Amlodipine/valsartan/hydrochlorothiazide Cinfa 10 mg/160 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

amlodipine/valsartan/hydrochlorothiazide cinfa 10 mg/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, consult 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 could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What amlodipine/valsartan/hydrochlorothiazide cinfa is and what it is used for
2. What you need to know before taking amlodipine/valsartan/hydrochlorothiazide cinfa
3. How to take amlodipine/valsartan/hydrochlorothiazide cinfa
4. Possible side effects
5. How to store 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 substances called amlodipine, valsartan and hydrochlorothiazide. All of these substances help 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, thereby preventing 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 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 these 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 amlodipine, valsartan and hydrochlorothiazide, and who may benefit from taking a single tablet containing the three substances.

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

Do not take amlodipine/valsartan/hydrochlorothiazide cinfa

• if you are more than 3 months pregnant. (In any case, use of this medicine is not recommended during early pregnancy – see Pregnancy section).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary tract 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 (primary biliary cirrhosis), leading to bile accumulation in the liver (cholestasis).
• if you have severe kidney problems or are undergoing dialysis.
• if you are unable to pass urine (anuria).
• if your blood potassium or sodium levels are too low despite treatment to increase potassium or sodium levels.
• if your blood calcium levels are too high despite treatment to reduce calcium levels.
• 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 condition in which your heart cannot supply enough blood to the body).
• if you have heart failure following a heart attack.
• if you have diabetes or kidney failure 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 conditions apply to you.

Warnings and precautions

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

• if you have low levels of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat).
• if you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, muscle twitching, seizures).
• if you have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle twitching, and muscle weakness).
• if you have kidney problems, have had a kidney transplant, or have been told you have 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 medicine (10 mg/320 mg/25 mg).
• if you have had a heart attack. Follow your doctor’s instructions carefully when starting treatment. Your doctor may also monitor your kidney function.
• if your doctor has told you that you have narrowing of the heart valves (called “aortic or mitral stenosis”) or abnormal thickening of your heart muscle (called “hypertrophic obstructive cardiomyopathy”).
• if you have hyperaldosteronism. A condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of this medicine is not recommended.
• if you have 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 high blood pressure medicines 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 medicines (including angiotensin-converting enzyme inhibitors). If you have these symptoms, stop taking this medicine and contact your doctor immediately. You must 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 a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur within hours to a week after taking this medicine. If untreated, this may lead to permanent vision loss.
• if you are taking any of the following medicines for high blood pressure (hypertension):
• an angiotensin-converting enzyme (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 cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking amlodipine/valsartan/hydrochlorothiazide cinfa.
• If you have had breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking amlodipine/valsartan/hydrochlorothiazide cinfa, seek medical attention immediately.

Consult your doctor if you develop abdominal pain, nausea, vomiting, or diarrhea after taking amlodipine/valsartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking amlodipine/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 the information under the heading “Do not take amlodipine/valsartan/hydrochlorothiazide cinfa”.

Inform your doctor if any of the above conditions apply to you.

Children and adolescents

This medicine is not recommended for use in children or adolescents under 18 years of age.

Elderly people (65 years and older)

This medicine may be used in people aged 65 years and older at the same dose as in other adults and in the same way as they have previously taken the three active substances amlodipine, valsartan, and hydrochlorothiazide. Blood pressure should be monitored periodically in elderly patients, particularly those taking the maximum dose of this medicine (10 mg/320 mg/25 mg).

Taking amlodipine/valsartan/hydrochlorothiazide cinfa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may need to adjust 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 taking any of the following:

Do not take together with:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• an ACE inhibitor or aliskiren (see also 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 undergoing surgery or other procedures);
• amantadine (used to treat Parkinson’s disease, also used to treat or prevent certain viral illnesses);
• anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anesthesia);
• anticonvulsants and mood stabilizers used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, or other resins (substances mainly used to treat high lipid levels in blood);
• simvastatin (a medicine used to control high cholesterol levels);
• cyclosporine (a medicine used in organ 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 agents (used in imaging procedures);
• medicines for diabetes (oral medicines such as metformin or insulin);
• medicines for gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-blockers, diazoxide);
• medicines that may cause “torsades de pointes” (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics;
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
• medicines that may reduce blood potassium levels, such as diuretics (medicines to increase urine output), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines to increase blood pressure, such as adrenaline or noradrenaline;
• medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medicines used for inflammation and ulceration of the esophagus (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (medicines used to relax muscles during surgery);
• 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 (by infusion for severe body temperature abnormalities);
• vitamin D and calcium salts.

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

People prescribed this medicine should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effects of this medicine. Consult your doctor before drinking alcohol. Alcohol may greatly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Generally, your doctor will advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative antihypertensive medicine. Use of this medicine is not recommended during early pregnancy, and it must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts. This medicine is not recommended for use in women during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if the baby is a newborn or premature.

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, drowsy, nauseous, or give you a headache. If you experience these symptoms, do not drive or operate tools or machinery.

Use in athletes

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

3. How to take amlodipine/valsartan/hydrochlorothiazide cinfa

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor again. This will help you achieve the best results and reduce the risk of adverse effects.

The usual dose of amlodipine/valsartan/hydrochlorothiazide cinfa is one tablet daily.

• It is best to take the tablet at the same time each day. The preferred time is in the morning.
• Swallow the tablet whole with a glass of water.
• You may take this medicine with or without food. Do not take this medicine with grapefruit or grapefruit juice.
• The tablet's score line is intended only for splitting the tablet if you find it difficult to swallow whole.

Depending on your response to treatment, your doctor may recommend 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, contact your doctor immediately. You may require medical attention.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 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 your next dose, you should only take the next tablet at the usual time. Do not take a double dose (two tablets at once) to make up for a missed dose.

If you stop taking amlodipine/valsartan/hydrochlorothiazide cinfa

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

Keep taking this medicine, even if you feel well

People with high blood pressure often do not experience any symptoms. Many feel perfectly well. It is very important that you take this medicine exactly as prescribed by your doctor to achieve the best results and reduce the risk of adverse effects. Continue attending your doctor's appointments even if you feel well.

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 will experience them.

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

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

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

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

• dizziness
• low blood pressure (feeling faint, dizzy, sudden loss of consciousness)

Uncommon (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 whistling sounds when breathing (sudden wheezing), chest pain, shortness of breath or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat causing severe difficulty breathing
• severe skin reactions including severe rash, hives, redness of the skin all over the body, intense itching, blistering, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack
• inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of malaise
• weakness, bruising, fever, and frequent infections
• stiffness
• acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion)

Other adverse effects may include:

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

• low potassium levels in the blood
• increased blood lipids

Common (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (awareness of heartbeat)
• hot flushes
• 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 upon standing
• decreased appetite
• nausea and vomiting
• itchy rash and other types of skin rashes
• inability to achieve or maintain an erection

Uncommon (may affect up to 1 in 100 patients)

• rapid heartbeat
• sensation of spinning (vertigo)
• vision disorders
• stomach discomfort
• chest pain
• increased blood urea nitrogen, creatinine, and uric acid levels
• high levels of calcium, lipids, or sodium in the blood
• decreased potassium levels in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• joint swelling
• cramps/weakness/pain in muscles
• limb pain
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness upon standing or after exercise
• low blood pressure upon standing
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden and transient loss of consciousness
• cough
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• tremor
• mood changes
• anxiety
• depression
• drowsiness
• taste disturbances
• fainting
• loss of pain sensation
• visual disturbances
• impaired vision
• ringing in the ears (tinnitus)
• sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• changes in bowel habits
• indigestion
• hair loss
• skin itching
• skin discoloration
• urinary disorders
• increased need to urinate at night
• increased frequency of urination
• discomfort or enlargement of the breasts in men
• pain
• feeling unwell
• 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)
• glucose in urine
• high blood sugar levels
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders which may occur with yellowing of the skin and eyes or dark-colored urine (hemolytic anemia)
• increased sensitivity of the skin to sunlight
• purplish spots on the skin
• kidney disorders
• confusion

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

• decreased number of white blood cells in the blood
• decreased platelets in the blood which may cause unusual bruising or easy bleeding (damage to red blood cells)
• inflammation of the gums
• abdominal swelling (gastritis)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• increased liver enzymes which may affect certain medical tests
• increased muscle tension
• inflammation of blood vessels, often with skin rashes
• light sensitivity
• 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 due to rupture of red blood cells in blood vessels and other body parts)
• confusion, fatigue, muscle cramps 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 disorders, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
• severe skin disease causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• abnormal blood test results for kidney function, increased potassium in the blood, low red blood cell count
• abnormal red blood cell count
• low levels of certain types of white blood cells and platelets in the blood
• increased creatinine 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 intraocular 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 dysfunction or kidney failure)
• severe skin disease causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• blistering skin disease (sign of a condition called bullous dermatitis)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any 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 amlodipine/valsartan/hydrochlorothiazide CINFA

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

Do not use this medicine after the expiry date stated on the packaging and blister 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 tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of amlodipine/valsartan/hydrochlorothiazide cinfa

The active substances in 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 12.5 mg of hydrochlorothiazide.

The other components are:

Tablet core: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, and magnesium stearate.

Coating: yellow iron oxide (E-172), polyvinyl alcohol, polyethylene glycol/macrogol, titanium dioxide (E-171), and talc.

Appearance of the product and contents of the container

Amlodipine/valsartan/hydrochlorothiazide cinfa 10 mg/160 mg/12.5 mg tablets are biconvex, oblong, yellow, film-coated tablets, scored on one side and marked with “A3” on the other.

Amlodipine/valsartan/hydrochlorothiazide cinfa is available in blister packs containing 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 most recent review of this leaflet: February 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (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 package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85175/P_85175.html

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