Amlodipine/valsartan/hydrochlorothiazide Viatris 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 Viatris 10 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, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

1. What Amlodipine/Valsartan/Hydrochlorothiazide Viatris is and what it is used for
2. What you need to know before taking Amlodipine/Valsartan/Hydrochlorothiazide Viatris
3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Viatris
4. Possible side effects
   1. How to store Amlodipine/Valsartan/Hydrochlorothiazide Viatris
   2. Contents of the pack and other information

1. What Amlodipine/Valsartan/Hydrochlorothiazide Viatris 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 the narrowing of blood vessels.

• 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.

Amlodipine/valsartan/hydrochlorothiazide is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan and hydrochlorothiazide separately, and who may benefit from taking a single tablet containing the three substances.

2. What you need to know before taking Amlodipine/Valsartan/Hydrochlorothiazide Viatris

Do not take Amlodipine/Valsartan/Hydrochlorothiazide Viatris

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medicine also 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 to 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 urinate (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 this medicine and inform your doctor if any of the above conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

• 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 Viatris, contact your doctor immediately.

• 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 cramps, and 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 amlodipine/valsartan/hydrochlorothiazide (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 check 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 aldosteronism. A condition in which the adrenal glands produce too much aldosterone hormone. This medicine is not recommended in this case.

• if you have a disease called systemic lupus erythematosus (also known as "lupus" or "SLE").

• if you have diabetes (high blood sugar).

• 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 diarrhoea).

• 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 amlodipine/valsartan/hydrochlorothiazide again.

• if you experience dizziness and/or fainting during treatment with amlodipine/valsartan/hydrochlorothiazide, inform your doctor as soon as possible.

• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur within hours to a week of taking amlodipine/valsartan/hydrochlorothiazide. 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 inhibitor (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 this medicine.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea 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 check 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 Viatris."

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

Children and adolescents

The use of amlodipine/valsartan/hydrochlorothiazide is not recommended in children and adolescents under 18 years of age.

Elderly (65 years and older)

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

Other medicines and Amlodipine/Valsartan/Hydrochlorothiazide Viatris

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 medicines:

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 Viatris" and "Warnings and precautions").

Use with caution with:

• alcohol, sleeping pills, and anaesthetics (medicines for patients undergoing surgery or other procedures);
• amantadine (treatment for Parkinson’s disease, also used to treat or prevent certain viral infections);
• 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 anaesthesia);
• 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);
• cyclosporine (a medicine used in organ transplantation 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 scans);
• medicines for treating diabetes (oral medicines such as metformin or insulin);
• medicines for treating gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-blockers, diazoxide);
• medicines that could induce torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines for heart conditions) 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 urination), 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 oesophagus (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (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 (intravenous infusion for severe body temperature abnormalities);
• tacrolimus (used to control the body’s immune response to allow acceptance of a transplanted organ);
• vitamin D and calcium salts.

Amlodipine/Valsartan/Hydrochlorothiazide Viatris with food, drinks, and alcohol

Patients 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 lead to an unpredictable increase in the blood pressure-lowering effects of amlodipine/valsartan/hydrochlorothiazide. 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

You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking this medicine before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Amlodipine/valsartan/hydrochlorothiazide is not recommended during early pregnancy and 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 breastfeeding or plan to breastfeed. It has been shown that amlodipine passes into breast milk in small amounts. This medicine is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breastfeed, especially if the infant is a newborn or premature.

Consult your doctor or pharmacist before taking 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.

3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Viatris

Follow exactly the instructions given by your doctor for taking this medicine. 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 is one tablet per day.

• 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 amlodipine/valsartan/hydrochlorothiazide with or without food. Do not take this medicine with grapefruit or grapefruit juice.

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 Viatris than you should

If you accidentally take too much amlodipine/valsartan/hydrochlorothiazide, 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.

If you forget to take Amlodipine/Valsartan/Hydrochlorothiazide Viatris

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

If you stop taking Amlodipine/Valsartan/Hydrochlorothiazide Viatris

Stopping your treatment with amlodipine/valsartan/hydrochlorothiazide 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 notice any symptoms of their condition. Many feel 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. Keep your doctor 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 substances, adverse effects associated with each individual component cannot be excluded. The adverse effects observed with this medicine 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 may be serious and require immediate medical attention.

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

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

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

Uncommon (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 whistling sound 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 intense rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and skin inflammation, 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 (signs include severe breathlessness, fever, weakness, and confusion)

Other adverse effects may include:

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

• low blood potassium levels
• increased blood lipids

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

• drowsiness
• palpitations (awareness of heartbeat)
• flushing
• swelling of the ankles (edema)
• abdominal pain
• stomach discomfort after eating
• fatigue
• headache
• frequent urination
• high blood uric acid levels
• low blood magnesium levels
• low blood sodium levels
• dizziness, dizziness upon standing
• decreased appetite
• nausea and vomiting
• itchy rash and other types of rash
• inability to achieve or maintain an erection

Uncommon (may affect up to 1 in 100 people):

• rapid heartbeat
• sensation of spinning (vertigo)
• vision disorders
• stomach discomfort
• chest pain
• increased blood urea nitrogen, creatinine, and uric acid
• high blood calcium, lipid, or sodium levels
• decreased blood potassium levels
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• joint swelling
• muscle cramps/weakness/muscle pain
• pain in limbs
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness upon standing or after exercise
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden and transient loss of consciousness
• low blood pressure upon standing
• 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
• visual impairment
• ringing in the ears
• 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 breasts in men
• pain
• feeling unwell
• weight loss

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

• low blood platelet count (sometimes with bleeding or bruising under the skin)
• presence of glucose in urine
• high blood sugar levels
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders, which may present with yellowing of the skin and eyes or dark-colored urine (hemolytic anemia)
• increased sensitivity of the skin to sunlight
• purpuric skin spots
• kidney disorders
• confusion

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

• decreased number of white blood cells
• decreased blood platelets, 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 reduction due to destruction of red blood cells both in blood vessels and other body parts)
• confusion, fatigue, muscle cramps 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 disorders, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, red-purple 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 causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• alteration in blood test results for kidney function, increased blood potassium, low number of red blood cells
• abnormal red blood cell count
• low levels of certain types of white blood cells and platelets in blood
• increased creatinine in blood
• abnormal liver function test
• marked decrease in urine production
• inflammation of blood vessels
• weakness, bruising, and frequent infections (aplastic anemia)
• reduced 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 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 type of adverse effect, consult 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 Viatris

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

Do not use this medicine after the expiry date stated on the carton and blister pack following “CAD/EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep the blister pack in the outer carton to protect it from light and moisture.

Do not use this medicine if you notice that 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 dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine/Valsartan/Hydrochlorothiazide Viatris

• The active substances 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 microcrystalline cellulose, crospovidone (Type A), colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol, talc, titanium dioxide (E-171), yellow iron oxide (E-172) and red iron oxide (E-172).

Appearance of the product and contents of the pack

Film-coated tablet, pale yellow, oblong, biconvex, with the imprint "HLL" on one side and smooth on the other.

Available in blister packs of 14, 28, 30, 90 or 98 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: March 2025

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