Package leaflet: Information for the patient

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

Keep this 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 you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Tezeo is and what it is used for
Important information before taking Tezeo
How to take Tezeo
Possible side effects
How to store Tezeo
Contents of the package 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 narrowing of blood vessels, leading to 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 (primary) 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 lead to damage of blood vessels in various organs, which in some cases may result in heart attack, heart or kidney failure, stroke, or loss of vision. High blood pressure usually does not cause any 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 risk, i.e. those who have had reduced blood flow to the heart or legs, who have had a stroke, or who have been diagnosed with diabetes.
Your doctor will inform you whether you belong to the risk group for these conditions.

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 (use of Tezeo should also be avoided during early pregnancy; see section "Pregnancy")
if the patient has severe liver problems such as cholestasis or biliary obstruction (impaired 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, inform the 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 the blood vessels supplying one or both kidneys)
liver disease
heart disease
elevated levels of aldosterone (retention of water and salt in the body, accompanied by disturbances in the balance of various minerals in the blood)
low blood pressure (hypotension), especially if the patient is dehydrated (excessive loss of water from the body) or has salt deficiency due to: use of diuretics (water tablets), a low-salt diet, diarrhoea or vomiting
increased potassium levels in the blood
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 take Tezeo".
A female patient must inform her doctor if she suspects she is pregnant (or could 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 anaesthesia, inform the doctor that the patient is taking Tezeo.
Tezeo may be less effective in lowering blood pressure in Black individuals.
Children and adolescents
Tezeo is not recommended for use in children and adolescents under 18 years of age.
Tezeo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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 concomitantly with Tezeo:

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 (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 tablets), 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 take Tezeo" and "Warnings and precautions");
digoxin.

The effect of Tezeo may be reduced when taking medicines such as 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 reduced 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 required, 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 child, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you suspect you are pregnant (or are planning a pregnancy). Your doctor will usually recommend discontinuing Tezeo before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend 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 intend to breastfeed. Use of Tezeo is not recommended during breastfeeding, especially when breastfeeding a newborn or preterm infant. Your doctor may recommend an alternative medicine.
Driving and using machines
Some patients taking Tezeo may experience dizziness or fatigue. If dizziness or fatigue occurs, do 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, i.e. the medicine is considered "sodium-free".
Tezeo contains 324.4 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 break down fructose, the patient should consult a doctor before taking this medicine.

3. How to use Tezeo

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Tezeo is available in the following strengths: 40 mg, 80 mg.
The recommended dose of Tezeo is one tablet daily. You should 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
daily unless otherwise advised by your doctor. If you feel that the effect of Tezeo is too strong or too weak,
you should consult your doctor or pharmacist.
For the treatment of hypertension, the usual dose of Tezeo for most patients is one 40 mg tablet once
daily to ensure blood pressure control over 24 hours. However, your doctor may sometimes recommend
a lower dose of 20 mg or a higher dose of 80 mg. The 20 mg dose can be obtained by splitting the
40 mg tablet along the break line.
Alternatively, your doctor may recommend Tezeo to be used concomitantly with diuretics (water pills),
such as hydrochlorothiazide, which have an additive blood pressure-lowering effect with telmisartan.
To reduce the risk of cardiovascular events, the usual dose of Tezeo is one 80 mg tablet once daily.
During initial treatment with the 80 mg dose, blood pressure should be monitored frequently.
In patients with impaired liver function, the usual dose should not exceed 40 mg once daily.
Taking more Tezeo than recommended
If you accidentally take too many tablets, contact your doctor or pharmacist immediately, or go to the
emergency department of your nearest hospital.
Missed dose of Tezeo
If you miss a dose, take it as soon as you remember, then continue taking the medicine according to
your regular schedule. If you do not take the dose on that day, take the next dose the following day at
your usual time.
Do not take a double dose to make up for a missed dose.
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* (commonly known as "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, discontinue the medicine immediately and contact your doctor 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), reduced number of red blood cells (anaemia), high potassium levels, difficulty falling asleep, 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, breathing difficulties, wheezing, facial swelling, or low blood pressure), low blood sugar levels (in diabetic patients), feeling of restlessness, drowsiness, visual disturbances, rapid 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 resulting in death), eruption (skin disorder), redness of the skin, urticaria, severe drug rash, joint pain, limb pain, tendon pain, influenza-like symptoms, decreased haemoglobin concentration (blood protein), 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 lung tissue fibrosis (interstitial lung disease)**
* The event may be coincidental or related to a currently unknown mechanism.
** Cases of progressive lung tissue fibrosis have been reported during telmisartan treatment. However, it has not been established whether this is caused by telmisartan use.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to gather further information on the safety of the medicine.

5. How to store the medicine Tezeo

Keep the medicine out of the 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 stated month.
Store below 30°C.
Keep in the original packaging to protect from moisture.
The Tezeo tablet should be removed from the blister pack immediately before use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

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

What Tezeo looks like and contents of the pack
Tezeo is white to yellowish, elongated, biconvex tablets, with the imprint "80" on one side, approximately 16 mm long, 8 mm wide, and 4.2 – 4.8 mm thick.
Pack sizes: 28, 56 tablets.
For more detailed information, please contact the responsible party or parallel importer.

Responsible party in the Czech Republic, country of export:
Zentiva, k. s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer:
Zentiva, k. s.
U Kabelovny 130
102 37 Prague 10
Czech Republic
S.C. Zentiva S.A.
B-dul. Theodor Pallady nr. 50, sector 3
Bucharest
Romania

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorization number in the Czech Republic, country of export: 58/312/10-C
Marketing authorization number for parallel import: 31/20