Tezeo

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Tezeo, 80 mg, Tablets

Telmisartan

The leaflet should be read carefully before taking the medicine because it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.

Table of Contents of the Leaflet

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

1. What is Tezeo and what is it used for

Tezeo 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 narrow, leading to an increase in blood pressure. Tezeo blocks the action of angiotensin II, which causes blood vessels to relax and blood pressure to decrease.
Tezeo is usedto treat essential hypertension (high blood pressure) in adults. Essential means that the high blood pressure is not caused by another disease.
Untreated high blood pressure can lead to damage to blood vessels in various organs, which can sometimes lead to heart attack, heart failure, or kidney disease, stroke, or vision loss. Usually, high blood pressure does not cause any symptoms before such disorders occur. Therefore, it is essential to regularly measure blood pressure to determine if its value is within the normal range.
Tezeo is also usedto reduce the frequency of cardiovascular events (such as heart attack or stroke) in adults at risk, i.e., those who have 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 Tezeo

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When not to take Tezeo

• if the patient is allergic to telmisartan or any other component of this medicine (listed in section 6)
• after the third month of pregnancy (it is also recommended to avoid taking Tezeo in early pregnancy, see section "Pregnancy")
• if the patient has severe liver disease, such as cholestasis or biliary obstruction (difficulty in 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, the doctor or pharmacist should be informed before taking Tezeo.

Warnings and precautions

Before starting to take Tezeo, the doctor or pharmacist should be consulted. The doctor should be informed if the patient has or has 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 disease
• increased aldosterone levels (water and salt retention in the body, accompanied by disturbances in the balance of various mineral components 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 salt deficiency due to: diuretic use, low-salt diet, diarrhea, or vomiting
• increased potassium levels in the blood
• diabetes.

Before starting to take Tezeo, the doctor should be informed:

• if the patient is taking digoxin
• if the patient is taking any of the following blood pressure-lowering medicines:
• angiotensin-converting enzyme (ACE) inhibitor (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 Tezeo".
The patient must inform the doctor if they are pregnant (or think they may be pregnant).
It is not recommended to take Tezeo in early pregnancy and it should not be taken after 3 months of pregnancy, as it may be very harmful to the baby (see section "Pregnancy").
In case of planned surgery or anesthesia, the doctor should be informed about taking Tezeo.
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Tezeo may be less effective in lowering blood pressure in black patients.

Children and adolescents

Tezeo should not be used in children and adolescents under 18 years of age.

Tezeo and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. The doctor may decide to change the dose and/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 Tezeo 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, certain diuretics, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive agents (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim;
• diuretics, especially when taken in high doses with Tezeo, as they can lead to significant water loss from the body and decreased blood pressure (hypotension);
• ACE inhibitors or aliskiren (used to treat high blood pressure) (see also the information under the heading "When not to take Tezeo" and "Warnings and precautions");
• digoxin.

The effect of Tezeo may be weakened when taking non-steroidal anti-inflammatory drugs (NSAIDs, 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 can cause a decrease in blood pressure (e.g., baclofen, amifostine). Additionally, the following may also lower blood pressure: alcohol, barbiturates, narcotics, or antidepressants. A symptom of too low blood pressure may be dizziness when standing up. If it is necessary to adjust the dose of other medicines taken with Tezeo, the doctor should be consulted.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The doctor should be informed about suspected (or planned) pregnancy. The doctor will usually recommend stopping Tezeo before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Tezeo. It is not recommended to take Tezeo in early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby.
Breastfeeding
The doctor should be informed about breastfeeding or intention to breastfeed. It is not recommended to take Tezeo during breastfeeding, especially in the case of breastfeeding a newborn or premature baby. The doctor may recommend taking 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, which means the medicine is considered "sodium-free".
The medicine contains 324.40 mg of sorbitol per tablet.
Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine.

3. How to take Tezeo

This medicine should always be taken as directed by the doctor or pharmacist. If there are any doubts, the doctor or pharmacist should be consulted.
Tezeo is available in the following strengths: 40 mg, 80 mg.
The recommended dose of Tezeo is one tablet per day. The patient should try to take the tablet at the same time every day. Tezeo can be taken with or without food.
The tablets should be swallowed with water or another non-alcoholic drink. It is essential to take Tezeo every day, unless the doctor recommends otherwise. If the patient feels that the effect of Tezeo is too strong or too weak, they should consult their doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Tezeo for most patients is one 40 mg tablet once daily to ensure blood pressure control for 24 hours. However, sometimes the doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. The 20 mg dose can be obtained by dividing a 40 mg tablet along the score line. Alternatively, the doctor may recommend taking Tezeo with diuretics (e.g., hydrochlorothiazide), which has 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 a dose of 80 mg, blood pressure should be frequently monitored.
In patients with liver dysfunction, the usual dose should not exceed 40 mg once daily.

Overdose of Tezeo

In case of accidental ingestion of too many tablets, the doctor or pharmacist should be contacted immediately, or the patient should go to the emergency department of the nearest hospital.

Missed dose of Tezeo

If a dose is missed, the missed dose should be taken as soon as possible, and then the patient should continue taking the medicine as scheduled. If the medicine is not taken on a given day, the next dose should be taken at the usual time the next day. A double dose should not be taken to make up for a missed dose.
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If there are any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

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

If any of the following symptoms occur, the doctor should be contacted immediately:
Septicaemia* (often called "blood poisoning", a severe infection with an inflammatory reaction of the whole body), sudden swelling of the skin and mucous membranes (angioedema). These side effects are rare (may occur in up to 1 in 1000 patients), but they are extremely serious. In such a case, the medicine should be stopped, and the doctor should be contacted immediately. If these symptoms are not treated, they may be fatal.

Possible side effects of Tezeo

Common side effects (may occur in up to 1 in 10 patients):
Low blood pressure (hypotension) in patients treated to reduce the frequency of cardiovascular events.
Uncommon side effects (may occur in up to 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, sleep disturbances, low mood (depression), fainting, spinning sensation (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness when standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle cramps, muscle pain (myalgia), kidney problems, including acute kidney failure, chest pain, feeling of weakness, and increased creatinine levels in the blood.
Rare side effects (may occur in up to 1 in 1000 patients):
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), feeling of anxiety, drowsiness, vision disturbances, rapid heart rate (tachycardia), dryness of the mucous membranes of the mouth, gastritis, taste disturbances, liver problems (more frequent in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which can also lead to death (angioedema, also fatal), skin rash, redness of the skin, hives, severe drug rash, joint pain, limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels, increased uric acid levels, increased liver enzyme activity or creatine phosphokinase in the blood.
Very rare side effects (may occur in up to 1 in 10,000 patients):
Progressive scarring of lung tissue (interstitial lung disease)**
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* The event may be coincidental or related to an unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it has not been established whether this is caused by telmisartan.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the State Agency of Medicines, Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Tezeo

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 Tezeo contains

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

What Tezeo looks like and contents of the pack

White to yellowish, with an imprint of "80" on one side, oblong, biconvex tablets, 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, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Latvia, the 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
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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Latvia, the country of export: 10-0175

Parallel import authorization number: 141/25

Date of approval of the leaflet: 14.04.2025

[Information about the trademark]
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