Tezeo

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Tezeo, 80 mg, tablets

Telmisartan

Read the leaflet carefully before taking the medicine because it contains important information for the patient.

• Keep the leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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 constrict, leading to an increase in blood pressure. Tezeo blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Tezeo is usedto treat high blood pressure in adults. The term "essential" means that high blood pressure is not caused by another disease.
Untreated high blood pressure can lead to damage to blood vessels in various organs, which in some cases can 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 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 of the other ingredients 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 "Pregnancy")
• if the patient has severe liver problems, 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 to take 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
• increased 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 a salt deficiency due to: taking diuretics, a low-salt diet, diarrhea, or vomiting
• high potassium levels in the blood
• diabetes

Before starting to take Tezeo, the patient should inform their doctor:

• if they are taking digoxin
• if they are taking any of the following medicines used to treat high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes.
• 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" and "Warnings and precautions".

The patient must inform their doctor if they suspect they are pregnant (or may become pregnant).
It is not recommended to take Tezeo in early pregnancy and it must not be taken after 3 months of pregnancy, as it may be very harmful to the fetus (see "Pregnancy").
In the event of planned surgery or anesthesia, the patient should inform their doctor about taking Tezeo.
Tezeo may be less effective in lowering blood pressure in people of black race.

Children and adolescents

It is not recommended to take Tezeo 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, certain diuretics, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive drugs (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 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 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 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 child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor 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 must not be taken after 3 months 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. If dizziness or fatigue occurs, the patient should not drive or operate machinery.

Tezeo contains sodium and sorbitol (E 420)

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".
This medicine contains 324.4 mg of sorbitol (E 420) 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, they 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 the patient has any doubts, they should consult their doctor or pharmacist.
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. 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, such as 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 the case of liver function disorders, the usual dose should not exceed 40 mg once daily.

Taking a higher dose of Tezeo than recommended

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.

Missing a dose of Tezeo

If a dose 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.
If the patient has any further doubts about taking this medicine, they 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 referred to as "blood poisoning", a severe infection with a systemic inflammatory response), 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 patient should stop taking the medicine and immediately contact their doctor. If these symptoms are not treated, they can 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, insomnia, depression, fainting, vertigo (benign paroxysmal 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 spasms, 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 common in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which can also lead to death (angioedema also resulting in death), skin eruption (skin disorder), 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)**
* 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 any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store 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 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 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

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

Tezeo, 80 mg, tablets are 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: 30, 60, or 90 tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Zentiva, k. s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer:

Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37, Prague 10, Czech Republic
Zentiva S.A., B-dul Theodor Pallady, nr. 50, sector 3, 032266, Bucharest, Romania

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:9443/2016/02

Parallel import authorization number: 342/22 Date of approval of the leaflet: 20.09.2022

[Information about the trademark]