AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE CINFA 5 mg/160 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

amlodipine/valsartan/hydrochlorothiazide cinfa 5 mg/160 mg/12.5 mg

film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

This medicine contains three active substances called amlodipine, valsartan, and hydrochlorothiazide. All these substances help to control high blood pressure.

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

As a result of the three mechanisms, the 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 amlodipine, valsartan, and hydrochlorothiazide, and who may benefit from taking a single tablet containing all three substances.

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

Do not take amlodipine/valsartan/hydrochlorothiazide cinfa

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medicine also at the start of your pregnancy - see section Pregnancy).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary infections), or any of the other ingredients of this medicine (listed in section 6).

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

• if you have liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the accumulation of bile in the liver (cholestasis).
• if you have severe kidney problems or if you are on 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 (uric acid crystals in the joints).
• if you have severe low blood pressure (hypotension).
• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation where your heart is unable to supply enough blood to your body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take amlodipine/valsartan/hydrochlorothiazide cinfa and inform your doctor if any of the above applies to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amlodipine/valsartan/hydrochlorothiazide cinfa:

• if you have low potassium or magnesium levels in your blood (with or without symptoms such as muscle weakness, muscle spasms, irregular heartbeat).
• if you have low sodium levels in your blood (with or without symptoms such as tiredness, confusion, muscle contractions, convulsions).
• if you have high calcium levels in your 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 had a kidney transplant, or have been told you have narrowing of the arteries to the kidney.
• if you have liver problems.
• if you have or have had heart failure or coronary artery disease, in particular if you have been prescribed the maximum dose of this medicine (10 mg/320 mg/25 mg).
• if you have had a heart attack. Follow your doctor's instructions to start treatment carefully. Your doctor may also check your kidney function.
• if your doctor has told you that you have narrowing of the heart valves (so-called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (so-called "hypertrophic cardiomyopathy").
• if you suffer from aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of this medicine is not recommended.
• if you suffer from a disease called systemic lupus erythematosus (also known as "lupus" or "SLE").
• if you have diabetes (high blood sugar levels).
• if you have high cholesterol or triglyceride levels in your blood.
• if you experience skin reactions such as rash after sun exposure.
• if you have had an allergic reaction to other blood pressure-lowering medicines or diuretics, especially if you suffer from 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 medicines (including ACE inhibitors). If you have these symptoms, stop taking this medicine and contact your doctor immediately. You should never take this medicine again.
• if you experience dizziness and/or fainting during treatment with this medicine, inform your doctor as soon as possible.
• if you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within hours to a week of administration of this medicine. If left untreated, this may result in permanent vision loss.
• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking amlodipine/valsartan/hydrochlorothiazide cinfa.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking amlodipine/valsartan/hydrochlorothiazide cinfa, seek medical attention immediately.

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

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

See also the information under the heading "Do not take amlodipine/valsartan/hydrochlorothiazide cinfa".

Tell your doctor if any of the above applies to you.

Children and adolescents

The use of this medicine is not recommended in children and adolescents under 18 years of age.

Elderly patients (65 years and older)

This medicine can be used in patients 65 years and older at the same dose as used in other adults and in the same way as they have already taken the three substances called amlodipine, valsartan, and hydrochlorothiazide. The blood pressure of elderly patients should be monitored periodically, especially those taking the maximum dose of this medicine (10 mg/320 mg/25 mg).

Using amlodipine/valsartan/hydrochlorothiazide cinfa with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Your doctor may need to change your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially important if you are using any of the following medicines:

Do not take with:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that may increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• an ACE inhibitor or aliskiren (see also the information under the headings "Do not take amlodipine/valsartan/hydrochlorothiazide cinfa" and "Warnings and precautions").

Should be used with caution with:

• alcohol, sleeping pills, and anesthetics (medicines for patients who are going to have an operation and other procedures);
• amantadine (treatment for Parkinson's disease, also used to treat or prevent certain viral diseases);
• anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia);
• anticonvulsant and mood-stabilizing medicines used to treat epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, or other resins (substances used mainly to treat high lipid levels in the blood);
• simvastatin (a medicine used to control high cholesterol levels);
• cyclosporine (a medicine used in transplants to prevent organ rejection or for other conditions, e.g., rheumatoid arthritis or atopic dermatitis);
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medicines used to treat heart problems);
• verapamil, diltiazem (heart medicines);
• iodinated contrast media (agents used in imaging studies);
• medicines for treating diabetes (oral medicines such as metformin or insulins);
• medicines for treating gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-blockers, diazoxide);
• medicines that may induce "torsades de pointes" (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics;
• medicines that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics;
• medicines that may reduce potassium levels in the blood, such as diuretics (medicines for urination), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines used to increase blood pressure, such as adrenaline or noradrenaline;
• medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medicines used for treating fungal infections (e.g., ketoconazole, itraconazole);
• medicines used for treating inflammation and ulceration of the esophagus (carbenoxolone);
• medicines used for pain relief or inflammation, especially non-steroidal anti-inflammatory medicines (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (medicines for relaxing muscles used during operations);
• nitroglycerin and other nitrates, or other substances called "vasodilators";
• other medicines used to treat high blood pressure, including methyldopa;
• rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John's Wort;
• dantrolene (in infusion for severe body temperature abnormalities);
• vitamin D and calcium salts.

Taking amlodipine/valsartan/hydrochlorothiazide cinfa with food, drinks, and alcohol

People who have been prescribed this medicine should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active substance amlodipine in the blood, which may cause an unpredictable increase in the blood pressure-lowering effect of this medicine. Consult your doctor before drinking alcohol. Alcohol may greatly lower your blood pressure and/or increase the possibility of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctorbefore using this medicine. Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you find out you are pregnant, and recommend that you take another blood pressure-lowering medicine instead. This medicine is not recommended during pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby when administered after this time.

Breastfeeding

Tell your doctorif you are about to start or are already breastfeeding. It has been shown that amlodipine passes into breast milk in small amounts. This medicine is not recommended for women during breastfeeding. Your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

As with other medicines used to treat high blood pressure, this medicine may make you feel dizzy, sleepy, nauseous, or have a headache. If you experience these symptoms, do not drive or use tools or machines.

Use in athletes

This medicine contains hydrochlorothiazide, which may produce a positive result in doping tests.

3. How to take amlodipine/valsartan/hydrochlorothiazide cinfa

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor again. This will help you get the best results and reduce the risk of side effects.

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

• It is best to take the tablet at the same time each day. The best time is in the morning.
• Swallow the tablet whole with a glass of water.
• You can take this medicine with or without food. Do not take this medicine with grapefruit or grapefruit juice.
• The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

Depending on your response to treatment, your doctor may suggest a higher or lower dose.

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 medicine, 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 Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take amlodipine/valsartan/hydrochlorothiazide cinfa

If you forget to take a dose of this medicine, 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, just take the next tablet at the usual time. Do not take a double dose (two tablets at the same time) to make up for forgotten doses.

If you stop taking amlodipine/valsartan/hydrochlorothiazide cinfa

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

Always take this medicine, even if you feel well

Hypertensive patients often do not notice any symptoms of their problem. Many feel well. It is very important that you take this medicine exactly as your doctor has told you to get the best results and reduce the risk of side effects. Keep your appointments with your doctor even if you feel well.

If you have any further questions on 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 all people suffer from them.

As with any combination containing three active ingredients, the adverse effects associated with each individual component cannot be excluded. The adverse effects observed with amlodipine/valsartan/hydrochlorothiazide or one of its three active ingredients (amlodipine, valsartan, and hydrochlorothiazide) are listed below and may occur with the use of this medicine.

Some adverse effects can be serious and require immediate medical attention.

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

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

• dizziness
• low blood pressure (feeling 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, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat, causing great difficulty breathing
• severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• heart attack
• pancreatitis, which can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort
• weakness, bruising, fever, and frequent infections
• stiffness
• acute difficulty breathing (symptoms include severe difficulty breathing, fever, weakness, and confusion)

Other adverse effects may include:

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

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

Frequent (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (feeling the heartbeat)
• hot flashes
• swelling of the ankles (edema)
• abdominal pain
• stomach discomfort after eating
• fatigue
• headache
• frequent 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
• itching rash and other types of rash
• inability to achieve or maintain an erection

Infrequent (may affect up to 1 in 100 patients)

• rapid heartbeat
• feeling that everything is spinning around
• vision disorder
• stomach discomfort
• chest pain
• increased urea, creatinine, and uric acid levels in the blood
• high calcium, lipid, or sodium levels in the blood
• low potassium levels in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered taste
• back pain
• joint swelling
• cramps/weakness/pain in the muscles
• pain in the limbs
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness when standing up or after exercising
• 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
• redness of the skin
• tremor
• mood changes
• anxiety
• depression
• drowsiness
• taste disturbances
• fainting
• loss of pain sensation
• visual disturbances
• visual impairment
• ringing in the ears
• sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• alteration of bowel habits
• indigestion
• hair loss
• itching of the skin
• skin discoloration
• urination disorder
• increased need to urinate at night
• increased frequency of urination
• discomfort or enlargement of the breasts in men
• pain
• feeling of discomfort
• weight loss

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

• low platelet count in the blood (sometimes with bleeding or bruising under the skin)
• sugar in the urine
• high sugar levels in the blood
• worsening of diabetic metabolic condition
• abdominal discomfort
• constipation
• liver disorders that may present with yellowing of the skin and eyes or darkening of the urine (hemolytic anemia)
• increased sensitivity of the skin to the sun
• purplish spots on the skin
• kidney disorders
• confusion

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

• decrease in the number of white blood cells in the blood
• decrease in blood platelets that can cause unusual bruising or easy bleeding (red blood cell damage)
• gum inflammation
• abdominal swelling (gastritis)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• increase in liver enzymes that can affect some medical tests
• increase in muscle tension
• inflammation of blood vessels, often with skin rashes
• sensitivity to light
• disorders combining stiffness, tremor, 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 urine (hemolytic anemia, abnormal decrease in red blood cells in the blood vessels and other parts of the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, purplish red spots, fever (vasculitis)
• severe skin disease that causes rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Angioedema of the intestine: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• alteration of kidney function test results in the blood, increased potassium levels in the blood, low red blood cell count
• abnormal red blood cell count
• low levels 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, bruising, and frequent infections (aplastic anemia)
• decreased vision or eye pain due to high eye pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of kidney disorder or kidney failure)
• severe skin disease that causes rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• blistering skin disease (sign of a disease called bullous dermatitis)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Amlodipine/Valsartan/Hydrochlorothiazide Cinfa

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

Do not use this medicine after the expiration date shown on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Amlodipine/Valsartan/Hydrochlorothiazide Cinfa

The active ingredients of amlodipine/valsartan/hydrochlorothiazide cinfa are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide.

Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.

The other components are:

Core of the tablet: silicified microcrystalline cellulose, crospovidone, and magnesium stearate.

Coating: polyvinyl alcohol, polyethylene glycol/macrogol, titanium dioxide (E-171), and talc.

Appearance of the Product and Package Contents

Amlodipine/valsartan/hydrochlorothiazide cinfa 5 mg/160 mg/12.5 mg tablets are film-coated, biconvex, oblong, white, scored on one side, and marked with "A1" on the other.

Amlodipine/valsartan/hydrochlorothiazide cinfa is available in blister packs of 28 film-coated tablets. One blister contains 7 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra)-Spain

Date of the Last Revision of this Prospectus: February 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85178/P_85178.html

QR code to: https://cima.aemps.es/cima/dochtml/p/85178/P_85178.html