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

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 packaging 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 relax, and blood pressure decreases.

Valtricom is used to treat high blood pressure in adult patients who have achieved blood pressure control while taking 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");

Warnings and precautions

Before starting to take Valtricom, you should discuss the following with your doctor or pharmacist:

• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren;

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

If any of the above conditions apply to you, you should discuss this with your doctor.

Children and adolescents

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

Elderly patients (65 years of age and older)

Valtricom can be used in patients 65 years of age 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, especially when taking the highest dose of Valtricom (10 mg + 320 mg + 25 mg), is recommended.

Valtricom and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Your 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").

Caution should be exercised 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, urinary 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 disorders (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 can increase blood sugar levels (beta-blockers, diazoxide);
• medicines that can cause "torsades de pointes" (heart rhythm disturbances), such as antiarrhythmic medicines (used to treat heart conditions) and certain antipsychotic medicines;
• medicines that can decrease sodium levels in the blood, such as antidepressant, antipsychotic, antiepileptic medicines;
• medicines that can 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 esophageal ulcers and esophagitis (carbenoxolone);
• medicines used to relieve pain and inflammation, especially nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• 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 (administered by infusion in cases of severe temperature regulation disorders);
• vitamin D and calcium salts.

Taking Valtricom with food, drink, and alcohol

While taking Valtricom, you 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 can cause unpredictable intensification of the effect of Valtricom, resulting in decreased blood pressure. Before drinking alcohol, you should consult your doctor. Alcohol can cause excessive lowering of blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

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

Driving and using machines

This medicine may cause dizziness, drowsiness, nausea, or headache. If you experience such symptoms, you 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 recommended by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist. This will help you 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, you should not eat grapefruits or drink grapefruit juice.

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

Taking a higher dose of Valtricom than recommended

If you accidentally take too many tablets of Valtricom, you should immediately consult your doctor. Medical attention may be necessary.
Even 24-48 hours after taking the medicine, shortness of breath caused by excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Valtricom

If you miss a dose, you should take it as soon as you remember. The next dose should be taken at the usual time. However, if it is close to the time for the next dose, you should take only the next dose at the usual time. You 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 your condition. You should not stop taking the medicine unless your doctor recommends it.
You should always take the medicine, even if you feel well.
Patient with high blood pressure usually do not notice any symptoms. Many people feel well. It is important to take this medicine strictly as recommended by your doctor to achieve the best treatment results and reduce the risk of side effects.
You should attend scheduled doctor's appointments, even if you feel well.
If you have any further doubts about taking this medicine, you should consult your 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 related to 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 you experience any of the following serious side effects after taking the medicine, you should immediately contact your doctor:

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

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

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

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

• significant decrease in urine production (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, as well as inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack
• pancreatitis, which can cause severe abdominal pain radiating to the back, with very poor general condition
• weakness, tendency to bruise, and 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
• itching rash and other types of rash
• erectile dysfunction

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 an upright position 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
• worsening of vision
• ringing in the ears (tinnitus)
• sneezing/runny nose caused by nasal mucosa inflammation (rhinitis)
• change in bowel movements
• constipation
• 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
• 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 can lead to unusual bruising and easier bleeding
• gum swelling
• abdominal bloating (gastritis)
• hepatitis
• yellowing of the skin (jaundice)
• increased liver enzyme activity, which can affect some test results
• increased muscle tone
• 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)
• pale skin, 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)
• rash on the face, 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, and 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 production
• vasculitis
• weakness, easy bruising, and frequent infections (aplastic anemia)
• worsening of vision or eye pain related to high pressure in the eye (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma)

Other side effects:

• shortness of breath
• significantly decreased urine production (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, and fever (erythema multiforme)
• muscle cramps
• fever
• blistering of the skin (symptom of pemphigus)
• non-melanoma skin cancer and lip cancer

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 on this medicine, you 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