Amlodipine + valsartan + hydrochlorothiazide polpharma

Package leaflet: Information for the patient

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 5 mg+160 mg+12.5 mg, film-coated tablets
Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 10 mg+160 mg+12.5 mg, film-coated tablets
Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 10 mg+320 mg+25 mg, film-coated tablets
Amlodipinum + Valsartanum + Hydrochlorothiazidum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Amlodipine + Valsartan + Hydrochlorothiazide Polpharma is and what it is 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 pack and other information

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

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma tablets contain three active substances:
amlodipine, valsartan, and hydrochlorothiazide.
All of these substances help control high blood pressure.

• Amlodipine belongs to a group of substances 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 the amount of urine produced, which also helps lower blood pressure. As a result of all three mechanisms, blood vessels relax and blood pressure is reduced.

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 a single tablet containing all three active substances.

2. Important information before taking Amlodipine + Valsartan + Hydrochlorothiazide

Polpharma
When not to take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma:

• after the third month of pregnancy (use of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma is also advised to be avoided in early pregnancy - see section “Pregnancy”);
• if the patient is allergic to amlodipine or other medicines in the calcium channel blocker group, valsartan, hydrochlorothiazide, sulfonamide-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 Amlodipine + Valsartan + Hydrochlorothiazide Polpharma and should consult their doctor;
• if the patient has liver disease, damage to the small bile ducts within the liver (primary biliary cirrhosis) leading to bile accumulation in the liver (cholestasis);
• if the patient has severe kidney function impairment or is undergoing 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;
• if the patient has gout (uric acid crystals in the joints);
• if the patient has significantly low blood pressure (hypotension);
• if the patient has aortic valve stenosis or cardiogenic shock (a condition in which the heart is unable to deliver sufficient blood to the body's cells);
• if the patient has heart failure following a myocardial infarction;
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren. If any of the above points apply to the patient, Amlodipine + Valsartan + Hydrochlorothiazide Polpharma must not be used and the patient should consult 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 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 kidney function impairment, has recently received a kidney transplant, or has renal artery stenosis;
• if the patient has liver function impairment;
• if the patient has heart failure or ischemic heart disease, especially if the patient has been prescribed the maximum dose of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma (10 mg + 320 mg + 25 mg);
• if the patient has had a myocardial infarction. The patient should strictly follow the doctor’s recommendations regarding the starting dose. The doctor may also monitor kidney function;
• if the patient has been diagnosed by a doctor with heart valve stenosis (aortic or mitral stenosis) or significantly increased thickness of the heart muscle (hypertrophic cardiomyopathy with outflow tract obstruction);
• if the patient has hyperaldosteronism; a condition in which the adrenal glands produce excessive amounts of a hormone called aldosterone. If this applies, use of 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 rash after sun exposure;
• if the patient has previously had allergic reactions to other blood pressure-lowering medicines or diuretics (also called water tablets), particularly 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 angiotensin-converting enzyme inhibitors - ACE inhibitors). If such symptoms occur, the patient must stop taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma immediately and contact their doctor. 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 develops visual disturbances or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid buildup between the choroid and sclera) or increased intraocular pressure – they may occur from several hours to weeks after taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma. If untreated, these may lead to permanent vision loss. Patients who previously had an allergy to penicillin or sulfonamides 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 impairment related to diabetes;
• aliskiren;
• if the patient has previously had skin cancer or develops unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially at high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, the patient should protect their skin from sunlight and UV radiation;
• if the patient has previously experienced 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 Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, they should seek immediate medical help.

The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.
See also 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
Use of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma is not recommended in children and adolescents under 18 years of age.
Elderly patients (aged 65 years and older)
Patients aged 65 years and older may take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma at the same dose and in the same manner as other adult patients who previously took the three separate medicines containing amlodipine, valsartan, and hydrochlorothiazide. In elderly patients, blood pressure should be monitored regularly, 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 inform their doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines they plan to take. The treating doctor may need to adjust the dose and/or take other precautions. In some cases, it may be necessary to discontinue one of the medicines. This is particularly important if the patient is taking any of the medicines listed below.
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 agents, and heparin;
• ACE inhibitors or aliskiren (see also information under the headings “When not to take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma” and “Warnings and precautions”);

Use with caution when taking together with:

• alcohol, sedatives, and anesthetics (medicines used during surgery and other procedures);
• amantadine (a medicine used for Parkinson’s disease and also for treating or preventing certain viral infections);
• 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 for 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);
• 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 agents such as metformin, or insulin);
• medicines used to treat gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-adrenergic blockers, diazoxide);
• medicines that may cause “torsades de pointes” (irregular heartbeat), such as antiarrhythmics (used in heart conditions) and certain antipsychotics;
• medicines that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics;
• 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 in HIV/AIDS treatment (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used to treat peptic ulcer 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 (muscle-relaxing 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 (Hypericum perforatum);
• dantrolene (an intravenous infusion used in severe disturbances of body temperature);
• vitamin D and calcium salts.

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma with food, drink, and alcohol
Patients prescribed Amlodipine + Valsartan + Hydrochlorothiazide Polpharma should not eat grapefruit or drink grapefruit juice, as grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, potentially causing unpredictable intensification of the medicine’s effect, including lowering of blood pressure. Patients should consult their doctor before consuming alcohol. Alcohol may cause excessive lowering of blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
Patients should inform their doctor if they suspect they are pregnant or are planning pregnancy. Usually, the doctor will advise stopping Amlodipine + Valsartan + Hydrochlorothiazide Polpharma before planned pregnancy or immediately after pregnancy is confirmed, and will prescribe an alternative medicine. Use of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to the unborn child.
Breastfeeding
Patients should inform their doctor if they are breastfeeding or intend 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 an alternative treatment during breastfeeding, especially when nursing newborns or preterm infants.
Consult a doctor or pharmacist before using this medicine.
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 take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor. This will help achieve the best treatment results and reduce the risk of adverse effects.

The usual recommended dose of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma is 1 tablet per day.

• It is recommended to take the medicine at the same time each day, preferably in the morning.
• Swallow the tablet whole with a glass of water.
• Amlodipine + Valsartan + Hydrochlorothiazide Polpharma can be taken with or without food. Do not take Amlodipine + Valsartan + Hydrochlorothiazide Polpharma together with grapefruit or grapefruit juice.

Depending on the patient's response to treatment, the doctor may prescribe a higher or lower dose. Do not exceed the prescribed dose.

Taking more than the recommended dose of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma
Breathlessness due to excess fluid accumulating in the lungs (pulmonary oedema) may occur within 24 to 48 hours after taking the medicine.
If too many tablets of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma have been taken by accident, contact your doctor immediately. Medical care may be required.

Missing a dose of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma
If a dose is missed, take it as soon as you remember. Take the next dose at the usual time. If it is almost time for the next dose, skip the missed dose and take the next one at the regular time. Do not take a double dose (two tablets at the same time) to make up for a missed tablet.

Stopping treatment with Amlodipine + Valsartan + Hydrochlorothiazide Polpharma
Stopping treatment with Amlodipine + Valsartan + Hydrochlorothiazide Polpharma may worsen the condition. Do not stop taking the medicine unless instructed by your doctor.
Always continue taking the medicine, even if the patient feels well.
Patients with high blood pressure usually do not experience any symptoms of the disease. 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. Attend all scheduled medical appointments, even if you feel well.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
As with any combination medicines containing three active substances, adverse effects related to each of the active substances cannot be ruled out. Adverse effects reported for medicines containing amlodipine, valsartan and hydrochlorothiazide or one of these three active substances are listed below; they may occur during treatment with Amlodipine + Valsartan + Hydrochlorothiazide Polpharma.
Some adverse effects may be serious and require immediate medical attention.
Contact your doctor immediately if any of the following serious adverse effects occur after taking the medicine:

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

• dizziness
• low blood pressure (feeling faint, sensation of "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 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 eyelids, face and lips
• swelling of the tongue and throat causing significant breathing difficulties
• severe skin reactions including intense rash, urticaria, redness of the entire body, severe itching, blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack
• pancreatitis, which may cause severe abdominal and back pain accompanied by very poor general condition
• weakness, tendency to develop bruises, 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
• feeling of 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 skin rash
• inability to achieve or maintain an erection

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

• rapid heart rate
• sensation of spinning
• visual disturbances
• feeling of discomfort in the abdominal cavity
• chest pain
• increased blood urea nitrogen, creatinine and uric acid levels
• 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
• muscle cramps/weakness/pain
• limb pain
• difficulty maintaining proper posture while standing or walking
• weakness
• coordination disturbances
• dizziness upon standing or after exertion
• low energy
• sleep disturbances
• tingling or numbness sensations
• 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/rhinorrhea due to inflammation of the nasal mucosa (rhinitis)
• changes in bowel habits
• indigestion
• hair loss
• skin itching
• skin colour changes
• urinary disorders
• 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 bruising under the skin)
• presence of glucose in urine
• high blood glucose levels
• worsening of diabetic metabolic control
• feeling of 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 skin sensitivity to sunlight
• purple skin spots
• kidney function disorders
• confusion

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

• decreased white blood cell count
• decreased 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
• 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 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)
• severe upper abdominal pain (pancreatitis)
• rash, itching, urticaria, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• breathing difficulties with fever, cough, wheezing, dyspnoea, weakness and confusion (respiratory disorder syndrome, pulmonary oedema, pneumonia, acute respiratory failure)
• 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 oral cavity, skin peeling, fever (toxic epidermal necrolysis)

Unknown (frequency cannot be estimated from available data):

• changes in kidney function test results, increased blood potassium levels, low red blood cell count
• abnormal red blood cell parameters
• low count 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 anaemia)
• visual impairment or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the avascular membrane 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 function disorders or kidney failure)
• severe skin disease causing rash, skin redness, blistering of lips, eyes or oral cavity, 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 suspected 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Amlodipine + Valsartan + Hydrochlorothiazide Polpharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP.
The expiry date refers to the last day of the stated month.
The marking 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

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

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

What Amlodipine + Valsartan + Hydrochlorothiazide Polpharma contains
10 mg+320 mg+25 mg, film-coated tablets
The active substances in Amlodipine + Valsartan + Hydrochlorothiazide Polpharma are amlodipine (as amlodipine maleate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 10 mg of amlodipine (as amlodipine maleate), 320 mg of valsartan and 25 mg of hydrochlorothiazide.
The other ingredients are:
tablet core: microcrystalline cellulose, crospovidone type A, colloidal anhydrous silica, magnesium stearate;
coating: hypromellose 2910, titanium dioxide (E171), polyethylene glycol 8000, yellow iron oxide (E172), red iron oxide (E172).

What Amlodipine + Valsartan + Hydrochlorothiazide Polpharma looks like and contents of the pack
Amlodipine + Valsartan + Hydrochlorothiazide Polpharma 5 mg+160 mg+12.5 mg, film-coated tablets are white or almost white, oval, biconvex film-coated tablets (14.1 mm ± 0.2 mm x 8.1 mm ± 0.2 mm); when broken, the core is white or almost white.
Pack sizes: 14, 28, 30, 56, 90, 98 film-coated tablets.

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma 10 mg+160 mg+12.5 mg, film-coated tablets are yellow, oval, biconvex film-coated tablets (14.1 mm ± 0.2 mm x 8.1 mm ± 0.2 mm); when broken, the core is white or almost white.
Pack sizes: 14, 28, 30, 56, 90, 98 film-coated tablets.

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma 10 mg+320 mg+25 mg, film-coated tablets are dark yellow, oval, biconvex film-coated tablets (18.2 mm ± 0.2 mm x 8.2 mm ± 0.2 mm); when broken, the core is white or almost white.
Pack sizes: 14, 28, 30, 56, 90, 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01