Telmisartan Hct Egis

Leaflet accompanying the packaging: patient information

Telmisartan HCT EGIS, 40 mg + 12.5 mg, tablets
Telmisartan HCT EGIS, 80 mg + 12.5 mg, tablets
Telmisartan HCT EGIS, 80 mg + 25 mg, tablets
Telmisartan + Hydrochlorothiazide

You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, please 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 inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Telmisartan HCT EGIS and what is it used for

Telmisartan HCT EGIS is a combination medicine that contains two active substances, telmisartan and hydrochlorothiazide, in one tablet. Both substances help to control high blood pressure.

• Telmisartan belongs to a group of medicines called angiotensin II receptor blockers. 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 organs, and in some cases, can lead to complications such as heart attack, heart failure, or kidney failure, stroke, or vision loss. Most often, before the onset of these complications, 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.
Telmisartan HCT EGIS is usedto treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by telmisartan alone.

2. Important information before taking Telmisartan HCT EGIS

When not to take Telmisartan HCT EGIS:

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to hydrochlorothiazide or sulfonamide derivatives;
• after the third month of pregnancy (you should also avoid taking Telmisartan HCT EGIS during early pregnancy - see "Pregnancy");
• if you have severe liver disease, such as cholestasis or biliary obstruction (disorders of bile flow from the liver and gallbladder);
• if you have severe kidney disease or anuria (less than 100 ml of urine per day).
• if your doctor has found that you have low potassium or high calcium levels in your blood that do not improve with treatment;
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Before starting to take this medicine, you should discuss it with your doctor or pharmacist if you have or have had any of the following conditions or diseases:

• if you have had problems with breathing or lungs (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Telmisartan HCT EGIS, you should seek medical attention immediately,
• low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive water loss from the body) or have low sodium levels due to taking diuretics (water pills), a low-salt diet, diarrhea, vomiting, or hemofiltration
• kidney disease or post-kidney transplant,
• renal artery stenosis (narrowing of the blood vessels of a single functioning kidney or both kidneys),
• liver disease,
• heart disease,
• diabetes.
• gout.
• increased aldosterone levels (water and salt retention in the body, along with electrolyte imbalance).
• systemic lupus erythematosus (SLE) - a disease in which the immune system attacks the body itself.
• the active substance, hydrochlorothiazide, may cause rare reactions that worsen vision and cause eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between the choroid and sclera) or increased pressure inside the eye - they may occur within a few hours to a week after taking Telmisartan HCT EGIS, and if left untreated, may lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be more prone to developing this disease. Before starting to take Telmisartan HCT EGIS, you should discuss this with your doctor:
• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood. See also the section "When not to take Telmisartan HCT EGIS".
• if you are taking digoxin.

You should inform your doctor about pregnancy, suspected pregnancy (or planning pregnancy). It is not recommended to take Telmisartan HCT EGIS during early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy").
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Telmisartan HCT EGIS, you should discuss this with your doctor. Your doctor will decide on further treatment. You should not stop taking Telmisartan HCT EGIS on your own.
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 (nausea), vomiting, fatigue, and irregular heartbeat (faster than 100 heartbeats per minute). If you experience any of these symptoms, you should inform your doctor.
You should also inform your doctor about increased sensitivity of the skin to sunlight, in the form of sunburn (such as redness, itching, swelling, blistering), appearing more quickly than usual.
In the event of planned surgery or anesthesia, you should inform your doctor about taking Telmisartan HCT EGIS.
Telmisartan HCT EGIS may be less effective in lowering blood pressure in black patients.

Children and adolescents

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

Telmisartan HCT EGIS and other medicines

You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Your doctor may decide to change the dose of these medicines or take other precautions. In some cases, it may be necessary to discontinue one of the medicines.
This is especially true for the following medicines taken with Telmisartan HCT EGIS:

• 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 mouth ulcers), sodium penicillin G (an antibiotic), and salicylic acid and its derivatives,
• iodine-based contrast agents used for imaging studies, - 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), medicines used to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), and medicines used to treat mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), as well as certain antibiotics (e.g., sparfloxacin, pentamidine), and certain medicines used to treat allergic reactions (e.g., terfenadine),
• medicines used to treat diabetes (insulin or oral medicines, such as metformin),
• cholestyramine and colestipol, medicines that lower cholesterol levels in the blood,
• medicines that increase blood pressure, such as noradrenaline,
• muscle relaxants, such as tubocurarine,
• calcium and/or vitamin D supplements,
• medicines with anticholinergic effects (used to treat various disorders, such as spasms of the digestive tract, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct during anesthesia), such as atropine and biphenhydramine,
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases)
• other medicines used to treat high blood pressure, corticosteroids, painkillers (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs)), medicines used to treat cancer, gout (e.g., allopurinol), or arthritis,
• ACE inhibitors or aliskiren (see also the sections "When not to take Telmisartan HCT EGIS" and "Warnings and precautions").
• digoxin.
• If you have had skin cancer or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially long-term use of high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Telmisartan HCT EGIS, you should protect your skin from sun exposure and UV radiation.

Telmisartan HCT EGIS may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines with blood pressure-lowering properties (e.g., baclofen, amifostine). Additionally, low blood pressure may be further reduced by: alcohol, barbiturates, opioids, or antidepressants. The symptom is dizziness when standing up. If necessary, the dose of another medicine you are taking while taking Telmisartan HCT EGIS should be adjusted, and you should consult your doctor.
The effect of Telmisartan HCT EGIS may be weakened when taken with NSAIDs (nonsteroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen).

Taking Telmisartan HCT EGIS with food and alcohol

Telmisartan HCT EGIS can be taken with or without food. You should avoid drinking 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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should inform your doctor about suspected (or planned) pregnancy. Usually, your doctor will recommend stopping Telmisartan HCT EGIS before planned pregnancy or as soon as possible after pregnancy is confirmed, and will recommend a different medicine instead of Telmisartan HCT EGIS. It is not recommended to take Telmisartan HCT EGIS during pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken after 3 months of pregnancy.
Breastfeeding
You should tell your doctor if you are breastfeeding or plan to breastfeed. Telmisartan HCT EGIS is not recommended for breastfeeding women. Your doctor may choose a different treatment if you want to breastfeed.

Driving and using machines

Some patients taking Telmisartan HCT EGIS may experience dizziness, fainting, or a spinning sensation. If you experience any of these side effects, you should not drive or operate machinery.

Telmisartan HCT EGIS contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Telmisartan HCT EGIS

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
The recommended dose of Telmisartan HCT EGIS is one tablet per day. You should try to take your tablet at the same time each day. Telmisartan HCT EGIS can be taken with or without food. The tablets should be swallowed whole, with a glass of water or a non-alcoholic drink. It is important to take Telmisartan HCT EGIS 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 Telmisartan HCT EGIS 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, worsening kidney function, including kidney failure. Due to the presence of hydrochlorothiazide, very low blood pressure and low potassium levels in the blood may also occur, which can lead to nausea, drowsiness, muscle cramps, and (or) heart rhythm disturbances, related to the simultaneous use of medicines such as digitalis glycosides or certain anti-arrhythmic medicines. You should contact your doctor or go to the emergency department of the nearest hospital immediately.

What to do if you forget to take Telmisartan HCT EGIS

If you miss a dose, you should take it as soon as you remember, on the same day. If you do not take the tablet on the same day, you should take your usual dose the next day. You should not take a double dose to make up for a missed dose.

What to do if you stop taking Telmisartan HCT EGIS

You should not stop taking Telmisartan HCT EGIS without consulting your doctor. Medicines used to treat high blood pressure may need to be taken for the rest of your life. If you stop taking Telmisartan HCT EGIS, your blood pressure may return to its pre-treatment levels within a few days.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention:

If you experience any of the following symptoms, you should contact your doctor immediately:
Septicemia* (often referred to as blood poisoning, being a severe infection with an inflammatory response of the whole body), sudden swelling of the skin and mucous membranes (angioedema, including anaphylactic reactions that can be life-threatening), blistering and peeling of the outer layer of the skin (toxic epidermal necrolysis). The above side effects are rare (may affect up to 1 in 1000 people) or very rare (may affect up to 1 in 10,000 people), but are extremely severe, and in such cases, you should stop taking the medicine and contact your doctor immediately. If the above symptoms are not treated, they may be fatal. An increased incidence of septicemia has been observed in patients taking telmisartan monotherapy, but it cannot be ruled out in the case of Telmisartan HCT EGIS therapy.

Possible side effects of Telmisartan HCT EGIS:

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 and numbness (paresthesia), spinning sensation, rapid heartbeat (tachycardia), heart rhythm disturbances, 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 spasms, 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):
Pneumonia (bronchitis), sore throat, sinusitis, increased uric acid levels, low sodium levels, feeling sad (depression), difficulty sleeping (insomnia), sleep disturbances, vision disturbances, blurred vision, breathing difficulties, abdominal pain, constipation, bloating (indigestion), nausea (vomiting), gastritis, abnormal liver function (more common in patients of Japanese origin), redness of the skin (rash), allergic reactions, such as itching or hives, increased sweating, hives, joint pain and limb pain (leg pain), muscle spasms, activation or exacerbation of systemic lupus erythematosus (a disease in which the body is attacked by its own immune system, causing joint pain, skin rashes, and fever), flu-like symptoms, low sodium levels, increased creatinine levels, increased liver enzyme activity or creatine phosphokinase in the blood.
Side effects reported for one of the active substances may also occur during treatment with Telmisartan HCT EGIS, even if they were not observed during clinical trials of the product.

Telmisartan

In patients taking telmisartan alone, 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, urinary tract infection, low red blood cell count (anemia), high potassium levels,
slow heart rate (bradycardia), kidney function disorders, 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, ), low blood sugar levels (in patients with diabetes), stomach upset (gastritis), skin disorder (including rash, skin eruptions, toxic skin eruptions), joint degeneration, tendon pain (symptoms mimicking 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 lungs (interstitial lung disease)**
Frequency not known (frequency cannot be estimated from the available data):
Angioedema of the intestine – after the use of similar products, angioedema of the intestine has been reported, with symptoms such as abdominal pain, nausea, vomiting, and diarrhea..
*This phenomenon may be coincidental or related to a mechanism that has not yet been understood.
**There have been reports of interstitial lung disease associated with the use of telmisartan. However, a causal relationship has not been established.

Hydrochlorothiazide

In patients taking hydrochlorothiazide alone, the following additional side effects have been observed:
Very common side effects (may affect more than 1 in 10 people):
Increased fat levels in the blood.
Common side effects (may affect up to 1 in 10 people):
Nausea, low magnesium levels in the blood, decreased appetite.
Uncommon side effects (may affect up to 1 in 100 people):
Acute kidney failure.
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, high blood sugar levels, headache, abdominal discomfort, jaundice (yellowing of the skin and eyes), elevated bilirubin levels in the blood (bile stagnation), allergic reactions, such as sensitivity to light, uncontrolled blood sugar levels in patients with diagnosed diabetes, presence of sugars in the urine (glucosuria).
Very rare side effects (may affect up to 1 in 10,000 people):
Abnormal breakdown of red blood cells (hemolytic anemia), inability of the bone marrow to function properly, decreased white blood cell count (leukopenia, agranulocytosis), severe allergic reactions (e.g., hypersensitivity), increased blood pH due to low chloride levels (electrolyte imbalance, hypochloremic alkalosis), acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion), pancreatitis, lupus-like syndrome (a disease that mimics systemic lupus erythematosus, in which the body is attacked by its own immune system), vasculitis (inflammation of blood vessels).
Frequency not known (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 (aplastic anemia), vision disturbances and eye pain (possibly symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive accumulation of fluid between the choroid and sclera - or acute glaucoma), skin disorders, such as vasculitis of the skin, 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 function disorders.
In isolated cases, low sodium levels have been reported, accompanied by symptoms related to the brain or nervous system (nausea, progressive disorientation, lack of interest or energy).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Telmisartan HCT EGIS

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP.
The expiry date refers to the last day of that month.
Aluminum/Aluminum Blister
There are no special precautions for storage.
PVC/PVDC/Aluminum Blister
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Telmisartan HCT EGIS 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 (E470b), potassium hydroxide, meglumine, povidone, sodium carboxymethylcellulose (type A), microcrystalline cellulose, mannitol (E421).

What Telmisartan HCT EGIS looks like and contents of the pack

40 mg + 12.5 mg
White or almost white, biconvex, oval-shaped tablets with dimensions of 6.55 x 13.6 mm, with the inscription "TH" on one side.
80 mg + 12.5 mg
White or almost white, capsule-shaped tablets with dimensions of 9.0 x 17.0 mm, with the inscription "TH 12.5" on both sides.
80 mg + 25 mg
White or almost white, biconvex, oval-shaped tablets with dimensions of 9.0 x 17.0 mm, with the inscription "TH" on one side and "25" on the other side.
Pack sizes:
40 mg + 12.5 mg
14, 28, 30, 56, 84, 98 tablets.
80 mg + 12.5 mg, 80 mg + 25 mg
14, 28, 30, 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC
1106 Budapest, Keresztúri út 30-38.
Hungary

Manufacturers

Actavis Ltd.
BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000
Malta
Egis Pharmaceuticals PLC
1165 Budapest, Bökényföldi út 118-120.
Hungary
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Date of last revision of the leaflet:20.02.2025