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, 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 of the side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

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 pack 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, resulting in the dilation of blood vessels and a decrease in blood pressure.
• 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 of the time, before these 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.
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 applies to you, inform your doctor or pharmacist before taking Telmisartan HCT EGIS.

Warnings and precautions

Before starting to take this medicine, 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. If you experience severe shortness of breath or difficulty breathing after taking Telmisartan HCT EGIS, seek medical help 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 fluid accumulation between the choroid and sclera) or increased intraocular pressure - they can occur within a few hours to a week after taking Telmisartan HCT EGIS and, if left untreated, can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be more prone to developing this condition. Before starting Telmisartan HCT EGIS, discuss this with your doctor:
• if you are taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitor, 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 (e.g., potassium) in the blood. See also the subsection "When not to take Telmisartan HCT EGIS".
• if you are taking digoxin.

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. It is not recommended to take Telmisartan HCT EGIS during early pregnancy, and you should not take it after the third month of pregnancy, as it can seriously harm your baby (see "Pregnancy").
If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartan HCT EGIS, discuss it with your doctor. Your doctor will decide on further treatment. Do 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, anxiety, muscle cramps, nausea (nausea), vomiting, fatigue, and irregular heartbeat (faster than 100 heartbeats 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, with sunburn (e.g., redness, itching, swelling, blistering), occurring more quickly than usual.
If you are scheduled for surgery or anesthesia, inform your doctor that you are taking Telmisartan HCT EGIS.
Telmisartan HCT EGIS may be less effective in lowering blood pressure in black patients.

Children and adolescents

Telmisartan HCT EGIS is not recommended for children and adolescents under 18 years of age.

Telmisartan HCT EGIS and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, 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 stop taking 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 contrast agents used for imaging studies, - medicines that can increase potassium levels in the blood, e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressive medicine), and other medicinal products, e.g., 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), medicines used to treat mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines, such as certain antibiotics (e.g., sparfloxacin, pentamidine), as well as 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 spastic conditions of the gastrointestinal tract, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct during anesthesia), such as atropine and bipiperiden,
• 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 subsections "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, 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, adjust the dose of the other medicine you are taking while taking Telmisartan HCT EGIS, 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 drink

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, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Inform your doctor if you are pregnant or think you may be pregnant. Your doctor will usually recommend stopping Telmisartan HCT EGIS before you become pregnant or as soon as you know you are pregnant, and will recommend a different medicine instead of Telmisartan HCT EGIS. You should not take Telmisartan HCT EGIS during pregnancy, and you must not take it after the third month of pregnancy, as it may seriously harm your baby, if taken after 3 months of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Telmisartan HCT EGIS is not recommended for women who are breastfeeding. 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 effects, do not drive or operate machinery.

Telmisartan HCT EGIS contains sodium

This 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Telmisartan HCT EGIS is one tablet per day. Try to take your tablet at the same time each day. Telmisartan HCT EGIS can be taken with or without food. Swallow the tablet whole with 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 heart rate, dizziness, vomiting, worsening kidney function, including kidney failure. 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, muscle cramps, and (or) heart rhythm disturbances, related to the concurrent use of medicines such as digitalis glycosides or certain anti-arrhythmic medicines. Contact your doctor or go to the emergency department of your nearest hospital immediately.

What to do if you forget to take Telmisartan HCT EGIS

If you forget to take a dose, take it as soon as you remember, on the same day. If you do not take the tablet on the scheduled day, take your usual dose the next day. Do not take a double dose to make up for a forgotten dose.

What to do if you stop taking Telmisartan HCT EGIS

Do not stop taking Telmisartan HCT EGIS without talking to 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 on the use of this product, 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 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, including anaphylactic shock), 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 1,000 people) or very rare (may affect up to 1 in 10,000 people), but are extremely severe, and you should stop taking the medicine and contact your doctor immediately. If left untreated, these symptoms can 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.

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 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, dry 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 1,000 people):
Pneumonia (inflammation of the lungs), sore throat, sinusitis, increased uric acid levels, low sodium levels, depression, 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), skin redness (rash), allergic reactions, such as itching or hives, increased sweating, urticaria, joint pain and limb pain (leg pain), muscle spasms, exacerbation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks itself, 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 when taking 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 problems, including acute kidney failure, weakness, cough.
Rare side effects (may affect up to 1 in 1,000 people):
Low platelet count (thrombocytopenia), increased white blood cell count (eosinophilia), severe allergic reaction (e.g., hypersensitivity, anaphylactic reaction), low blood sugar levels (in diabetic patients), stomach upset, skin disorders (including rash, skin exfoliation, toxic skin reactions), joint pain, 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):
Intestinal angioedema – angioedema of the intestine has been reported with similar products, 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.
**Cases of interstitial lung disease have been reported in association with 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 1,000 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), abnormal liver function (including bile flow obstruction), allergic reactions, such as itching or hives, increased sensitivity to sunlight, rash, skin redness, blistering of the skin, liver disorders, including hepatitis (inflammation of the liver), and abnormal liver function tests.
Very rare side effects (may affect up to 1 in 10,000 people):
Hemolytic anemia (a condition in which red blood cells are destroyed faster than they can be made), bone marrow failure (a condition in which the bone marrow fails to produce enough blood cells), severe allergic reactions (e.g., hypersensitivity), high blood sugar levels in diabetic patients, kidney problems, including acute kidney failure, and other kidney disorders.
Frequency not known (frequency cannot be estimated from the available data):
Salivary gland inflammation, malignant tumors of the skin and lips (non-melanoma skin cancer), bone marrow failure (aplastic anemia), vision disturbances 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), skin disorders, such as vasculitis (inflammation of blood vessels in the skin), increased sensitivity to sunlight, rash, skin redness, blistering of the skin, fever (possibly symptoms of erythema multiforme), weakness, kidney problems.
In isolated cases, low sodium levels have been reported, accompanied by symptoms affecting the brain or nerves (nausea, progressive disorientation, lack of interest or energy).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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:
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

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 or blister after EXP. The expiry date refers to the last day of that month.
Aluminium/Aluminium blister
No special storage precautions are required.
PVC/PVDC/Aluminium blister
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 pack 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, 6.55 x 13.6 mm in size, with the inscription "TH" on one side.
80 mg + 12.5 mg
White or almost white, capsule-shaped tablets, 9.0 x 17.0 mm in size, with the inscription "TH 12.5" on both sides.
80 mg + 25 mg
White or almost white, biconvex, oval-shaped tablets, 9.0 x 17.0 mm in size, 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