Valsartan/hydrochlorothiazide CINFA 160 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

valsartan/hydrochlorothiazide cinfa 160 mg/12.5 mg film-coated tablets EFG

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

• 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What valsartan/hydrochlorothiazide cinfa is and what it is used for
2. What you need to know before taking valsartan/hydrochlorothiazide cinfa
3. How to take valsartan/hydrochlorothiazide cinfa
4. Possible side effects
5. How to store valsartan/hydrochlorothiazide cinfa
6. Contents of the pack and other information

1. What valsartan/hydrochlorothiazide cinfa is and what it is used for

Valsartan/hydrochlorothiazide film-coated tablets contain 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 output, which also lowers blood pressure.

Valsartan/hydrochlorothiazide is used to treat high blood pressure that is not adequately controlled with a single component.

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 conditions.

2. What you need to know before taking valsartan/hydrochlorothiazide cinfa

Do not take valsartan/hydrochlorothiazide cinfa

• if you are allergic to valsartan, hydrochlorothiazide, sulphonamide-derived substances (chemically related to hydrochlorothiazide), or any of the other ingredients of this 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 during early pregnancy – see Pregnancy section).

• if you have severe liver disease, destruction of small bile ducts in the liver (biliary cirrhosis) leading 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 abnormally low levels of potassium or sodium in your blood, or if your blood calcium levels remain high 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, inform your doctor and do not take valsartan/hydrochlorothiazide.

Warnings and precautions

Talk to your doctor or pharmacist before taking valsartan/hydrochlorothiazide cinfa

• if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase blood potassium levels, such as heparin. Your doctor may consider regular monitoring of potassium levels necessary.
• if you have low blood potassium levels.
• 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 heart failure or have had a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also monitor your kidney function.
• if you have narrowing of the artery to the kidney (renal artery stenosis).
• 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 have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If you develop these symptoms while taking valsartan/hydrochlorothiazide, stop treatment immediately and never take it again. See also section 4 “Possible side effects”.
• 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 elevated cholesterol or triglyceride levels in your blood.
• if you have previously had an allergic reaction to another medicine of this class used to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.
• if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from several hours to one week after taking valsartan/hydrochlorothiazide. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulphonamides.
• if you are taking any of the following medicines used to treat hypertension (high blood pressure):
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., 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, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun exposure and UV rays while taking valsartan/hydrochlorothiazide cinfa.
• If you have previously experienced breathing or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnoea or severe difficulty breathing after taking valsartan/hydrochlorothiazide cinfa, seek medical attention immediately.

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

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

See also information under the heading “Do not take valsartan/hydrochlorothiazide cinfa”.

Valsartan/hydrochlorothiazide may increase skin sensitivity to sunlight.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. Use of valsartan/hydrochlorothiazide 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 Pregnancy section.

Children and adolescents

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

Taking valsartan/hydrochlorothiazide cinfa with other medicines

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

The effect of treatment with valsartan/hydrochlorothiazide may be altered when taken together with certain medicines. Your doctor may need to adjust 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 psychiatric disorders

• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin

• medicines that may decrease blood potassium levels, such as diuretics (medicines to increase urine production), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G.

• certain antibiotics (rifampicin group), a drug used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may enhance the effect of valsartan/hydrochlorothiazide

• medicines that may induce "torsades de pointes" (irregular heartbeats), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics

• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics

• medicines for gout, such as allopurinol, probenecid, sulfinpyrazone

• therapeutic vitamin D and calcium supplements

• medicines for diabetes (insulin or oral antidiabetics such as metformin)

• other blood pressure-lowering medicines including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take valsartan/hydrochlorothiazide cinfa” and “Warnings and precautions”).

• medicines that may increase blood pressure, such as noradrenaline or adrenaline

• digoxin or other digitalis glycosides (medicines used to treat heart problems)

• medicines that may increase blood sugar levels, such as diazoxide or beta-blockers

• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide

• pain medicines such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid at doses exceeding 3 g

• muscle relaxants, such as tubocurarine

• anticholinergic medicines (used to treat a wide range of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anaesthesia)

• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral infections)

• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels)

• cyclosporine, a medicine used to prevent rejection of transplanted organs

• alcohol, sleeping medicines, and anaesthetics (medicines with sedative or pain-relieving effects, used for example during surgery)

• iodinated contrast agents (used in diagnostic imaging procedures)

Taking valsartan/hydrochlorothiazide cinfa with food, drinks and alcohol

Avoid drinking alcohol until you have consulted your doctor. Alcohol may further lower your blood pressure and/or increase the likelihood 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/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Use of valsartan/hydrochlorothiazide 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 start or are currently breastfeeding, as valsartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if the infant is a newborn or premature.

Driving and using machines

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

valsartan/hydrochlorothiazide cinfa contains lactose.

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

valsartan/hydrochlorothiazide cinfa contains sorbitol.

This medicine contains 18.5 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which fructose cannot be broken down, consult your doctor before taking this medicine.

valsartan/hydrochlorothiazide cinfa contains sodium.

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

3. How to take valsartán/hidroclorotiazida cinfa

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

People with high blood pressure often do not experience any noticeable symptoms; many feel perfectly normal. This makes it very important to keep your medical appointments, even if you feel well.

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

• The recommended dose of valsartan/hydrochlorothiazide 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 valsartan/hydrochlorothiazide with or without food.
• Swallow the tablet with a glass of water.

If you take more valsartán/hidroclorotiazida 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, contact 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 cinfa

If you miss 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 cinfa

If you discontinue treatment with valsartan/hydrochlorothiazide, your hypertension may worsen. Do not stop taking the medicine unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious and require immediate medical attention:

You should see your doctor immediately if you notice symptoms of angioedema, such as:

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

These adverse 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 adverse effects include:

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

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

• dizziness
• diarrhea
• joint pain

Frequency not known (cannot be estimated from available data):

• difficulty breathing
• severe reduction in urine output
• low sodium levels in blood (which, in severe cases, may cause fatigue, confusion, muscle twitching and/or seizures)
• low potassium levels in 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 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 blood (which, in severe cases, may trigger an attack of gout)
• syncope (fainting)

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

Valsartan

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

• sensation of spinning
• abdominal pain

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

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

Frequency not known (cannot be estimated from available data):

• blisters on the skin (sign of bullous dermatitis)
• rash with or without itching, together with 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 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 blood (which, in severe cases, may cause anemia)
• renal failure
• low sodium levels in blood (which, in severe cases, may cause fatigue, confusion, muscle twitching and/or seizures)

Hydrochlorothiazide

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

• low potassium levels in blood
• increased blood lipids

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

• low sodium levels in blood
• low magnesium levels in blood
• high uric acid levels in blood
• itchy rash and other types of skin rash
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness upon standing
• inability to achieve or maintain an erection

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

• swelling and blisters on the skin (due to increased sensitivity to sunlight)
• high calcium levels in blood
• high blood sugar levels
• sugar in urine
• worsening of diabetic metabolic status
• constipation, diarrhea, stomach or intestinal discomfort, liver disorders which may occur together with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• sadness (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 spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders
• fever (lupus erythematosus)
• severe upper abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (breathing difficulty including pneumonitis and pulmonary edema)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle jerks and spasms, rapid breathing (hypochloremic alkalosis)
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion)

Frequency not known (cannot be estimated from available data):

• skin and lip cancer (non-melanoma skin cancer)
• weakness, bruising and frequent infections (aplastic anemia)
• marked decrease in urine production (possible signs of kidney impairment or kidney failure)
• skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle cramps
• fever (pyrexia)
• weakness (asthenia)
• decreased vision or eye pain due to elevated 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of valsartan/hydrochlorothiazide cinfa

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C.
• Do not use this medicine if the packaging is damaged or shows signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to a SIGRE point.

6. Contents of the pack and other information

Composition of valsartan/hydrochlorothiazide cinfa

• The active substances 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 corn starch, Pregelatinized corn starch, Povidone (E-1201), Stearyl 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, Iron oxide red (E-172), Iron oxide brown (E-172).

Appearance of the product and contents of the pack

Reddish, cylindrical, biconvex, coated tablets marked with the code “VH2”.

The tablets are available in packs of 28 and 280 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent review of this leaflet: February 2025

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

You can access detailed and up-to-date 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/73018/P_73018.html

QR code: https://cima.aemps.es/cima/dochtml/p/73018/P_73018.html