Package leaflet: Information for the patient

Polsart, 40 mg, tablets
Polsart, 80 mg, tablets
Telmisartanum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed strictly for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Polsart is and what it is used for
Important information before taking Polsart
How to take Polsart
Possible side effects
How to store Polsart
Contents of the pack and other information

1. What Polsart is and what it is used for

Polsart belongs to a group of medicines known as angiotensin II receptor antagonists.
Angiotensin II is a substance produced by the body that causes blood vessels to narrow, thereby
increasing blood pressure. Polsart blocks the action of angiotensin II, allowing 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 may damage blood vessels in various organs, potentially leading to heart attack, heart or kidney failure, stroke, or vision loss. Often, there are no symptoms of high blood pressure before such complications occur. Therefore, it is important to regularly monitor blood pressure to ensure it remains within normal limits.
Polsart is also used to reduce the frequency of cardiovascular events (such as heart attack or stroke) in patients at risk, i.e. those who have reduced blood flow to the heart or legs, have had a stroke, or have diabetes. Your doctor will inform you whether you belong to this risk group.

2. Important information before taking Polsart

When not to take Polsart

if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6);
after the third month of pregnancy. (Polsart should also be avoided during early pregnancy – see section "Pregnancy");
if you have severe liver problems, such as biliary obstruction or cholestasis (problems with bile flow from the liver and gallbladder), or any other severe liver disease;
if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, inform your doctor or pharmacist before taking Polsart.

Warnings and precautions

Talk to your doctor before starting Polsart if you have or have had any of the following conditions or diseases:

kidney disease or status post kidney transplant,
renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys),
liver disease,
heart problems,
elevated aldosterone levels (water and salt retention in the body, accompanied by imbalances in various blood minerals),
low blood pressure (hypotension), especially if you are dehydrated (excessive loss of body water) or have low salt levels due to diuretic (water tablet) use, low-salt diet, diarrhoea, or vomiting,
high potassium levels in the blood,
diabetes.

Talk to your doctor:

if you are taking any of the following medicines used to treat high blood pressure:
- angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
- aliskiren. Your 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 Polsart".
if you are taking digoxin.

Inform your doctor if you suspect or are planning pregnancy. Polsart is not recommended during early pregnancy. Do not take this medicine after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy").
If you are scheduled for surgery or anaesthesia, inform your doctor that you are taking Polsart.
Polsart may be less effective in lowering blood pressure in patients of black racial origin.
If you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Polsart, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Polsart on your own.

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

Polsart with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Your doctor may decide to adjust the dose of these medicines or take other precautions.
In some cases, it may be necessary to discontinue one of the medicines. This particularly applies when taking the following medicines together with Polsart:

lithium preparations, used to treat certain types of depression,
medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (certain water tablets), ACE inhibitors (angiotensin-converting enzyme inhibitors used for high blood pressure), angiotensin II receptor antagonists (used for high blood pressure), NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen), heparin (a blood-thinning medicine), immunosuppressants (e.g. cyclosporine or tacrolimus), and the chemotherapeutic agent trimethoprim,
diuretics (water tablets), especially when taken in high doses together with Polsart, as they may lead to significant fluid loss and low blood pressure (hypotension),
if you are taking an ACE inhibitor or aliskiren (see also information under "When not to take Polsart" and "Warnings and precautions"),
digoxin.

The effect of Polsart may be reduced when taken with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen) or corticosteroids.
Polsart may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may cause low blood pressure (e.g. baclofen, amifostine). Additionally, alcohol, barbiturates, narcotics, or antidepressants may further lower blood pressure. Symptoms include dizziness upon standing. If dose adjustment of another medicine taken during Polsart treatment is needed, consult your doctor.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you suspect or plan pregnancy. Your doctor will usually recommend stopping Polsart before planned pregnancy or immediately after confirming pregnancy and will prescribe an alternative medicine. Polsart 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. Polsart is not recommended during breastfeeding. Your doctor may choose an alternative treatment during breastfeeding, especially when nursing newborns or premature infants.

Driving and operating machinery
Some patients taking Polsart may experience dizziness or fatigue. In such cases, do not drive or operate machinery.

Polsart contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Polsart

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The usual recommended dose of Polsart is 1 tablet once daily. Try to take the tablet at the same time
every day.
Polsart may be taken during or between meals. Tablets should be swallowed with water or another
non-alcoholic drink. It is important to take Polsart every day unless otherwise advised by your doctor.
If you feel that the effect of Polsart is too strong or too weak, consult your doctor or pharmacist.
For the treatment of high blood pressure, the usual recommended dose of Polsart in most patients is
1 tablet of Polsart 40 mg once daily, to maintain blood pressure control for over 24 hours. Your 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 (water pills), such as hydrochlorothiazide, which enhances the
blood pressure-lowering effect of Polsart.
To reduce the risk of cardiovascular events, the usual recommended dose of Polsart is 1 tablet of
80 mg once daily. At the beginning of treatment with the 80 mg dose of Polsart, blood pressure should
be monitored frequently.
In patients with impaired liver function, the usual recommended dose should not exceed 40 mg once
daily.
Taking more Polsart than recommended
If you accidentally take too many tablets, contact your doctor, pharmacist, or the nearest hospital
emergency department immediately.
Missing a dose of Polsart
If you miss a dose, take it as soon as you remember, then continue taking the medicine as before. If
the missed tablet is not taken within the same day, take the usual recommended dose the next day.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and require immediate medical attention:
If any of the following adverse reactions occur, contact your doctor immediately:

Septicaemia* (often called blood poisoning, a severe infection causing systemic inflammatory response)
Sudden swelling of the skin and mucous membranes (angioedema). These adverse reactions are rare (occurring in less than 1 in 1,000 patients), but extremely serious. In such cases, stop taking the medicine immediately and contact your doctor without delay. If these symptoms are not treated, they may result in death.

Possible adverse reactions of Polsart medicine:
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), reduced number of red blood cells (anaemia), high potassium levels in plasma, difficulty sleeping, low mood (depression), fainting, sensation of spinning (peripheral vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for hypertension, dizziness upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, drug rash, back pain, muscle cramps, muscle pain, kidney function disorders, including acute kidney failure, chest pain, feeling of weakness, and increased blood creatinine levels.
Rare (occurring in less than 1 in 1,000 patients):
Septicaemia* (often called blood poisoning, a severe infection causing systemic inflammatory response, which may lead to death), increased number of certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (e.g. rash, itching, breathing difficulties, wheezing, facial swelling, or low blood pressure), low blood sugar levels (in patients with diabetes), feeling of anxiety, drowsiness, visual disturbances, rapid heart rate (tachycardia), dryness of the oral mucosa, gastritis, taste disturbances, liver function disorders (occurring more frequently in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which may also lead to death (angioedema, including fatal cases), skin eruptions (skin disease), redness of the skin, urticaria, severe drug rash, joint pain, limb pain, tendon pain, influenza-like symptoms, decreased haemoglobin concentration (a protein in the blood), increased uric acid levels, increased activity of liver enzymes or creatine phosphokinase in blood.
Very rare (occurring in less than 1 in 10,000 patients):
Progressive fibrosis of the lung alveoli (interstitial lung disease)**
Frequency not known (frequency cannot be estimated from available data):
Angioedema of the intestine – after administration of similar products, intestinal swelling has occurred with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
* The reaction may be coincidental or related to a currently unknown mechanism.
** Cases of interstitial lung disease have been reported in temporal association with telmisartan use. However, a causal relationship has not been established.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Polsart medicine
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, tablet container or blister. The expiry date refers to the last day of the stated month.
The label on the packaging shows EXP followed by the expiry date, and Lot/LOT followed by the batch number.
Aluminium/Aluminium foil blisters in a cardboard box.
Store in the original packaging to protect from light.
Tablet container: Keep the container tightly closed to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Polsart contains

The active substance is telmisartan. Each tablet contains 40 mg or 80 mg of telmisartan.
The other ingredients are: magnesium stearate, sodium croscarmellose, 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 division line and the logo “T” on one side.
The tablet can be divided into two equal parts.
Polsart 80 mg: white, oval, biconvex tablets with the logo “T1” on one side.
Polsart is packed in aluminium/aluminium blisters.
Pack sizes: 28, 30, or 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 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