Telmisartan Egis

Package Leaflet: Information for the User

Telmisartan EGIS, 40 mg, coated tablets

Telmisartan EGIS, 80 mg, coated tablets

Telmisartanum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 the package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the package leaflet:

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

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

Telmisartan EGIS belongs to a group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a substance produced by the body that causes blood vessels to narrow, leading to an increase in blood pressure. Telmisartan EGIS blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Telmisartan EGISis used to treat essential hypertension (high blood pressure) in adults. The term "essential" means that the high blood pressure is not caused by another condition.
Untreated high blood pressure can cause damage to blood vessels in various organs, which can lead to heart attack, heart failure, or kidney failure, stroke, or vision loss. Most people with high blood pressure do not notice any symptoms until complications develop. Therefore, it is important to regularly check blood pressure to ensure it is within the normal range.
Telmisartan EGIS is also usedto reduce the risk of cardiovascular events (such as heart attack or stroke) in patients at high risk, i.e., those with reduced blood flow to the heart or legs, who have had a stroke, or who have diabetes.
Your doctor will inform you if you are at risk of these conditions.

2. Important information before taking Telmisartan EGIS

When not to take Telmisartan EGIS

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
• after the third month of pregnancy. You should also avoid taking Telmisartan EGIS during early pregnancy (see "Pregnancy");
• if you have severe liver problems, such as cholestasis or biliary obstruction (problems with bile flow from the liver and gallbladder) or any other severe liver disease;
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.

If any of these conditions apply to you, inform your doctor or pharmacist before taking Telmisartan EGIS.

Warnings and precautions

Before taking Telmisartan EGIS, discuss it with your doctor or pharmacist.
Tell your doctor if you have or have had any of the following conditions or diseases:

• kidney disease or kidney transplant;
• renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys);
• liver disease;
• heart problems;
• high aldosterone levels (water and salt retention in the body, accompanied by mineral imbalance in the blood);
• low blood pressure (hypotension), which is more likely if you are dehydrated or have low salt levels due to diuretic use, low-salt diet, diarrhea, or vomiting;
• high potassium levels in the blood;
• diabetes,
• if you are taking any of the following medicines for high blood pressure:
• 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. See also the information under "When not to take Telmisartan EGIS" and "Warnings and precautions". Before taking Telmisartan EGIS, inform your doctor:
• about taking digoxin. Inform your doctor if you are pregnant or planning to become pregnant. Telmisartan EGIS is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may harm the baby (see "Pregnancy").

If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartan EGIS, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Telmisartan EGIS on your own.
In case of planned surgery or anesthesia, inform your doctor that you are taking Telmisartan EGIS.
Like other blood pressure-lowering medicines, Telmisartan EGIS may be less effective in lowering blood pressure in black patients.

Children and adolescents

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

Telmisartan EGIS with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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 Telmisartan EGIS:

• lithium preparations used to treat certain types of depression;
• medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, or the antibiotic trimethoprim;
• diuretics, especially when taken in high doses with Telmisartan EGIS, as they can lead to significant water loss and low blood pressure (hypotension);
• if you are taking an ACE inhibitor or aliskiren (see also the information under "When not to take Telmisartan EGIS" and "Warnings and precautions").
• digoxin. As with other blood pressure-lowering medicines, the effect of Telmisartan EGIS may be reduced when taken with non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin or ibuprofen) or corticosteroids.

Telmisartan EGIS may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can cause low blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure can be further reduced by: alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. If you need to adjust the dose of another medicine you are taking while taking Telmisartan EGIS, consult your doctor.

Telmisartan EGIS with food and drink

You can take Telmisartan EGIS with or without food.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Normally, your doctor will advise you to stop taking Telmisartan EGIS before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Telmisartan EGIS. You should not take Telmisartan EGIS during early pregnancy and should not take it after the third month of pregnancy, as it may harm the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor ifyou are breastfeeding or plan to breastfeed. Telmisartan EGIS is not recommended for breastfeeding women. Your doctor may choose a different treatment if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Some patients may experience dizziness or fatigue while taking Telmisartan EGIS. If you experience dizziness or fatigue, do not drive or operate machinery.

Telmisartan EGIS contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Telmisartan EGIS

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Telmisartan EGIS is one tablet per day. Try to take the tablet at the same time each day.
Telmisartan EGIS can be taken with or without food. Swallow the tablet with water or another non-alcoholic drink.
It is important to take Telmisartan EGIS every day, unless your doctor tells you to stop.
If you feel that the effect of Telmisartan EGIS is too strong or too weak, talk to your doctor or pharmacist.
In the treatment of high blood pressure, the recommended dose for most patients is one Telmisartan EGIS 40 mg tablet per day, which provides blood pressure control for more than 24 hours. Your doctor may recommend a lower dose of one 20 mg tablet per day or a higher dose of one 80 mg tablet per day.
(Since a 20 mg dose cannot be achieved with Telmisartan EGIS, your doctor may prescribe a different telmisartan-containing medicine for this purpose).
Telmisartan EGIS can also be taken in combination with a diuretic (such as hydrochlorothiazide), which enhances the blood pressure-lowering effect of Telmisartan EGIS.
To reduce the risk of cardiovascular events, the recommended dose of Telmisartan EGIS is one 80 mg tablet per day. When starting treatment with Telmisartan EGIS 80 mg, blood pressure should be frequently monitored.
In patients with liver dysfunction, the recommended dose should not exceed 40 mg per day.

Take more than the recommended dose of Telmisartan EGIS

If you accidentally take too many tablets, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.

Miss a dose of Telmisartan EGIS

If you miss a dose, do not worry. Take it as soon as you remember, and then continue taking your medicine as usual. If you do not take a tablet during the day, take your usual dose the next day. Do not take a double dose to make up for a forgotten dose.

Stop taking Telmisartan EGIS

Do not stop taking Telmisartan EGIS without consulting your doctor.
Medicines for high blood pressure may need to be taken for the rest of your life.
If you stop taking Telmisartan EGIS, your blood pressure will return to its pre-treatment level within a few days.
If you have any further questions about taking this medicine, 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 may require immediate medical attention:

Seek medical attention immediately if you experience any of the following symptoms:
sepsis* (also known as "blood poisoning", a severe infection with inflammation throughout the body), sudden swelling of the skin and mucous membranes (angioedema). These are rare (may affect up to 1 in 1000 people) but very serious side effects, and you must stop taking the medicine and contact your doctor immediately. If these side effects are not treated, they can be fatal.

Side effects that may occur with Telmisartan EGIS:

Common side effects (may affect up to 1 in 10 people):
low blood pressure (hypotension) in patients being treated to reduce the risk of cardiovascular events.
Uncommon side effects (may affect up to 1 in 100 people):
urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), decreased red blood cell count (anemia), high potassium levels in the blood, difficulty sleeping, low mood (depression), fainting, feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients being treated for high blood pressure, dizziness when standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhea, discomfort in the abdomen, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle cramps, muscle pain, kidney problems, including acute kidney failure, chest pain, feeling of weakness, and increased creatinine levels in the blood.
Rare side effects (may affect up to 1 in 1000 people):
sepsis* (also known as "blood poisoning", a severe infection with inflammation throughout the body, which can be fatal), increased eosinophil count (a type of white blood cell), low platelet count (thrombocytopenia), severe allergic reaction (anaphylaxis), allergic reaction (e.g., rash, itching, breathing problems, wheezing, facial swelling, or low blood pressure), low blood pressure (hypotension) in patients with diabetes, feeling of anxiety, drowsiness, vision problems, fast heart rate (tachycardia), dry mouth, gastritis, taste disturbances, liver problems (Japanese patients are more likely to experience this side effect), sudden swelling of the skin and mucous membranes (angioedema), which can be fatal, skin eruptions (skin disease), skin redness, hives, severe skin rash, joint pain, limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels (a protein in the blood), increased uric acid levels, increased liver enzyme activity or creatine phosphokinase in the blood.
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 – intestinal angioedema has been reported with similar products, with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
* The event may be coincidental or related to an unknown mechanism.
** Cases of interstitial lung disease have been reported in association with telmisartan. However, a causal relationship has not been established.

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the online reporting system at 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 Telmisartan EGIS

Store in the original package to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
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 EGIS contains

• The active substance is telmisartan. Each tablet contains 40 mg or 80 mg of telmisartan.

Other ingredients are:
sodium hydroxide,
povidone (K-25),
meglumine,crosopovidone,
yellow iron oxide (E 172),
magnesium stearate.
Coating:
hypromellose,
titanium dioxide (E 171),
macrogol 400,
talc,
yellow iron oxide (E 172)

What Telmisartan EGIS looks like and contents of the pack

Telmisartan EGIS 40 mg tablets: yellow, capsule-shaped, coated tablets with "40" engraved on one side and "T" on the other side.
Telmisartan EGIS 80 mg tablets: yellow, capsule-shaped, coated tablets with "80" engraved on one side and "T" on the other side.
Telmisartan EGIS is available in aluminum/aluminum blister packs containing 14, 15, 28, 30, 56, 60, 84, 90, or 98 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Glenmark Pharmaceuticals s.r.o.
Fibichova 143, 566 17 Vysoké Mýto
Czech Republic
Egis Pharmaceuticals PLC
Bökényföldi út 118-120, 1165 Budapest
Hungary

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

Czech Republic: Telmisartan EGIS
Hungary:
Telmisartan EGIS 20mg/40mg/80mg filmtabletta
Poland:
Telmisartan EGIS
Slovakia:
Telmisartan EGIS 20mg/40mg/80mg
Date of last revision of the package leaflet:13.01.2025