Tezeo Hct

Package Leaflet: Information for the Patient

Tezeo HCT, 80 mg + 12,5 mg, tablets
Telmisartan + Hydrochlorothiazide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Tezeo HCT and what is it used for

Tezeo HCT is a combination medicine that contains two active substances, telmisartan and hydrochlorothiazide, in one tablet. Both substances help control high blood pressure.

• Telmisartan belongs to a group of medicines called angiotensin II receptor blockers. Angiotensin II is a substance produced by the body that causes blood vessels to constrict, leading to high blood pressure. Telmisartan blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase urine production, leading to a decrease in blood pressure.

Untreated high blood pressure can cause damage to blood vessels in many organs, which can sometimes lead to heart attack, heart failure, or kidney failure, stroke, or vision loss. Usually, before these complications occur, no symptoms are observed due to high blood pressure. Therefore, it is essential to regularly measure blood pressure to check if it is within the normal range of values.
Tezeo HCT is usedto treat high blood pressure (essential hypertension) in adults who are not adequately controlled by telmisartan alone.

2. Important information before taking Tezeo HCT

When not to take Tezeo HCT

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to hydrochlorothiazide or other sulfonamide derivatives,
• after the third month of pregnancy (you should also avoid taking Tezeo HCT in early pregnancy, see section on pregnancy),
• if you have 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 you have severe kidney disease or anuria (less than 100 ml of urine per day),
• if your doctor has found that you have low potassium or high calcium levels in your blood that do not improve with treatment,
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, inform your doctor or pharmacist before taking Tezeo HCT.

Warnings and precautions

Before starting to take Tezeo HCT, discuss with your doctor if you have or have had any of the following conditions or diseases:

• low blood pressure (hypotension), which is more likely if you are dehydrated (excessive water loss from the body) or have a low salt level due to the use of diuretics, a low-salt diet, diarrhea, vomiting, or hemofiltration,
• kidney disease or post-kidney transplant,
• renal artery stenosis (narrowing of the blood vessels of one or both kidneys),
• liver disease,
• heart disease,
• diabetes,
• gout,
• increased aldosterone levels (water and salt retention in the body, accompanied by electrolyte imbalance),
• systemic lupus erythematosus (also known as "lupus" or "SLE"), a disease in which the immune system attacks the body,
• hydrochlorothiazide may cause rare reactions that limit vision and cause eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure in the eyeball, which may occur within a few hours to a few weeks after taking Tezeo HCT. If left untreated, they can lead to permanent vision impairment,

Before starting to take Tezeo HCT, inform your doctor:

• if you are taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme inhibitor (ACE) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Tezeo HCT".
when taking digoxin,

• if you have had problems with breathing or lungs (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or difficulty breathing after taking Tezeo HCT, seek medical attention immediately.

You must inform your doctor if you suspect that you are pregnant (or may have become pregnant). It is not recommended to take Tezeo HCT in early pregnancy. Do not take it

• after the 3rd month of pregnancy, as it may harm the baby (see section on pregnancy).

Treatment with hydrochlorothiazide may lead to electrolyte imbalance in the body. Typical symptoms of water and electrolyte imbalance include dryness of the mucous membranes in the mouth, weakness, lethargy, drowsiness, anxiety, muscle cramps, nausea (nausea), vomiting, fatigue, and abnormally rapid heartbeat (faster than 100 beats per minute). If you experience any of these symptoms, inform your doctor.
You should also inform your doctor about increased skin sensitivity to sunlight, in the form of sunburn (such as redness, itching, swelling, blistering) that occurs more quickly than usual.
In the event of planned surgery or anesthesia, inform your doctor that you are taking Tezeo HCT.
Tezeo HCT may be less effective in lowering blood pressure in black patients.
If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Tezeo HCT, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Tezeo HCT on your own.

Children and adolescents

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

Tezeo HCT and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Your doctor may decide to change the dose of these medicines or take other precautions.
In some cases, it may be necessary to stop taking one of these medicines.
This applies in particular to the simultaneous use of Tezeo HCT with the following medicines:

• lithium preparations used to treat certain types of depression,
• medicines that lower potassium levels in the blood (hypokalemia), such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), and salicylic acid and its derivatives,
• iodine contrast agent used for imaging studies,
• medicines that increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressive medicine), and other medicines such as sodium heparin (an anticoagulant),
• medicines whose effects are influenced by changes in potassium levels in the blood, such as cardiac glycosides (e.g., digoxin) and medicines used to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used to treat mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines used to treat allergic reactions (e.g., terfenadine),
• medicines used to treat diabetes (insulin or oral medicines such as metformin),
• cholestyramine and colestipol, medicines that lower blood lipid levels,
• medicines that increase blood pressure, such as norepinephrine,
• muscle relaxants such as tubocurarine,
• calcium and/or vitamin D supplements,
• medicines with anticholinergic effects (used to treat a range of disorders such as spasms in the digestive tract, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct to anesthesia) such as atropine and biperiden,
• amantadine (a medicine used to treat Parkinson's disease and also to treat and prevent certain viral diseases),
• other medicines used to treat high blood pressure, corticosteroids, painkillers (e.g., non-steroidal anti-inflammatory drugs, NSAIDs), medicines used to treat cancer, gout, or arthritis,
• if you are taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Tezeo HCT" and "Warnings and precautions"),
• digoxin.

Tezeo HCT may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may cause a decrease in blood pressure (e.g., baclofen, amifostine). Additionally, the following may have an additive effect on lowering blood pressure: alcohol, barbiturates, narcotics, or antidepressants. A symptom of low blood pressure in patients may be dizziness when standing up. Consult your doctor if you need to adjust the dose of other medicines you are taking while taking Tezeo HCT.
The effect of Tezeo HCT may be reduced when taking non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen).

Using Tezeo HCT with food and alcohol

Tezeo HCT can be taken with or without food. You should avoid drinking alcohol until you have talked to your doctor. Alcohol may further lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will normally advise you to stop taking Tezeo HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Tezeo HCT.
Tezeo HCT should not be used during pregnancy. Do not take it after the 3rd month of pregnancy, as it may harm the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed.
Tezeo HCT should not be used during breastfeeding. Your doctor may use a different treatment if you want to breastfeed.

Driving and using machines

Some patients taking Tezeo HCT may experience dizziness, fainting, or a spinning sensation. If you experience such effects, do not drive or operate machinery.

Tezeo HCT contains sorbitol (E420) and sodium

• The medicine contains 348.3 mg of sorbitol in each tablet.

Sorbitol is a source of fructose. If you have been told by your doctor that you have an intolerance to some sugars or have hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is essentially 'sodium-free'.

3. How to take Tezeo HCT

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Tezeo HCT is one tablet per day. Try to take your tablet at the same time each day. Tezeo HCT can be taken with or without food. Swallow the tablet whole with water or another non-alcoholic drink. It is important to take Tezeo HCT every day, unless your doctor tells you to stop.

What to do if you take more Tezeo HCT than you should

If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. There have also been reports of slow heartbeat, dizziness, vomiting, worsening kidney function, including kidney failure. Due to the presence of hydrochlorothiazide, very low blood pressure and low potassium levels in the blood may also occur, which can lead to nausea, drowsiness, and muscle cramps and/or irregular heartbeat associated with the simultaneous use of medicines such as cardiac glycosides and certain anti-arrhythmic medicines. Contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

What to do if you forget to take Tezeo HCT

If you forget to take a dose, take the missed dose as soon as you remember, and then continue taking your medicine as prescribed. If you do not take a tablet on a given day, take the next dose the next day. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

If you experience any of the following symptoms, contact your doctor immediately:

• Sepsis* (often referred to as "blood poisoning", a serious infection with a systemic inflammatory response).
• Sudden swelling of the skin and mucous membranes (angioedema).
• Blistering and peeling of the outer layer of the skin (toxic epidermal necrolysis).

These side effects are rare (may affect up to 1 in 1000 people) or very rare (may affect up to 1 in 10,000 people), but they are very serious. In such cases, stop taking this medicine and contact your doctor immediately. If these symptoms are not treated, they can be fatal.
There has been an increased incidence of sepsis in patients taking telmisartan monotherapy, but it cannot be ruled out in the case of Tezeo HCT therapy.

Side effects of Tezeo HCT:

Common (may affect up to 1 in 10 people):

• dizziness.

Uncommon (may affect up to 1 in 100 people):

• low potassium levels in the blood,
• anxiety,
• fainting (syncope),
• tingling,
• tingling and burning sensation (paresthesia),
• spinning sensation (vertigo),
• rapid heartbeat (tachycardia),
• heart rhythm disturbances,
• low blood pressure,
• sudden drop in blood pressure when standing up,
• shortness of breath (dyspnea),
• diarrhea,
• dryness of the mucous membranes in the mouth,
• bloating,
• back pain,
• muscle cramps,
• muscle pain,
• erectile dysfunction (inability to achieve and maintain an erection),
• chest pain,
• increased uric acid levels in the blood.

Rare (may affect up to 1 in 1000 people):

• pneumonia (inflammation of the lungs),
• sore throat,
• sinusitis,
• increased uric acid levels,
• low sodium levels,
• feeling sad (depression),
• difficulty sleeping (insomnia),
• sleep disturbances,
• vision disturbances,
• blurred vision,
• breathing difficulties,
• abdominal pain,
• constipation,
• bloating (indigestion),
• nausea (vomiting),
• gastritis,
• liver function disorders (more common in patients of Japanese origin),
• redness of the skin (rash),
• allergic reactions, such as itching or rash,
• increased sweating,
• hives,
• joint pain and limb pain (leg pain),
• muscle cramps,
• activation or exacerbation of systemic lupus erythematosus (a disease in which the immune system attacks the body, causing joint pain, skin rashes, and fever),
• flu-like symptoms,
• pain,
• increased creatinine levels, increased liver enzyme activity, or creatine phosphokinase in the blood.

Frequency not known (frequency cannot be estimated from the available data):

• intestinal angioedema - after the use of similar products, intestinal angioedema has occurred with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

* This event may be coincidental or related to an unknown mechanism.
** Cases of progressive pulmonary fibrosis have been reported during treatment with telmisartan. However, it has not been established whether this is caused by telmisartan.

Telmisartan

In patients taking telmisartan alone, the following additional side effects have been observed:
Uncommon (may affect up to 1 in 100 people):

• upper respiratory tract infections (e.g., sore throat, sinusitis, common cold),
• urinary tract infections,
• cytitis,
• anemia (low red blood cell count),
• high potassium levels,
• slow heart rate (bradycardia),
• cough,
• kidney function disorders, including acute kidney failure,
• weakness.

Rare (may affect up to 1 in 1000 people):

• low platelet count (thrombocytopenia),
• increased number of certain white blood cells (eosinophilia),
• severe allergic reactions (e.g., hypersensitivity, anaphylactic reaction),
• low blood sugar levels (in diabetic patients),
• drowsiness,
• gastrointestinal disorders,
• rash (skin disorder),
• drug rash,
• toxic rash,
• tendon pain (symptoms mimicking tendonitis),
• low hemoglobin levels (a protein in the blood).

Very rare (may affect up to 1 in 10,000 people):

• progressive scarring of lung tissue (interstitial lung disease)**.

Frequency not known (frequency cannot be estimated from the available data):

• intestinal angioedema - after the use of similar products, intestinal angioedema has occurred with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

* This event may be coincidental or related to an unknown mechanism.
** Cases of progressive pulmonary fibrosis have been reported during treatment with telmisartan. However, it has not been established whether this is caused by telmisartan.

Hydrochlorothiazide

In patients taking hydrochlorothiazide alone, the following additional side effects have been observed:
Very common (may affect more than 1 in 10 people):

• increased blood lipid levels.

Common (may affect up to 1 in 10 people):

• nausea,
• low magnesium levels in the blood,
• decreased appetite.

Uncommon (may affect up to 1 in 100 people):

• acute kidney failure.

Rare (may affect up to 1 in 1000 people):

• low platelet count (thrombocytopenia), which increases the risk of bleeding or bruising (small, purple-red spots on the skin or in other tissues, caused by bleeding),
• high calcium levels in the blood,
• high blood sugar levels,
• headache,
• abdominal discomfort,
• jaundice (yellowing of the skin and eyes),
• bile accumulation in the blood (bile stasis),
• reactions to sunlight,
• uncontrolled blood sugar levels in diabetic patients,
• presence of sugars in the urine (glucosuria).

Very rare (may affect up to 1 in 10,000 people):

• hemolytic anemia (a condition in which red blood cells are broken down),
• bone marrow failure,
• low white blood cell count (leukopenia, agranulocytosis),
• severe allergic reactions (e.g., hypersensitivity),
• alkalosis (elevated blood pH due to low chloride levels),
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion),
• pancreatitis,
• lupus-like syndrome (a disease that mimics systemic lupus erythematosus, in which the immune system attacks the body),
• vasculitis (inflammation of blood vessels).

Frequency not known (frequency cannot be estimated from the available data):

• salivary gland inflammation,
• malignant tumors of the skin and lips (non-melanoma skin cancer),
• aplastic anemia (a condition in which the bone marrow fails to produce blood cells),
• visual impairment and eye pain (possible symptoms of fluid accumulation in the vascular layer surrounding the eye or increased pressure in the eyeball),
• skin disorders, such as vasculitis, photosensitivity, rash, redness of the skin, blistering of the skin, excessive peeling of the skin, fever (possible symptoms of erythema multiforme),
• weakness,
• kidney function disorders,
• in isolated cases, low sodium levels have been reported, which were accompanied by symptoms affecting the brain or nerves (nausea, progressive disorientation, lack of interest or energy).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Monitoring, 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tezeo HCT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store in a temperature not above 25°C.
Store in the original package to protect from moisture.
Medicines should 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 HCT contains

The active substances are telmisartan and hydrochlorothiazide.
Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
The other ingredients are sorbitol, sodium hydroxide, povidone 25, and magnesium stearate.

What Tezeo HCT looks like and contents of the pack

Tezeo HCT, 80 mg + 12.5 mg tablets: white to yellowish, oval, biconvex tablets, with the inscription "81" on one side, measuring 16.5 mm in length and 8.3 mm in width.
Packaging
Blister packs with OPA/Aluminum/PVC-Aluminum in a cardboard box.
Pack sizes: 28, 56, or 84 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
S.C. Zentiva S.A., 50 Theodor Pallady Blvd., District 3, 032266 Bucharest, Romania
UAB "Oriola Vilnius", Laisves pr. 75, LT-06144, Vilnius, Lithuania

For further information on the medicine and its names in the Member States of the European Economic Area, please contact the representative of the Marketing Authorization Holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:March 2025