Prospecto: information for the user

Amlodipino/Valsartán/Hidroclorotiazida Viatris 5 mg/160 mg/12,5 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist,even if they are possible adverse effects that do not appear in this prospect. See section 4.

1.What is Amlodipino/Valsartán/Hidroclorotiazida Viatris and for what it is used

2.What you need to know before starting to take Amlodipino/Valsartán/Hidroclorotiazida Viatris

3.How to take Amlodipino/Valsartán/Hidroclorotiazida Viatris

4.Possible adverse effects

1. Storage of Amlodipino/Valsartán/Hidroclorotiazida Viatris
2. Contents of the package and additional information

This medication 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 antagonists".
• Amlodipino prevents calcium from entering the blood vessel wall, which prevents blood vessel constriction.
• Valsartán belongs to a group of substances called "angiotensin II receptor antagonists". Angiotensin II is produced by the body and causes blood vessels to constrict, thereby raising 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.

Amlodipino/valsartán/hidroclorotiazida 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 Viatris

• 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 antagonist, 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 aliskirén.

Do not take this medication 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 this medication.

• 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 shortness of breath or severe difficulty breathing after taking Amlodipino/Valsartán/Hidroclorotiazida Viatris, see your doctor immediately.
• 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 amlodipino/valsartán/hidroclorotiazida (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 renal function.
• if your doctor has told you that you have a narrowing of the heart valves (which is called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (which is called "hypertrophic obstructive cardiomyopathy").
• if you have a condition called aldosteronismo. 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 sick (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 amlodipino/valsartán/hidroclorotiazida again.
• if you experience dizziness and/or fainting during treatment with amlodipino/valsartán/hidroclorotiazida, 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 amlodipino/valsartán/hidroclorotiazida. If not treated, this can cause permanent vision loss.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):

• a renin-angiotensin-aldosterone system inhibitor (RAAS inhibitor) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén.

• 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 this medication.

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

Your doctor may check your renal function, blood pressure, and electrolyte levels in the blood (such as potassium) at regular intervals.

See also the information under the heading "Do not take Amlodipino/Valsartán/Hidroclorotiazida Viatris".

Inform your doctor if you are affected by any of the cases mentioned.

Children and adolescents

Amlodipino/valsartán/hidroclorotiazida is not recommended for use in children or adolescents under 18 years old.

Older adults (65 years and older)

This medication may be used in people 65 years old 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 amlodipino, valsartán, and hidroclorotiazida. Renal function should be monitored periodically in elderly patients, particularly those taking the maximum dose of amlodipino/valsartán/hidroclorotiazida (10 mg/320 mg/25 mg).

Other medications and Amlodipino/Valsartán/Hidroclorotiazida Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. 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 medications. This is especially important if you are using any of the medications listed below:

Do not take with:

• lithium (a medication used to treat certain types of depression);
• medications or substances that may increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin;
• a RAAS inhibitor or aliskirén (see also the information under the headings "Do not take Amlodipino/Valsartán/Hidroclorotiazida Viatris" and "Warnings and precautions".

Use with caution with:

• alcohol, sleeping pills, and anesthetics (medications for patients undergoing surgery and other procedures);
• amantadina (treatment for Parkinson's disease, also used to treat or prevent certain diseases caused by viruses);
• anticholinergic medications (medications used to treat various disorders such as gastrointestinal upset, urinary tract 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 (for example, carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• colestiramine, colestipol, or other resins (substances used mainly to treat high levels of lipids in the blood);
• simvastatina (a medication used to control high levels of cholesterol);
• ciclosporina (a medication used in transplants to prevent organ rejection or for other conditions, such as rheumatoid arthritis or atopic dermatitis);
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medications used to treat heart problems);
• verapamilo, diltiazem (heart medications);
• contrast agents and iodinated substances (agents used in imaging tests);
• medications used to treat diabetes (oral medications such as metformin or insulin);
• medications used to treat gout, such as allopurinol;
• medications that may increase blood sugar levels (beta-blockers, diazoxide);
• medications that may induce torsades de pointes (irregular heart rhythm), such as antiarrhythmics (heart medications) and certain antipsychotics;
• medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptic medications;
• medications that may reduce the amount of potassium in the blood, such as diuretics, corticosteroids, laxatives, amphotericin B, or penicillin G;
• medications used to increase blood pressure, such as adrenaline or noradrenaline;
• medications used to treat HIV/AIDS (for example, ritonavir, indinavir, nelfinavir);
• medications used to treat fungal infections (for example, ketoconazole, itraconazole);
• medications used to treat esophageal inflammation and ulceration (carbenoxolone);
• medications used to relieve pain or inflammation, especially nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors;
• muscle relaxants (medications used to relax muscles during surgery);
• nitroglycerin and other nitrates, or other substances called "vasodilators";
• other medications used to treat high blood pressure, including methyldopa;
• rifampicina (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John's Wort;
• dantrolene (in perfusion for severe body temperature abnormalities);
• tacrolimus (used to control the body's immune response, allowing it to accept the transplanted organ);
• vitamin D and calcium salts.

Amlodipino/Valsartán/Hidroclorotiazida Viatris with food, drinks, and alcohol

People who have been prescribed this medication should not consume grapefruit or grapefruit juice.This is because grapefruit and grapefruit juice may lead to an increase in the blood levels of the active ingredient amlodipino, which may cause unpredictable reductions in the blood pressure-lowering effects of amlodipino/valsartán/hidroclorotiazida. Consult your doctor before drinking alcohol. Alcohol may significantly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor

Breastfeeding

You must inform your doctor

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

As with other medications used to treat high blood pressure, this medication may make you feel dizzy, drowsy, nauseous, or experience headaches. If you experience these symptoms, do not drive or operate tools or machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again. This will help you achieve better results and reduce the risk of adverse effects.

The normal dose of amlodipino/valsartán/hidroclorotiazida is one tablet per 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 amlodipino/valsartán/hidroclorotiazida with or without food. Do not take this medication with grapefruit or grapefruit juice.

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 Amlodipino/Valsartán/Hidroclorotiazida Viatris than you should

If you accidentally take too much amlodipino/valsartán/hidroclorotiazida, consult your doctor immediately. You may need medical attention.

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

If you forget to take Amlodipino/Valsartán/Hidroclorotiazida Viatris

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 make up for missed doses.

If you interrupt treatment with Amlodipino/Valsartán/Hidroclorotiazida Viatris

Stopping your treatment with amlodipino/valsartán/hidroclorotiazida 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 condition. Many feel fine. It is very important that you take this medication exactly as your doctor has instructed to achieve 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 this medicine or one of its three active principles (amlodipine, valsartan, and hydrochlorothiazide) appear below and may occur with the use of this medicine.

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

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

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

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

Less frequent (may affect up to 1 in 100 people):

• decreased urine production (reduced kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

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

• sudden hissing sounds when breathing (sudden sibilance), 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, which can cause severe abdominal pain and back pain accompanied by severe discomfort
• weakness, bruises, fever, and frequent infections
• stiffness
• acute respiratory difficulty (signs include severe breathing difficulty, fever, weakness, and confusion)

Other side effects may include:

Very frequent (may affect more than 1 in 10 people):

• low potassium levels in the blood
• increased blood lipids

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

• drowsiness
• palpitations (feeling the heartbeat)
• flushing
• 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 rash
• inability to achieve or maintain an erection

Less frequent (may affect up to 1 in 100 people):

• rapid heartbeat
• sensation of spinning
• vision disorder
• gastric discomfort
• chest pain
• increased nitrogen, 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 sense of taste
• back pain
• swelling of the joints
• muscle cramps, weakness, or pain
• pain in the extremities
• inability to stand or walk 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 or nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• alteration of bowel habits
• indigestion
• hair loss
• itching skin
• skin discoloration
• urination disorder
• increased nocturia
• increased frequency of urination
• male breast discomfort or enlargement in men
• pain
• discomfort
• weight loss

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

• low platelet count in the blood (sometimes with bleeding or hematoma under the skin)
• glucose presence 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 people):

• decreased white blood cell count
• low platelet count in the blood, which may cause unusual bruises or easy bleeding (damage to red blood cells)
• gingival inflammation
• abdominal swelling (gastritis)
• liver inflammation (hepatitis)
• yellow skin discoloration (jaundice)
• increased liver enzymes, which may affect some medical tests
• muscle tension increase
• inflammation of blood vessels, often with skin eruptions
• light sensitivity
• movement 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-colored urine (hemolytic anemia, abnormal decrease due to red blood cell rupture, both in blood vessels and other parts of the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe upper abdominal pain (pancreatitis inflammation)
• difficulty breathing with fever, cough, sibilance, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle alteration, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such aseruption, 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)
• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• alteration of kidney function test results in blood, increased potassium levels in blood, low red blood cell count in blood
• abnormal red blood cell count
• low count of a certain type of white blood cell and platelets in blood
• increased creatinine levels in blood
• abnormal liver function test
• important 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 alteration 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)
• vesiculobullous dermatitis (sign of a disease called dermatitis bullosa)
• skin 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 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.

Do not use this medication after the expiration date that appears on the box and on the blister after “CAD/EXP”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Store the blister in the outer packaging to protect it from light and moisture.

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

Medications should not be disposed of through drains or in the trash. Deposit the containers 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 containers and medications you no longer need. In this way, you will help protect the environment.

Amlodipino/Valsartán/Hidroclorotiazida Viatris Composition

• The active ingredients are amlodipine (as amlodipine besilate), valsartan, and hydrochlorothiazide. Each film-coated tablet contains 5mg of amlodipine (as amlodipine besilate), 160mg of valsartan, and 12.5mg of hydrochlorothiazide.
• The other components are microcrystalline cellulose, crospovidone (Type A), anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, and titanium dioxide (E-171).

Appearance of the product and contents of the package

White, oblong, biconvex film-coated tablet with the inscription“LLL”on one face and smooth on the other.

They are available in blister packs of 14, 28, 30, 90, or 98 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Genepharm S.A.

18th km Marathonos Avenue

15351 Pallini Attiki

Greece

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road,

Dublin 13,

Ireland

Mylan Hungary Kft.

H-2900 Komárom, Mylan utca. 1

Hungary

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:March 2025

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/).