Telexer

Leaflet accompanying the packaging: patient information

TELEXER, 150 mg, hard capsules

Dabigatran etexilate

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 inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Telexer and what is it used for

Telexer contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. Its action involves blocking a substance in the body responsible for blood clot formation.
Telexer is used in adults to:

• prevent blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a form of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs and prevent repeated formation of blood clots in the veins of the legs and lungs. Telexer is used in children to:
• treat blood clots and prevent recurrence of blood clots.

2. Important information before taking Telexer

When not to take Telexer

Warnings and precautions

Before starting Telexer, discuss it with your doctor. If you have experienced symptoms or undergone surgery while taking this medicine, you should also consult your doctor.
The patient should inform the doctorif they have or have had any medical conditions or diseases, especially those listed below:

When to be particularly careful when taking Telexer

you should immediately inform your doctor if you experience numbness or weakness in your lower limbs or bowel or bladder problems after the anesthesia has worn off, as urgent medical attention is necessary.
if you have fallen or injured yourself while taking Telexer, especially if you have injured your head. You should seek medical attention immediately. The doctor will examine you to see if you may have an increased risk of bleeding.
if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

Telexer and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take. In particular, tell your doctor before taking Telexer if you are taking any of the following
medicines:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are used only on the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking verapamil-containing medicines, the doctor may recommend a lower dose of Telexer, depending on the condition for which it was prescribed. See section 3.
• Medicines used to prevent organ rejection (e.g. tacrolimus, cyclosporine).
• A combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac).
• St. John's Wort, a herbal medicine used to treat depression.
• Antidepressant medicines called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medicines used to treat AIDS (e.g. ritonavir).
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effect of Telexer on pregnancy and the unborn child is not known. You should not take this medicine during pregnancy, unless your doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Telexer.
Do not breastfeed while taking Telexer.

Driving and using machines

Telexer has no effect on the ability to drive and use machines.

3. How to take Telexer

Telexer capsules can be used in adults and children aged 8 years or older who can swallow capsules whole.
This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor.

Telexer should be taken as follows:

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart function and treatment of blood clots in the veins of the legs and lungs and prevention of repeated formation of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken in the form of one 150 mg capsule twice a day.
In patients aged 80 years or olderthe recommended dose is 220 mg taken in the form of one 110 mg capsuletwice a day.
Patients taking verapamil-containing medicinesshould receive reduced-dose Telexer treatment to 220 mg taken in the form of one 110 mg capsuletwice a day, due to the possible increased risk of bleeding.
In patients with potentially increased risk of bleedingthe doctor may recommend taking the medicine at a dose of 220 mg taken in the form of one 110 mg capsuletwice a day.
Taking this medicine can be continued if the patient needs to restore normal heart function using a procedure called cardioversion or using a procedure called catheter ablation in atrial fibrillation. Telexer should be taken as instructed by the doctor.
In the case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, the patient may receive Telexer treatment, after the doctor has confirmed that blood clotting control has been achieved. Telexer should be taken as instructed by the doctor.
Treatment of blood clots and prevention of recurrence of blood clots in children
Telexer should be taken twice a day, one dose in the morning and one dose in the evening, at approximately the same time every day. The interval between doses should be approximately 12 hours.
The recommended dose depends on the patient's weight and age. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. All other medicines should be continued, unless the doctor instructs otherwise.
Table 1 shows the single and total daily doses of Telexer in milligrams (mg). Doses depend on the patient's weight in kilograms (kg) and age in years:
Table 1: Telexer dosing table in capsule form

Doses requiring the combination of more than one capsule:
300 mg:
two 150 mg capsules or
four 75* mg capsules
260 mg:
one 110 mg capsule and one 150 mg capsule or
one 110 mg capsule and two 75* mg capsules
220 mg:
two 110 mg capsules
185* mg: one 75* mg capsule and one 110 mg capsule
150 mg:
one 150 mg capsule or
two 75* mg capsules
*The 75 mg dose of Telexer is not available, so it is not suitable for the above patient groups. In these patients, other medicinal products containing dabigatran etexilate at a dose of 75 mg should be used.

How to take Telexer

Telexer can be taken with or without food. The capsules should be swallowed whole, with a glass of water, to facilitate passage into the stomach. They should not be broken, chewed or the pellets spilled from the capsule, as this may increase the risk of bleeding.
Instructions for opening blisters
In the case of perforated foil: A single dose should be torn off from the blister along the perforated line.
Push the capsules through the blister foil.

Changing anticoagulant medicine

Do not change your anticoagulant medicine without receiving detailed instructions from your doctor.

Taking a higher dose of Telexer than recommended

Taking too much of this medicine increases the risk of bleeding. If you have taken too many capsules, you should contact your doctor immediately. Specific treatment methods are available.

Missing a dose of Telexer

A missed dose can be taken up to 6 hours before the next scheduled dose.
If there are less than 6 hours left until the next scheduled dose, do not take the missed dose. Do not take a double dose to make up for a missed dose.

Stopping Telexer treatment

Telexer should be taken as instructed by your doctor. Do not stop taking this medicine without consulting your doctor first, as the risk of blood clot formation may be higher if treatment is stopped prematurely. You should contact your doctor if you experience indigestion after taking Telexer.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Telexer can cause side effects, although not everybody gets them.
Telexer affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding. Major or severe bleeding may occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of location. In some cases, these bleedings may not be visible.
If you experience bleeding that does not stop on its own, or symptoms of excessive bleeding (extreme weakness, fatigue, paleness, dizziness, headache or unexplained swelling), you should contact your doctor immediately. The doctor may decide to monitor you closely or change your medicine.
If you experience a severe allergic reaction that can cause breathing difficulties or dizziness, you should contact your doctor immediately.
The following possible side effects are grouped by frequency of occurrence.
Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart function

• Frequent (may affect up to 1 in 10 people):
• Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Indigestion
• Frequent passage of loose or liquid stools
• Nausea

Uncommon (may affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur from hematomas, from the rectum, or into the brain
• Hematoma formation
• Coughing up blood or sputum discolored with blood
• Decreased platelet count
• Decreased hemoglobin content in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophageal and stomach inflammation
• Acid reflux
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

Rare (may affect up to 1 in 1,000 people):

• Bleeding may occur into a joint, from a wound, from a surgical incision, from an injection site, or from a catheter insertion site
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash in the form of dark red, raised, itchy bumps caused by an allergic reaction
• Decreased white blood cell count
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disease

Frequency not known (frequency cannot be estimated from the available data):

• Breathing difficulties or wheezing
• Decreased red blood cell count
• Loss of hair

In a clinical study, the frequency of heart attacks in patients taking dabigatran etexilate was numerically higher than in patients taking warfarin. The overall number of events was low.
Treatment of blood clots in the veins of the legs and lungs and prevention of repeated formation of blood clots in the veins of the legs and lungs
Frequent (may affect up to 1 in 10 people):

• Bleeding may occur from the nose, into the stomach or intestines, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Indigestion

Uncommon (may affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur into a joint or due to injury
• Bleeding may occur from hematomas
• Decreased red blood cell count
• Hematoma formation
• Coughing up blood or sputum discolored with blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophageal and stomach inflammation
• Acid reflux
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent passage of loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

Rare (may affect up to 1 in 1,000 people):

• Bleeding may occur from a surgical incision, from an injection site, or from a catheter insertion site into a vein or brain
• Decreased platelet count
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash in the form of dark red, raised, itchy bumps caused by an allergic reaction
• Difficulty swallowing

Frequency not known (frequency cannot be estimated from the available data):

• Breathing difficulties or wheezing
• Decreased hemoglobin content in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Decreased white blood cell count (which help fight infections)
• Yellowing of the skin or whites of the eyes due to liver or blood disease
• Loss of hair

Treatment of blood clots and prevention of recurrence of blood clots in children
Frequent (may affect up to 1 in 10 people):

• Decreased red blood cell count
• Decreased platelet count
• Skin rash in the form of dark red, raised, itchy bumps caused by an allergic reaction
• Sudden change in skin color or appearance
• Hematoma formation
• Nosebleeds
• Acid reflux
• Vomiting
• Nausea
• Frequent passage of loose or liquid stools
• Indigestion
• Loss of hair
• Increased liver enzyme activity

Uncommon (may affect up to 1 in 100 people):

• Decreased white blood cell count (which help fight infections)
• Bleeding may occur into the stomach or intestines, into the brain, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased hemoglobin content in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Itching
• Coughing up blood or sputum discolored with blood
• Abdominal pain or stomach pain
• Esophageal and stomach inflammation
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes due to liver or blood disease

Frequency not known (frequency cannot be estimated from the available data):

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing facial or throat swelling
• Breathing difficulties or wheezing
• Bleeding
• Bleeding may occur into a joint, from a wound, from a surgical incision, from an injection site, or from a catheter insertion site into a vein
• Bleeding may occur from hematomas.
• Stomach or intestinal ulcer (including esophageal ulceration).
• Abnormal liver function test results.

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 Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Telexer

Keep the medicine out of the sight and reach of children.
There are no special storage temperature requirements for this medicine.
Store the medicine in its original packaging to protect it from moisture.
Do not use this medicine after the expiry date stated on the blister and carton after:
“EXP”/“Expiry date (EXP)”. The expiry date refers to the last day of the month stated.
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 Telexer contains

• The active substance of Telexer is dabigatran etexilate. Each hard capsule contains 150 mg of dabigatran etexilate (as mesylate).
• The other ingredients are: tartaric acid, hypromellose, dimeticone 350, talc, hydroxypropylcellulose.
• The capsule shell contains: carrageenan (E 407), potassium chloride, titanium dioxide (E 171), indigo carmine (E 132), hypromellose.
• The black ink used for printing contains: shellac (E 904), iron oxide black (E 172), propylene glycol (E 1520), concentrated ammonia solution (E 527), potassium hydroxide (E 525).

What Telexer looks like and contents of the pack

Telexer, 150 mg, hard capsules with a blue cap and white body (approximately 21.7 mm in length). The cap is printed with the Gedeon Richter company logo, and the body is printed with the symbol “150”.
Blisters made of OPA/Aluminum/PE/Aluminum foil with a desiccant, containing 10 hard capsules.
Each carton contains 10, 30, or 60 hard capsules.
A collective packaging containing 3 packages of 60 hard capsules (180 hard capsules).
Each individual packaging of the collective packaging contains 6 blisters made of OPA/Aluminum/PE/Aluminum foil with a desiccant, containing 10 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki

Manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

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

Bulgaria:
TELEXER 150 mg capsule hard
Czech Republic:
TELEXER
Estonia:
TELEXER
Hungary:
TELEXER 150 mg hard capsule
Latvia: TELEXER 150 mg hard capsules
Lithuania:
TELEXER 150 mg hard capsules
Poland: TELEXER
Romania:
TELEXER 150 mg capsule
Slovakia:
TELEXER 150 mg hard capsules
To obtain more detailed information on this medicine, please contact:
Gedeon Richter Polska Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: +48 (22) 755 96 48
[email protected]

Date of last revision of the leaflet: