Leaflet: information for the user

Valsartan/hydrochlorothiazide cinfamed 320 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 isValsartan/hydrochlorothiazide cinfamedand what it is used for

2.What you need to know before you start takingValsartan/hydrochlorothiazide cinfamed

3.How to takeValsartan/hydrochlorothiazide cinfamed

4.Possible side effects

5.Storage ofValsartan/hydrochlorothiazide cinfamed

6.Contents of the pack and additional informationl

Valsartán/hidroclorotiazida cinfamed contains two active principles 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 diuretic thiazides. 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 load on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and may cause a cerebral infarction, heart failure, or renal insufficiency. High blood pressure increases the risk of cardiac attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not take Valsartán/hidroclorotiazida cinfamed

• if you are allergic to valsartán, hidroclorotiazida, sulfonamide derivatives (substances chemically related to hidroclorotiazida), peanuts or soy 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 and breastfeeding section),
• if you have a severe liver disease, destruction of small bile ducts in the liver (biliary cirrhosis) that leads to a buildup of bile 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 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 valsartán/hidroclorotiazida.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartán/hidroclorotiazida cinfamed

• 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 Valsartán/hidroclorotiazida cinfamed
• if you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium, or other medications that increase blood potassium levels, such as heparin. Your doctor may consider regularly controlling 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 hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartán/hidroclorotiazida cinfamed 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 valsartán/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 time frame of 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 had an allergy to penicillin or sulfonamides previously.
• if you are taking any of the following medications 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 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 Valsartán/hidroclorotiazida cinfamed, see your doctor immediately.

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

Valsartán/hidroclorotiazida may increase skin sensitivity to the sun.

If you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, inform your doctor. Generally, your doctor will advise you to stop taking Valsartán/hidroclorotiazida before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartán/hidroclorotiazida is not recommended to be administered from the third month of pregnancy as it may cause severe damage to your baby (see Pregnancy and breastfeeding section).

Children and adolescents

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

Use in athletes:This medication contains hidroclorotiazida, which may produce a positive result in doping control tests.

Taking Valsartán/hidroclorotiazida cinfamed 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 Valsartán/hidroclorotiazida cinfamed 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 particularly applicable to the following medications:

• litium, a medication used to treat certain types of psychiatric diseases
• medications or substances that may increase blood potassium levels. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin
• medications that may decrease blood potassium levels, such as diuretics (urine-producing medications), corticosteroids, laxatives, carbenoxolona, amfotericina, or penicillin G

• some antibiotics (of the rifampicina 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 valsartán/hidroclorotiazida.
• medications that may induce "torsades de pointes" (irregular heartbeats), such as antiarrhythmic medications (heart problem medications) and some antipsychotics
• medications that may decrease blood sodium levels, such as antidepressants, antipsychotics, antiepileptics
• medications used to treat gout, such as alopurinol, probenecid, sulfinpirazona
• vitamin D therapy and calcium supplements
• medications used to treat diabetes (insulin or oral antidiabetic medications such as metformin)

• other medications to reduce blood pressure, including metildopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskirén (see also the information under the headings "Do not take Valsartán/hidroclorotiazida cinfamed" and "Warnings and precautions")
• medications that increase blood pressure, such as noradrenaline or adrenaline

• digoxina or other digitalis glycosides (heart problem medications)

• medications that may increase blood sugar levels, such as diazoxida or beta-blockers
• cytotoxic medications (used to treat cancer), such as metotrexato or ciclofosfamida medications for pain, such as anti-inflammatory non-steroidal medications (NSAIDs), including selective COX-2 inhibitors and aspirin in doses above 3 g
• muscle relaxants, such as tubocurarina
• anticholinergic medications (medications used to treat a wide range of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, travel sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia)
• amantadina (a medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses)
• colestiramina and colestipol (medications used primarily to treat high levels of lipids in the blood)
• ciclosporina, a medication used to prevent organ rejection in transplant patients

• 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 Valsartán/hidroclorotiazida cinfamed 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

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

Before driving a vehicle, using tools, or operating machines, or engaging in other activities that require concentration, make sure you know your reactions to the effects of valsartán/hidroclorotiazida. Like many other medications used to treat high blood pressure, valsartán/hidroclorotiazida may cause, in rare cases, dizziness and affect concentration.

Valsartán/hidroclorotiazida cinfamed contains lactose.

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

Valsartán/hidroclorotiazida cinfamed contains sodium.

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

Valsartán/hidroclorotiazida cinfamed contains soy lecithin.

This medication contains soy oil. It should not be used in case of an allergy to peanuts or soy.

Follow exactly the administration instructions of this medication 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 valsartán/hidroclorotiazida you should take. Depending on how you respond to the treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of Valsartán/hidroclorotiazida is one tablet per day.
• Do not change the dose or interrupt the 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 with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartán/hidroclorotiazida cinfamed 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 Valsartán/hidroclorotiazida cinfamed

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 the treatment with Valsartán/hidroclorotiazida cinfamed

If you stop taking valsartán/hidroclorotiazida, 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 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 (can affect up to 1 in 10,000 patients) or of unknown frequency (cannot be estimated from available data)

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:

Uncommon(can 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
• Tickling or numbness
• Blurred vision
• Noises (e.g. ringing or buzzing) in the ears

Rare(can 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 can cause fatigue, confusion, muscle twitching, and/or convulsions)
• 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 levels of uric acid in the blood (which, in severe cases, can trigger a gout attack)
• Syncope (fainting)

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

Valsartan:

Uncommon(can affect up to 1 in 100 patients)

• Sensation of rotation
• Abdominal pain

Rare (can 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)

• Blisters on the skin (sign of dermatitis bullous)
• 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
• 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 spasms, abnormal heart rhythm)
• Allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• Swelling mainly of the face and throat; rash; itching
• Increased 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
• Low sodium levels in the blood (which, in severe cases can cause fatigue, confusion, muscle twitching, and/or convulsions)

Hidroclorotiazida:

Very common (can affect more than 1 in 10 patients)

• Low potassium levels in the blood
• Increased levels of lipids in the blood

Common (can 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

• Rash with itching and other types of rash
• Loss of appetite
• Mild vomiting and nausea
• Dizziness, dizziness when standing up
• Inability to achieve or maintain an erection

Rare(can 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 alterations that may appear with yellow skin and eyes
• Irregular heartbeat
• Headache
• Sleep disturbances
• Depression (sadness)
• Low platelet count (sometimes with bleeding or bruising under the skin)
• Dizziness
• Tingling or numbness
• Visual disturbances

Rare(can affect up to 1 in 10,000 patients)

• Inflammation of the blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• Rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• 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 twitching, 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)
• 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)
• Weakness, bruises, and frequent infections (aplastic anemia)
• Significant decrease in urine production (possible signs of renal dysfunction or renal failure)
• Rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme)
• Muscle spasms
• Fever (pyrexia)
• Weakness (asthenia)

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.

Keep this medication out of the sight and reach of children.

Blister packs: Do not store at a temperature above 30°C.

Bottles: No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if 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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Valsartán/hidroclorotiazida cinfamed

The active principles are valsartán and hidroclorotiazida. Each tablet contains 320 mg of valsartán and 25 mg of hidroclorotiazida.

The other components are: microcrystalline cellulose, lactose monohydrate, croscarmelosa sodium, povidone K29-K32, talc, magnesium stearate, anhydrous colloidal silica, polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, soy lecithin (E-322), iron oxide red and iron oxide yellow (E-172).

Appearance of the product and content of the container

Valsartán/hidroclorotiazida cinfamed is presented in the form of coated tablets, yellow in color, oval, biconvex, scored on one face and on the sides, with the inscription “V” on one face and “H” on the other.

Valsartán/hidroclorotiazida cinfamed tablets are available in blisters containing 28 or 280 (clinical pack) tablets.

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder and responsible for manufacturing and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - España

Responsible for manufacturing

Actavis Limited Bulebel Industrial Estate Zejtun ZTN 3000 Malta

or

BALKANPHARMA DUPNITSA AD

3, Samokovsko Shosse Str. 2600 Dupnitsa

Bulgaria

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - España

Last review date of this leaflet: February 2025

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

You can access detailed and updated information about this medicine 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/75388/P_75388.html

QR code to: https://cima.aemps.es/cima/dochtml/p/75388/P_75388.html