Amlodipine + valsartan + hydrochlorothiazide polpharma

Package leaflet: Information for the patient

Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 5 mg + 160 mg + 25 mg,
film-coated tablets
Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 10 mg + 160 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, as 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. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Amlodipine + Valsartan + Hydrochlorothiazide Polpharma is and what it is used for
2. What you need to know 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 three 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 vessel constriction, thereby increasing blood pressure. Valsartan works by blocking the effects 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 already 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:

• during the third trimester of pregnancy (it is also recommended to avoid using Amlodipine + Valsartan + Hydrochlorothiazide Polpharma in early pregnancy - see section "Pregnancy");
• if the patient is allergic to amlodipine or other drugs from the calcium channel blocker group, 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 within the liver (primary biliary cirrhosis) leading to bile accumulation in the liver (biliary stasis);
• 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 blood potassium or sodium levels despite treatment aimed at increasing potassium or sodium levels in the blood;
• if the patient has high blood calcium levels despite treatment aimed at reducing 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 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 function impairment and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above points apply, do not take
Amlodipine + Valsartan + Hydrochlorothiazide Polpharma and discuss this with your doctor.
Warnings and precautions
Before starting treatment with Amlodipine + Valsartan + Hydrochlorothiazide Polpharma,
discuss the following with your doctor or pharmacist:

• if the patient has low blood potassium or magnesium levels (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat);
• if the patient has low blood sodium levels (with or without symptoms such as fatigue, confusion, muscle twitching, seizures);
• if the patient has high blood calcium levels (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 been diagnosed with renal artery stenosis;
• if the patient has liver function impairment;
• if the patient has or has had 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. Strictly follow the doctor's recommendations regarding the initial 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 blood cholesterol or triglyceride levels;
• 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 known as water tablets), particularly in patients with asthma or allergies;
• if the patient experiences vomiting or diarrhea;
• if the patient develops swelling, especially of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors - ACE inhibitors). If such symptoms occur, stop taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma immediately and contact your 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, 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 vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure - these may occur from several hours to weeks after taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma. If left untreated, they may lead to permanent vision loss.
• if the patient is taking any of the following medicines used to treat 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 an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially at high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, protect the 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, 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, discuss them with your doctor.
Children and adolescents
The 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, as previously taken when using the
three separate medicines containing amlodipine, valsartan, and hydrochlorothiazide. In elderly
patients, blood pressure should be regularly monitored, 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
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines planned for future use. 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 simultaneously with:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing agents, and heparin;
• an ACE inhibitor or aliskiren (see also information in sections "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 diseases);
• 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 disorders (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, and other resins (substances mainly used to treat high blood lipid (fat) levels);
• simvastatin (a medicine used to reduce high blood cholesterol levels);
• cyclosporine (a medicine used after organ transplants 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-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 blood sodium levels, such as antidepressants, antipsychotics, anticonvulsants;
• medicines that may reduce blood potassium levels, 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 (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 (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, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John's wort (Hypericum perforatum);
• dantrolene (an intravenous preparation used in severe temperature disorders);
• 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, which could unpredictably intensify the effect of Amlodipine +
Valsartan + Hydrochlorothiazide Polpharma, leading to a drop in blood pressure. Consult your 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
Inform your doctor if you suspect or are planning a pregnancy. Usually, the doctor will advise
discontinuing Amlodipine + Valsartan + Hydrochlorothiazide Polpharma before a planned pregnancy
or immediately after confirming pregnancy and will prescribe an alternative medicine. Amlodipine +
Valsartan + Hydrochlorothiazide Polpharma is not recommended during 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. Amlodipine + Valsartan + Hydrochlorothiazide
Polpharma is not recommended during breastfeeding. The doctor may choose an alternative
treatment during breastfeeding, especially when nursing newborns or premature infants.
Consult your 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 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 every day, 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 together with grapefruit or grapefruit juice.

Depending on the patient's response to treatment, the doctor may recommend a higher or lower dose.
Do not take more than the prescribed dose.

Taking a higher than recommended dose of Amlodipine + Valsartan + Hydrochlorothiazide Polpharma
Breathlessness caused by 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 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 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 you feel well.
Patients with high blood pressure usually do not experience any symptoms. Many feel completely normal. It is important to take this medicine exactly as directed by your doctor to achieve the best treatment outcomes and reduce the risk of adverse effects. Keep scheduled doctor's 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 medicine containing three active substances, adverse effects related to
each of the active substances cannot be ruled out. The 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):

• marked decrease in urine output (impaired kidney function)

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

• spontaneous bleeding
• irregular heart function
• liver function disorders

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

• sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing
• swelling of the eyelids, face and lips
• swelling of the tongue and throat causing significant breathing difficulties
• severe skin reactions including intense rash, urticaria, redness of the entire skin, 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 shortness of breath, fever, weakness and confusion)
• heart attack
• pancreatitis, which may cause sudden severe abdominal and back pain accompanied by a very poor general condition
• 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 potassium levels in the blood
• increased lipid levels in the blood

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

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

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

• rapid heart rate
• sensation of spinning
• visual disturbances
• discomfort in the abdominal cavity
• chest pain
• increased levels of blood urea nitrogen, creatinine and uric acid in the blood
• high levels of calcium, lipids or sodium in the blood
• decreased potassium levels in the blood
• unpleasant breath odour
• diarrhea
• dryness of the oral mucosa
• weight gain
• loss of appetite
• taste disturbances
• back pain
• joint swelling
• muscle cramps/weakness/muscle pain
• limb pain
• difficulty maintaining proper balance while standing or walking
• weakness
• coordination disorders
• dizziness upon standing or after exertion
• lack of 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 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 color 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 accompanied by bleeding or subcutaneous bruising)
• presence of glucose in urine
• high blood sugar levels
• worsening of diabetic metabolic control
• 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 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 (gastric irritation)
• 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
• photosensitivity
• disorders involving stiffness, tremor and/or difficulty moving
• fever, sore throat or mouth ulcers, increased frequency of 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)
• acute upper abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory failure, pulmonary edema, pneumonia)
• facial rash, joint pain, muscle diseases, fever (lupus erythematosus)
• vasculitis with symptoms such as rash, purplish-red spots, fever
• severe skin disease causing rash, skin redness, blistering on lips, eyes or in the mouth, skin peeling, fever (toxic epidermal necrolysis)

Not known (frequency cannot be estimated from available data):

• changes in kidney function test results, increased potassium levels in blood, low red blood cell count
• abnormal red blood cell parameters
• low count of certain types of white blood cells and platelets
• increased creatinine levels in blood
• abnormal liver function test results
• marked decrease in urine output
• vasculitis
• weakness, easy bruising and frequent infections (aplastic anemia)
• impaired vision or eye pain due to elevated 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
• significantly reduced urine output (possible symptoms of kidney function disorders or kidney failure)
• severe skin disease causing rash, skin redness, blistering on lips, eyes or in the mouth, skin peeling, fever (erythema multiforme)
• muscle cramps
• fever
• skin blisters (a sign of a disease called bullous pemphigoid)
• skin and lip cancers (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 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 to 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 indicated after EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following 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 + 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 5 mg of amlodipine (as amlodipine maleate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
• Other components are: tablet core: microcrystalline cellulose, crospovidone type A, colloidal anhydrous silica, magnesium stearate; coating: hypromellose 2910, titanium dioxide (E 171), macrogol 8000, talc, yellow iron oxide (E 172).

What Amlodipine + Valsartan + Hydrochlorothiazide Polpharma contains
10 mg + 160 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), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
• Other components are: tablet core: microcrystalline cellulose, crospovidone type A, colloidal anhydrous 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 contents of the pack
Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 5 mg + 160 mg + 25 mg, film-coated tablets are elongated, biconvex, light yellow, with the number "5" embossed on one side (15.2 mm ± 0.2 mm x 7.4 mm ± 0.2 mm). The core colour is white or almost white when broken.
Pack sizes: 14, 28, 30, 56, 90, 98 film-coated tablets.
Amlodipine + Valsartan + Hydrochlorothiazide Polpharma, 10 mg + 160 mg + 25 mg, film-coated tablets are oval, biconvex, dark yellow, with the number "10" embossed on one side (15.2 mm ± 0.2 mm x 7.4 mm ± 0.2 mm). The core colour is white or almost white when broken.
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.
Pelplińska 19, 83-200 Starogard Gdański, Poland
Tel. +48 22 364 61 01