Tezeo

Package Leaflet: Information for the Patient

Tezeo, 40 mg, Tablets

Tezeo, 80 mg, Tablets

Telmisartan

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

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

Table of Contents of the Package 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 constrict, leading to increased blood pressure. Tezeo blocks the action of angiotensin II, causing 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 condition.
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 symptoms before such disorders occur. Therefore, it is essential to regularly measure blood pressure to determine if it is within the normal range.
Tezeo is also usedto reduce the risk of cardiovascular events (such as heart attack or stroke) in adults 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 Tezeo

When not to take Tezeo

• 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 Tezeo during early pregnancy, see section "Pregnancy")
• if the patient has severe liver disease, such as cholestasis or biliary obstruction (obstruction of 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 Tezeo.

Warnings and precautions

Before starting treatment with Tezeo, the patient should discuss it with their doctor or pharmacist. The patient should inform 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 disease
• high aldosterone levels (water and salt retention in the body, accompanied by mineral imbalance in the blood)
• low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive water loss from the body) or has low salt levels due to: taking diuretics, a low-salt diet, diarrhea, or vomiting
• high potassium levels in the blood
• diabetes

Before starting treatment with Tezeo, the patient should inform their doctor:

• if they are taking digoxin
• if they are taking any of the following medicines for high blood pressure:
• 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 Tezeo".
A female patient must inform their doctor if they are pregnant (or think they may be pregnant).
It is not recommended to take Tezeo during early pregnancy and it should not be taken after the third month of pregnancy, as it may be very harmful to the fetus (see section "Pregnancy").
In case of planned surgery or anesthesia, the patient should inform their doctor about taking Tezeo.
Tezeo may be less effective in lowering blood pressure in black patients.
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Tezeo, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Tezeo on their own.

Children and adolescents

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

Tezeo 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 and/or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines taken with Tezeo:

• lithium preparations used to treat certain types of depression
• medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics (some diuretics), 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 and low 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 reduced 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 low blood pressure may be dizziness when standing up. If it is necessary to adjust the dose of other medicines taken with Tezeo, the patient should consult their doctor.

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 patient should inform their doctor about a suspected (or planned) pregnancy. The doctor will usually recommend stopping Tezeo before a planned pregnancy or as soon as pregnancy is confirmed and recommend taking another medicine instead of Tezeo. It is not recommended to take Tezeo during early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus.
Breastfeeding
The patient should inform their doctor about breastfeeding or intending 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

Some patients taking Tezeo may experience dizziness or fatigue.
In case of dizziness or fatigue, the patient should not drive or operate machinery.

Tezeo contains sodium and sorbitol

This medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".
Tezeo, 40 mg, tablets: this medicine contains 162.2 mg of sorbitol per tablet.
Tezeo, 80 mg, tablets: this medicine contains 324.4 mg of sorbitol per tablet.
Sorbitol is a source of fructose. If the patient has 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, they should consult their doctor before taking this medicine.

3. How to take Tezeo

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
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 per day 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. A 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.
Tezeo, 40 mg, tablets
Tezeo 40 mg tablets can be divided using a tablet splitter or by pressing or breaking them at the score line with the hands (hands must be clean and dry). The unused half of the tablet should be stored in the original packaging and can be used for the next dose (see section "How to store Tezeo").

Overdose of Tezeo

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

Missed dose of Tezeo

If a dose of Tezeo is missed, the patient should take the missed dose as soon as they remember, and then continue taking the medicine as scheduled. If the medicine is not taken on a given day, the patient should take the next dose at the usual time the next day. The patient should not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

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

If the patient experiences any of the following symptoms, they should immediately contact their doctor:
sepsis* (often called "blood poisoning", a severe infection with an inflammatory reaction throughout the 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 are extremely serious. In such a case, the patient should stop taking the medicine and immediately contact their doctor. If these symptoms are not treated, they can be fatal.

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 risk 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, difficulty sleeping, 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, stomach 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 weak, 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 anxious, drowsiness, vision disturbances, fast heart rate (tachycardia), dry mouth, stomach upset, liver problems (more common in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which can also lead to death (angioedema, also fatal), skin rash, skin redness, hives, severe skin rash, joint pain, limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels (a protein in the blood), 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)**
Frequency not known (frequency cannot be estimated from the available data):
angioedema of the intestine - after taking similar products, angioedema of the intestine has occurred with symptoms such as stomach pain, nausea, vomiting, and diarrhea.
* 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this 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 expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
Tezeo, 40 mg, tablets
The Tezeo tablet should be removed from the blister pack immediately before use. If a Tezeo 40 mg tablet is divided into two halves, the unused half of the tablet should be placed in an open blister pack and stored in the original paper box (for a maximum of 1 day).
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 Tezeo contains

Tezeo, 40 mg, tablets: the active substance is telmisartan. Each tablet contains 40 mg of telmisartan.
Tezeo, 80 mg, tablets: the active substance is telmisartan. Each tablet contains 80 mg of telmisartan.
Other ingredients are: meglumine, sorbitol (E420), sodium hydroxide, povidone (K 25), magnesium stearate.

What Tezeo looks like and contents of the pack

Tezeo, 40 mg, tablets: white to yellowish, oblong, biconvex tablets with a score line on both sides, approximately 12 mm long, 6 mm wide, and 3.2-3.8 mm thick. The tablet can be divided into two equal parts.
Tezeo, 80 mg, tablets: white to yellowish, with the inscription "80" on one side, oblong, biconvex tablets, approximately 16 mm long, 8 mm wide, and 4.2-4.8 mm thick.
Pack sizes: 28, 30, 56, or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

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
Zentiva S.A., 50 Theodor Pallady Blvd., 3 district, 032266 Bucharest, Romania

For more information about this medicine and its names in the Member States of the European Economic Area, please contact:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00
Date of last revision of the leaflet:January 2025