POLSART 80 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Polsart, 40 mg, tablets
3. Polsart, 80 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Polsart and what is it used for
   1. Important information before taking Polsart
   2. When not to take Polsart
   3. Warnings and precautions
   4. Children and adolescents
   5. Polsart and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Polsart contains sodium
5. How to take Polsart
   1. Overdose of Polsart
   2. Missed dose of Polsart
6. Possible side effects
   1. Some side effects may be serious and require immediate medical attention:
   2. Possible side effects of Polsart:
   3. Reporting side effects
   4. How to store Polsart
7. Contents of the pack and other information
   1. What Polsart contains
   2. What Polsart looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Package Leaflet: Information for the Patient

Polsart, 40 mg, tablets

Polsart, 80 mg, tablets

Telmisartan

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of Contents of the Leaflet

• 1. What is Polsart and what is it used for
• 2. Important information before taking Polsart
• 3. How to take Polsart
• 4. Possible side effects
• 5. How to store Polsart
• 6. Contents of the pack and other information

1. What is Polsart and what is it used for

Polsart belongs to a group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a substance produced by the body that causes blood vessels to constrict, leading to an increase in blood pressure. Polsart blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Polsart is used to treat essential hypertension (high blood pressure).
The term "essential" means that high blood pressure is not caused by another disease.
Untreated high blood pressure can cause damage to blood vessels in various organs, which can lead to heart attack, heart failure, or kidney disease, stroke, or vision loss. Most often, before the above complications occur, no symptoms of high blood pressure are observed. Therefore, it is essential to regularly measure blood pressure to check if it is within the normal range.
Polsart is also used to reduce the frequency of cardiovascular events (such as heart attack or stroke) in patients at risk, i.e., those with reduced blood flow to the heart or legs, who have had a stroke, or who have diabetes. The doctor will inform the patient if they are at risk of these disorders.
2.

Important information before taking Polsart

When not to take Polsart

• if the patient is allergic to telmisartan or any other ingredient of this medicine (listed in section 6);

after the third month of pregnancy. (It is also recommended to avoid taking Polsart in early pregnancy - see section "Pregnancy");

• if the patient has severe liver dysfunction, such as cholestasis or biliary obstruction (problems with bile flow from the liver and gallbladder) or any other severe liver disease;
• 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 situations apply to the patient, they should inform their doctor or pharmacist before taking Polsart.

Warnings and precautions

Before starting treatment with Polsart, the patient should discuss with their doctor if they have or have had any of the following conditions or diseases:

• kidney disease or kidney transplant,
• renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys),
• liver disease,
• heart problems,
• high aldosterone levels (water and salt retention in the body, accompanied by mineral balance disorders in the blood),
• low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive water loss from the body) or has a low salt level due to the use of diuretics, a low-salt diet, diarrhea, or vomiting,
• high potassium levels in the blood,
• diabetes.

Before starting treatment with Polsart, the patient should discuss with their doctor:

• if the patient is taking any of the following blood pressure-lowering medicines:
• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney disease.
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under the heading "When not to take Polsart" and "Warnings and precautions".
• if the patient is taking digoxin.

The patient should inform their doctor if they suspect or plan to become pregnant. It is not recommended to take Polsart in early pregnancy. Do not take this medicine after the third month of pregnancy, as it may seriously harm the baby (see section "Pregnancy").
In case of planned surgery or anesthesia, the patient should inform their doctor about taking Polsart.
Polsart may be less effective in lowering blood pressure in black patients.
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Polsart, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Polsart on their own.

Children and adolescents

Polsart is not recommended for use in children and adolescents under 18 years of age.

Polsart and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The doctor may decide to change the dose of these medicines or take other precautions.
In some cases, it may be necessary to stop taking one of the medicines. This applies especially to the simultaneous use of Polsart with the following medicines:

• lithium preparations used to treat certain types of depression,
• medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen), heparin, or immunosuppressive agents (e.g., cyclosporine or tacrolimus), and the chemotherapeutic agent trimethoprim,
• diuretics, especially when taken in high doses with Polsart, as they can lead to significant water loss and low blood pressure (hypotension),
• if the patient is taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Polsart" and "Warnings and precautions"),
• digoxin.

The effect of Polsart may be reduced when taken with non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.
Polsart may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can cause a decrease in blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be further decreased by: alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. If necessary, the patient should consult their doctor to adjust the dose of the other medicine taken with Polsart.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctor if they suspect or plan to become pregnant. The doctor will usually recommend stopping Polsart before planned pregnancy or immediately after pregnancy is confirmed and prescribe another medicine instead of Polsart. It is not recommended to take Polsart in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Polsart is not recommended during breastfeeding. The doctor may choose another treatment during breastfeeding, especially in the period of breastfeeding newborns and premature infants.

Driving and using machines

Some patients taking Polsart may experience dizziness or fatigue. In such cases, they should not drive or operate machines.

Polsart contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Polsart

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should ask their doctor or pharmacist.
The recommended dose of Polsart is usually one tablet once a day. The patient should try to take the tablet at the same time every day.
Polsart can be taken with or without food. The tablets should be swallowed with water or another non-alcoholic liquid. It is essential to take Polsart every day, unless the doctor recommends otherwise. If the patient feels that the effect of Polsart is too strong or too weak, they should consult their doctor or pharmacist.
In the treatment of high blood pressure, the recommended dose of Polsart for most patients is one 40 mg tablet once a day, to control blood pressure for more than 24 hours. The doctor may also recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Polsart may be given in combination with diuretics (e.g., hydrochlorothiazide), which enhances the blood pressure-lowering effect of Polsart.
To reduce the frequency of cardiovascular events, the recommended dose of Polsart is usually one 80 mg tablet once a day. At the beginning of treatment with the 80 mg dose of Polsart, blood pressure should be frequently monitored.
In patients with liver dysfunction, the recommended dose of Polsart should not exceed 40 mg once a day.

Overdose of Polsart

If the patient has accidentally taken too many tablets, they should immediately contact their doctor or pharmacist or the nearest hospital emergency department.

Missed dose of Polsart

If the patient misses a dose, they should take it as soon as they remember, and then continue taking the medicine as scheduled. If the tablet is not taken within a day, the patient should take the usual recommended dose the next day. Do nottake a double dose to make up for the missed dose.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Polsart can cause side effects, although not everybody gets them.

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

If the patient experiences any of the following side effects, they should immediately contact their doctor:

• sepsis* (often referred to as blood poisoning, a severe infection with an inflammatory response throughout the body)
• sudden swelling of the skin and mucous membranes (angioedema). These side effects are rare (occurring in less than 1 in 1,000 patients) but are extremely severe, and the patient should stop taking the medicine and immediately contact their doctor. If these symptoms are not treated, they can be fatal.

Possible side effects of Polsart:

Common(occurring in less than 1 in 10 patients):
Low blood pressure (hypotension) in patients treated to reduce the frequency of cardiovascular events.
Uncommon(occurring in less than 1 in 100 patients):
Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), decreased red blood cell count (anemia), high potassium levels in the blood, insomnia, depression, fainting, peripheral vertigo (dizziness), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, orthostatic hypotension (dizziness when standing up), shortness of breath, cough, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle cramps, muscle pain, kidney problems, including acute kidney failure, chest pain, feeling of weakness, and increased creatinine levels in the blood.
Rare(occurring in less than 1 in 1,000 patients):
Septicemia* (often referred to as blood poisoning, a severe infection with an inflammatory response throughout the body, which can lead to death), increased white blood cell count (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in patients with diabetes), restlessness, drowsiness, vision disturbances, rapid heart rate (tachycardia), dry mouth, gastritis, liver function disorders (more common in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which can also lead to death (angioedema), skin eruptions (skin disease), skin redness, hives, severe drug rash, joint pain, limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels (protein in the blood), increased uric acid levels, increased liver enzyme activity or creatine phosphokinase in the blood.
Very rare(occurring in less than 1 in 10,000 patients):
Progressive interstitial lung disease (interstitial lung disease)**
Frequency not known(frequency cannot be estimated from the available data):
Angioedema of the intestine - after the use of similar products, angioedema occurred in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
* The effect may be coincidental or related to an unknown mechanism.
** Cases of interstitial lung disease have been reported in temporal association with the use of telmisartan. However, a causal relationship has not been established.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be collected on the safety of the medicine.
5.

How to store Polsart

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or tablet container. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Blisters of Aluminum/Aluminum in a cardboard box.
Store in the original packaging to protect from light.
Tablet container: Store the container tightly closed to protect from light.
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 pack and other information

What Polsart contains

• The active substance of Polsart is telmisartan. Each tablet contains 40 mg or 80 mg of telmisartan.
• The other ingredients are: magnesium stearate, croscarmellose sodium, mannitol (E421), povidone (K-29/32), potassium hydroxide.

What Polsart looks like and contents of the pack

Polsart 40 mg: white, oval, biconvex tablets with a score line and the logo "T" on one side.
The tablet can be divided into two halves.
Polsart 80 mg are white, oval, biconvex tablets with the logo "T1" on one side.
Polsart is packaged in Aluminum/Aluminum blisters.
The pack contains: 28, 30, 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Poland
Date of last revision of the leaflet:March 2025