Amlodipina + Valsartan + Hidrohlorotiazid Macleods

Leaflet accompanying the packaging: patient information

Avasart Trio, 5 mg + 160 mg + 12.5 mg, film-coated tablets

Avasart Trio, 10 mg + 160 mg + 12.5 mg, film-coated tablets

Avasart Trio, 5 mg + 160 mg + 25 mg, film-coated tablets

Avasart Trio, 10 mg + 160 mg + 25 mg, film-coated tablets

Avasart Trio, 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 your 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 Avasart Trio and what is it used for
• 2. Important information before taking Avasart Trio
• 3. How to take Avasart Trio
• 4. Possible side effects
• 5. How to store Avasart Trio
• 6. Contents of the packaging and other information

1. What is Avasart Trio and what is it used for

Avasart Trio contains three active substances: amlodipine, valsartan, and hydrochlorothiazide. All three 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 the amount of urine, which also lowers blood pressure. As a result of all three mechanisms, blood vessels relax, and blood pressure is lowered.

Avasart Trio is used to treat high blood pressure in adult patients whose blood pressure is controlled by taking amlodipine, valsartan, and hydrochlorothiazide, and for whom it may be beneficial to take one tablet containing all three substances.

2. Important information before taking Avasart Trio

When not to take Avasart Trio:

• after the third month of pregnancy (it is also recommended to avoid taking Avasart Trio in early pregnancy - see "Pregnancy");
• in patients with gout (uric acid crystals in the joints);

If any of the above points apply to you, do not take Avasart Trio and consult your doctor.

Warnings and precautions

Before starting treatment with Avasart Trio, you should discuss it with your doctor or pharmacist.

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

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Avasart Trio".

If any of the above points apply to you, you should discuss them with your doctor.

Children and adolescents

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

Elderly patients (65 years and older)

Avasart Trio 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 previously taken the three substances called amlodipine, valsartan, and hydrochlorothiazide. In elderly patients, blood pressure should be regularly checked, especially if they are taking the maximum dose of Avasart Trio (10 mg + 320 mg + 25 mg).

Avasart Trio 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 need to change the dose and/or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This applies in particular to the following medicines:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• ACE inhibitors or aliskiren (see also the information under the heading "When not to take Avasart Trio" and "Warnings and precautions").

Caution should be exercised when taking the following medicines:

• alcohol, sleeping pills, and anesthetics (medicines used during surgery and other procedures);
• amantadine (a medicine used to treat Parkinson's disease, also used 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 medicines and mood stabilizers 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 (a medicine used to reduce high cholesterol levels in the blood);
• cyclosporine (a medicine used after transplants to prevent organ rejection or in other diseases, such as 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 conditions);
• verapamil, diltiazem (medicines used to treat heart conditions);
• iodinated contrast agents (medicines used for imaging tests);
• medicines used to treat diabetes (oral medicines, 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" (irregular heartbeat), such as antiarrhythmic medicines (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 inflammation (carbenoxolone);
• medicines used to relieve pain and inflammation, especially nonsteroidal anti-inflammatory medicines (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (medicines that relax muscles, used during surgical procedures);
• nitroglycerin and other nitrates, or other 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 (an infusion used in cases of severe temperature regulation disorders);
• vitamin D and calcium salts.

Taking Avasart Trio with food, drink, and alcohol

Patients taking Avasart Trio should not eat grapefruit or drink grapefruit juice, as both grapefruit 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 Avasart Trio, resulting in lowered 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 doctorif you suspect (or plan) pregnancy. Usually, your doctor will recommend stopping Avasart Trio before planned pregnancy or immediately after pregnancy is confirmed and recommend a different medicine instead of Avasart Trio. Avasart Trio 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 doctorif you are breastfeeding or plan to breastfeed. It has been shown that small amounts of amlodipine pass into human milk. Avasart Trio is not recommended during breastfeeding. Your doctor may choose a different treatment during breastfeeding, especially in the case of newborns and premature infants.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and operating machinery

This medicine can cause dizziness, drowsiness, nausea, or headache. If you experience these symptoms, you should not drive vehicles or operate tools or machinery.

3. How to take Avasart Trio

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should consult your doctor. This will help you get the best results from treatment and reduce the risk of side effects.
Usually, the recommended dose of Avasart Trio is 1 tabletper 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.
• Avasart Trio can be taken with or without food. Do not take Avasart Trio with grapefruit or grapefruit juice.

Depending on your response to treatment, your doctor may recommend a higher or lower dose of the medicine.
Do not take a dose of the medicine that is higher than prescribed.

Taking a higher dose of Avasart Trio than recommended

If you accidentally take too many Avasart Trio tablets, you should consult your doctor immediately. You may need medical attention.
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 Avasart Trio

If you miss a dose of the medicine, you should take it as soon as you remember. The next dose should be taken at the usual time. If it is almost time for the next dose, you should take it at the usual time. Do nottake a double dose (two tablets at the same time) to make up for the missed tablet.

Stopping treatment with Avasart Trio

Stopping treatment with Avasart Trio 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 of the disease. Many of them feel completely normal. It is essential to take this medicine exactly as directed by your doctor 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, Avasart Trio can cause side effects, although not everybody gets them.
As with any combination medicine containing three active substances, it cannot be excluded that side effects related to each individual active substance may occur.
Side effects reported for Avasart Trio or one of the three active substances (amlodipine, valsartan, and hydrochlorothiazide) are presented below and may occur when taking Avasart Trio.

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

If you experience any of the following serious side effects after taking Avasart Trio, you should contact your doctor immediately:

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

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

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

• significantly reduced urine output (impaired kidney function).

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

• spontaneous bleeding;
• irregular heartbeat;
• liver function disorders.

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

• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, and lips;
• swelling of the tongue and throat, causing severe breathing difficulties;
• severe skin reactions, including intense rash, hives, redness of the skin, severe itching, blisters, 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, fever, and frequent infections;
• stiffness;
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Other side effects of Avasart Trio may include

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

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

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

• drowsiness;
• palpitations (feeling of heartbeat);
• flushing;
• swelling of the ankles (edema);
• abdominal pain;
• discomfort in the stomach after meals;
• 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 affect up to 1 in 100 people):

• rapid heartbeat;
• 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 of the mouth;
• weight gain;
• loss of appetite;
• taste disturbances;
• back pain;
• joint swelling;
• muscle cramps, weakness, and/or muscle 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;
• 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;
• tinnitus;
• sneezing, runny nose due to nasal inflammation (rhinitis);
• changes in bowel movements;
• nausea;
• 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 feeling of being unwell;
• weight loss.

Rare (may affect up to 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 diabetic metabolic balance;
• 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;
• disorientation.

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

• decreased white blood cell count;
• decreased platelet count, which can lead to unusual bruising and easier bleeding (red blood cell damage);
• 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 including 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);
• rash, itching, hives, difficulty breathing or swallowing, dizziness (allergic reactions);
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress syndrome, pulmonary edema, pneumonia);
• rash on the face, joint pain, muscle disease, fever (lupus erythematosus);
• vasculitis with symptoms such as rash, purpura, fever (vasculitis);
• severe skin disease causing rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (toxic epidermal necrolysis).

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

• changes in kidney function test results, 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;
• significantly reduced urine output;
• vasculitis;
• weakness, easy bruising, and frequent infections (aplastic anemia);
• vision loss or eye pain related to high blood pressure (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);
• shortness of breath;
• significantly reduced urine output (possible symptoms of kidney function disorders or kidney failure);
• severe skin disease causing rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (erythema multiforme);
• muscle cramps;
• fever;
• blisters on the skin (symptom of a disease called pemphigus);
• malignant skin tumors and lip cancer (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 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
e-mail: 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 the medicine.

5. How to store Avasart Trio

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date stated on the carton and blister after: EXP.
The expiration date refers to the last day of the month indicated.
Do not store above 30°C.
Do not use any packaging that has been previously opened or damaged.
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

The active substances of Avasart Trio are amlodipine (in the form of amlodipine besylate), valsartan, and hydrochlorothiazide.

Avasart Trio, 5 mg + 160 mg + 12.5 mg, film-coated tablets

Each film-coated tablet contains 5 mg of amlodipine (in the form of amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.

Avasart Trio, 10 mg + 160 mg + 12.5 mg, film-coated tablets

Each film-coated tablet contains 10 mg of amlodipine (in the form of amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.

Avasart Trio, 5 mg + 160 mg + 25 mg, film-coated tablets

Each film-coated tablet contains 5 mg of amlodipine (in the form of amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.

Avasart Trio, 10 mg + 160 mg + 25 mg, film-coated tablets

Each film-coated tablet contains 10 mg of amlodipine (in the form of amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.

Avasart Trio, 10 mg + 320 mg + 25 mg, film-coated tablets

Each film-coated tablet contains 10 mg of amlodipine (in the form of amlodipine besylate), 320 mg of valsartan, and 25 mg of hydrochlorothiazide.
The other ingredients are:
Microcrystalline cellulose PH (101)
Crospovidone
Silica, colloidal anhydrous
Magnesium stearate
Coating:
Hypromellose 6 cPs
Macrogol 4000
Talc
Titanium dioxide (E 171) (only 5 mg + 160 mg + 12.5 mg film-coated tablets, 10 mg + 160 mg + 12.5 mg film-coated tablets, 5 mg + 160 mg + 25 mg film-coated tablets)
Iron oxide red (E 172) (only 10 mg + 160 mg + 12.5 mg film-coated tablets)
Iron oxide yellow (E 172) (only 10 mg + 160 mg + 12.5 mg film-coated tablets, 5 mg + 160 mg + 25 mg film-coated tablets, 10 mg + 160 mg + 25 mg film-coated tablets, 10 mg + 320 mg + 25 mg film-coated tablets)

What Avasart Trio looks like and contents of the pack

Avasart Trio, 5 mg + 160 mg + 12.5 mg, film-coated tablets are white, oval, biconvex film-coated tablets with the inscription "T23" on one side and smooth on the other side.
Avasart Trio, 5 mg + 160 mg + 25 mg, film-coated tablets are yellow, oval, biconvex film-coated tablets with the inscription "T25" on one side and smooth on the other side.
Avasart Trio, 10 mg + 160 mg + 12.5 mg, film-coated tablets are light yellow, oval, biconvex film-coated tablets with the inscription "C96" on one side and smooth on the other side.
Avasart Trio, 10 mg + 160 mg + 25 mg, film-coated tablets are brown-yellow, oval, biconvex film-coated tablets with the inscription "C97" on one side and smooth on the other side.
Avasart Trio, 10 mg + 320 mg + 25 mg, film-coated tablets are brown-yellow, oval, biconvex film-coated tablets with the inscription "T98" on one side and smooth on the other side.
The following pack sizes are available: cardboard boxes containing blisters of 14, 28, 56, and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Phone: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: polfarmex@polfarmex.pl

Manufacturer/Importer

Synoptis Industrial Sp. z o. o.
ul. Rabowicka 15
62-020 Swarzędz
Poland
HEUMANN PHARMA
GmbH & Co. Generica KG
Südwestpark 50 · 90449 Nürnberg
Germany

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

Portugal
Amlodipine + Valsartan + Hydrochlorothiazide Macleods
Germany
Amlodipin/Valsartan/Hydrochlorothiazid Heumann
Spain
Amlodipino/Valsartán/Hidroclorotiazida Combix
Poland
Avasart Trio
Date of last revision of the leaflet:July 2025