Avasart trio

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
Amlodipinum + Valsartanum + Hydrochlorothiazidum
Please read all of this leaflet carefully before taking this medicine, because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Avasart Trio is and what it is used for
2. What you need to know 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 Avasart Trio is and what it is 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 medicines called "calcium channel blockers". Amlodipine prevents calcium from entering the walls of blood vessels, which helps prevent 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 vessels to constrict, thereby 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 helps lower blood pressure. As a result of all three mechanisms, blood vessels relax and blood pressure is reduced.

Avasart Trio is used for the treatment of 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 a single tablet containing all three active substances.

2. Important information before using Avasart Trio

When not to use Avasart Trio:

• after the third month of pregnancy (it is also recommended to avoid using Avasart Trio in early pregnancy – see section “Pregnancy”);
• if the patient is allergic (hypersensitive) to amlodipine or other calcium channel blockers, valsartan, hydrochlorothiazide, sulphonamide-derived drugs (medicines used to treat respiratory or urinary tract infections), or any of the other ingredients of this

medicine (listed in section 6). If the patient thinks they may be allergic, they should not
take Avasart Trio and should speak to their doctor;

• if the patient has liver disease, damage to the small bile ducts in the liver (primary biliary cirrhosis) leading to bile accumulation in the liver (cholestasis);
• if the patient has severe kidney function impairment or is on dialysis;
• if the patient is unable to pass urine (anuria);
• if the patient has low levels of potassium or sodium in the blood, despite treatment aimed at increasing potassium or sodium levels;
• if the patient has high levels of calcium in the blood, despite treatment aimed at reducing calcium levels;
• in patients with gout (uric acid crystals in the joints);
• if the patient has significantly low blood pressure (hypotension);
• if the patient has aortic valve stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body’s cells);
• if the patient has heart failure following a heart attack;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren. If any of the above conditions apply to the patient, Avasart Trio must not be used and the patient should consult their doctor.

Warnings and precautions
Before starting Avasart Trio, discuss this with your doctor or pharmacist.

• if the patient has low levels of potassium or magnesium in the blood (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat);
• if the patient has low levels of sodium in the blood (with or without symptoms such as fatigue, confusion, muscle twitching, seizures);
• if the patient has high levels of calcium in the blood (with or without symptoms such as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle weakness, and muscle twitching);
• if the patient has impaired kidney function, has recently received a kidney transplant, or has renal artery stenosis;
• if the patient has impaired liver function;
• if the patient has had heart failure or ischemic heart disease, particularly if prescribed the maximum dose of Avasart Trio (10 mg + 320 mg + 25 mg);
• if the patient has had a heart attack. Strictly follow the doctor’s recommendations regarding the starting dose. The doctor may also check kidney function;
• if the patient has been diagnosed by a doctor with heart valve narrowing (called aortic or mitral stenosis) or significantly increased thickness of the heart muscle (called hypertrophic cardiomyopathy with outflow tract obstruction);
• if the patient has hyperaldosteronism; a condition in which the adrenal glands produce too much of a hormone called aldosterone. If this condition is present, Avasart Trio is not recommended;
• if the patient has a disease called systemic lupus erythematosus (also known as discoid 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 develops skin reactions such as rash after sun exposure;
• if the patient has previously experienced allergic reactions after taking other blood pressure-lowering medicines or diuretics (also called water tablets), especially in patients with asthma or allergies;
• if the patient has vomiting or diarrhea;
• if the patient develops swelling, particularly of the face and throat, while taking other medicines (including ACE inhibitors). If such symptoms occur, stop taking Avasart Trio immediately and contact a doctor. The patient should never take Avasart Trio again;
• if the patient experiences dizziness and/or fainting while taking Avasart Trio, inform the doctor as soon as possible;
• if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the uvea (the vascular layer surrounding the eye) or increased intraocular pressure – they may occur from several hours to weeks after taking Avasart Trio. Untreated, they may lead to permanent vision loss. If the patient previously had an allergy to penicillin or sulphonamides, they may be at increased risk of developing these symptoms;
• if the patient is taking any of the following medicines for high blood pressure:
• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes;
• aliskiren;
• if the patient has previously had skin cancer or develops unexpected skin changes during treatment. Hydrochlorothiazide treatment, especially at high doses over a long period, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). While taking Avasart Trio, protect the skin from sunlight and UV radiation;
• if the patient previously had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after taking Avasart Trio, seek immediate medical help.

The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g.,
potassium) at regular intervals.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Avasart Trio,
discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Avasart Trio
on your own.
See also information under the heading “When not to use Avasart Trio”.
If any of the above points apply to the patient, discuss this with the doctor.
Children and adolescents
Avasart Trio is not recommended for use in children and adolescents under 18 years of age.
Elderly patients (aged 65 years and older)
Avasart Trio can be used in patients aged 65 years and older at the same dose and in the same way
as in other adult patients who previously took the three substances known as amlodipine, valsartan, and
hydrochlorothiazide. In elderly patients, blood pressure should be monitored regularly, especially if
they are taking the maximum dose of Avasart Trio (10 mg + 320 mg + 25 mg).
Avasart Trio and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines the patient plans to take. The treating doctor may need to adjust the
dose and/or take additional precautions. In some cases, it may be necessary to discontinue one of the
medicines. This particularly applies to the following medicines:
Do not use together with:

• 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 potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• ACE inhibitors or aliskiren (see also information under the headings “When not to use Avasart Trio” and “Warnings and precautions”).

Use with caution when taking together:

• alcohol, sleeping pills, and anesthetics (medicines used during surgery and other procedures);
• amantadine (a medicine for Parkinson’s disease, also used to treat or prevent certain virus-related illnesses);
• anticholinergic medicines (used to treat various disorders such as stomach and intestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as adjuncts in anesthesia);
• anticonvulsants and mood-stabilizing medicines used in epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, and other resins (substances mainly used to treat high blood lipid levels);
• simvastatin (a medicine used to reduce high cholesterol levels in the blood);
• cyclosporine (a medicine used after organ transplantation to prevent organ rejection or in other diseases such as rheumatoid arthritis and atopic dermatitis);
• cytotoxic medicines (used in cancer treatment), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medicines used in heart conditions);
• verapamil, diltiazem (medicines used in heart conditions);
• iodinated contrast agents (medicines used in imaging procedures);
• medicines used to treat diabetes (oral medicines such as metformin or insulin);
• medicines used to treat gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-blockers, diazoxide);
• medicines that may cause “torsades de pointes” (irregular heartbeat), such as antiarrhythmics (medicines used in heart conditions) and certain antipsychotics;
• medicines that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, anticonvulsants;
• medicines that may reduce potassium levels in the blood, such as diuretics (water tablets), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines that may increase blood pressure, such as adrenaline or noradrenaline;
• medicines used to treat HIV/AIDS infection (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used to treat peptic ulcers and esophagitis (carbenoxolone);
• medicines used to relieve pain and inflammation, especially non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (medicines used during surgical procedures);
• nitroglycerin and other nitrates, or other vasodilating substances;
• other medicines used to treat high blood pressure, including methyldopa;
• rifampicin (used, for example, in tuberculosis treatment), erythromycin, clarithromycin (antibiotics);
• St. John’s wort;
• dantrolene (an intravenous infusion used in severe body temperature disorders);
• tacrolimus (used to control the immune system response, allowing the body to accept a transplanted organ);
• vitamin D and calcium salts.

Taking Avasart Trio with food, drink, and alcohol
Patients prescribed Avasart Trio should not eat grapefruit or drink grapefruit juice,
as both grapefruit and grapefruit juice may increase blood levels of the active substance – amlodipine, which may lead to unpredictable intensification of Avasart Trio’s blood pressure-lowering effect.
Before drinking alcohol, consult your doctor. Alcohol may cause excessive lowering of blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. Usually, the doctor will advise
discontinuing Avasart Trio before planned pregnancy or immediately after confirming pregnancy, and will recommend an alternative medicine instead of Avasart Trio. Avasart Trio is not recommended in early
pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if 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. The doctor may choose an alternative treatment during breastfeeding, especially when feeding newborns or premature infants.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery
This medicine may cause dizziness, drowsiness, nausea, or headache. If the patient experiences these
symptoms, they should not drive or operate tools or machinery.

3. How to use Avasart Trio

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the
doctor. This will help achieve the best treatment results and reduce the risk of adverse effects.
The usual dose of Avasart Trio is 1 tablet per day.

• It is recommended to take the medicine daily at the same time, preferably in the morning.
• The tablet should be swallowed whole with a glass of water.
• Avasart Trio may be taken with or without food. Do not take Avasart Trio together with grapefruit or grapefruit juice.

Depending on the response to treatment, the doctor may recommend a higher or lower dose of the medicine.
Do not take a higher dose than prescribed.
Taking more Avasart Trio than prescribed
If too many tablets of Avasart Trio have been taken by accident, consult a doctor immediately.
Medical attention may be required.
Breathlessness caused by excess fluid accumulating in the lungs (pulmonary oedema) may occur up to
24–48 hours after taking the medicine.
Missing a dose of Avasart Trio
If a dose of Avasart Trio is missed, take it as soon as remembered. Take the next dose at the usual time.
If it is almost time for the next dose, take the next dose at the usual time. Do not take a double dose (two tablets at the same time) to make up for a missed tablet.
Stopping Avasart Trio
Stopping Avasart Trio may cause worsening of the disease. Do not stop taking the medicine unless advised by the doctor.
Always take the medicine, even if the patient feels well
Patients with high blood pressure usually do not notice any symptoms of the condition. Many feel completely normal. It is important to take this medicine exactly as directed by the doctor to achieve the best treatment outcomes and reduce the risk of adverse effects.
Regular medical check-ups should be attended, even if the patient feels well.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
As with any combination medicine containing three active substances, adverse effects associated
with each individual active substance cannot be ruled out. The adverse effects reported for Avasart Trio
or for one of the three active substances (amlodipine, valsartan and hydrochlorothiazide) are listed
below and may occur during treatment with Avasart Trio.
Some adverse effects may be serious and require immediate medical attention.
If any of the following serious adverse effects occur after taking the medicine,
contact your doctor immediately:
Common (may affect up to 1 in 10 people):

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

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

• significant reduction in urine output (impaired kidney function).

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

• spontaneous bleeding;
• irregular heart rhythm;
• liver dysfunction.

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 difficulty in breathing;
• severe skin reactions including intense rash, urticaria, redness of the entire skin surface, severe itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• acute respiratory failure (symptoms include severe breathlessness, fever, weakness and confusion);
• heart attack;
• pancreatitis, which may cause sudden severe upper abdominal pain radiating to the back, accompanied by general malaise;
• weakness, tendency to bruising, fever and frequent infections;
• stiffness.

Other adverse effects of the medicine may include
Very common (may affect more than 1 in 10 people):

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

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

• drowsiness;
• palpitations (awareness of heartbeat);
• flushing;
• ankle swelling (oedema);
• abdominal pain;
• discomfort in the stomach after meals;
• fatigue;
• headache;
• frequent urination;
• high blood uric acid levels;
• low blood magnesium levels;
• low blood sodium levels;
• dizziness, fainting upon standing;
• decreased appetite;
• nausea and vomiting;
• itchy rash and other types of rash;
• inability to achieve or maintain an erection.

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

• rapid heartbeat;
• sensation of spinning;
• visual disturbances;
• discomfort in the abdominal cavity;
• chest pain;
• increased blood levels of urea, creatinine and uric acid;
• high blood calcium, lipid or sodium levels;
• decreased blood potassium levels;
• unpleasant breath odour;
• diarrhoea;
• dryness of the oral mucosa;
• weight gain;
• loss of appetite;
• taste disturbances;
• back pain;
• joint swelling;
• cramps, weakness and (or) muscle pain;
• limb pain;
• difficulty maintaining proper posture while standing or walking;
• weakness;
• coordination disturbances;
• dizziness upon standing or after exertion;
• lack of energy;
• sleep disturbances;
• tingling or numbness;
• neuropathy;
• sudden transient loss of consciousness;
• low blood pressure upon standing;
• cough;
• shortness of breath;
• throat irritation;
• excessive sweating;
• itching;
• swelling, redness and pain along the course of a vein;
• skin redness;
• tremor;
• mood changes;
• anxiety;
• depression;
• insomnia;
• taste disturbances;
• fainting;
• lack of pain sensation;
• visual disturbances;
• worsening of vision;
• tinnitus;
• sneezing, runny nose due to inflammation of the nasal mucosa (rhinitis);
• changes in bowel habits;
• indigestion;
• hair loss;
• skin itching;
• skin colour changes;
• urinary disturbances;
• increased need to urinate at night;
• increased frequency of urination;
• discomfort or enlargement of the breasts in men;
• pain;
• malaise;
• weight loss.

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

• low platelet count (sometimes with accompanying bleeding or skin bruising);
• presence of glucose in urine;
• high blood glucose levels;
• worsening of diabetic metabolic control;
• discomfort in the abdominal cavity;
• constipation;
• liver dysfunction, which may be accompanied by yellowing of the skin and eyes or dark-coloured urine (hemolytic anemia);
• increased skin sensitivity to sunlight;
• purple skin spots;
• kidney dysfunction;
• disorientation.

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

• reduced white blood cell count;
• reduced platelet count, which may lead to unusual bruising and easier bleeding (damage to red blood cells);
• gum swelling;
• abdominal bloating (gastritis);
• hepatitis;
• yellowing of the skin (jaundice);
• increased liver enzyme activity, which may affect certain laboratory test results;
• increased muscle tone;
• vasculitis, often with skin rash;
• light sensitivity;
• movement disorders involving stiffness, tremor and (or) difficulty moving;
• fever, sore throat or mouth ulcers, more frequent infections (absence or low number of white blood cells);
• pale skin, fatigue, shortness of breath, dark-coloured urine (hemolytic anemia, abnormal breakdown of red blood cells in blood vessels or other body parts);
• confusion, fatigue, muscle tremor and cramps, rapid breathing (hypochloremic alkalosis);
• acute upper abdominal pain (pancreatitis);
• rash, itching, urticaria, difficulty breathing or swallowing, dizziness (hypersensitivity reactions);
• breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory disorder syndrome, pulmonary edema, pneumonia);
• facial rash, joint pain, muscle diseases, fever (lupus erythematosus);
• vasculitis with symptoms such as rash, purplish-red spots, fever (vasculitis);
• severe skin disease causing rash, skin redness, blistering of lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis);
• angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

• changes in kidney function test results, increased blood potassium levels, low red blood cell count;
• abnormal parameters regarding red blood cells;
• low number of certain types of white blood cells and platelets;
• increased blood creatinine levels;
• abnormal liver function test results;
• significant reduction in urine output;
• vasculitis;
• weakness, easy bruising and frequent infections (aplastic anemia);
• visual impairment or eye pain related to high blood pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma);
• shortness of breath;
• markedly reduced urine output (possible symptoms of kidney dysfunction or kidney failure);
• severe skin disease causing rash, skin redness, blistering of lips, eyes or mouth, skin peeling, fever (erythema multiforme);
• muscle cramps;
• fever;
• skin blisters (symptom of a disease called bullous pemphigoid);
• malignant skin and lip tumours (non-melanoma skin cancers).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
e-mail: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Avasart Trio

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Do not use any packaging that has been previously opened or damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

The active substances in Avasart Trio are amlodipine (as amlodipine besilate), valsartan,
and hydrochlorothiazide.
Avasart Trio, 5 mg + 160 mg + 12.5 mg, film-coated tablets
Each film-coated tablet contains 5 mg amlodipine (as amlodipine besilate), 160 mg
valsartan, and 12.5 mg hydrochlorothiazide.
Avasart Trio, 10 mg + 160 mg + 12.5 mg, film-coated tablets
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besilate), 160 mg
valsartan, and 12.5 mg hydrochlorothiazide.
Avasart Trio, 5 mg + 160 mg + 25 mg, film-coated tablets
Each film-coated tablet contains 5 mg amlodipine (as amlodipine besilate), 160 mg
valsartan, and 25 mg hydrochlorothiazide.
Avasart Trio, 10 mg + 160 mg + 25 mg, film-coated tablets
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besilate), 160 mg
valsartan, and 25 mg hydrochlorothiazide.
Avasart Trio, 10 mg + 320 mg + 25 mg, film-coated tablets
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besilate), 320 mg
valsartan, and 25 mg hydrochlorothiazide.
Other ingredients are:
Microcrystalline cellulose PH (101)
Crospovidone
Anhydrous colloidal silica
Magnesium stearate
Coating:
Hypromellose 6 cPs
Macrogol 4000
Talc
Titanium dioxide (E 171) (only in 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 in 10 mg + 160 mg + 12.5 mg film-coated tablets)
Iron oxide yellow (E 172) (only in 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 imprint "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 imprint "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 imprint "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 imprint "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 imprint "T98" on one side and smooth on the other side.
Available pack sizes: cardboard boxes containing blisters of 14, 28, 56, and 98
film-coated tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer/importer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: + 48 24 357 44 44
Fax: + 48 24 357 45 45
e-mail: [email protected]
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 authorised in the Member States of the European Economic Area under the following names:
Portugal Amlodipine + Valsartan + Hydrochlorothiazide Macleods
Germany Amlodipine/Valsartan/Hydrochlorothiazid Heumann
Spain Amlodipino/Valsartán/Hidroclorotiazida Combix
Poland Avasart Trio