Amlodipina + Valsartan + Hidrohlorotiazid Macleods

Package Leaflet: Information for the Patient

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

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their 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 pack 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 blood vessel walls, which inhibits blood vessel constriction.
• Valsartan belongs to a group of substances called "angiotensin II receptor antagonists". Angiotensin II is produced in the human body and causes blood vessel constriction, 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 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 is beneficial to take one tablet containing all three active 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");
• if the patient is allergic (hypersensitive) to amlodipine or other calcium antagonists, valsartan, hydrochlorothiazide, sulfonamide derivatives (medications used to treat respiratory or urinary tract infections) or any of the other ingredients of this medication (listed in section 6). If the patient thinks they may be allergic, they should not take Avasart Trio and should consult a doctor;
• if the patient has liver disease, bile duct obstruction (liver 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 reduce calcium levels in the blood;
• in patients with gout (uric acid crystals in the joints);
• if the patient has significantly low blood pressure (hypotension);
• if the patient has aortic stenosis (narrowing of the aortic valve) 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 taking a blood pressure-lowering medication containing aliskiren.

If any of the above points apply to the patient, they should not take Avasart Trio and should consult a doctor.

Warnings and precautions

Before starting treatment with Avasart Trio, the patient should discuss it with their doctor or pharmacist.

• if the patient has low potassium or magnesium levels in the blood (with or without symptoms, such as muscle weakness, muscle cramps, irregular heartbeat);
• if the patient has low sodium levels in the blood (with or without symptoms, such as fatigue, confusion, tremors, seizures);
• if the patient has high calcium levels in the blood (with or without symptoms, such as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle weakness, and tremors);
• if the patient has kidney problems, has recently had a kidney transplant, or has been diagnosed with renal artery stenosis;
• if the patient has liver problems;
• if the patient has heart failure or coronary heart disease, especially if they have been prescribed the maximum dose of Avasart Trio (10 mg + 320 mg + 25 mg);
• if the patient has had a heart attack. The patient should strictly follow the doctor's recommendations regarding the initial dose. The doctor may also check kidney function;
• if the patient has been informed by their doctor that they have valvular heart disease (aortic or mitral stenosis) or significantly increased heart muscle thickness (hypertrophic cardiomyopathy with outflow obstruction);
• if the patient has hyperaldosteronism; this is a disease in which the adrenal glands produce too much of a hormone called aldosterone. If the patient has this disease, taking Avasart Trio 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 rash;
• if the patient has a history of allergic reactions after taking other blood pressure-lowering medications 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 medications (including ACE inhibitors). If the patient experiences such symptoms, they should stop taking Avasart Trio and consult a doctor immediately. The patient should never take Avasart Trio again;
• if the patient experiences dizziness and/or fainting while taking Avasart Trio, they should inform their doctor as soon as possible;
• if the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased eye pressure - they can occur within a few hours to weeks after taking Avasart Trio. If left untreated, they can lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, they may be at increased risk of developing these symptoms;
• if the patient is taking any of the following medications for high blood pressure:
• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic nephropathy;
• aliskiren;
• if the patient has a history of malignant skin tumors 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 treatment with Avasart Trio, the patient should protect their skin from sunlight and UV radiation;
• if the patient has a history of breathing or lung problems after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If the patient experiences severe shortness of breath or difficulty breathing after taking Avasart Trio, they should seek medical help immediately.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the 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 the patient, they should discuss it with their 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 taken by elderly patients (65 years and older) at the same dose as other adult patients and in the same way as they have previously taken the three active substances 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 medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. The 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 medications. This applies especially to the medications listed below:

• lithium (a medication used to treat certain types of depression);
• medications or substances that increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, 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 medications:

• alcohol, sedatives, and anesthetics (medications used during surgery and other procedures);
• amantadine (a medication used to treat Parkinson's disease, also used to treat or prevent certain viral infections);
• anticholinergic medications (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 to anesthesia);
• antiepileptic medications and mood stabilizers used to treat epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, and other resins (substances used primarily to treat high lipid levels in the blood);
• simvastatin (a medication used to lower high cholesterol levels in the blood);
• cyclosporine (a medication used after transplants to prevent organ rejection or in other diseases, such as rheumatoid arthritis and atopic dermatitis);
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medications used to treat heart conditions);
• verapamil, diltiazem (medications used to treat heart conditions);
• iodinated contrast agents (medications used for imaging studies);
• medications used to treat diabetes (oral medications, such as metformin or insulin);
• medications used to treat gout, such as allopurinol;
• medications that can increase blood sugar levels (beta-adrenergic blockers, diazoxide);
• medications that can cause "torsades de pointes" (irregular heartbeat), such as antiarrhythmic medications (medications used to treat heart conditions) and certain antipsychotic medications;
• medications that can decrease sodium levels in the blood, such as antidepressant, antipsychotic, or antiepileptic medications;
• medications that can decrease potassium levels in the blood, such as diuretics (water pills), corticosteroids, laxatives, amphotericin, or penicillin G;
• medications that can increase blood pressure, such as adrenaline or noradrenaline;
• medications used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medications used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medications used to treat esophageal ulcers and inflammation (carbenoxolone);
• medications used to relieve pain and inflammation, especially nonsteroidal anti-inflammatory medications (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (medications that relax muscles, used during surgical procedures);
• nitroglycerin and other nitrates, or other vasodilators;
• other medications used to treat high blood pressure, including methyldopa;
• rifampicin (used to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John's Wort;
• dantrolene (an infusion used in cases of severe body temperature 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, the patient should consult their doctor. Alcohol can cause excessive lowering of blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctorif they suspect or plan to become pregnant. The doctor will usually recommend stopping Avasart Trio before planned pregnancy or immediately after pregnancy is confirmed and will recommend a different medication instead of Avasart Trio. Avasart Trio is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it can seriously harm the fetus.
Breastfeeding
The patient should tell their doctorif they 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. The doctor may choose a different treatment during breastfeeding, especially in the case of newborns and premature infants.
Before taking any medication, the patient should consult their doctor or pharmacist.

Driving and operating machinery

This medication can cause dizziness, drowsiness, nausea, or headache. If the patient experiences these symptoms, they should not drive or operate tools or machinery.

3. How to take Avasart Trio

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor. This will help achieve the best treatment results and reduce the risk of side effects.
The usual dose of Avasart Trio is 1 tabletper day.

• It is recommended to take the medication daily 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. However, the patient should not take Avasart Trio with grapefruit or grapefruit juice.

Depending on the response to treatment, the doctor may recommend a higher or lower dose of the medication.
The patient should not take a dose of the medication that is higher than prescribed.

Taking a higher than recommended dose of Avasart Trio

In case of accidental ingestion of too many Avasart Trio tablets, the patient should immediately consult their doctor. The patient may require medical attention.
Even 24-48 hours after taking the medication, shortness of breath due to excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Avasart Trio

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. If it is almost time for the next dose, the patient should take it at the usual time. The patient should 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 the condition. The patient should not stop taking the medication unless their doctor recommends it.

The patient should always take the medication, even if they feel well

Patients 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 medication exactly 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.
In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Avasart Trio can cause side effects, although not everyone will experience them.
As with any combination medication containing three active substances, it is impossible to exclude side effects related to each individual active substance.
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 the patient experiences any of the following serious side effects after taking Avasart Trio, they should contact their 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 production (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 significant breathing difficulties;
• severe skin reactions, including intense rash, hives, redness of the skin, severe itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membrane (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, bruising, 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;
• ankle swelling (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 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 membrane of the mouth;
• weight gain;
• loss of appetite;
• disturbances of taste;
• back pain;
• joint swelling;
• 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 disorders;
• 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 mucous membrane 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;
• breast discomfort or enlargement in men;
• pain;
• general malaise;
• weight loss.

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

• low platelet count (sometimes with accompanying bleeding or bruising under the skin);
• glucose 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 bleeding (damage to red blood cells);
• gum swelling;
• abdominal bloating (gastritis);
• hepatitis;
• jaundice (yellowing of the skin);
• 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 (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);
• 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, blistering of 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 production;
• 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 production (possible symptoms of kidney function disorders or kidney failure);
• severe skin disease causing rash, redness of the skin, blistering of the lips, eyes, or mouth, peeling of the skin, fever (erythema multiforme);
• muscle cramps;
• fever;
• blistering skin (symptom of a disease called pemphigus);
• malignant skin tumors and lip cancer (non-melanoma skin cancer).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their 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:
Jerozolimskie Avenue 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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Avasart Trio

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton and blister after EXP.
The expiration date refers to the last day of the month stated.
Do not store above 30°C.
Do not use any packaging that has been previously opened or damaged.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

The active substances of Avasart Trio are amlodipine (as 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 (as 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 (as 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 (as 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 (as 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 (as amlodipine besylate), 320 mg of valsartan, and 25 mg of hydrochlorothiazide.
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.
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.
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