Package leaflet: Information for the user

Telmizek, 40 mg, tablets
Telmizek, 80 mg, tablets
Telmisartanum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
Speak to your doctor or pharmacist if you have any doubts.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Telmizek is and what it is used for

Telmizek 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. Telmizek blocks the action of angiotensin II, allowing blood vessels to
relax and blood pressure to decrease.
Telmizek 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, which in some cases
can lead to heart attack, heart or kidney failure, stroke, or loss of vision. Often, there are no symptoms
before these complications occur. Therefore, it is important to regularly monitor blood pressure to
ensure it remains within normal limits.
Telmizek is also used to reduce the risk of cardiovascular events (such as heart attack or stroke) in
patients at risk, such as those with reduced blood flow to the heart or legs, those who have had a
stroke, or those with diabetes. Your doctor will inform you if you belong to this high-risk group.

2. Important information before taking Telmizek

When not to take Telmizek

If you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
After the third month of pregnancy. (Telmizek should also be avoided during early pregnancy – see section “Pregnancy”);
If you have severe liver problems, such as biliary obstruction or blockage of bile outflow (problems with bile drainage 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 Telmizek.

Warnings and precautions

If you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Telmizek, discuss this
with your doctor. Your doctor will decide whether treatment should continue. Do not stop taking
Telmizek on your own.

Inform your doctor 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 disturbances in mineral balance),
Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of water from the body) or have low salt levels due to diuretic (water tablet) use, low-salt diet, diarrhoea, or vomiting,
High potassium levels in the blood,
Diabetes.

Before starting Telmizek, discuss with your doctor:

If you are taking any of the following medicines for high blood pressure:
- Angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially 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.
If you are taking digoxin.

Inform your doctor if you are pregnant or suspect you may be pregnant, or if you are planning a
pregnancy. Telmizek 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 (see section “Pregnancy”).
If you are scheduled for surgery or anaesthesia, inform your doctor that you are taking Telmizek.
Telmizek may be less effective in lowering blood pressure in patients of Black race.

Children and adolescents

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

Telmizek 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 need to adjust the dose of these medicines or take other precautions. In some cases,
one of the medicines may need to be discontinued. This is especially important when taking the
following medicines together with Telmizek:

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 (some water tablets), angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive medicines (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim,
Diuretics (water tablets), especially when taken in high doses together with Telmizek, 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 Telmizek” and “Warnings and precautions”),
Digoxin.

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

Pregnancy and breastfeeding

Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
Your doctor will usually advise stopping Telmizek before planning a pregnancy or immediately after
confirming pregnancy, and will recommend an alternative medicine. Telmizek 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 if used beyond 3 months of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Telmizek is not recommended
during breastfeeding. Your doctor may choose an alternative treatment during breastfeeding,
especially when feeding newborns or premature infants.

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

Telmizek contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose (40 mg or 80 mg), meaning it is
considered "sodium-free".

3. How to use Telmizek

Telmizek must always be taken exactly as directed by the physician. In case of doubt,
consult a doctor or pharmacist.
The recommended dose is one tablet daily. Try to take the tablet at the same time every day. Telmizek
can be taken during or between meals. Tablets should be swallowed with water or another non-alcoholic
drink. It is important to take Telmizek every day unless otherwise advised by the physician. If you feel
that the effect of Telmizek is too strong or too weak, consult your doctor or pharmacist.
In the treatment of arterial hypertension, the usual dose of Telmizek is one 40 mg tablet once daily for
most patients, providing blood pressure control for 24 hours. The physician may recommend a lower
dose of one 20 mg tablet daily or a higher dose of one 80 mg tablet daily.
Telmizek may also be administered in combination with a diuretic (water tablet), such as
hydrochlorothiazide, which enhances the blood pressure-lowering effect of Telmizek.
To reduce the frequency of cardiovascular events, the usual dose of Telmizek is one 80 mg tablet once
daily. Blood pressure should be monitored frequently at the beginning of treatment.
In patients with impaired liver function, the usual dose must not exceed 40 mg once daily.
Taking more Telmizek than prescribed
If too many tablets are taken by mistake, contact a doctor or pharmacist immediately or go to the
nearest hospital emergency department.
Missing a dose of Telmizek
If you miss a dose, take it as soon as you remember, then continue taking the medicine as before. If
the tablet is not taken within the same day, take the usual dose the next day. Do not take a double
dose to make up for a missed dose.
Stopping Telmizek
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, 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 symptoms occur, contact your doctor immediately:
Sepsis* (often called blood poisoning, a severe infection causing a systemic inflammatory response), sudden swelling of the skin and mucous membranes (angioedema).
The above adverse reactions are rare (may occur in up to 1 in 1,000 patients), but are extremely serious. In such cases, treatment with the medicine must be discontinued immediately and medical advice must be sought without delay. If the above symptoms are not treated, they may result in death.
Possible adverse reactions of Telmizek:
Frequent adverse reactions (may occur in up to 1 in 10 patients):
Low blood pressure (hypotension) in patients treated to reduce the frequency of cardiovascular events.
Uncommon adverse reactions (may occur in up to 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 falling asleep, 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 adverse reactions (may occur in up to 1 in 1,000 patients):
Sepsis* (often called blood poisoning, a severe infection causing a 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, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in patients with diabetes), feeling of restlessness, drowsiness, visual disturbances, fast heart rate (tachycardia), dryness of the oral mucosa, gastritis, taste disturbances, liver function disorders (more frequently observed 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 adverse reactions (may occur in up to 1 in 10,000 patients):
Progressive fibrosis of pulmonary alveoli (interstitial lung disease)**
Frequency not known (frequency cannot be estimated from available data):
Angioedema of the intestine – following administration of similar products, intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea has been reported.
*The event may be coincidental or related to a currently unknown mechanism.
**Cases of interstitial lung disease temporally associated with telmisartan use have been reported. However, a causal relationship has not been established.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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, e-mail: https://smz.ezdrowie.gov.pl .
Reporting adverse reactions helps provide more information on the safety of the medicine.
5. How to store Telmizek
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, tablet container or blister pack after "EXP". The expiry date refers to the last day of the stated month.
Aluminium/Aluminium blisters: Store in the original packaging to protect from light.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Telmizek 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 (E 421), povidone (K-29/32), potassium hydroxide.

What Telmizek looks like and contents of the pack
Telmizek 40 mg: white, oval, biconvex tablets with a score line and the logo T on one side. The tablet can be divided into two equal parts.
Telmizek 80 mg: white, oval, biconvex tablets with the logo T1 on one side.
Telmizek is available in aluminium/aluminium blister packs containing 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer
Actavis Ltd
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
{Poland} {Telmizek}
March 2025