Tezeo Hct

Package Leaflet: Information for the Patient

Tezeo HCT, 40 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 Package 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 to 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 narrow, leading to increased 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.
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 any of the above applies to you, inform your doctor or pharmacist before taking Tezeo HCT.

Warnings and precautions

Before taking 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 taking diuretics, a low-salt diet, diarrhea, vomiting, or hemofiltration,
• kidney disease or post-kidney transplant status,
• 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 taking Tezeo HCT, inform your doctor:

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

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

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, restlessness, 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, such as sunburn (such as redness, itching, swelling, blistering) that occurs more quickly than usual.
If you are planning 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 is not recommended for 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, have recently taken, or 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 is especially true for the following medicines taken with Tezeo HCT:

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 further lower blood pressure: alcohol, barbiturates, narcotics, or antidepressants. A symptom of low blood pressure 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 weakened when taking non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen).

Taking 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 find out that you are pregnant and will advise you to take a different medicine instead of Tezeo HCT. It is not recommended to take Tezeo HCT 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 planning to breastfeed. It is not recommended to take Tezeo HCT while breastfeeding. Your doctor may prescribe a different treatment if you want to breastfeed.

Driving and Using Machines

Some patients taking Tezeo HCT may feel dizzy, faint, or have a spinning sensation. If you experience any of these effects, do not drive or operate machinery.

Tezeo HCT Contains Sorbitol (E420) and Sodium

• The medicine contains 174.15 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 if you have a rare genetic disorder (hereditary fructose intolerance), 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 it 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, you may also experience very low blood pressure and low potassium levels in the blood, which can lead to nausea, drowsiness, muscle cramps, and irregular heartbeat associated with the use of medicines such as digitalis 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 usual. If you miss a dose, take the next dose at the usual time. 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:

• Septicemia* (often referred to as "blood poisoning", a severe infection with an inflammatory response throughout the body).
• 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 1,000 people) or very rare (may affect up to 1 in 10,000 people) but are very serious. If you experience any of these, stop taking this medicine and contact your doctor immediately. If left untreated, these can be fatal.
Increased frequency of septicemia has been observed in patients taking telmisartan monotherapy, but it cannot be ruled out in the case of Tezeo HCT therapy.

Other Possible 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 or 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 spasms,
• muscle pain,
• chest pain,
• increased uric acid levels in the blood.

Rare (may affect up to 1 in 1,000 people):

• lung infection (bronchitis),
• sore throat,
• sinusitis,
• increased uric acid levels,
• low sodium levels,
• feeling sad (depression),
• difficulty sleeping (insomnia),
• sleep disturbances,
• blurred vision,
• breathing difficulties,
• abdominal pain,
• bloating (indigestion),
• nausea (vomiting),
• increased sweating,
• pain,

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

• intestinal angioedema - angioedema of the intestine 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 pulmonary fibrosis have been reported during telmisartan treatment. 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,
• urinary tract infections,
• high potassium levels,

Rare (may affect up to 1 in 1,000 people):

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 - angioedema of the intestine 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 pulmonary fibrosis have been reported during telmisartan treatment. 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 lipid levels in the blood.

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

• nausea,

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

Rare (may affect up to 1 in 1,000 people):

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

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

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 Safety 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 exceeding 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 of Tezeo HCT are telmisartan and hydrochlorothiazide.
Each tablet contains 40 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, 40 mg + 12.5 mg tablets: white to yellowish, oval, biconvex tablets, with "41" engraved on one side, measuring 12 mm in length and 6 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

For More Information on This Medicinal Product, Please Contact:

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