Amlodipine + Valsartan+ Hidrohlorothiazide Polpharma

Leaflet accompanying the packaging: patient information

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 5 mg+160 mg+12.5 mg, tablets

coated

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 10 mg+160 mg+12.5 mg, coated tablets

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 10 mg+320 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.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is 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 blood vessel walls, 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 excreted, which also lowers blood pressure. As a result of all three mechanisms, blood vessels dilate, 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 any of the above points apply to you, do not take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma and talk to your doctor.

Warnings and precautions

Before starting to take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, you should discuss it with your doctor or pharmacist:

• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have diabetic kidney problems;
• 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 Amlodipine + Valsartan + Hydrochlorothiazide Polpharma".

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

Children and adolescents

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma is not recommended for children and adolescents under 18 years of age.

Elderly patients (65 years of age and older)

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma can be taken by patients 65 years of age 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

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 is especially important if you are taking any of the following medicines.

Do not take 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 salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• ACE inhibitors or aliskiren (see also the information under the heading "When not to take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma" and "Warnings and precautions");

Be cautious when taking:

• 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 and 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 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 conditions) 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 increase blood pressure, such as adrenaline or noradrenaline;
• medicines used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used to treat esophageal ulcers and esophagitis (carbenoxolone);
• medicines used to relieve pain and inflammation, especially nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (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 increased levels of the active substance amlodipine in the blood, which can cause unpredictable intensification of the effect of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, resulting in lowered blood pressure. Before consuming alcohol, you should talk to 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 tell your doctorif you are pregnant or planning to become pregnant. Usually, your doctor will advise you to stop taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma before a planned pregnancy or as soon as you find out you are pregnant, and prescribe a different medicine instead. It is not recommended to take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma in early pregnancy and it must not be taken after the third month of pregnancy, as it can seriously harm the baby.
Breastfeeding
You should tell your doctorif you are breastfeeding or planning to breastfeed. It has been shown that small amounts of amlodipine pass into human milk. Amlodipine + Valsartan + Hydrochlorothiazide Polpharma is not recommended during breastfeeding. Your doctor may choose a different treatment during breastfeeding, especially during breastfeeding of newborns and premature babies.
Before taking this medicine, you should consult your doctor or pharmacist.

Driving and using machines

This medicine can cause dizziness, drowsiness, nausea, or headache. If you experience these symptoms, you 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 your doctor. If you have any doubts, you should consult your doctor. This will help you get the best results from the treatment and reduce the risk of side effects.
Usually, the recommended dose of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma 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.
• Amlodipine + Valsartan + Hydrochlorothiazide Polpharma can be taken with or without food. Do not take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma with grapefruit or grapefruit juice.

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

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 you accidentally take too many Amlodipine + Valsartan + Hydrochlorothiazide Polpharma tablets, you should contact your doctor immediately. You may need medical attention.

Missing a dose of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma

If you miss a dose, 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 your next dose, 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 Amlodipine + Valsartan + Hydrochlorothiazide Polpharma

Stopping treatment with Amlodipine + Valsartan + Hydrochlorothiazide Polpharma may worsen your condition. Do not stop taking the medicine unless your doctor advises you to.

You should always take the medicine, even if you 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 medicine exactly as directed by your doctor to get the best results from the 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, this medicine can cause side effects, although not everybody gets them.
As with any combination medicine containing three active substances, it cannot be ruled out that side effects related to each of the active substances may occur. 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 can be serious and require immediate medical attention.

You should contact your doctor immediately if you experience any of the following serious side effects after taking the medicine:

Frequent (may occur in 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 occur in up to 1 in 100 people):

• significantly reduced urine output (impaired kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver function disorders

Very rare (may occur in 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, 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 and back pain with very poor general condition
• weakness, tendency to bruise, frequent infections (aplastic anemia)
• 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

• 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
• itchy rash and other types of rash
• impotence

Uncommon (may occur in 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 odor from the mouth
• diarrhea
• dryness of the mucous membrane of the mouth
• weight gain
• loss of appetite
• taste disturbances
• back pain
• joint swelling
• muscle cramps/weakness/pain
• limb pain
• difficulty maintaining a normal position while standing or walking
• weakness
• coordination disorders
• dizziness when standing up or after exertion
• lack of energy
• sleep disorders
• feeling of 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
• taste disturbances
• fainting
• loss of pain sensation
• vision disturbances
• impairment of vision
• tinnitus
• coughing/sneezing due to nasal congestion (rhinitis)
• change in bowel movements
• constipation
• 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 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
• confusion

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

• decreased white blood cell count
• decreased 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, often with skin rash
• sensitivity to light
• disorders including stiffness, tremors, and/or difficulty moving
• fever, sore throat, or mouth sores, frequent infections (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)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (allergic reactions)
• difficulty breathing with fever, cough, wheezing, shortness of breath, weakness, and confusion (respiratory distress syndrome, pulmonary edema, acute respiratory failure);
• rash on the face, joint pain, diseases of the muscles, 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)

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
• significantly reduced urine output
• vasculitis
• weakness, easy bruising, and frequent infections (aplastic anemia)
• vision loss or eye pain due to 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.
• 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 (a symptom of a disease called pemphigus)
• malignant skin tumors and lip cancer (non-melanoma skin cancer)

Reporting suspected side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine + Valsartan + Hydrochlorothiazide Polpharma

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 5 mg+160 mg+12.5 mg, coated tablets contain,

and what does it look like?

The active substances of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma are amlodipine (as amlodipine maleate), valsartan, and hydrochlorothiazide. Each coated tablet contains 5 mg of amlodipine (as amlodipine maleate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
Other ingredients are:
tablet core: microcrystalline cellulose, crospovidone type A, anhydrous colloidal silica, magnesium stearate;
coating: hypromellose 2910, titanium dioxide (E171), macrogol 6000.

What does Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 10 mg+160 mg+12.5 mg, coated tablets contain,

and what does it look like?

The active substances of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma are amlodipine (as amlodipine maleate), valsartan, and hydrochlorothiazide. Each coated tablet contains 10 mg of amlodipine (as amlodipine maleate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
Other ingredients are:
tablet core: microcrystalline cellulose, crospovidone type A, anhydrous colloidal silica, magnesium stearate;
coating: hypromellose 2910, titanium dioxide (E171), macrogol 6000, yellow iron oxide (E172), red iron oxide (E172).

What does Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 10 mg+320 mg+25 mg, coated tablets contain,

and what does it look like?

The active substances of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma are amlodipine (as amlodipine maleate), valsartan, and hydrochlorothiazide. Each coated tablet contains 10 mg of amlodipine (as amlodipine maleate), 320 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 (E171), macrogol 8000, yellow iron oxide (E172), red iron oxide (E172).

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

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 5 mg+160 mg+12.5 mg, coated tablets are white or almost white, oval, biconvex, coated tablets (14.1 mm ± 0.2 mm x 8.1 mm ± 0.2 mm); after breaking the tablet, the core is white or almost white.
Pack sizes: 14, 28, 30, 56, 90, 98 coated tablets.
Amlodipine + Valsartan + Hydrochlorothiazide, 10 mg+160 mg+12.5 mg, coated tablets are yellow, oval, biconvex, coated tablets (14.1 mm ± 0.2 mm x 8.1 mm ± 0.2 mm); after breaking the tablet, the core is white or almost white.
Pack sizes: 14, 28, 30, 56, 90, 98 coated tablets.
Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 10 mg+320 mg+25 mg coated tablets are dark yellow, oval, biconvex, coated tablets (18.2 mm ± 0.2 mm x 8.2 mm ± 0.2 mm); after breaking the tablet, the 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:July 2022