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 that 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");
• if you are allergic to amlodipine or other calcium antagonists, valsartan, hydrochlorothiazide, sulfonamide derivatives (antibiotics used to treat respiratory or urinary tract infections) or any of the other ingredients of this medicine (listed in section 6); if you are unsure whether you are allergic, you should not take Valtricom and should discuss it with your doctor;
• if you have liver disease, bile duct obstruction (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 you have low potassium or sodium levels in your blood, despite treatment to increase potassium or sodium levels in your blood;
• if you have high calcium levels in your blood, despite treatment to reduce calcium levels in your blood;
• if you have gout (uric acid crystal accumulation in the joints);
• if you have significantly low blood pressure (hypotension);
• if you have 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 you have heart failure after a heart attack;
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren. If any of the above situations apply to you, you should not take Valtricom and should discuss it with your doctor.

Warnings and precautions

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

• if you have low potassium or magnesium levels in your blood (with symptoms such as muscle weakness, muscle cramps, heart rhythm disturbances, or without such symptoms);
• if you have low sodium levels in your blood (with symptoms such as fatigue, confusion, muscle tremors, seizures, or without such symptoms);
• if you have high calcium levels in your blood (with symptoms such as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, weakness, and muscle tremors, or without such symptoms);
• if you have kidney problems, have recently had a kidney transplant, or have renal artery stenosis;
• if you have liver problems;
• if you have heart failure or coronary heart disease, especially if you have been prescribed the highest dose of Valtricom (10 mg + 320 mg + 25 mg);
• if you have had a heart attack - you should strictly follow your doctor's recommendations regarding the initial dose; your doctor may also check your kidney function;
• if you have aortic valve stenosis (aortic stenosis) or hypertrophic cardiomyopathy with outflow tract obstruction;
• if you have been diagnosed with hyperaldosteronism (a condition in which the adrenal glands produce too much of a hormone called aldosterone) - in such cases, it is not recommended to take Valtricom;
• if you have a disease called systemic lupus erythematosus (also known as lupus or SLE);
• if you have diabetes (high blood sugar levels);
• if you have high cholesterol or triglyceride levels in your blood;
• if you experience skin reactions, such as sun-induced rash;
• if you have had allergic reactions to other blood pressure-lowering medicines or diuretics (also known as water pills), especially if you have asthma or allergies;
• if you have vomiting or diarrhea;
• if you have swelling, especially of the face and throat, while taking other medicines (including ACE inhibitors) - if you experience such symptoms, you should stop taking Valtricom, consult your doctor, and never take Valtricom again;
• if you experience dizziness and/or fainting while taking Valtricom - you should inform your doctor as soon as possible;
• if you experience 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 you are taking any of the following medicines for high blood pressure:
• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have diabetic kidney problems,
• aliskiren;
• if you have had 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, you should protect your skin from sunlight and UV radiation;
• if you have had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or difficulty breathing after taking Valtricom, you should seek medical help immediately.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood.
If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valtricom, you should discuss it 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 it with your 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 taken by patients 65 years and older at the same dose as for 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 your 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 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, e.g., 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-adrenergic 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 your blood, such as antidepressant, antipsychotic, antiepileptic medicines;
• medicines that can decrease potassium levels in your 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 (relaxing muscles, 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 increase the levels of the active substance amlodipine in your blood, which can lead to unpredictable intensification of the effect of Valtricom, resulting in blood pressure lowering.
Before drinking alcohol, you should consult your doctor. Alcohol can cause excessive blood pressure lowering 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 in 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 intention to breastfeed. 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 can 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 exactly as recommended by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. This will help you get the best results from treatment and reduce the risk of side effects.
Usually, the recommended dose of Valtricom is one 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 higher dose 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 essential to take this medicine strictly according to your doctor's recommendations to get the best results from treatment 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 the 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 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 can cause severe abdominal pain radiating to the back, with very poor general condition
• weakness, tendency to bruise, frequent infections
• stiffness

Other possible side effects:

• fast 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 levels of calcium, lipids, or sodium in the blood
• decreased potassium levels in the blood
• unpleasant mouth odor
• diarrhea
• dryness of the mucous membrane of 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
• loss of consciousness
• loss of pain sensation
• vision disturbances
• worsening of vision
• ringing in the ears (tinnitus)
• coughing/sneezing due to nasal 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
• poor general condition
• 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 tension
• vasculitis, often with skin rash
• sensitivity to light
• disorders including stiffness, tremors, and/or difficulty moving
• fever, sore throat, or mouth ulcers, more frequent infections (leukopenia)
• 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 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 of the skin, fever (toxic epidermal necrolysis)
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion)
• angioedema of the intestine: 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 platelet
• increased creatinine levels in the blood
• abnormal liver function test results
• significant decrease in urine output
• vasculitis
• weakness, easy bruising, frequent infections (aplastic anemia)
• worsening of vision or eye pain related to high pressure in the eyeball (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)

dyspnea

• 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 a disease called pemphigus)
• malignant tumors of the skin and lips (non-melanoma skin 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 Drug Safety Monitoring of the Office for Registration 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.
By reporting side effects, you can help provide more information on the safety of this 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.
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.

• The other ingredients are: microcrystalline cellulose, povidone K25, sodium croscarmellose, sodium lauryl sulfate, mannitol, silicon dioxide, and magnesium stearate in the tablet core, and polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, iron oxide red (E 172) - only in tablets coated with a dose of 10 mg + 160 mg + 12.5 mg and 10 mg + 320 mg + 25 mg, and iron oxide yellow (E 172) - only in tablets coated with a dose of 5 mg + 160 mg + 25 mg and 10 mg + 160 mg + 25 mg 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, 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