Telmizek hct

Package leaflet: Information for the patient

Telmizek HCT, 40 mg + 12.5 mg, tablets
Telmizek HCT, 80 mg + 12.5 mg, tablets
Telmizek HCT, 80 mg + 25 mg, tablets
Telmisartanum + Hydrochlorothiazidum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

Telmizek 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 antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, causing blood vessels to widen and blood pressure to decrease.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase urine production, leading to a reduction in blood pressure.

Untreated high blood pressure may damage blood vessels in various organs and, in some cases, may lead to complications such as heart attack, heart failure or kidney failure, stroke, or vision loss. Often, there are no 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.
Telmizek HCT is used for the treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by telmisartan alone.

2. Important information before using Telmizek HCT

When not to use Telmizek 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 sulfonamide derivatives;
• after the third month of pregnancy (the use of Telmizek HCT should also be avoided during early pregnancy – see section “Pregnancy”);
• if the patient has severe liver disease, such as biliary obstruction or cholestasis (impaired bile flow from the gallbladder), or any other severe liver disease;
• if the patient has severe kidney disease;
• if the doctor has diagnosed low blood potassium levels or high blood calcium levels that do not improve with treatment;
• if the patient has diabetes or kidney problems 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 Telmizek HCT.

Warnings and precautions

If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Telmizek HCT, discuss this with the doctor. The doctor will decide whether treatment should continue. Do not stop taking Telmizek HCT on your own.

Inform your doctor if the patient has or has 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 a salt deficiency due to diuretics (water tablets), a low-salt diet, diarrhoea, vomiting, or haemodialysis;
• kidney disease or kidney transplant;
• renal artery stenosis (narrowing of the blood vessels to one or both kidneys);
• liver disease;
• heart problems;
• diabetes;
• gout;
• increased aldosterone levels (retention of water and salt in the body along with 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 cause rare reactions leading to vision disturbances and eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid buildup between the choroid and sclera) or increased intraocular pressure, which may occur within hours to weeks after taking Telmizek HCT. If untreated, these may lead to permanent vision impairment.
• if the patient has previously had skin cancer or develops unexpected skin changes. 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 Telmizek HCT, protect the skin from sunlight and UV radiation.

Before starting Telmizek HCT, discuss the following with your 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), especially 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.
• if the patient is taking digoxin.
• if the patient 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 difficulty breathing after taking Telmizek HCT, seek immediate medical help.

Inform your doctor if pregnancy is suspected (or planned). Telmizek HCT is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy”).

Treatment with hydrochlorothiazide may lead to electrolyte imbalance in the body. Typical symptoms of fluid or electrolyte imbalance include dryness of the mucous membranes in the mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, fatigue, and abnormally rapid heartbeat (faster than 100 beats per minute). If any of these symptoms occur, inform your doctor.

Also inform your doctor if the patient experiences skin hypersensitivity to sunlight, such as sunburn (e.g. redness, itching, swelling, blistering) occurring more easily than usual.

If undergoing surgery or anaesthesia, inform the doctor about taking Telmizek HCT.

Telmizek HCT may be less effective in lowering blood pressure in black patients.

Children and adolescents

The use of Telmizek HCT in children and adolescents under 18 years of age is not recommended.

Telmizek HCT with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

The treating doctor may need to adjust the dose and/or take additional precautions. In some cases, one of the medicines may need to be discontinued. This particularly applies when Telmizek HCT is taken together with any of the following medicines:

• lithium preparations, used to treat certain types of depression;
• medicines associated with low blood potassium levels (hypokalaemia), such as other diuretics (water tablets), laxatives (e.g. castor oil), corticosteroids (e.g. prednisolone), 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;
• medicines that may increase blood potassium levels, e.g. potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicinal products, e.g. sodium heparin (an anticoagulant);
• medicines affected by changes in blood potassium levels, such as heart medicines (e.g. digoxin) or medicines regulating heart rate (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 in treating allergic reactions (e.g. terfenadine);
• medicines used in 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 in the treatment or prevention of certain viral infections);
• 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;
• use of an ACE inhibitor or aliskiren (see also information under the headings “When not to take MicardisPlus” and “Warnings and precautions”);
• digoxin.

Telmizek 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, low blood pressure may be further reduced by alcohol, barbiturates, narcotics, or antidepressants. Symptoms include dizziness upon standing. If necessary, consult your doctor about adjusting the dose of other medicines taken during Telmizek HCT treatment.

The effect of Telmizek HCT may be reduced when taken together with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen).

Taking Telmizek HCT with food and alcohol

Telmizek HCT can be taken with food or independently of meals.

Avoid alcohol until you have spoken with your doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if pregnancy is suspected (or planned). Usually, the doctor will recommend stopping Telmizek HCT before a planned pregnancy or immediately after pregnancy is confirmed and will prescribe an alternative medicine. Telmizek HCT is not recommended during pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used after 3 months of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Telmizek HCT is not recommended during breastfeeding. The doctor may choose an alternative treatment during breastfeeding, especially if the baby is a newborn or was born prematurely.

Driving and operating machinery

Some patients taking Telmizek HCT may experience dizziness or fatigue. In such cases, do not drive or operate machinery.

Telmizek HCT contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose (40 mg + 12.5 mg, 80 mg + 12.5 mg, or 40 mg + 25 mg), meaning the medicine is considered “sodium-free”.

3. How to take Telmizek HCT

Telmizek HCT must always be taken according to the doctor's instructions. If in doubt,
consult a doctor or pharmacist.
The recommended dose of Telmizek HCT is one tablet per day. Try to take the tablet
at the same time each day. Telmizek HCT may be taken with or without food.
Tablets should be swallowed with water or a non-alcoholic drink. It is important to take Telmizek
HCT every day, unless otherwise advised by your doctor.
If the patient has impaired liver function, the usual dose should not exceed 40 mg
of telmisartan and 12.5 mg of hydrochlorothiazide per day.
Taking more Telmizek HCT than recommended
If too many tablets are taken by mistake, symptoms such as low blood pressure and rapid heartbeat may occur.
Cases of slow 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,
leading to nausea, drowsiness, muscle cramps, and/or irregular heartbeat, particularly when used concomitantly with drugs such as cardiac glycosides or certain antiarrhythmic medications.
Seek immediate medical advice from a doctor or pharmacist, or go to the nearest hospital emergency department.
Missing a dose of Telmizek HCT
If a patient forgets to take a dose, they should take it as soon as they remember, on the same day.
If a tablet is not taken one day, the usual dose should be taken the next day. Do not take a double dose to make up for a missed dose.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Some adverse reactions may be serious and require immediate medical attention.
If any of the following symptoms occur, contact your doctor immediately:
Sepsis* (commonly known as blood poisoning, a severe infection causing systemic inflammatory response), sudden swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer layer of skin (toxic epidermal necrolysis). The above adverse reactions are rare (may occur in up to 1 in 1,000 patients) or of unknown frequency (in the case of toxic epidermal necrolysis), but are extremely serious; in such cases, treatment with the medicine must be discontinued and immediate medical advice sought. If left untreated, these symptoms may lead to death. Increased incidence of sepsis has been observed in individuals taking telmisartan as monotherapy; however, it cannot be excluded in patients treated with Telmizek HCT.
Possible adverse reactions of Telmizek HCT:
Common adverse reactions (may occur in up to 1 in 10 patients):
Dizziness
Uncommon adverse reactions (may occur in up to 1 in 100 patients):
Decreased blood potassium levels, anxiety, fainting, tingling and numbness (paresthesia), vertigo, rapid heartbeat (tachycardia), heart rhythm disturbances, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnea), diarrhea, dryness of oral mucous membranes, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain erection), chest pain, increased blood uric acid levels.
Rare adverse reactions (may occur in up to 1 in 1,000 patients):
Lung inflammation (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks its own tissues, causing joint pain, skin rash, and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty falling asleep (insomnia), visual disturbances, breathing difficulties, abdominal pain, constipation, bloating (dyspepsia), nausea (vomiting), inflammation of the stomach mucosa, liver function abnormalities (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, muscle cramps, flu-like symptoms, pain, low sodium levels, increased creatinine levels, increased blood liver enzymes or creatine kinase activity.
Adverse reactions reported for one of the components may also occur during treatment with Telmizek HCT, even if they were not observed in clinical trials of the product.

Telmisartan
In patients receiving telmisartan alone, the following additional adverse reactions have been observed:
Uncommon adverse reactions (may occur in up to 1 in 100 patients):
Upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), urinary tract infections, low red blood cell count (anemia), high potassium levels, slow heart rate (bradycardia), kidney function impairment, including acute renal failure, fatigue, cough.
Rare adverse reactions (may occur in up to 1 in 1,000 patients):
Low platelet count (thrombocytopenia), increased number of certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood glucose levels (in patients with diabetes), gastritis, rash (skin disorder), joint degeneration, tendonitis, decreased hemoglobin levels (blood protein), drowsiness.
Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Progressive scarring of lung alveoli (interstitial lung disease)**
Frequency not known (frequency cannot be estimated from available data):
Angioedema of the intestine – following administration of similar products, intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported.
* This phenomenon may be coincidental or related to a mechanism not yet understood.
** Cases of interstitial lung disease temporally associated with telmisartan use have been reported. However, a causal relationship has not been established.

Hydrochlorothiazide
In patients receiving hydrochlorothiazide alone, the following additional adverse reactions have been observed:
Common adverse reactions (may occur in up to 1 in 10 patients):
Nausea, low blood magnesium levels.
Rare adverse reactions (may occur in up to 1 in 1,000 patients):
Decreased platelet count, increasing the risk of bleeding or bruising (small purple-red skin or tissue lesions due to hemorrhage), high blood calcium levels, headache.
Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Increased pH (disturbed acid-base balance) due to low blood chloride levels, acute respiratory failure (symptoms include severe shortness of breath, fever, fatigue, and confusion).
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
Salivary gland inflammation, skin and lip malignancies (non-melanoma skin cancers), decreased number (or even absence) of blood cells, including low numbers of red and white blood cells, severe allergic reactions (e.g. hypersensitivity, anaphylactic reactions), decreased or loss of appetite, restlessness, feeling of emptiness in the head, blurred or yellow-tinted vision, visual field restriction and eye pain (possibly symptoms of fluid accumulation in the uvea—the layer surrounding the eye—or excessive fluid buildup between choroid and sclera—or acute myopia or acute angle-closure glaucoma), vasculitis (necrotizing vasculitis), pancreatitis, gastritis, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a disorder mimicking systemic lupus erythematosus, in which the body's immune system attacks its own tissues), skin disorders such as cutaneous vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering on lips, eyes, and mouth, skin peeling, fever (possible symptoms of erythema multiforme), fatigue, kidney inflammation or impaired kidney function, presence of glucose in urine (glucosuria), fever, electrolyte imbalance, increased blood cholesterol levels, reduced blood volume, increased blood glucose levels, difficulty controlling blood/morning glucose levels in patients with diagnosed diabetes, or blood lipids.

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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Telmizek 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, blister pack, or container following "EXP". The expiry date refers to the last day of the specified month.
For Aluminium/Aluminium blisters and HDPE containers:
No special storage conditions required.
For PVC/PVDC/Aluminium blisters:
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Telmizek HCT contains

• The active substances are: telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The active substances are: telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The active substances are: telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
• Other components are: magnesium stearate, potassium hydroxide, meglumine, povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol.

What Telmizek HCT looks like and contents of the pack
Telmizek HCT, 40 mg + 12.5 mg are white or almost white, oval-shaped, biconvex tablets, 6.55 x 13.6 mm in size, marked with “TH” on one side.
Telmizek HCT, 80 mg + 12.5 mg are white or almost white, capsule-shaped tablets, 9.0 x 17.0 mm in size, marked with “TH 12.5” on both sides.
Telmizek HCT, 80 mg + 25 mg are white or almost white, oval-shaped, biconvex tablets, 9.0 x 17.0 mm in size, marked with “TH” on one side and “25” on the other side.
Telmizek HCT, 40 mg + 12.5 mg is available in blisters containing 28, 56, 84 and 98 tablets and in HDPE bottles containing 30, 90 and 250 tablets.
Telmizek HCT, 80 mg + 12.5 mg is available in blisters containing 28, 56 tablets and in HDPE bottles containing 30, 90 and 250 tablets.
Telmizek HCT, 80 mg + 25 mg is available in blisters containing 28, 56 tablets and in HDPE bottles containing 30, 90 and 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer:
Actavis Ltd.
BLB 016 Bulebel Industrial Estate, Zejtun, ZTN 3000
Malta
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
{Poland} {Telmizek HCT}
March 2025