Leaflet: information for the user

amlodipino/valsartán/hidroclorotiazida cinfa 10 mg/160 mg/25 mg

film-coated tablets EFG

Read this leaflet carefully before you start to take 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.

This medicine contains three substances called amlodipino, valsartán and hidroclorotiazida. All these substances help control high blood pressure.

• Amlodipino belongs to a group of substances called ”calcium channel blockers“. Amlodipino prevents calcium from entering the blood vessel wall, which prevents blood vessels from narrowing.
• Valsartán belongs to a group of substances called ”angiotensin II receptor antagonists“. Angiotensin II is produced by the body and causes blood vessels to narrow, thereby increasing blood pressure.Valsartán acts by blocking the effect of angiotensin II.
• Hidroclorotiazida belongs to a group of substances known as ”thiazide diuretics“. Hidroclorotiazida increases urine production, which also lowers blood pressure.

As a result of the three mechanisms, blood vessels relax and blood pressure decreases.

This medicine is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipino, valsartán and hidroclorotiazida and who may benefit from taking a tablet that contains the three substances.

Do not take amlodipino/valsartán/hidroclorotiazida cinfa

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medication also at the beginning of your pregnancy - see Pregnancy section).
• if you are allergic to amlodipino or to any other calcium channel blocker, valsartán, hidroclorotiazida, sulfonamide-derived medications (medications used to treat chest or urinary tract infections), or to any of the other components of this medication (included in section 6).

If you think you may be allergic, do not take this medication and inform your doctor.

• if you have liver disease, destruction of the small bile ducts inside the liver (biliary cirrhosis) that leads to the accumulation of bile in the liver (cholestasis).
• if you have severe kidney problems or if you are undergoing dialysis.
• if you are unable to urinate (anuria).
• if your blood potassium or sodium levels are too low despite treatment to increase potassium or sodium levels in the blood.
• if your blood calcium levels are too high despite treatment to reduce calcium levels in the blood.
• if you have gout (crystals of uric acid in the joints).
• if you have severe low blood pressure (hypotension).
• if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation in which your heart cannot supply enough blood to the body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskiren.

Do not take amlodipino/valsartán/hidroclorotiazida cinfa and inform your doctor if you are affected by any of the above cases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amlodipino/valsartán/hidroclorotiazida cinfa:

• if you have low levels of potassium or magnesium in the blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
• if you have low levels of sodium in the blood (with or without symptoms such as fatigue, confusion, muscle contractions, seizures).
• if you have high levels of calcium in the blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle contractions, and muscle weakness).
• if you have kidney problems, have undergone a kidney transplant, or if you have been told that you have a narrowing of the kidney arteries.
• if you have liver problems.
• if you have or have had heart failure or coronary artery disease, particularly if you have been prescribed the maximum dose of this medication (10 mg/320 mg/25 mg).
• if you have had a heart attack. Follow your doctor's instructions to start taking the medication carefully.Your doctor may also check your renal function.
• if you have a narrowing of the heart valves (also known as "aortic or mitral stenosis") or if your heart muscle has become abnormally thickened (also known as "hypertrophic obstructive cardiomyopathy").
• if you have a condition called aldosteronism. A disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of this medication is not recommended.
• if you have a disease called systemic lupus erythematosus (also known as "lupus" or "LES").
• if you have diabetes (high blood sugar levels).
• if you have high levels of cholesterol or triglycerides in the blood.
• if you experience skin reactions such as sunburn.
• if you have had an allergic reaction to other medications for high blood pressure or diuretics, especially if you have asthma and allergies.
• if you have been ill (with vomiting or diarrhea).
• if you have experienced swelling, particularly in the face and throat, while taking other medications (including ACE inhibitors). If you have these symptoms, stop taking this medication and contact your doctor immediately. You should never take this medication again.
• if you experience dizziness and/or fainting during treatment with this medication, inform your doctor as soon as possible.
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased intraocular pressure and may appear within hours to a week of administering this medication. If not treated, this can cause permanent vision loss.
• if you are taking any of the following medications used to treat high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

Consult your doctor or pharmacist before taking amlodipino/valsartán/hidroclorotiazida cinfa if you experience any of the above symptoms.

Do not take amlodipino/valsartán/hidroclorotiazida cinfa and inform your doctor if you are affected by any of the above cases.

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a tomar amlodipino/valsartán/hidroclorotiazida cinfa:

• si tiene niveles bajos de potasio o magnesio en sangre (con o sin síntomas tales como debilidad muscular, espasmos musculares, ritmo anormal del corazón).
• si tiene un nivel bajo de sodio en sangre (con o sin síntomas tales como cansancio, confusión, contracciones musculares, convulsiones).
• si tiene un nivel alto de calcio en sangre (con o sin síntomas tales como náuseas, vómitos, estreñimiento, dolor de estómago, orinar con frecuencia, sed, contracciones musculares y debilidad muscular).
• si tiene problemas de riñón, se ha sometido a un transplante de riñón o si le han informado que sufre un estrechamiento de las arterias del riñón.
• si tiene problemas de hígado.
• si tiene o ha tenido una insuficiencia cardiaca o una enfermedad coronaria, en particular si le han recetado la dosis máxima de este medicamento (10 mg/320 mg/25 mg).
• si ha tenido un ataque al corazón. Siga las instrucciones de su médico para iniciar cuidadosamente la dosificación.Su médico también puede comprobar su función renal.
• si su médico le ha informado de que sufre un estrechamiento de las válvulas del corazón (lo que se llama ”estenosis aórtica o mitral“) o de que el grosor de su músculo cardiaco ha aumentado de forma anormal (lo que se llama ”cardiomiopatía hipertrófica obstructiva”).
• si sufre aldosteronismo. Una enfermedad en la que las glándulas adrenales producen demasiada hormona aldosterona. En este caso, no se recomienda el uso de este medicamento.
• si sufre una enfermedad llamada lupus eritematoso sistémico (también conocida como ”lupus“ o ”LES”).
• si tiene diabetes (nivel alto de azúcar en sangre).
• si tiene niveles altos de colesterol o triglicéridos en sangre.
• si experimenta reacciones cutáneas como erupción tras la exposición al sol.
• si ha sufrido una reacción alérgica a otros medicamentos para la presión arterial elevada o diuréticos, especialmente si sufre asma y alergias.
• si ha estado enfermo (con vómitos o diarrea).
• si ha experimentado hinchazón, en particular en la cara y la garganta, mientras tomaba otros medicamentos (incluidos los inhibidores de la enzima convertidora de angiotensina). Si tiene estos síntomas, deje de tomar este medicamento y contacte inmediatamente con su médico. Nunca debe volver a tomar este medicamento.
• si experimenta mareo y/o desmayos durante el tratamiento con este medicamento, informe a su médico lo antes posible.
• si experimenta una disminución de la visión o dolor en el ojo. Éstos pueden ser síntomas de acumulación de líquido en la capa vascular del ojo (derrame coroideo) o un aumento de la presión ocular y pueden aparecer en cuestión de horas a una semana de la administración de este medicamento. Si no se trata, esto puede producir un deterioro permanente de la visión.
• si está tomando alguno de los siguientes medicamentos utilizados para tratar la hipertensión (presión arterial alta):
• un inhibidor de la enzima convertidora de angiotensina (IECA) (por ejemplo enalapril, lisinopril, ramipril), en particular si sufre problemas renales relacionados con la diabetes.
• aliskiren.

Consulte a su médico si presenta dolor abdominal, náuseas, vómitos o diarrea después de tomar amlodipino/valsartán/hidroclorotiazida. Su médico decidirá si continuar con el tratamiento. No deje de tomar amlodipino/valsartán/hidroclorotiazida por su cuenta.

Puede que su médico le controle la función renal, la presión arterial y los niveles de electrolitos (por ejemplo, potasio) en la sangre a intervalos regulares.

Ver también la información bajo el encabezado “No tome amlodipino/valsartán/hidroclorotiazida cinfa”.

Informe a su médico si le afecta alguno de los casos mencionados.

Niños y adolescentes

No se recomienda el uso de este medicamento en niños ni adolescentes menores de 18 años.

Personas de edad avanzada (65 años y mayores)

Este medicamento puede utilizarse en personas de 65 años y mayores a la misma dosis que la utilizada en otros adultos y del mismo modo que ya habrán tomado las tres sustancias llamadas amlodipino, valsartán e hidroclorotiazida. Debe controlarse periódicamente la presión arterial de los pacientes de edad avanzada, en particular aquellos que tomen la dosis máxima de este medicamento (10 mg/320 mg/25 mg).

Uso de amlodipino/valsartán/hidroclorotiazida cinfa con otros medicamentos

Informe a su médico o farmacéutico si está utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento. Puede que su médico deba modificar su dosis y/ o tomar otras precauciones. En algunos casos puede tener que dejar de tomar uno de los medicamentos. Esto es especialmente importante si está utilizando alguno de los medicamentos que se listan a continuación:

No tomar junto con:

• litio (un medicamento utilizado para tratar ciertos tipos de depresión);
• medicamentos o sustancias que puedan aumentar la cantidad de potasio en sangre. Estos incluyen suplementos de potasio o sustitutos de la sal que contengan potasio, medicamentos ahorradores de potasio y heparina;
• un IECA o aliskiren (ver también la información bajo los encabezados “No tome amlodipino/valsartán/hidroclorotiazida cinfa” y “Advertencias y precauciones”.

Deben utilizarse con precaución con:

• alcohol, pastillas para dormir y anestésicos (medicamentos para los pacientes que van a ser sometidos a una operación y otros procesos);
• amantadina (tratamiento para el Parkinson, también utilizado para tratar o prevenir ciertas enfermedades producidas por virus);
• medicamentos anticolinérgicos (medicamentos utilizados para tratar diferentes trastornos como retortijones gastrointestinales, espasmos de la vejiga urinaria, asma, mareo causado por movimiento, espasmos musculares, enfermedad de Parkinson y como ayuda en la anestesia);
• medicamentos anticonvulsivantes y estabilizadores del estado de ánimo utilizados para tratar la epilepsia y el trastorno bipolar (p.ej. carbamazepina, fenobarbital, fenitoína, fosfenitoína, primidona);
• colestiramina, colestipol u otras resinas (sustancias utilizadas principalmente para tratar niveles altos de lípidos en sangre);
• simvastatina (un medicamento utilizado para el control de los niveles altos de colesterol);
• ciclosporina (un medicamento usado en transplantes para evitar el rechazo de órganos o para otras condiciones, p. ej. artritis reumatoide o dermatitis atópica);
• medicamentos citotóxicos (utilizados para tratar el cáncer), tales como metotrexato o ciclofosfamida;
• digoxina u otros glucósidos digitálicos (medicamentos utilizados para tratar problemas de corazón);
• verapamilo, diltiazem (medicamentos para el corazón);
• medios de contraste yodados (agentes utilizados en exploraciones por la imagen);
• medicamentos para tratar la diabetes (medicamentos orales como la metformina o insulinas);
• medicamentos para tratar la gota, tales como alopurinol;
• medicamentos que pueden aumentar los niveles de azúcar en sangre (betabloqueantes, diazóxido);
• medicamentos que pueden inducir”torsades de pointes“(latido irregular del corazón), tales como antiarrítmicos (medicamentos utilizados para tratar los problemas del corazón) y algunos antipsicóticos;
• medicamentos que pueden reducir la cantidad de sodio en sangre, tales como antidepresivos, antipsicóticos, antiepilépticos;
• medicamentos que pueden reducir la cantidad de potasio en sangre, tales como diuréticos (medicamentos para orinar), corticosteroides, laxantes, anfotericina o penicilina G;
• medicamentos para aumentar la presión arterial tales como adrenalina o noradrenalina;
• medicamentos utilizados para el VIH/SIDA (p. ej. ritonavir, indinavir, nelfinavir);
• medicamentos utilizados para tratar infecciones fúngicas (p. ej. ketoconazol, itraconazol);
• medicamentos utilizados para una inflamación y ulceración del esófago (carbenoxolona);
• medicamentos utilizados para aliviar el dolor o inflamación, especialmente medicamentos antiinflamatorios no esteroideos (AINEs), incluyendo los inhibidores selectivos de la ciclooxigenasa 2 (inhibidores de la COX-2);
• relajantes musculares (medicamentos para relajar los músculos que se utilizan durante las operaciones);
• nitroglicerina y otros nitratos, u otras sustancias llamadas ”vasodilatadores”;
• otros medicamentos utilizados para tratar la presión arterial elevada, incluyendo metildopa;
• rifampicina (utilizada, por ejemplo, para tratar la tuberculosis), eritromicina, claritromicina (antibióticos);
• hierba de San Juan;
• dantroleno (en perfusión para las anomalías graves de la temperatura corporal);
• vitamina D y sales de calcio.

Toma de amlodipino/valsartán/hidroclorotiazida cinfa con alimentos, bebidas y alcohol

Las personas a las que se ha recetado este medicamento no deben consumir pomelo ni zumo de pomelo. Ello se debe a que el pomelo y el zumo de pomelo pueden dar lugar a un aumento en los niveles en sangre del principio activo amlodipino, que puede causar un aumento imprevisible en los efectos reductores de este medicamento sobre la presión arterial. Consulte a su médico antes de beber alcohol. El alcohol puede disminuir mucho su presión arterial y/o aumentar la posibilidad de mareo o desmayo.

Embarazo y lactancia

Embarazo

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada,consulte a su médicoantes de utilizar este medicamento. Por lo general, su médico le aconsejará que deje de tomar este medicamento antes de quedarse embarazada o tan pronto como se quede embarazada, y le recomendará tomar otro medicamento antihipertensivo en su lugar. No se recomienda utilizar este medicamento al inicio del embarazo y en ningún caso debe administrarse a partir del tercer mes de embarazo ya que puede causar daños graves a su bebé cuando se administra a partir de ese momento.

Lactancia

Informe a su médicosiva a iniciar o está en periodo de lactancia.Se ha demostrado que amlodipino pasa a la leche materna en pequeñas cantidades. No se recomienda administrar este medicamento a mujeres durante este periodo. Su médico puede decidir administrarle un tratamiento que sea más adecuado si quiere dar el pecho, especialmente a recién nacidos o prematuros.

Consulte a su médico o farmacéutico antes de utilizar cualquier medicamento.

Conducción y uso de máquinas

Como con otros medicamentos utilizados para tratar la presión arterial elevada, puede que este medicamento le haga sentir mareado, somnoliento, con náuseas o tener dolor de cabeza. Si experimenta estos síntomas, no conduzca o utilice herramientas o máquinas.

Uso en deportistas

Este medicamento contiene hidroclorotiazida que puede producir un resultado positivo en las pruebas de control de dopaje.

amlodipino/valsartán/hidroclorotiazida cinfa contiene tartrazina (E-102) y amarillo anaranjado (E-110).

Este medicamento puede producir reacciones alérgicas porque contiene tartrazina (E-102) y amarillo anaranjado (E-110). Puede provocar asma, especialmente en pacientes alérgicos al ácido acetilsalicílico.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again. This will help you obtain the best results and reduce the risk of adverse effects.

The usual dose of amlodipine/valsartan/hydrochlorothiazide cinfa isone tabletper day.

• It is best to take the tablet at the same time every day. The best time is in the morning.
• Swallow the tablet whole with a glass of water.
• You can take this medication with or without food. Do not take this medication with grapefruit or grapefruit juice.
• The groove is only for breaking the tablet if it is difficult to swallow it whole.

Your doctor may suggest a higher or lower dose depending on your response to treatment.

Do not exceed the prescribed dose.

If you take more amlodipine/valsartan/hydrochlorothiazide cinfa than you should

If you have accidentally taken too many tablets of this medication, consult your doctor immediately. You may need medical attention.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that may develop up to 24-48 hours after ingestion.

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 amlodipine/valsartan/hydrochlorothiazide cinfa

If you forget to take a dose of this medication, take it as soon as you remember and then take the next dose at the usual time. If it is almost time for the next dose, only take the next tablet at the usual time. Do not take a double dose (two tablets at once) to compensate for the missed doses.

If you interrupt treatment with amlodipine/valsartan/hydrochlorothiazide cinfa

Stopping your treatment with this medication may cause your condition to worsen. Do not stop taking the medication unless your doctor tells you to.

Always take this medication, even if you feel well

People with hypertension often do not notice any symptoms of their problem. Many feel well. It is very important that you take this medication exactly as your doctor has instructed to obtain the best results and reduce the risk of adverse effects. Keep your appointments with your doctor even if you feel well.

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.

As with any combination that contains three active principles, it cannot be ruled out that side effects associated with each individual component may occur. The side effects observed with amlodipino/valsartán/hidroclorotiazida or one of its three active principles (amlodipino, valsartán, and hidroclorotiazida) appear below and may occur with the use of this medicine.

Some side effects may be severe and require immediate medical attention.

Consult your doctor immediately if, after taking this medicine, you experience any of the following severe side effects:

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

• dizziness
• low blood pressure (sensation of fainting, dizziness, sudden loss of consciousness)

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

• decreased urine production (reduced kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

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

• sudden wheezing while breathing (sudden wheezing), chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat that causes severe difficulty breathing
• severe skin reactions that include intense skin rash, blisters, skin redness all over the body, severe itching, blister formation, skin peeling, skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack
• pancreatitis that can cause severe abdominal pain and back pain accompanied by severe discomfort
• weakness, bruises, fever, and frequent infections
• stiffness
• difficulty breathing (signs include severe difficulty breathing, fever, weakness, and confusion)

Other side effects may include:

Very frequent (may affect more than 1 in 10 patients)

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

Frequent (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (feeling the heartbeat)
• angina
• swelling of the ankles (edema)
• abdominal pain
• postprandial discomfort
• fatigue
• headache
• frequency of urination
• high uric acid levels in the blood
• low magnesium levels in the blood
• low sodium levels in the blood
• dizziness, dizziness when standing up
• decreased appetite
• nausea and vomiting
• pruritic rash and other types of rashes
• difficulty achieving or maintaining an erection

Infrequent (may affect up to 1 in 100 patients)

• rapid heartbeat
• sensation of everything spinning around
• vision disorder
• gastric discomfort
• chest pain
• increased levels of urea nitrogen, creatinine, and uric acid in the blood
• high levels of calcium, lipids, or sodium in the blood
• low potassium levels in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• swelling of the joints
• muscle cramps/weakness/pain
• pain in the extremities
• difficulty standing or walking normally
• weakness
• abnormal coordination
• dizziness when standing up or after exercise
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden and transient loss of consciousness
• low blood pressure when standing up
• cough
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• shaking
• mood changes
• anxiety
• depression
• drowsiness
• altered sense of taste
• syncope
• loss of pain sensation
• visual disturbances
• visual deterioration
• tinnitus in the ears
• runny nose/secretion caused by nasal mucosa inflammation (rhinitis)
• alteration of bowel habits
• indigestion
• hair loss
• itching skin
• skin discoloration
• urination disorder
• increased nocturia
• increased frequency of urination
• breast discomfort in men
• pain
• discomfort
• weight loss

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

• low platelet count in the blood (sometimes with bleeding or hematoma under the skin)
• glucose in the urine
• high blood sugar levels
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver alterations that may be accompanied by yellow skin and eyes, or dark-colored urine (hemolytic anemia)
• increased skin sensitivity to the sun
• purpuric skin spots
• kidney alterations
• confusion

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

• decreased white blood cell count
• low platelet count in the blood that may cause unusual bruises or easy bleeding (damage to red blood cells)
• gingivitis
• abdominal swelling (gastritis)
• liver inflammation (hepatitis)
• yellow skin discoloration (jaundice)
• increased liver enzymes that may affect some medical tests
• muscle tension increase
• inflammation of blood vessels often with skin eruptions
• light sensitivity
• movement disorders combining stiffness, shaking, and/or movement disorders
• fever, sore throat, or mouth ulcers, increased frequency of infections (low or very low white blood cell count)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia, abnormal decrease in red blood cells due to rupture in blood vessels or other parts of the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe upper abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle alteration, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Angioedema intestinal: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency unknown (the frequency cannot be estimated from available data)

• alteration of kidney function test results in blood, increased potassium levels in the blood, low red blood cell count in the blood
• abnormal red blood cell count
• low count of a certain type of white blood cell and platelets in the blood
• increased creatinine levels in the blood
• abnormal liver function test
• significant decrease in urine production
• inflammation of blood vessels
• weakness, bruises, and frequent infections (aplastic anemia)
• decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of renal impairment or renal insufficiency)
• severe skin disease that causes rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• bullous dermatitis (sign of a disease called dermatitis bullosa)
• skin cancer and lip cancer (non-melanoma skin cancer)

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 prospectus. You can also report them directly through the Spanish System for 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.

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

Do not store at a temperature above 30°C.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

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

Composition of amlodipine/valsartan/hydrochlorothiazide cinfa

The active principles of amlodipine/valsartan/hydrochlorothiazide cinfa are amlodipine (as amlodipine besilate), valsartan, and hydrochlorothiazide.

Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.

The other components are:

Core of the tablet:microcrystalline cellulose, crospovidone, anhydrous colloidal silica, and magnesium stearate.

Coating: polyvinyl alcohol, polyethylene glycol/macrogol, titanium dioxide (E-171), talc, aluminum lake FD&C yellow no. 5/tartrazine (E-102), aluminum lake FD&C yellow no. 6/amaranth yellow FCF (E-110), yellow iron oxide (E-172), and aluminum lake FD&C blue no. 1/brilliant blue FCF (E-133).

Appearance of the product and content of the packaging

The amlodipine/valsartan/hydrochlorothiazide cinfa 10 mg/160 mg/25 mg tablets are biconvex, oblong, yellow-brown film-coated tablets, scored on one side, and marked with “A4” on the other.

amlodipine/valsartan/hydrochlorothiazide cinfa isavailable in blister packs of 28 film-coated tablets. A blister pack contains 7 film-coated 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 on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

You can access detailed and updated information on 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/85176/P_85176.html

QR code to:https://cima.aemps.es/cima/dochtml/p/85176/P_85176.html