Tezeo Hct

Leaflet accompanying the packaging: patient information

Tezeo HCT, 80 mg + 25 mg, tablets
Telmisartan + Hydrochlorothiazide

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 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 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 Tezeo HCT 80 mg + 12.5 mg or who have been previously effectively treated with telmisartan and hydrochlorothiazide separately.

2. Important information before taking Tezeo HCT

When not to take Tezeo HCT

• if the patient is allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to hydrochlorothiazide or other sulfonamide derivatives,
• after the third month of pregnancy (it is also recommended to avoid taking Tezeo HCT in early pregnancy, see section on pregnancy),
• if the patient has severe liver disorders, 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 severe kidney disease or anuria (less than 100 ml of urine per day),
• if the doctor has found that the patient has low potassium or high calcium levels in the blood that do not improve with treatment,
• if the patient has diabetes or kidney function disorders 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 HCT.

Warnings and precautions

Before starting to take Tezeo HCT, the patient should discuss with their doctor if they have or have had any of the following conditions or diseases:

• 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 the use of diuretics, a low-salt diet, diarrhea, vomiting, or hemofiltration,
• kidney disease or a history of kidney transplantation,
• 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 called "lupus" or "SLE"), a disease in which the immune system attacks the body itself,
• 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 intraocular pressure, 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,
• if the patient has a history of skin cancer or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Tezeo HCT, the patient should protect their skin from sunlight and UV radiation,

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

• if they are taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme inhibitor (ACE) (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney function disorders associated with 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 HCT".
• if they are taking digoxin,
• if they have had problems with breathing or lungs (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing after taking Tezeo HCT, they should seek medical help immediately.

The patient must inform their doctor if they suspect they 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 significantly harm the fetus (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 irregular heartbeat (faster than 100 beats per minute). If any of these symptoms occur, the patient should inform their doctor.
The patient should also inform their doctor if they experience increased skin sensitivity to sunlight, in the form of sunburn (such as redness, itching, swelling, blistering) that appears more quickly than usual.
In the event of planned surgery or anesthesia, the patient should inform their doctor that they are taking Tezeo HCT.
Tezeo HCT may be less effective in lowering blood pressure in black patients.
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Tezeo HCT, they should discuss this with their doctor. The doctor will decide on further treatment. The patient should not stop taking Tezeo HCT on their own.

Children and adolescents

Tezeo HCT is not recommended for children and adolescents under 18 years of age.

Tezeo HCT and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The 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 especially 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), adrenocorticotropic hormone (ACTH), 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 can 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 various 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 the patient is 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 can cause a decrease in blood pressure (e.g., baclofen, amifostine). Additionally, the following may further lower blood pressure: alcohol, barbiturates, narcotics, or antidepressants. A symptom of low blood pressure in the patient may be dizziness when standing up. The patient should consult their doctor if they need to adjust the dose of other medicines they are taking while taking Tezeo HCT.
The effect of Tezeo HCT may be weakened 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. The patient should avoid consuming alcohol until they have talked to their doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
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.
The doctor will usually recommend stopping Tezeo HCT before planned pregnancy or as soon as pregnancy is confirmed and recommend taking a different medicine instead of Tezeo HCT.
Tezeo HCT is not recommended during pregnancy. Do not take it after the 3rd month of pregnancy, as it may significantly harm the fetus if taken after the third month of pregnancy.
Breastfeeding
The patient should inform their doctor about breastfeeding or intending to breastfeed.
Tezeo HCT is not recommended during breastfeeding. The doctor may use a different treatment for patients who want to breastfeed.

Driving and operating machinery

Some patients taking Tezeo HCT may experience dizziness, fainting, or a spinning sensation. If such side effects occur, the patient should not drive vehicles 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 the patient has been diagnosed with intolerance to some sugars or 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.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Tezeo HCT

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose of Tezeo HCT is one tablet per day. The patient should try to take the tablet at the same time every day. Tezeo HCT can be taken with or without food. The tablets should be swallowed whole, with a glass of water or another non-alcoholic drink. It is essential to take Tezeo HCT every day, unless the doctor recommends otherwise.
In patients with liver function disorders, the usual dose should not exceed 40 mg of telmisartan per day.

Taking a higher dose of Tezeo HCT than recommended

In case of accidental ingestion of too many tablets, the following symptoms may occur: low blood pressure and rapid heartbeat. There have also been reports of slow heartbeat, dizziness, vomiting, worsening of kidney function, including kidney failure. Due to the content 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. The patient should contact their doctor, pharmacist, or the nearest hospital emergency department immediately.

Missing a dose of Tezeo HCT

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 tablet is not taken on a given day, the patient should take the next dose 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 HCT can cause side effects, although not everybody gets them.

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

If the patient experiences any of the following symptoms, they should contact their doctor immediately:

• Septicemia* (often called "blood poisoning", a severe infection with an inflammatory response of the whole body),
• Sudden swelling of the skin and mucous membranes (angioedema),
• Formation of blisters and peeling of the outer layer of the skin (toxic epidermal necrolysis).

These side effects are rare (may occur in fewer than 1 in 1000 people) or very rare (may occur in fewer than 1 in 10,000 people), but they are very serious. In such cases, the patient should stop taking this medicine and contact their doctor immediately. If these symptoms are not treated, they can be fatal. An increased incidence of septicemia has been observed in patients taking telmisartan monotherapy; however, it cannot be ruled out in the case of Tezeo HCT therapy.

Possible side effects of Tezeo HCT:

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

• dizziness.

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

• low potassium levels in the blood,
• anxiety,
• fainting (syncope),
• tingling and burning sensation (paresthesia),
• spinning sensation (vertigo),
• rapid heartbeat (tachycardia),
• heart rhythm disorders,
• 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 occur in up to 1 in 1000 people):

• lung infection (bronchitis),
• sore throat,
• sinusitis,
• increased uric acid levels,
• low sodium levels,
• feeling of sadness (depression),
• difficulty sleeping (insomnia),
• sleep disorders,
• 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 hives,
• 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 itself, causing joint pain, skin rashes, and fever),
• flu-like symptoms,
• pain,
• increased creatinine levels, increased liver enzyme activity, or creatine phosphokinase in the blood.

Side effects reported for one of the active substances may also occur during therapy with the combination product of telmisartan and hydrochlorothiazide, even if they were not observed during clinical trials of this combination.

Telmisartan

In patients taking telmisartan alone, the following additional side effects have been observed:

Uncommon (may occur in 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 occur in up to 1 in 1000 people):

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

Very rare (may occur in fewer than 1 in 10,000 people):

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

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

• angioedema of the intestine - intestinal angioedema has been reported with similar products, with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

* This event may be coincidental or related to an unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported in patients taking 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 occur in more than 1 in 10 patients):

• increased blood lipid levels.

Common (may occur in up to 1 in 10 patients):

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

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

• acute kidney failure.

Rare (may occur in up to 1 in 1000 patients):

• low platelet count (thrombocytopenia), which can increase 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 duct obstruction (obstruction of bile flow from the liver and gallbladder),
• reactions to sunlight,
• uncontrolled blood sugar levels in patients with diabetes,
• presence of sugars in the urine (glucosuria).

Very rare (may occur in up to 1 in 10,000 patients):

• hemolytic anemia (abnormal breakdown of red blood cells),
• 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 body's immune system attacks itself),
• 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 (reduced ability of the bone marrow to produce blood cells)
• visual impairment and eye pain (possible symptoms of fluid accumulation in the vascular layer surrounding the eye or glaucoma),
• skin disorders, such as vasculitis, photosensitivity, rash, redness of the skin, blistering of the lips, eyes, and mouth, 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 the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be collected on the safety of the medicine.

5. How to store Tezeo HCT

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
Expiry date. The expiry date refers to the last day of the month stated.
Store at a temperature below 25°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 HCT contains

The active substances of the medicine are telmisartan and hydrochlorothiazide.
Each tablet contains 80 mg of telmisartan and 25 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 + 25 mg tablets: white to yellowish, oval, biconvex tablets, with the imprint "82" on one side, measuring 16 mm in length and 8 mm in width.
Pack contents
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