Telmizek Hct

Leaflet accompanying the packaging: patient information

Telmizek HCT, 40 mg + 12.5 mg, tablets
Telmizek HCT, 80 mg + 12.5 mg, tablets
Telmizek 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, so you can read it again if you need to.
• If you have any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Telmizek HCT and what is it 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 packaging and other information

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

Telmizek 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 antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, causing blood vessels to dilate 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 various organs, and in some cases, it can lead to complications such as heart attack, heart failure, or kidney failure, stroke, or vision loss. Most often, before the above complications occur, no symptoms of high blood pressure are observed. Therefore, it is essential to regularly measure blood pressure to check if it is within the normal range.

Telmizek HCT is usedto treat high blood pressure (essential hypertension) in adults who are not adequately controlled by telmisartan alone.

2. Important information before taking Telmizek HCT

When not to take Telmizek HCT

• after the third month of pregnancy (it is also recommended to avoid taking Telmizek HCT in early pregnancy - see "Pregnancy");

If any of the above situations apply to you, inform your doctor or pharmacist before taking Telmizek HCT.

Warnings and precautions

If you experience stomach pain, nausea, vomiting, or diarrhea after taking Telmizek HCT, discuss it with your doctor. The doctor will decide on further treatment. Do not stop taking Telmizek HCT on your own.

Tell your doctor if you have or have had any of the following conditions or diseases:

• low blood pressure (hypotension), which is more likely to occur if you are dehydrated (have excessive water loss) or have a low salt level due to taking diuretics (water pills), a low-salt diet, diarrhea, vomiting, or hemodialysis;
• kidney disease or kidney transplant;
• renal artery stenosis (narrowing of the blood vessels of one or both kidneys);
• liver disease;
• heart problems;
• diabetes;
• gout;
• increased aldosterone levels (water and salt retention in the body, along with electrolyte imbalance);
• systemic lupus erythematosus (also called "lupus" or "SLE"), a disease in which the immune system attacks the body;
• hydrochlorothiazide may cause rare reactions that lead to vision loss and 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 can occur within a few hours to a few weeks after taking Telmizek HCT. If left untreated, they can lead to permanent vision impairment.
• If you have a history of malignant skin tumor 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 Telmizek HCT, protect your skin from sunlight and UV radiation.

Before starting Telmizek HCT, discuss the following with your doctor:

• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have diabetic kidney disease.
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

Tell your doctor if you suspect (or plan) pregnancy. It is not recommended to take Telmizek HCT during pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "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 cramps, nausea (vomiting), vomiting, fatigue, and irregular heartbeat (faster than 100 beats per minute). If you experience any of these symptoms, inform your doctor.

Also, inform your doctor if you experience increased sensitivity of the skin to sunlight, such as sunburn (e.g., redness, itching, swelling, blistering) that occurs more quickly than usual.

If you are scheduled for surgery or anesthesia, inform your doctor that you are taking Telmizek HCT.

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

Children and adolescents

Telmizek HCT should not be used in children and adolescents under 18 years of age.

Telmizek HCT and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Your doctor may need to change the dose and/or take other precautions.

In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines taken with Telmizek HCT:

• lithium preparations used to treat certain types of depression;
• medicines that can cause low potassium levels in the blood (hypokalemia), such as other diuretics (water pills), laxatives (e.g., castor oil), corticosteroids (e.g., prednisolone), adrenocorticotropic hormone (ACTH), amphotericin (an antifungal medicine), carbenoxolone (used to treat stomach ulcers), sodium penicillin G (an antibiotic), and salicylic acid and its derivatives;
• 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 heart medicines (e.g., digoxin) or medicines that regulate 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)

Telmizek 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, low blood pressure may be further decreased by: alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. If necessary, the dose of other medicines you are taking with Telmizek HCT should be adjusted by your doctor.

The effect of Telmizek HCT may be reduced when taken with nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin or ibuprofen).

Taking Telmizek HCT with food and alcohol

Telmizek HCT can be taken with or without food.

Avoid 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

Tell your doctor if you suspect (or plan) pregnancy. Usually, your doctor will advise you to stop taking Telmizek HCT before planned pregnancy or as soon as you know you are pregnant and will prescribe a different medicine instead of Telmizek HCT. It is not recommended to take Telmizek HCT during pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy").

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Telmizek HCT is not recommended during breastfeeding. Your doctor may choose a different treatment during breastfeeding, especially if the baby is a newborn or premature.

Driving and using machines

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

Telmizek HCT contains sodium

The 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), which means it is essentially "sodium-free".

3. How to take Telmizek HCT

Always take Telmizek HCT exactly as your doctor has told you. If you are not sure, ask your 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 can be taken with or without food.

Swallow the tablets with water or a non-alcoholic drink. It is important to take Telmizek HCT every day, unless your doctor tells you to stop.

If you have liver problems, the usual dose should not exceed 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide per day.

If you take more Telmizek HCT than you should

If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, worsening kidney function, including kidney failure, have also been reported. 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 use of medicines such as digitalis glycosides and certain anti-arrhythmic medicines. Contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.

If you forget to take Telmizek HCT

If you miss a dose, take it as soon as you remember on the same day. If the tablet is not taken on one day, take the usual dose the next day. Do nottake a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmizek HCT 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 skin (toxic epidermal necrolysis). These side effects are rare (may affect up to 1 in 1000 people) or have an unknown frequency (cannot be estimated from the available data), but they are extremely serious; in such cases, stop taking the medicine and contact your doctor immediately. If left untreated, they can be fatal. The increased frequency of septicemia has been observed in patients taking telmisartan in monotherapy; however, it cannot be ruled out in the case of Telmizek HCT therapy.

Side effects of Telmizek HCT:

Common side effects (may affect up to 1 in 10 people):
Dizziness
Uncommon side effects (may affect up to 1 in 100 people):
Low potassium levels in the blood, anxiety, fainting, tingling or numbness (paresthesia), spinning sensation, rapid heartbeat (tachycardia), irregular heartbeat, 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 or maintain an erection), chest pain, increased uric acid levels in the blood.
Rare side effects (may affect up to 1 in 1000 people):
Bronchitis (inflammation of the airways), sinusitis (inflammation of the sinuses), activation or exacerbation of systemic lupus erythematosus (a disease in which the immune system attacks the body, causing joint pain, skin rashes, and fever), sore throat, sinusitis, depression (feeling sad), insomnia (difficulty sleeping), vision disturbances, breathing difficulties, stomach pain, constipation, bloating (indigestion), nausea (vomiting), stomach inflammation, abnormal liver function (more common in Japanese patients), redness of the skin (rash), allergic reactions, such as itching or hives, increased sweating, hives, joint pain and limb pain, muscle cramps, flu-like symptoms, pain, low sodium levels, increased creatinine levels, increased liver enzyme activity or creatine phosphokinase in the blood.

Telmisartan

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

Uncommon side effects (may affect up to 1 in 100 people):
Upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), urinary tract infections, low red blood cell count (anemia), high potassium levels in the blood, slow heart rate (bradycardia), kidney problems, including acute kidney failure, weakness, cough.
Rare side effects (may affect up to 1 in 1000 people):
Low platelet count (thrombocytopenia), increased white blood cell count (eosinophilia), severe allergic reaction (e.g., hypersensitivity, anaphylactic reaction, skin rash), low blood sugar levels (in diabetic patients), stomach upset, skin peeling (exfoliative dermatitis), joint degeneration, tendonitis, decreased hemoglobin levels (a protein in the blood), drowsiness.
Very rare side effects (may affect up to 1 in 10,000 people):
Progressive scarring of the lung tissue (interstitial lung disease)**
Frequency not known (cannot be estimated from the available data):
Intestinal angioedema - angioedema of the intestine has been reported with similar products, with symptoms such as stomach pain, nausea, vomiting, and diarrhea.
* This phenomenon may be coincidental or related to a mechanism that has not yet been understood.
** Cases of interstitial lung disease have been reported in association with telmisartan; however, a causal relationship has not been established.

Hydrochlorothiazide

In patients taking only hydrochlorothiazide, the following additional side effects have been observed:

Common side effects (may affect up to 1 in 10 people):
Nausea, low magnesium levels in the blood.
Rare side effects (may affect up to 1 in 1000 people):
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, headache.
Very rare side effects (may affect up to 1 in 10,000 people):
Increased pH (disturbed acid-base balance) due to low chloride levels in the blood, acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).
Side effects with unknown frequency (frequency cannot be estimated from the available data):
Salivary gland inflammation, malignant skin tumors and lip tumors (non-melanoma skin cancer), decreased blood cell count (or lack thereof), including low red and white blood cell count, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or lost appetite, restlessness, feeling of emptiness in the head, blurred vision or yellow vision, limited vision and eye pain (likely symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute glaucoma or acute angle-closure glaucoma), vasculitis (inflammation of blood vessels), pancreatitis (inflammation of the pancreas), jaundice (yellowing of the skin or eyes), lupus-like syndrome (a disease that mimics systemic lupus erythematosus, in which the body is attacked by its own immune system), skin disorders, such as vasculitis, increased sensitivity to sunlight, rash, redness of the skin, blistering on the lips, eyes, and mouth, skin peeling, fever (possible symptoms of erythema multiforme), weakness, kidney inflammation or kidney problems, glucose in the urine (glycosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased blood sugar levels, difficulty controlling blood sugar levels/urine in patients with diagnosed diabetes.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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. By reporting side effects, you can help provide more information on the safety of this 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 packaging, blister, or container after "EXP". The expiry date refers to the last day of the month stated.

For Aluminum/Aluminum blisters and HDPE containers:

No special storage precautions.

For PVC/PVDC/Aluminum blisters:

Do not store above 30°C.

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 packaging 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.
• The other ingredients 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, biconvex tablets, 6.55 x 13.6 mm in size, with "TH" engraved 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, with "TH 12.5" engraved on both sides.

Telmizek HCT, 80 mg + 25 mg, are white or almost white, oval, biconvex tablets, 9.0 x 17.0 mm in size, with "TH" engraved on one side and "25" on the other.

Telmizek HCT, 40 mg + 12.5 mg, is available in blisters of 28, 56, 84, and 98 tablets and in HDPE containers of 30, 90, and 250 tablets.

Telmizek HCT, 80 mg + 12.5 mg, is available in blisters of 28 and 56 tablets and in HDPE containers of 30, 90, and 250 tablets.

Telmizek HCT, 80 mg + 25 mg, is available in blisters of 28 and 56 tablets and in HDPE containers of 30, 90, and 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Manufacturer:

Actavis Ltd.

BLB 016 Bulebel Industrial Estate, Zejtun, ZTN 3000

Malta

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

{Poland}

{Telmizek HCT}

Date of last revision of the leaflet:

March 2025