Patient Information Leaflet

Caution! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Tezeo, 80 mg, tablets
Telmisartanum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Tezeo is and what it is used for
What you should know before taking Tezeo
How to take Tezeo
Possible side effects
How to store Tezeo
Contents of the pack and other information

1. What Tezeo is and what it is used for

Tezeo 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, resulting in increased blood pressure. Tezeo blocks the action of angiotensin II, allowing blood vessels to relax and thereby lowering blood pressure.

Tezeo is used to treat essential hypertension (high blood pressure) in adults. The term "essential" means that the high blood pressure is not caused by another disease.

Untreated high blood pressure may damage blood vessels in various organs and, in some cases, may lead to heart attack, heart or kidney failure, stroke, or loss of vision. High blood pressure usually causes no symptoms before such complications occur. Therefore, it is important to measure blood pressure regularly to determine whether it is within the normal range.

Tezeo is also used to reduce the frequency of cardiovascular events (such as heart attack or stroke) in adult patients at high risk, i.e., those who have reduced blood flow to the heart or legs, who have had a stroke, or who have diabetes.

Your doctor will inform you whether you belong to this high-risk group.

2. Important information before using Tezeo

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When not to use Tezeo

if the patient is allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6)
after the third month of pregnancy (use of Tezeo should also be avoided during early pregnancy; see section "Pregnancy")
if the patient has severe liver problems such as biliary obstruction or bile duct narrowing (impaired bile flow from the liver and gallbladder) or any other severe liver disease
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 situations apply, the patient should inform their doctor or
pharmacist before taking Tezeo.
Warnings and precautions
Before starting Tezeo, discuss this with your doctor or pharmacist. Inform your doctor if the patient has or has previously had any of the following conditions or diseases:

kidney disease or status post kidney transplant
renal artery stenosis (narrowing of blood vessels supplying one or both kidneys)
liver disease
heart disease
elevated aldosterone levels (retention of water and salt in the body accompanied by imbalances in blood mineral components)
low blood pressure (hypotension), especially if the patient is dehydrated (excessive loss of body water) or has salt deficiency due to: use of diuretics (water pills), low-salt diet, diarrhea, or vomiting
increased blood potassium levels
diabetes.

Before starting Tezeo, inform your doctor:

if the patient is taking digoxin
if the patient is taking any of the following medicines used to treat high blood pressure:
- angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), particularly if the patient has 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 use Tezeo".
A female patient must inform her doctor if she suspects she is pregnant (or could have become pregnant).
Use of Tezeo is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may be highly harmful to the unborn child (see section "Pregnancy").
If undergoing planned surgery or anesthesia, inform the doctor about taking Tezeo.
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Tezeo may be less effective in lowering blood pressure in black patients.
Children and adolescents
Tezeo is not recommended for use in children and adolescents under 18 years of age.
Tezeo with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. The treating doctor may decide to adjust the dose and/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 Tezeo:

lithium preparations used to treat certain types of depression;
medicines that may increase blood potassium levels, such as potassium-containing salt substitutes, potassium-sparing diuretics (certain diuretics), 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 pills), especially when taken in high doses together with Tezeo, as they may lead to significant fluid loss and low blood pressure (hypotension);
ACE inhibitors or aliskiren (used to treat high blood pressure) (see also information under the headings "When not to use Tezeo" and "Warnings and precautions");
digoxin.

The effect of Tezeo may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Tezeo 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 of low blood pressure may include dizziness upon standing. If dose adjustment of other medicines taken concomitantly with Tezeo is needed, consult your doctor.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if pregnancy is suspected (or planned). The doctor will usually recommend discontinuing Tezeo before planned pregnancy or immediately after pregnancy is confirmed and will prescribe an alternative medicine. Use of Tezeo 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. Use of Tezeo is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. The doctor may recommend using another medicine.
Driving and using machines
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Some patients taking Tezeo may experience dizziness or fatigue. If dizziness or fatigue occurs, the patient should not drive or operate machinery.
Tezeo contains sodium and sorbitol (E 420)
This medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".
The medicine contains 324.40 mg of sorbitol in each tablet.
Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot metabolize fructose, the patient should contact their doctor before taking this medicine.

3. How to take Tezeo

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Tezeo is available in the following doses: 40 mg, 80 mg.
The recommended dose of Tezeo is one tablet daily. Try to take the tablet at the same time every day.
Tezeo may be taken with food or independently of meals.
Tablets should be swallowed with water or another non-alcoholic drink. It is important to take Tezeo
every day, unless otherwise advised by your doctor. If you feel that the effect of Tezeo is too strong or
too weak, consult your doctor or pharmacist.
For the treatment of arterial hypertension, the usual dose of Tezeo for most patients is one 40 mg
tablet once daily to ensure 24-hour blood pressure control. However, your doctor may sometimes
prescribe a lower dose of 20 mg or a higher dose of 80 mg. The 20 mg dose can be obtained by
splitting a 40 mg tablet along the score line.
Alternatively, your doctor may prescribe Tezeo together with diuretics (water pills), such as
hydrochlorothiazide, which have an additive blood pressure-lowering effect with telmisartan.
To reduce the frequency of cardiovascular events, the usual dose of Tezeo is one 80 mg tablet once
daily. At the beginning of treatment with the 80 mg dose, blood pressure should be monitored
frequently.
In case of impaired liver function, the usual dose must not exceed 40 mg once daily.
Taking more Tezeo than prescribed
If you accidentally take too many tablets, contact your doctor or pharmacist immediately, or go to the
emergency department of your nearest hospital.
If you forget to take Tezeo
If you miss a dose, take it as soon as you remember, then continue taking the medicine according to
your regular schedule. If the missed dose is not taken on the same day, take the next dose at the
usual time the following day.
Do not take a double dose to make up for a missed dose.
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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 symptoms occur, contact your doctor immediately:
Sepsis* (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 (may occur in up to 1 in 1,000 patients), but extremely serious. In such cases, treatment with the medicine must be discontinued immediately and medical advice sought without delay. If left untreated, these symptoms may result in death.

Possible adverse reactions of Tezeo
Common 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), decreased number of red blood cells (anaemia), high potassium levels, difficulty sleeping, low mood (depression), fainting, sensation of spinning (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 (myalgia), 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):
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 diabetic patients), feeling of restlessness, drowsiness, visual disturbances, fast heart rate (tachycardia), dryness of the oral mucosa, gastritis, taste disturbances, liver function disorders (more frequently reported in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which may also lead to death (angioedema resulting in death), skin eruptions (skin disorders), skin redness, urticaria, severe drug rash, joint pain, limb pain, tendon pain, influenza-like symptoms, decreased haemoglobin levels (blood protein), increased uric acid levels, increased liver enzyme activity or increased creatine kinase activity in blood.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Progressive fibrosis of lung tissue (interstitial lung disease)**
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* The event may be coincidental or related to a currently unknown mechanism.
** Cases of progressive fibrosis of lung tissue have been reported during treatment with telmisartan. However, it has not been established whether this is caused by telmisartan.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Tezeo

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store below 30°C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Tezeo contains
The active substance is telmisartan. Each tablet contains 80 mg of telmisartan.
The other components are: meglumine, sorbitol (E 420), sodium hydroxide, povidone 25, magnesium stearate.

What Tezeo looks like and contents of the pack
White to yellowish, elongated, biconvex tablets, with an embossed "80" on one side, approximately 16 mm long, 8 mm wide, and 4.2 – 4.8 mm thick.
Pack sizes: 30, 60 or 90 tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Latvia, country of export:
Zentiva k.s., U kabelovny 130, Dolní Mĕcholupy, 102 37 Prague 10, Czech Republic

Manufacturer:
Zentiva k.s., U kabelovny 130, Dolní Mĕcholupy, 102 37 Prague 10, Czech Republic
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S.C. Zentiva S.A., 50 Theodor Pallady Blvd., the 3rd district, Bucharest, 032266, Romania

Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing Authorisation Number in Latvia, country of export: 10-0175
Parallel Import Licence Number: 141/25
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