Tezeo hct

Package leaflet: Information for the patient

Tezeo HCT, 80 mg + 12.5 mg, tablets
Telmisartanum + Hydrochlorothiazidum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, 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 those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet 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 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 effects of angiotensin II, allowing blood vessels to relax and thereby lowering blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase urine production, resulting in a reduction of blood pressure.

Untreated high blood pressure may damage blood vessels in various organs and may eventually lead to heart attack, heart or kidney failure, stroke, or loss of vision. Usually, there are no warning signs or symptoms of high blood pressure before such complications occur. Therefore, it is important to measure blood pressure regularly to ensure it remains within normal limits.
Tezeo HCT is used in 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,
• during the third trimester of pregnancy (Tezeo HCT should also be avoided in early pregnancy; see section on pregnancy),
• 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 potassium or abnormally high calcium levels in the patient's blood that do not improve with treatment,
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

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

• low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive loss of body water) or has salt deficiency due to diuretics (water tablets), low-salt diet, diarrhoea, vomiting, or haemofiltration,
• kidney disease or status post kidney transplantation,
• renal artery stenosis (narrowing of the blood vessels to one or both kidneys),
• liver disease,
• heart disease,
• diabetes,
• gout,
• elevated aldosterone levels (fluid and salt retention in the body accompanied by electrolyte imbalances),
• systemic lupus erythematosus (also known as "lupus" or "SLE"), a condition in which the immune system attacks the body itself,
• the active ingredient hydrochlorothiazide may cause rare reactions leading to vision disturbances and eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid buildup between choroid and sclera) or increased intraocular pressure, which may occur within hours to weeks after taking Tezeo HCT. If untreated, this may lead to permanent vision impairment,
• if the patient has previously had skin cancer or develops unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially at high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. During treatment with Tezeo HCT, the skin should be protected from sunlight and UV radiation.

Before starting Tezeo HCT, inform the doctor:

• 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.

The treating 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”.
when taking digoxin,

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

The patient must inform the doctor immediately if pregnancy is suspected (or if the patient may have become 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 section on pregnancy).

Treatment with hydrochlorothiazide may lead to electrolyte imbalance in the body. Typical symptoms of disturbed water or electrolyte balance include dryness of the oral mucosa, 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 the doctor.
The patient should also inform the doctor about skin photosensitivity, such as sunburn (e.g. redness, itching, swelling, blistering) occurring more easily than usual.
If surgery or anaesthesia is planned, inform the doctor about taking Tezeo HCT.
Tezeo HCT may be less effective in lowering blood pressure in Black patients.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Tezeo HCT, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Tezeo HCT on your own.

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 currently taken or recently taken, as well as any medicines the patient plans to take.
The 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 when taking the following medicines together with Tezeo HCT:

• lithium preparations, used to treat certain types of depression,
• medicines that reduce potassium levels in the blood (hypokalaemia), such as other diuretics, laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat oral ulcers), sodium salt of penicillin G (an antibiotic), salicylic acid and its derivatives,
• iodinated contrast agents used in imaging procedures,
• medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, angiotensin-converting enzyme (ACE) inhibitors, cyclosporine (an immunosuppressant), and other medicines such as sodium heparin (an anticoagulant),
• medicines affected by changes in blood potassium levels, such as cardiac glycosides (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, lipid-lowering medicines,
• 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 (used in Parkinson's disease and also in the treatment and prevention of 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 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 dose adjustments of other medicines taken during Tezeo HCT treatment are needed.
The blood pressure-lowering 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 may 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult her doctor or pharmacist before using this medicine.
The doctor will usually recommend discontinuing Tezeo HCT before a planned pregnancy or immediately after pregnancy is confirmed, and will prescribe an alternative medicine.
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 after the third month of pregnancy.

Breastfeeding
Inform the treating doctor if the patient is breastfeeding or intends to breastfeed.
Tezeo HCT is not recommended during breastfeeding. The doctor may choose an alternative treatment for patients who wish to breastfeed.

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

Tezeo HCT contains sorbitol (E420) and sodium

• The medicine contains 348.3 mg of sorbitol per tablet.

Sorbitol is a source of fructose. If the patient has 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 their 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

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
The recommended dose of Tezeo HCT is one tablet daily. It is advisable to take the tablet at the same
time each day. Tezeo HCT may be taken independently of meals. Tablets should be swallowed whole
with water or another non-alcoholic drink. It is important to take Tezeo HCT every day, unless otherwise
instructed by your doctor.
In case of impaired liver function, the usual dose should not exceed 40 mg of telmisartan once daily.
Taking more Tezeo HCT than prescribed
If an excessive amount of tablets is accidentally taken, symptoms such as low blood pressure and
increased heart rate may occur. Cases of slowed heart rate, 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, which could lead to nausea,
drowsiness, muscle cramps, and/or irregular heartbeat, particularly when used concomitantly with
medicines such as cardiac glycosides and certain antiarrhythmic drugs. You should contact your doctor,
pharmacist, or nearest hospital emergency department immediately.
Missing a dose of Tezeo HCT
If you miss a dose, take it as soon as you remember, then continue taking the medicine according to
your regular 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 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 you experience any of the following symptoms, contact your doctor immediately:

• Septicaemia* (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).

These 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. If left untreated, these symptoms may result in death.
An increased incidence of septicaemia has been observed in patients receiving telmisartan monotherapy; however, it cannot be excluded during treatment 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 blood potassium levels,
• anxiety,
• fainting (syncope),
• tingling,
• sensation of tingling and burning (paraesthesia),
• sensation of spinning (dizziness),
• rapid heartbeat (tachycardia),
• heart rhythm disorders,
• low blood pressure,
• sudden drop in blood pressure upon standing,
• shortness of breath (dyspnoea),
• diarrhoea,
• dryness of the oral mucosa,
• bloating,
• back pain,
• muscle cramps,
• muscle pain,
• erectile dysfunction (inability to achieve and maintain erection),
• chest pain,
• increased blood uric acid levels.

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 disorders (more frequent in patients of Japanese origin),
• skin redness (erythema),
• 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),
• flu-like symptoms,
• pain,
• increased creatinine levels, increased liver enzyme activity or increased creatine phosphokinase in blood.

Adverse reactions reported for one of the components may also occur during therapy with the fixed-dose combination product containing telmisartan and 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,
• cystitis,
• low red blood cell count - anaemia,
• high potassium levels,
• abnormally slow heart rate (bradycardia),
• cough,
• kidney function disorders, including acute renal failure,
• weakness.

Rare (may occur in up to 1 in 1,000 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 patients with diabetes),
• drowsiness,
• gastrointestinal discomfort,
• rash (skin disorder),
• drug eruption,
• toxic skin eruption,
• tendon pain (symptoms mimicking tendonitis),
• decreased haemoglobin concentration (blood protein).

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

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

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

• angioedema of the intestine – with similar products, intestinal swelling has occurred with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

* 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, it has not been established whether this is caused by telmisartan use.
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):

• elevated blood lipid levels.

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

• nausea,
• low blood magnesium levels,
• 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 spots on the skin or other tissues caused by bleeding),
• high blood calcium levels,
• high blood sugar levels,
• headache,
• abdominal discomfort,
• yellowing of the skin or eyes (jaundice),
• excess bile substances in the blood (cholestasis),
• photosensitivity reactions,
• uncontrolled blood glucose levels in patients with diagnosed diabetes,
• presence of sugar in urine (glucosuria).

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

• abnormal breakdown of red blood cells (haemolytic anaemia),
• bone marrow failure to function properly,
• reduced number of white blood cells (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, weakness 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 not known (frequency cannot be estimated from available data):

• sialadenitis (inflammation of the salivary glands),
• malignant skin and lip tumours (non-melanoma skin cancer),
• reduced blood cell count (aplastic anaemia),
• visual impairment and eye pain (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive fluid accumulation between choroid and sclera – or closed-angle 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 accompanied by neurological or cerebral 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 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.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps 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 stated on the carton and blister pack after:
Expiry date. 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 practices 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 telmisartan and 12.5 mg 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 imprint "81" on one side, measuring 16.5 mm in length and 8.3 mm in width.

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

Marketing Authorisation Holder
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 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 about the medicine and its names in the European Economic Area countries,
please contact the local 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