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, 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 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 pack 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 applies to you, tell 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. Your 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 low salt levels due to taking diuretics, 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 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 intraocular pressure, 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 tumors 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). When taking Telmizek HCT, protect your skin from sunlight and UV radiation.

Before starting Telmizek HCT, discuss 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 to become pregnant. 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. Typical symptoms of fluid or electrolyte disorders 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, tell your doctor.

Also, tell 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, tell 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 might 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, 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 digitalis (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 non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid 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 to become pregnant. Your doctor will normally advise you to stop taking Telmizek HCT before you become pregnant or as soon as you find out you are pregnant, and will advise you to take 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.

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 your baby is newborn or premature.

Driving and using machines

Some patients taking Telmizek HCT may experience dizziness or fatigue. If this happens, 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), which 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 your tablet at the same time each day. Telmizek HCT can be taken with or without food.

Swallow the tablet with water or a non-alcoholic drink. It is important to take Telmizek HCT every day, until 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.

What to do 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. There have also been reports of slow heartbeat, dizziness, vomiting, decreased kidney function, including kidney failure. Due to the hydrochlorothiazide content, you may also experience very low blood pressure and low potassium levels in the blood, which can lead to nausea, drowsiness, and muscle cramps, and/or irregular heartbeat associated with the use of digitalis glycosides and certain anti-arrhythmic medicines. Contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.

What to do if you forget to take Telmizek HCT

If you forget to take 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 a systemic inflammatory response), 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 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.

Other possible 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):
Respiratory tract infections (e.g., bronchitis), 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, insomnia, vision disturbances, breathing difficulties, abdominal 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, urticaria, 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, tendon inflammation, decreased hemoglobin levels (a protein in the blood), drowsiness.
Very rare side effects (may affect up to 1 in 10,000 people):
Progressive interstitial lung disease (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 abdominal pain, nausea, vomiting, and diarrhea.

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 increases 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 (cannot be estimated from the available data):
Salivary gland inflammation, malignant skin tumors and lip cancer (non-melanoma skin cancer), decreased blood cell count (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 (possibly symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute glaucoma), vasculitis (inflammation of blood vessels), pancreatitis, stomach upset, liver dysfunction (e.g., jaundice), lupus-like syndrome (a disease that mimics systemic lupus erythematosus, in which the immune system attacks the body), skin disorders, such as vasculitis, increased sensitivity to sunlight, rash, redness of the skin, blistering of the skin, peeling of the skin, 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, or difficulty controlling blood sugar levels in patients with known diabetes.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell 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, 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 which is stated on the carton, blister, or container after "EXP". The expiry date refers to the last day of that month.

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. These measures will help 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.
• 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