregnant or if you plan to become pregnant, inform your doctor. It is generally recommended that you stop takingvalsartan/hidroclorotiazidabefore becoming pregnant or as soon as you become pregnant, and that your doctor recommend another antihypertensive medicine instead. Valsartan/hidroclorotiazida should not be administered during the first three months of pregnancy 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/hidroclorotiazidais not recommended for use in children and adolescents (under 18 years).

Taking valsartan/hidroclorotiazida cinfa with other medicines

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

The effect of treatment withvalsartan/hidroclorotiazidamay be altered if taken with certain medicines. Your doctor may need to modify your dose and/or take other precautions or, in some cases, discontinue treatment with one of the medicines. This is particularly applicable to the following medicines:

• lithium, a medicine used to treat certain types of mental illnesses

• medicines or substances that may increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin
• medicines that may decrease the amount of potassium in the blood, such as diuretics (urine-producing medicines), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G
• some antibiotics (of the rifampicin group), a medicine used to protect against rejection in a transplant (ciclosporina) or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect ofvalsartan/hidroclorotiazida
• medicines that may induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (heart medicines) and some antipsychotics
• medicines that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpirazona
• therapeutic vitamin D and calcium supplements
• medicines used to treat diabetes (insulin ororal antidiabetic medicinessuch as metformin)
• other medicines used to lower 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”).
• medicines that increase blood pressure, such as noradrenaline or adrenaline

• digoxin or other digitalis glycosides??medicines used totreating heart problems)
• medicines that may increase blood sugar levels, such as diazoxide or beta-blockers
• chemotherapy medicines, such as methotrexate or cyclophosphamideda
• pain medicines, 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 medicines (medicines 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 medicine used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses)
• colestiramine and colestipol (medicines used mainly to treat high levels of lipids in the blood)
• ciclosporina, a medicine used to prevent organ rejection after transplant
• alcohol, sleep medicines and anesthetics (medicines with sedative or pain-relieving effects used, for example, in surgery)
• contrast agents containing iodine (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, if you suspect you may be pregnant or if you plan to become pregnant.Generally, your doctor will advise you to stop takingvalsartan/hidroclorotiazidabefore becoming pregnant or as soon as you become pregnant, and recommend another antihypertensive medicine instead. Valsartan/hidroclorotiazida should not be administered during the first three months of pregnancy 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 breastfeedingas 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 in newborns or premature babies.

Driving and operating machinery

Before driving a vehicle, using tools or operating machinery, or engaging in other activities that require concentration, make sure you know how you react to the effects ofvalsartan/hidroclorotiazida. Like many other medicines used to treat high blood pressure,valsartan/hidroclorotiazidamay cause, in rare cases, dizziness and affect concentration.

valsartan/hidroclorotiazida cinfa contains lactose.

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

valsartan/hidroclorotiazida cinfa contains sorbitol.

This medicine contains 9.25 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, 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 medicine.

valsartan/hidroclorotiazida cinfa contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this 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 of valsartan/hydrochlorothiazide you should take. Depending on how you respond to the treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of valsartan/hydrochlorothiazide is 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 take valsartan/hydrochlorothiazide with 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 taking valsartan/hydrochlorothiazide, 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 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 may 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 or buzzing in the ears

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)
• high bilirubin levels in the blood (which, in severe cases, may cause yellowing of the skin and eyes)
• high levels of urea nitrogen and creatinine in the blood (which may indicate abnormal kidney function)
• high 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):

• skin blisters (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 flu-like symptoms
• skin rash, red-purple patches, fever, itching (signs 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
• high 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 levels of uric acid 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
• sugar in the urine
• worsening of diabetic metabolic state
• constipation, diarrhea, stomach or intestinal discomfort, liver changes that may appear with yellow skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• depression
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disturbances

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

• inflammation of blood vessels with symptoms such as skin rash, red-purple patches, fever (vasculitis)
• skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• skin rash, joint pain, muscle disorders,
• fever (lupus erythematosus)
• severe stomach pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (difficulty breathing that includes pneumonitis and pulmonary edema)
• pale skin, fatigue, shortness of breath, dark-colored 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, bruising, 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 the 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 andmedications that you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of valsartan/hydrochlorothiazide cinfa

• The active principles 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 cornstarch, Pregelatinized cornstarch, Povidone (E-1201), Stearate of fumaric acid and sodium, Sodium lauryl sulfate, Crospovidone, Anhydrous colloidal silica.
  • The tablet coating: Lactose Monohydrate, Hypromellose (E-464), Titanium dioxide (E-171), Macrogol 4000, Iron oxide red (E-172).

Appearance of the product and contents of the packaging

Cylindrical, biconvex tablets, coated with a pink color and marked with the code “VH1”.

The tablets are presented in packs of 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:February 2025

The detailed information of this medicine 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 medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/73019/P_73019.html

QR code to:https://cima.aemps.es/cima/dochtml/p/73019/P_73019.html