Amlodipine + Valsartan + Hidrohlorothiazide Polpharma

Leaflet attached to the packaging: patient information

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 5 mg + 160 mg + 25 mg,

coated tablets

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 10 mg + 160 mg + 25 mg, coated tablets

Amlodipine + Valsartan + Hydrochlorothiazide

You should carefully read the contents of the 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.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Amlodipine + Valsartan + Hydrochlorothiazide Polpharma and what is it used for
• 2. Important information before taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma
• 3. How to take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma
• 4. Possible side effects
• 5. How to store Amlodipine + Valsartan + Hydrochlorothiazide Polpharma
• 6. Contents of the packaging and other information

1. What is Amlodipine + Valsartan + Hydrochlorothiazide Polpharma and what is it used for

what it is used for
Amlodipine + Valsartan + Hydrochlorothiazide Polpharma tablets contain three 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 contraction 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 contract, 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 excreted, which also lowers blood pressure. As a result of all three mechanisms, blood vessels relax, and blood pressure is lowered.

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma 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 Amlodipine + Valsartan + Hydrochlorothiazide Polpharma

Polpharma

When not to take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma:

• after the third month of pregnancy (it is also recommended to avoid taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma in early pregnancy - see "Pregnancy");
• if the patient is allergic to amlodipine or other calcium antagonists, valsartan, hydrochlorothiazide, sulfonamide derivatives (drugs 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 Amlodipine + Valsartan + Hydrochlorothiazide Polpharma and should discuss this with their doctor;
• if the patient has liver disease, damage to the small bile ducts in the liver (biliary cirrhosis) leading to the accumulation of bile 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;
• if the patient has gout (uric acid crystals in the joints);
• if the patient has significantly low blood pressure (hypotension);
• if the patient has a narrowing of the aortic valve (aortic stenosis) 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 being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above points apply to the patient, they should not take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma and should discuss this with their doctor.

Warnings and precautions

Before starting to take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, the patient should discuss the following 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 narrowing of the renal artery;
• 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 Amlodipine + Valsartan + Hydrochlorothiazide Polpharma (10 mg+320 mg+25 mg);
• if the patient has had a heart attack. The patient should strictly follow their 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 a narrowing of the heart valves (called aortic or mitral stenosis) or a significantly increased thickness of the heart muscle (called 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 this applies to the patient, taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma is not recommended;
• if the patient has a disease called 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 rashes;
• if the patient has a history of allergic reactions after taking other blood pressure-lowering medicines 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 medicines (including ACE inhibitors). If the patient experiences such symptoms, they should stop taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma and contact their doctor immediately. The patient should never take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma again;
• if the patient experiences dizziness and/or fainting while taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 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 pressure inside the eye - they can occur within a few hours to weeks after taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma. If left untreated, they can lead to permanent vision loss.
• if the patient is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes;
• 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 malignant skin tumors and lip tumors (non-melanoma skin cancer). During treatment with Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 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 Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, they should seek medical help immediately.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma".

If any of the above points apply to the patient, they should discuss this with their doctor.

Children and adolescents

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma should not be used in children and adolescents under the age of 18.

Elderly patients (65 years and older)

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma can be taken by patients aged 65 and older at the same dose as for other adult patients and in the same way as they have previously taken the three medicines containing amlodipine, valsartan, and hydrochlorothiazide. In elderly patients, blood pressure should be regularly checked, especially if they are taking the maximum dose of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma (10 mg+320 mg+25 mg).

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines 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 medicines. This is especially important if the patient is taking any of 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, salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• an ACE inhibitor or aliskiren (see also the information in the sections "When not to take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma" and "Warnings and precautions").

The patient should be cautious 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 (such as 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 and atopic dermatitis);
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medicines used to treat heart diseases);
• verapamil, diltiazem (medicines used to treat heart diseases);
• iodinated contrast agents (medicines used for imaging tests);
• medicines used to treat diabetes (oral medicines, such as metformin or insulins);
• 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 (used to treat heart diseases) and certain antipsychotic medicines;
• medicines that can decrease sodium levels in the blood, such as antidepressant, antipsychotic, or antiepileptic medicines;
• medicines that can decrease potassium levels in the blood; such as diuretics (water pills), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines that can increase blood pressure, such as adrenaline or noradrenaline;
• medicines used to treat HIV/AIDS (such as ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (such as ketoconazole, itraconazole);
• medicines used to treat esophageal ulcers or esophagitis (carbenoxolone);
• medicines used to relieve pain and inflammation, especially non-steroidal 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.

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma with food, drink, and alcohol

Patients who have been prescribed Amlodipine + Valsartan + Hydrochlorothiazide Polpharma should not eat grapefruits or drink grapefruit juice, as grapefruits and grapefruit juice can lead to an increase in the level of the active substance - amlodipine - in the blood, which can cause unpredictable intensification of the effect of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, resulting in a decrease in blood pressure. Before consuming alcohol, the patient should discuss this with 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 Amlodipine + Valsartan + Hydrochlorothiazide Polpharma before planned pregnancy or immediately after becoming pregnant and will prescribe a different medicine instead. Amlodipine + Valsartan + Hydrochlorothiazide Polpharma should not be used in early pregnancy and should not be used after the third month of pregnancy, as it may 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. Amlodipine + Valsartan + Hydrochlorothiazide Polpharma is not recommended during breastfeeding. The doctor may choose a different treatment during breastfeeding, especially during breastfeeding of newborns and premature babies.
Before taking this medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

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

3. How to take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma

This medicine 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 recommended dose of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma is usually 1 tabletper day.

• The patient should take the medicine every day at the same time, preferably in the morning.
• The tablet should be swallowed whole, with a glass of water.
• Amlodipine + Valsartan + Hydrochlorothiazide Polpharma can be taken with or without food. The patient should not take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma with grapefruit or grapefruit juice.

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

Taking a higher dose of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma than recommended

Polpharma

Even 24-48 hours after taking the medicine, shortness of breath due to excessive fluid accumulation in the lungs (pulmonary edema) may occur.
If the patient accidentally takes too many Amlodipine + Valsartan + Hydrochlorothiazide Polpharma tablets, they should contact their doctor immediately. The patient may require medical attention.

Missing a dose of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma

If the patient misses a dose of the medicine, 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 Amlodipine + Valsartan + Hydrochlorothiazide Polpharma

Stopping treatment with Amlodipine + Valsartan + Hydrochlorothiazide Polpharma may worsen the disease. The patient should not stop taking the medicine unless their doctor recommends it.

The patient should always take the medicine, even if they 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 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.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlodipine + Valsartan + Hydrochlorothiazide Polpharma can cause side effects, although not everyone will experience them.
As with any combination medicine containing three active substances, it is not possible to exclude side effects associated with each of the active substances. Side effects reported for the medicine containing amlodipine, valsartan, and hydrochlorothiazide or any of these three active substances are listed below; they may occur when taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma.

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

The patient should contact their doctor immediately if they experience any of the following serious side effects after taking the medicine:

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

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

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

• significant decrease in urine output (impaired kidney function)

Rare (may occur in less than 1 in 1,000 people):

• spontaneous bleeding
• irregular heartbeat
• liver dysfunction

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, and lips
• swelling of the tongue and throat, causing significant difficulty breathing
• 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
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion)
• heart attack
• pancreatitis, which can cause severe abdominal and back pain with very poor general condition
• weakness, tendency to bruise, fever, and frequent infections
• stiffness

Other side effects of the medicine may include:

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

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

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

• drowsiness
• palpitations (feeling of heartbeat)
• flushing
• swelling of the ankles (edema)
• abdominal pain
• discomfort in the stomach after eating
• fatigue
• headache
• frequent urination
• high uric acid levels in the blood
• low magnesium levels in the blood
• low sodium levels in the blood
• dizziness, fainting when standing up
• decreased appetite
• nausea and vomiting
• itching rash and other types of rash
• impotence

Uncommon (may occur in less than 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 taste in the mouth
• diarrhea
• dryness of the mucous membrane of the mouth
• weight gain
• loss of appetite
• disturbances of taste
• back pain
• swelling of the joints
• 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 disorders
• tingling or numbness
• neuropathy
• sudden transient loss of consciousness
• low blood pressure
• cough
• shortness of breath
• irritation of the throat
• excessive sweating
• swelling, redness, and pain along the vein
• redness of the skin
• tremors
• mood changes
• anxiety
• depression
• insomnia
• disturbances of taste
• fainting
• loss of pain sensation
• vision disturbances
• worsening of vision
• tinnitus
• coughing/sneezing due to inflammation of the nasal mucosa (rhinitis)
• change in bowel habits
• 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 diabetic metabolic balance
• discomfort in the abdominal cavity
• constipation
• liver dysfunction, 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 dysfunction
• state of confusion

Very rare (may occur in less than 1 in 10,000 people):

• decrease in white blood cell count
• decrease in platelet count, which can lead to unusual bruising and easier 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 tone
• vasculitis (inflammation of blood vessels), often with a skin rash
• sensitivity to light
• disorders including stiffness, tremors, and/or difficulty moving
• fever, sore throat, or mouth ulcers (leukopenia)
• pallor, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal breakdown of red blood cells in the blood vessels or other parts of the body)
• confusion, fatigue, tremors, and/or muscle cramps (hypochloremic alkalosis)
• severe abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory failure);
• skin rash, joint pain, kidney disease, fever (lupus erythematosus)
• vasculitis (inflammation of blood vessels) with symptoms such as rash, purple spots, fever (vasculitis)
• severe skin disease causing rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling, and swelling of the skin, fever (toxic epidermal necrolysis)

Unknown (frequency cannot be estimated from 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
• significant decrease in urine output
• vasculitis (inflammation of blood vessels)
• weakness, easy bruising, and frequent infections (aplastic anemia)
• vision loss or eye pain due to increased 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 decreased urine output (possible symptoms of kidney dysfunction or kidney failure)
• severe skin disease causing rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling, and swelling of the skin, fever (erythema multiforme)
• muscle cramps
• fever
• blistering skin (symptom of a disease called pemphigus)
• malignant skin tumors and lip tumors (non-melanoma skin cancer)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Amlodipine + Valsartan + Hydrochlorothiazide Polpharma

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
The medicine should not be stored at temperatures above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 5 mg + 160 mg + 25 mg, coated tablets contain

• The active substances of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma are amlodipine (in the form of amlodipine maleate), valsartan, and hydrochlorothiazide. Each coated tablet contains 5 mg of amlodipine (in the form of amlodipine maleate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
• Other ingredients are: tablet core: microcrystalline cellulose, crospovidone type A, anhydrous colloidal silica, magnesium stearate; coating: hypromellose 2910, titanium dioxide (E 171), macrogol 8000, talc, yellow iron oxide (E 172).

What Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 10 mg + 160 mg + 25 mg, coated tablets contain

• The active substances of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma are amlodipine (in the form of amlodipine maleate), valsartan, and hydrochlorothiazide. Each

coated tablet contains 10 mg of amlodipine (in the form of amlodipine maleate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.

• Other ingredients are: tablet core: microcrystalline cellulose, crospovidone type A, anhydrous colloidal silica, magnesium stearate; coating: hypromellose 2910, titanium dioxide (E 171), macrogol 8000, yellow iron oxide (E 172), red iron oxide (E 172).

What Amlodipine + Valsartan + Hydrochlorothiazide Polpharma looks like and what the pack contains

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 5 mg + 160 mg + 25 mg, are oval, biconvex, yellow coated tablets with "5" embossed on one side (15.2 mm ± 0.2 mm x 7.4 mm ± 0.2 mm), after breaking the color of the tablet core is white or almost white.
Pack sizes: 14, 28, 30, 56, 90, 98 coated tablets.
Amlodipine + Valsartan + Hydrochlorothiazide, 10 mg + 160 mg + 25 mg, are oval, biconvex, dark yellow coated tablets with "10" embossed on one side (15.2 mm ± 0.2 mm x 7.4 mm ± 0.2 mm), after breaking the color of the tablet core is white or almost white.
Pack sizes: 14, 28, 30, 56, 90, 98 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the leaflet: