Valtricom

Leaflet attached to the packaging: patient information

Valtricom, 5 mg + 160 mg + 12.5 mg, film-coated tablets

Valtricom, 5 mg + 160 mg + 25 mg, film-coated tablets

Valtricom, 10 mg + 160 mg + 12.5 mg, film-coated tablets

Valtricom, 10 mg + 160 mg + 25 mg, film-coated tablets

Valtricom, 10 mg + 320 mg + 25 mg, film-coated tablets

Amlodipine + valsartan + hydrochlorothiazide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Valtricom and what is it used for
• 2. Important information before taking Valtricom
• 3. How to take Valtricom
• 4. Possible side effects
• 5. How to store Valtricom
• 6. Contents of the pack and other information

1. What is Valtricom and what is it used for

Valtricom tablets contain three active substances: amlodipine, valsartan, and hydrochlorothiazide.
All these substances help control high blood pressure.

• Amlodipine belongs to a group of substances called calcium antagonists. Amlodipine prevents calcium from entering the walls of blood vessels, which inhibits the constriction of blood vessels.
• Valsartan belongs to a group of substances called angiotensin II receptor antagonists. Angiotensin II is produced in the human body and causes blood vessels to constrict, increasing blood pressure. Valsartan works by blocking the action of angiotensin II.
• Hydrochlorothiazide belongs to a group of substances called thiazide diuretics. Hydrochlorothiazide increases urine production, which also lowers blood pressure. As a result of all three mechanisms, blood vessels dilate, and blood pressure decreases.

Valtricom is used to treat high blood pressure in adult patients who have been controlled on amlodipine, valsartan, and hydrochlorothiazide, and for whom it is beneficial to take one tablet containing all three active substances.

2. Important information before taking Valtricom

When not to take Valtricom

• after the third month of pregnancy (it is also recommended to avoid taking Valtricom in early pregnancy - see "Pregnancy");
• if the patient is allergic to amlodipine or other calcium antagonists, valsartan, hydrochlorothiazide, sulfonamide derivatives (drugs used to treat respiratory or urinary tract infections) or any of the other ingredients of this medicine (listed in section 6) - if the patient has doubts, they should not take Valtricom and should discuss it with their doctor;
• if the patient has liver disease, bile duct obstruction (biliary cirrhosis) leading to bile accumulation in the liver (bile stasis);
• if the patient has severe kidney problems or is undergoing dialysis;
• if the patient is unable to urinate (anuria);
• if the patient has low potassium or sodium levels in the blood, despite treatment to increase potassium or sodium levels in the blood;
• if the patient has high calcium levels in the blood, despite treatment to decrease calcium levels in the blood;
• if the patient has gout (uric acid crystal accumulation in the joints);
• if the patient has significantly low blood pressure (hypotension);
• if the patient has aortic stenosis (aortic valve narrowing) or cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body's cells);
• if the patient has heart failure after a heart attack;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren. If any of the above situations apply to the patient, they should not take Valtricom and should discuss it with their doctor.

Warnings and precautions

Before starting to take Valtricom, the patient should discuss it with their doctor or pharmacist:

• if the patient has low potassium or magnesium levels in the blood (with symptoms such as muscle weakness, muscle cramps, heart rhythm disturbances, or without symptoms);
• if the patient has low sodium levels in the blood (with symptoms such as fatigue, confusion, muscle tremors, seizures, or without symptoms);
• if the patient has high calcium levels in the blood (with symptoms such as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, weakness, and muscle tremors, or without symptoms);
• if the patient has kidney problems, has recently had a kidney transplant, or has renal artery stenosis;
• if the patient has liver problems;
• if the patient has heart failure or coronary artery disease, especially if they have been prescribed the highest dose of Valtricom (10 mg + 320 mg + 25 mg);
• if the patient has had a heart attack - they should strictly follow their doctor's instructions regarding the initial dose; the doctor may also check their kidney function;
• if the patient has aortic valve stenosis (aortic stenosis) or hypertrophic cardiomyopathy with outflow obstruction;
• if the patient has hyperaldosteronism (a disease in which the adrenal glands produce too much of a hormone called aldosterone) - in such cases, Valtricom is not recommended;
• if the patient has systemic lupus erythematosus (also known as lupus or SLE);
• if the patient has diabetes (high blood sugar levels);
• if the patient has high cholesterol or triglyceride levels in the blood;
• if the patient experiences skin reactions, such as sun-induced rashes;
• if the patient has a history of allergic reactions to other blood pressure-lowering medicines or diuretics (also known as water pills), especially in patients with asthma or allergies;
• if the patient has vomiting or diarrhea;
• if the patient experiences swelling, especially of the face and throat, while taking other medicines (including ACE inhibitors) - if the patient experiences such symptoms, they should stop taking Valtricom, contact their doctor, and never take Valtricom again;
• if the patient experiences dizziness and/or fainting while taking Valtricom - they should inform their doctor as soon as possible;
• if the patient experiences vision impairment or eye pain - these symptoms may indicate fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased eye pressure and may occur within a few hours to weeks after taking Valtricom, and if left untreated, may lead to permanent vision loss. Patients with a history of penicillin or sulfonamide allergy may be more prone to developing this condition;
• if the patient is taking any of the following medicines for high blood pressure:
• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney problems,
• aliskiren;
• if the patient has a history of skin cancer or if an unexpected skin change occurs during treatment - treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer); during Valtricom treatment, the patient should protect their skin from sunlight and UV radiation;
• if the patient has a history of breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing after taking Valtricom, they should seek medical help immediately.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Valtricom, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Valtricom on their own.
See also the section "When not to take Valtricom".

If any of the above conditions apply to the patient, they should discuss it with their doctor.

Children and adolescents

Valtricom is not recommended for children and adolescents under 18 years of age.

Elderly patients (65 years and older)

Valtricom can be used in patients 65 years and older at the same dose as in other adult patients and in the same way as they have been taking the three active substances - amlodipine, valsartan, and hydrochlorothiazide. In elderly patients, regular monitoring of blood pressure is recommended, especially when taking the highest dose of Valtricom (10 mg + 320 mg + 25 mg).

Valtricom and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The doctor may recommend a dose change and/or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This applies especially to the medicines listed below.
Valtricom should not be taken with:

• lithium (used to treat certain types of depression);
• medicines or substances that increase potassium levels in the blood, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics, and heparin;
• ACE inhibitors or aliskiren (see also the sections "When not to take Valtricom" and "Warnings and precautions").

Care should be taken when taking:

• alcohol, sleeping pills, and anesthetics (administered during surgical procedures and other procedures);
• amantadine (used to treat Parkinson's disease and to treat or prevent certain viral diseases);
• anticholinergic medicines (used to treat various disorders, such as stomach and intestinal cramps, bladder cramps, asthma, motion sickness, muscle cramps, Parkinson's disease, and as adjuncts in anesthesia);
• antiepileptic and mood-stabilizing medicines used to treat epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, and other resins (substances used mainly to treat high lipid levels in the blood);
• simvastatin (used to reduce high cholesterol levels in the blood);
• cyclosporine (used after transplantation to prevent organ rejection or in other diseases, such as rheumatoid arthritis and atopic dermatitis);
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (used to treat heart conditions);
• verapamil, diltiazem (used to treat heart conditions);
• iodine-containing contrast agents (used in imaging studies);
• medicines used to treat diabetes (oral, such as metformin or insulin);
• medicines used to treat gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-adrenergic blockers, diazoxide);
• medicines that may cause "torsades de pointes" (heart rhythm disturbances), such as antiarrhythmic medicines (used to treat heart conditions) and certain antipsychotic medicines;
• medicines that may decrease sodium levels in the blood, such as antidepressant, antipsychotic, antiepileptic medicines;
• medicines that may decrease potassium levels in the blood, such as diuretics (water pills), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines that increase blood pressure, such as adrenaline or noradrenaline;
• medicines used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used to treat esophagitis or esophageal ulceration (carbenoxolone);
• medicines used to relieve pain and inflammation, especially nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (muscle relaxants used during surgical procedures);
• glyceryl trinitrate and other nitrates or other vasodilators;
• other medicines used to treat high blood pressure, including methyldopa;
• rifampicin (used, e.g., to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John's Wort;
• dantrolene (given by infusion in cases of severe body temperature disorders);
• vitamin D and calcium salts.

Taking Valtricom with food, drink, and alcohol

While taking Valtricom, the patient should not eat grapefruits or drink grapefruit juice, as both grapefruits and grapefruit juice can lead to increased levels of the active substance amlodipine in the blood, which may result in unpredictable intensification of the effect of Valtricom, leading to a decrease in blood pressure.
Before drinking alcohol, the patient should consult their doctor. Alcohol may cause excessive lowering of blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Valtricom before planned pregnancy or immediately after pregnancy is confirmed and will recommend another medicine instead of Valtricom. Valtricom is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus.
Breastfeeding
The patient should tell their doctor about breastfeeding or intending to breastfeed. It has been shown that small amounts of amlodipine pass into human milk. Valtricom is not recommended during breastfeeding. The doctor may recommend another medicine if the patient wants to breastfeed, especially if the baby is a newborn or premature.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

This medicine may cause dizziness, drowsiness, nausea, or headache. If the patient experiences such symptoms, they should not drive vehicles, use tools, or operate machines.

Valtricom contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Valtricom

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. This will help achieve the best treatment results and reduce the risk of side effects.
Usually, the recommended dose of Valtricom is 1 tablet per day.

• It is recommended to take the medicine every day at the same time, preferably in the morning.
• The tablet should be swallowed whole, with a glass of water.
• Valtricom can be taken with or without food. While taking Valtricom, the patient should not eat grapefruits or drink grapefruit juice.

Depending on the response to treatment, the doctor may recommend a higher or lower dose of the medicine.
The patient should not take a higher dose than recommended.

Taking a higher dose of Valtricom than recommended

In case of accidental ingestion of too many tablets of Valtricom, the patient should immediately consult their doctor. Medical attention may be necessary.
Even 24-48 hours after taking the medicine, shortness of breath due to excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Valtricom

If the patient misses a dose, they should take it as soon as they remember. The next dose should be taken at the usual time. However, if it is close to the time for the next dose, the patient should take only the next dose at the usual time. The patient should not take a double dose (two tablets at the same time) to make up for the missed dose.

Stopping Valtricom treatment

Stopping Valtricom treatment may worsen the disease. The patient should not stop taking the medicine unless their doctor recommends it.
The patient should always take the medicine, even if they feel well.
Patients with high blood pressure usually do not notice any symptoms. Many people feel well. It is essential to take this medicine strictly as directed by the doctor to achieve the best treatment results and reduce the risk of side effects.
The patient should attend scheduled doctor's appointments, even if they feel well.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Valtricom can cause side effects, although not everybody gets them.
As with all combination medicines containing three active substances, it cannot be excluded that side effects associated with individual active substances may occur.
The following side effects have been reported for Valtricom or for the individual three active substances (amlodipine, valsartan, and hydrochlorothiazide), which may occur when taking Valtricom.
Some side effects may be serious and may require immediate medical attention.
If any of the following serious side effects occur after taking the medicine, the patient should immediately contact their doctor:
Frequent (may occur in less than 1 in 10 people):

• dizziness
• low blood pressure (feeling of fainting, feeling of "emptiness" in the head, sudden loss of consciousness)

Uncommon (may occur in less than 1 in 100 people):

• significant decrease in urine output (worsening of kidney function)

Rare (may occur in less than 1 in 1,000 people):

• spontaneous bleeding
• heart rhythm disturbances
• liver function disorders

Very rare (may occur in less than 1 in 10,000 people):

• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat, causing significant breathing difficulties
• severe skin reactions, including intense rash, hives, redness of the skin, severe itching, blistering, and peeling of the skin, as well as inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack
• pancreatitis, which may cause severe abdominal pain radiating to the back, with very poor general condition
• weakness, tendency to bruise, frequent infections
• stiffness

Other possible side effects:

Very common (may occur in at least 1 in 10 people):

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

Common (may occur in less than 1 in 10 people):

• drowsiness
• palpitations (feeling of heart activity)
• sudden flushing (especially of the face)
• swelling of the ankles (edema)
• abdominal pain
• discomfort in the stomach 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, fainting when standing up
• decreased appetite
• nausea and vomiting
• itchy rash and other types of rash
• impotence

Uncommon (may occur in less than 1 in 100 people):

• rapid heart rate
• feeling of spinning
• vision disturbances
• discomfort in the abdominal cavity
• chest pain
• increased levels of urea, creatinine, and uric acid in the blood
• high calcium, lipid, or sodium levels in the blood
• decreased potassium levels in the blood
• unpleasant mouth odor
• diarrhea
• dryness of the mucous membranes in the mouth
• weight gain
• loss of appetite
• taste disturbances
• back pain
• joint swelling
• muscle cramps/weakness/pain
• limb pain
• difficulty maintaining a normal posture while standing or walking
• weakness
• coordination disorders
• dizziness when standing up or after exertion
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden transient loss of consciousness
• low blood pressure when standing up
• cough
• shortness of breath
• throat irritation
• excessive sweating
• swelling, redness, and pain along the vein
• redness of the skin
• tremors
• mood changes
• anxiety
• depression
• insomnia
• taste disturbances
• fainting
• loss of pain sensation
• vision disturbances
• vision impairment
• ringing in the ears (tinnitus)
• sneezing/runny nose caused by nasal mucosa inflammation (rhinitis)
• change in bowel movements
• indigestion
• hair loss
• itching of the skin
• skin color changes
• urination disorders
• increased need to urinate at night
• increased frequency of urination
• discomfort or enlargement of the breasts in men
• pain
• general malaise
• weight loss

Rare (may occur in less than 1 in 1,000 people):

• low platelet count (sometimes with accompanying bleeding or bruising under the skin)
• presence of sugar in the urine
• high blood sugar levels
• worsening of metabolic balance in diabetes
• discomfort in the abdominal cavity
• constipation
• liver function disorders, which may be accompanied by yellowing of the skin and eyes or dark urine (hemolytic anemia)
• increased sensitivity of the skin to sunlight
• purple spots on the skin
• kidney function disorders
• confusion

Very rare (may occur in less than 1 in 10,000 people):

• decreased white blood cell count
• decreased platelet count, which may lead to unusual bruising and easier bleeding
• gum swelling
• abdominal bloating (gastritis)
• hepatitis
• jaundice (yellowing of the skin)
• increased liver enzyme activity, which may affect some test results
• increased muscle tension
• vasculitis, often with skin rash
• sensitivity to light
• disorders involving stiffness, tremors, and/or difficulty moving
• fever, sore throat, or mouth ulcers, more frequent infections (low white blood cell count)
• pallor, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal breakdown of red blood cells in blood vessels or other parts of the body)
• state of confusion, fatigue, tremors, and/or muscle cramps, rapid breathing (hypochloremic alkalosis)
• severe abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress syndrome, pulmonary edema, pneumonia)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• vasculitis with symptoms such as rash, purpura, fever
• severe skin disease causing rash, redness of the skin, blistering on the lips, eyes, or mouth, peeling of the skin, fever (toxic epidermal necrolysis)
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion)
• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Unknown (frequency cannot be estimated from available data):

• changes in blood test results for kidney function, increased potassium levels in the blood, low red blood cell count
• abnormal red blood cell parameters
• low count of a certain type of white blood cell and platelets
• increased creatinine levels in the blood
• abnormal liver function test results
• significant decrease in urine output
• vasculitis
• weakness, easy bruising, frequent infections (aplastic anemia)
• vision impairment or eye pain related to high pressure in the eye (possible symptoms of excessive fluid accumulation in the vascular layer surrounding the eye or acute angle-closure glaucoma)

Other side effects:

• shortness of breath
• significantly decreased urine output (possible symptoms of kidney function disorders or kidney failure)
• severe skin disease causing rash, redness of the skin, blistering on the lips, eyes, or mouth, peeling of the skin, fever (erythema multiforme)
• muscle cramps
• fever
• blistering of the skin (symptom of pemphigus)
• non-melanoma skin cancer and lip cancer

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Valtricom

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Valtricom contains

• The active substances of Valtricom are amlodipine, valsartan, and hydrochlorothiazide. 5 mg + 160 mg + 12.5 mg Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide. 5 mg + 160 mg + 25 mg Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide. 10 mg + 160 mg + 12.5 mg:

Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
10 mg + 160 mg + 25 mg:
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
10 mg + 320 mg + 25 mg:
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 320 mg of valsartan, and 25 mg of hydrochlorothiazide.

• Other ingredients are microcrystalline cellulose, povidone K25, sodium croscarmellose, sodium lauryl sulfate, mannitol, colloidal anhydrous silica, and magnesium stearate in the tablet core, and polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, red iron oxide (E 172) - only in 10 mg + 160 mg + 12.5 mg and 10 mg + 320 mg + 25 mg film-coated tablets, and yellow iron oxide (E 172) - only in 5 mg + 160 mg + 25 mg and 10 mg + 160 mg + 25 mg film-coated tablets in the tablet coating. See section 2 "Valtricom contains sodium".

What Valtricom looks like and contents of the pack

5 mg + 160 mg + 12.5 mg:
White or almost white, oval, biconvex film-coated tablets (tablets) with the imprint "K1" on one side of the tablet. Dimensions: approximately 13 x 8 mm.
5 mg + 160 mg + 25 mg:
Light yellow, oval, biconvex film-coated tablets (tablets) with the imprint "K3" on one side of the tablet. Dimensions: approximately 13 x 8 mm.
10 mg + 160 mg + 12.5 mg:
Pink, oval, biconvex film-coated tablets (tablets) with the imprint "K2" on one side of the tablet. Dimensions: approximately 13 x 8 mm.
10 mg + 160 mg + 25 mg:
Brown-yellow, oval, biconvex film-coated tablets (tablets) with the imprint "K4" on one side of the tablet. Dimensions: approximately 13 x 8 mm.
10 mg + 320 mg + 25 mg:
Brown-red, oval, biconvex film-coated tablets. Dimensions: approximately 18 x 9 mm.
Valtricom is available in cartons containing:

• 28 film-coated tablets in blisters.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00
Date of last revision of the leaflet:19.03.2025