Tezeo hct

Package leaflet: Information for the patient

Tezeo HCT, 40 mg + 12.5 mg, tablets
Telmisartanum + Hydrochlorothiazidum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

• Telmisartan belongs to a group of medicines known as 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, allowing blood vessels to relax and blood pressure to decrease.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase urine production, thereby lowering blood pressure.

Untreated high blood pressure may damage blood vessels in various organs and sometimes lead to heart attack, heart or kidney failure, stroke, or loss of vision. Usually, there are no prior symptoms indicating high blood pressure before these complications occur. Therefore, it is important to measure blood pressure regularly to ensure it remains within the normal range.
Tezeo HCT is used for the treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled by telmisartan alone.

2. Important information before using Tezeo HCT

When not to use 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 (use of Tezeo HCT should also be avoided during early pregnancy; see pregnancy section),
• if the patient has severe liver disorders such as biliary obstruction or cholestasis (impaired 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 urine per day),
• if the doctor has diagnosed abnormally low blood potassium levels or abnormally high blood calcium levels that do not improve with treatment,
• if the patient has diabetes or kidney impairment and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply, inform your doctor or
pharmacist before taking Tezeo HCT.
Warnings and precautions
Before starting Tezeo HCT, discuss with your doctor if you
have or have ever had any of the following conditions or diseases:

• low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic (water tablet) therapy, low-salt diet, diarrhoea, vomiting, or haemofiltration,
• kidney disease or status post kidney transplant,
• renal artery stenosis (narrowing of the blood vessels to one or both kidneys),
• liver disease,
• heart disease,
• diabetes,
• gout,
• elevated aldosterone levels (retention of water and salt 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 itself,
• the active substance hydrochlorothiazide may rarely cause reactions leading to visual impairment and eye pain. These may be symptoms of fluid accumulation in the non-vascular membrane surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure, which may occur within a few hours to several weeks after taking Tezeo HCT. If left untreated, these may lead to permanent vision impairment.
• if you have previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Tezeo HCT, protect your skin from sunlight and UV radiation.

Before starting Tezeo HCT, inform your doctor:

• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if you have 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 use Tezeo HCT”.

• about taking digoxin,
• if you have previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or breathing difficulties after taking Tezeo HCT, seek immediate medical help.

You must inform your doctor if you suspect you are pregnant (or could be pregnant). Use of Tezeo HCT is not recommended during early pregnancy. Do not use it after
the 3rd month of pregnancy, as it may seriously harm the unborn child (see pregnancy section).

Treatment with hydrochlorothiazide may lead to electrolyte imbalance
in the body. Typical symptoms of water or electrolyte imbalance include dryness of the mucous membranes in the mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and abnormally rapid heartbeat (faster than 100 beats per minute). If any of these symptoms occur, inform your doctor.
You should also inform your doctor if you experience skin hypersensitivity to sunlight,
manifesting as sunburn (such as redness, itching, swelling, or blistering) occurring more quickly than usual.
If you are scheduled for surgery or anaesthesia, inform your doctor
that you are taking Tezeo HCT. Tezeo HCT may be less effective in lowering blood pressure in individuals of Black race.
If you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Tezeo HCT,
discuss this with your doctor. Your doctor will decide on further treatment. Do not make independent decisions to stop taking Tezeo HCT.

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

Tezeo HCT and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Your doctor may decide to adjust the dose of these medicines or take other precautions.
In some cases, it may be necessary to discontinue one of these medicines.
This particularly applies to concomitant use of Tezeo HCT with the following medicines:

• lithium preparations used to treat certain types of depression,
• medicines that reduce blood potassium levels (hypokalaemia), such as other diuretics (water tablets), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (adrenocorticotropic hormone), amphotericin (antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium salt of penicillin G (antibiotic), salicylic acid and its derivatives,
• iodinated contrast agents used in imaging procedures,
• medicines that may increase blood potassium levels, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, angiotensin-converting enzyme (ACE) inhibitors, cyclosporine (immunosuppressive medicine), and other medicines such as sodium heparin (anticoagulant),
• medicines affected by changes in blood potassium levels, such as cardiac medicines (e.g. digoxin) or medicines used to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used to treat psychiatric 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 for diabetes (insulin or oral medicines such as metformin),
• cholestyramine and colestipol, medicines that lower blood lipid levels,
• medicines that raise blood pressure such as noradrenaline,
• muscle relaxants such as tubocurarine,
• calcium supplements and (or) vitamin D,
• anticholinergic medicines (used to treat various disorders such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as adjuncts in anaesthesia), such as atropine and biperiden,
• amantadine (a medicine used in Parkinson's disease and also for treating and preventing certain viral diseases),
• other medicines used to treat hypertension, 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 information under the headings “When not to use 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 low blood pressure (e.g. baclofen, amifostine). Additionally, alcohol,
barbiturates, narcotics, or antidepressants may further lower blood pressure. Symptoms of excessively low blood pressure may include dizziness upon standing. Consult your doctor if dosage adjustments of other medicines taken during Tezeo HCT therapy are needed.
The effect of Tezeo HCT may be reduced when taking NSAIDs
(non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen).

Taking Tezeo HCT with food and alcohol
Tezeo HCT can be taken with food or independently of meals. Avoid consuming alcohol until you have spoken with your doctor. Alcohol may additionally lower blood pressure and (or) increase the risk of dizziness or fainting.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will usually recommend discontinuing Tezeo HCT before planned pregnancy or immediately after pregnancy is confirmed, and will prescribe an alternative medicine instead of Tezeo HCT. Use of Tezeo HCT is not recommended during pregnancy. Do not use it after the 3rd month of pregnancy, as it may seriously harm the unborn child if used beyond the third month of pregnancy.
Breastfeeding
Inform your treating doctor if you are breastfeeding or plan to breastfeed.
Use of Tezeo HCT is not recommended during breastfeeding. Your doctor may prescribe alternative treatment for patients who intend to breastfeed.

Driving and operating machinery
Some patients taking Tezeo HCT may experience dizziness, fainting, or vertigo. If such adverse effects occur, do not drive or operate machinery.

Tezeo HCT contains sorbitol (E420) and sodium

• The medicine contains 174.15 mg of sorbitol per tablet.

Sorbitol is a source of fructose. If you have 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, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tezeo HCT
Always use this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose of Tezeo HCT is one tablet daily. Try to take the tablet at the same time each day. Tezeo HCT can be taken independently of meals. Swallow the tablets whole with water or another non-alcoholic drink. It is important to take Tezeo HCT daily unless otherwise instructed by your doctor.
In case of impaired liver function, the usual dose should generally not exceed 40 mg telmisartan once daily.

Taking more Tezeo HCT than recommended
If too many tablets are accidentally taken, signs such as low blood pressure and rapid heartbeat may occur. Cases of slowed heartbeat, dizziness, vomiting, worsening kidney function, including kidney failure, have also been reported. Due to the presence of hydrochlorothiazide, markedly low blood pressure and low blood potassium levels may also occur, potentially leading to nausea, drowsiness, muscle cramps, and/or irregular heartbeat, particularly when used concomitantly with medicines such as cardiac glycosides and certain antiarrhythmic drugs. Seek immediate medical help from your doctor, pharmacist, or the nearest hospital emergency department.

Missed dose of Tezeo HCT
If you miss a dose, take it as soon as you remember, then continue with your regular dosing schedule. If a tablet is not taken on a given day, take the next dose the following day. Do not take a double dose to make up for a missed dose.
If you have any further questions about using 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* (often called "blood poisoning", a severe infection causing 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).

The above adverse reactions are rare (may occur in up to 1 in 1,000 people) or very rare (in the case of toxic epidermal necrolysis; may occur in up to 1 in 10,000 patients), but are very serious. In such cases, treatment with this medicine must be stopped immediately and medical advice sought without delay. If the above symptoms are not treated, they may result in death.
An increased incidence of sepsis has been observed in patients taking telmisartan as monotherapy; however, sepsis cannot be excluded in patients treated with Tezeo HCT.
Possible adverse reactions of Tezeo HCT:
Common (may occur in up to 1 in 10 people):

• dizziness.

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

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

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

• lung inflammation (bronchitis),
• sore throat,
• sinusitis,
• increased uric acid levels,
• low sodium levels,
• feeling of sadness (depression),
• difficulty falling asleep (insomnia),
• sleep disturbances,
• visual disturbances,
• blurred vision,
• breathing difficulties,
• abdominal pain,
• constipation,
• bloating (dyspepsia),
• nausea (vomiting),
• inflammation of the gastric mucosa,
• liver function abnormalities (more frequently observed in patients of Japanese origin),
• skin redness (flushing),
• allergic reactions such as itching or rash,
• increased sweating,
• urticaria,
• joint pain and limb pain (leg pain),
• muscle cramps,
• activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body itself, causing joint pain, skin rashes and fever),
• influenza-like symptoms,
• pain,
• increased creatinine levels, increased liver enzymes or creatine kinase in blood.

Adverse reactions reported for one of the components may also occur during treatment with the fixed-dose combination product telmisartan with hydrochlorothiazide, even if they were not observed in clinical trials of this combination.
Telmisartan
In patients receiving telmisartan alone, the following additional adverse reactions 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,
• urinary tract infections,
• red blood cell deficiency - anemia,
• high potassium levels,
• abnormally slow heart rate (bradycardia),
• cough,
• kidney function disorders, including acute renal failure,
• fatigue.

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

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

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

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

Frequency unknown (cannot be estimated from available data):

• intestinal angioedema – following administration of similar products, intestinal swelling has occurred with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

* This event may be coincidental or related to a currently unknown mechanism.
** Cases of progressive lung tissue scarring have been reported during telmisartan treatment. However, a causal relationship with telmisartan use has not been established.
Hydrochlorothiazide
In patients receiving hydrochlorothiazide alone, the following additional adverse reactions 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 blood,
• decreased appetite.

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

• acute renal failure.

Rare (may occur in up to 1 in 1,000 patients):

• low platelet count (thrombocytopenia), increasing the risk of bleeding or bruising (small purple-red skin lesions or in other tissues caused by bleeding),
• high calcium levels in blood,
• high blood sugar levels,
• headache,
• abdominal discomfort,
• yellowing of the skin or eyes (jaundice),
• increased bile substances in blood (cholestasis),
• photosensitivity reactions,
• uncontrolled blood glucose levels in patients with diagnosed diabetes,
• presence of sugars in urine (glucosuria).

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

• abnormal breakdown of red blood cells (hemolytic anemia),
• inability of bone marrow to function properly,
• reduced white blood cell count (leukopenia, agranulocytosis),
• severe allergic reactions (e.g. hypersensitivity),
• increased pH due to low chloride levels in blood (acid-base imbalance, hypochloremic alkalosis),
• acute respiratory failure (symptoms include severe shortness of breath, fever, fatigue and confusion),
• pancreatitis,
• lupus-like syndrome (a disease mimicking systemic lupus erythematosus, in which the body is attacked by its own immune system),
• vasculitis (necrotizing vasculitis).

Frequency unknown (cannot be estimated from available data):

• sialadenitis (inflammation of salivary glands),
• malignant skin and lip tumors (non-melanoma skin cancers),
• reduced blood cell count (aplastic anemia),
• visual impairment and eye pain (possible symptoms of fluid accumulation in the uvea – excessive fluid buildup between choroid and sclera – or acute angle-closure glaucoma),
• skin disorders such as cutaneous vasculitis, photosensitivity, rash, skin redness, blistering on lips, eyes and mouth, excessive skin peeling, fever (possible symptoms of erythema multiforme),
• weakness,
• kidney function disorders,
• isolated cases of low sodium levels associated with neurological or brain symptoms (nausea, progressive disorientation, lack of interest or energy).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also 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, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the 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 stated on the carton and blister pack after:
Expiry. The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Tezeo HCT contains
The active substances in this medicine are: telmisartan and hydrochlorothiazide.
Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
The other components 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 the imprint "41" on one side, measuring 12 mm in length and 6 mm in width.

Contents of the pack
Blister packs made of OPA/Aluminium/PVC-Aluminium in cardboard boxes.
Pack sizes: 28, 56 or 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 detailed information about the medicine and its names in the countries of the European Economic Area, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00