Telexer

Package Leaflet: Information for the Patient

TELEXER, 110 mg, Hard Capsules

Dabigatran Etexilate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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 medications called anticoagulants. Its action involves blocking a substance in the body responsible for blood clot formation.
Telexer is used in adults to:

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

2. Important information before taking Telexer

When not to take Telexer

• if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medication (listed in section 6).
• if the patient has severe kidney impairment.
• if the patient is currently bleeding.
• if the patient has a disease of any internal organ that increases the risk of significant bleeding (e.g., stomach ulcer, brain injury, or bleeding into the brain, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by the use of other medications.
• if the patient is taking anticoagulant medications (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment, introducing a venous or arterial catheter, or when heparin is administered to maintain catheter patency or restore normal heart function through a procedure called catheter ablation in atrial fibrillation.
• if the patient has severe liver impairment or liver disease that may lead to death.
• if the patient is taking oral ketoconazole or itraconazole, medications used to treat fungal infections.
• if the patient is taking oral cyclosporine, a medication used to prevent organ rejection.
• if the patient is taking dronedarone, a medication used to treat heart rhythm disorders.
• if the patient is taking a combination medication containing glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C.
• if the patient has a mechanical heart valve that requires continuous anticoagulation.

Warnings and precautions

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

• if the patient has an increased risk of bleeding, such as recent bleeding, recent surgical biopsy, recent severe injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment), esophageal or gastric inflammation, or gastroesophageal reflux disease. if the patient is taking medications that may increase the risk of bleeding. See "Telexer and other medications" below. if the patient is taking anti-inflammatory medications such as diclofenac, ibuprofen, or piroxicam. if the patient has an infection of the heart (bacterial endocarditis). if the patient has reduced kidney function or is dehydrated (feeling thirsty and producing a reduced amount of dark, concentrated urine). if the patient is over 75 years old. if the patient is an adult and weighs 50 kg or less. only in children: if the child has an infection around or in the brain.
• in case of a previous heart attack or if the patient has been diagnosed with conditions that increase the risk of heart attack.
• if the patient has liver disease affecting blood test results. In such cases, the use of this medication is not recommended.

When to exercise special caution when taking Telexer

• if the patient needs to undergo surgery: In such cases, it is necessary to discontinue Telexer temporarily due to the increased risk of bleeding during and after surgery. It is very important to take Telexer before and after surgery exactly as the doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g., for epidural or spinal anesthesia or pain relief): it is very important to take Telexer before and after surgery exactly as the doctor has instructed.

and inform the doctor immediately if the patient experiences numbness or weakness in the lower limbs or problems with the intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.

• if the patient has fallen or injured themselves during treatment, especially if they have injured their head. The patient should seek medical attention immediately. The doctor will examine the patient to determine if there is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether to change the treatment.

Telexer and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. In particular, the patient should
tell their doctor before taking Telexer if they are taking any of the following medications:

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

Pregnancy and breastfeeding

The effect of Telexer on pregnancy and the unborn child is unknown. This medication should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Telexer.
Telexer should not be taken during breastfeeding.

Driving and using machines

Telexer does not affect the ability to drive or use machines.

3. How to take Telexer

Telexer capsules can be used in adults and children aged 8 years or older who can swallow the capsules whole.
This medication should always be taken as directed by the doctor. In case of doubts, consult a doctor.

Telexer should be taken as follows:

Prevention of blood clots after hip or knee replacement surgery
The recommended dose is 220 mg once daily(taken as 2 capsules of 110 mg each).
If kidney function is reducedby more than half or in patients aged 75 years or older,
the recommended dose is 150 mg once daily(taken as 2 capsules of 75 mg* each).
In patients taking medications containing amiodarone, quinidine, or verapamil, the recommended dose of Telexer is 150 mg once daily(taken as 2 capsules of 75 mg* each).
Patients taking medications containing verapamilwith reduced kidney function by more than half should take a reduced dose of 75 mg*of dabigatran etexilate due to the increased risk of bleeding.
In both types of surgery, treatment should not be started if there is bleeding from the surgical site. If it is not possible to start treatment the next day after surgery, it should be started with a dose of 2 capsules once daily.
*A dose of 75 mg of Telexer is not available; therefore, it is not suitable for the above-mentioned patient groups. In these patients, other medicinal products containing dabigatran etexilate in a dose of 75 mg should be used.
After hip replacement surgery
Telexer treatment should be started with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, two capsules should be taken once daily for a total of 28 to 35 days.
After knee replacement surgery
Telexer treatment should be started with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, two capsules should be taken once daily for a total of 10 days.
Prevention of blood clots in the brain and body due to irregular heartbeat and treatment of blood clots in the legs and lungs and prevention of recurrence of blood clots in the legs and lungs
The recommended dose is 300 mgtaken as one capsule of 150 mg twice daily.
In patients aged 80 years or older, the recommended dose is 220 mgtaken as one capsule of 110 mg twice daily.
Patients taking medications containing verapamilshould receive a reduced dose of Telexer to 220 mgtaken as one capsule of 110 mg twice dailydue to the increased risk of bleeding.
In patients with potentially increased risk of bleeding, the doctor may recommend a dose of 220 mgtaken as one capsule of 110 mg twice daily.
Telexer can be continued if the patient needs to restore normal heart function through a procedure called cardioversion. Telexer should be taken as directed 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 coagulation is under control. Telexer should be taken as directed by the doctor.
Treatment of blood clots and prevention of recurrence of blood clots in children
Telexer should be taken twice daily, 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 medications should be continued unless the doctor recommends stopping any of them.
Table 1 shows the single and total daily doses of Telexer in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years:

Doses requiring the combination of more than one capsule:
300 mg:
two capsules of 150 mg or
four capsules of 75* mg
260 mg:
one capsule of 110 mg and one capsule of 150 mg or
one capsule of 110 mg and two capsules of 75* mg
220 mg:
two capsules of 110 mg
185* mg: one capsule of 75* mg and one capsule of 110 mg
150 mg:
one capsule of 150 mg or
two capsules of 75* mg
*A dose of 75 mg of Telexer is not available; therefore, it is not suitable for the above-mentioned patient groups. In these patients, other medicinal products containing dabigatran etexilate in 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 emptied 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.
The capsules should be pressed through the foil of the blister.

Changing anticoagulant medication

Do not change anticoagulant medication without receiving detailed instructions from a doctor.

Taking a higher dose of Telexer than recommended

Taking too much of this medication increases the risk of bleeding. If the patient has taken too many capsules, they should contact their doctor immediately. Specific treatments are available.

Missing a dose of Telexer

Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Telexer at the same time the next day.
Do not take a double dose to make up for the missed dose.
Use in adults: Prevention of blood clots in the brain and body due to irregular heartbeat and treatment of blood clots in the legs and lungs and prevention of recurrence of blood clots in the legs and lungs
A missed dose can be taken up to 6 hours before the next scheduled dose.
If there are less than 6 hours until the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Telexer treatment

Telexer should be taken as directed by the doctor. The patient should not stop taking this medication without consulting their doctor first, as the risk of blood clot formation may be higher if treatment is stopped prematurely. The patient should contact their doctor if they experience indigestion after taking Telexer.
In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, 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. Severe or heavy 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.
In case of bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), the patient should contact their doctor immediately. The doctor may decide to closely monitor the patient or change the medication.
In case of a severe allergic reaction that can cause breathing difficulties or dizziness, the patient should contact their doctor immediately.
Possible side effects are listed below by frequency of occurrence.

• Frequent (may occur in up to 1 in 10 people):

Prevention of blood clots after hip or knee replacement surgery

• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results

Infrequent (may occur in up to 1 in 100 people):

• Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discoloration due to blood), or under the skin
• Formation of hematomas or bruising after surgery
• Blood in the stool detected by laboratory tests
• Decreased red blood cell count
• Decreased hematocrit
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Nausea
• Wound exudate (oozing of fluid from the surgical wound)
• Increased liver enzyme activity
• Jaundice of the skin or whites of the eyes due to liver or blood disease

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

• Bleeding
• Bleeding may occur into the brain, from the surgical wound, from the injection site, or from the catheter insertion site
• Exudate from the catheter insertion site discolored by blood
• Coughing up blood or sputum discolored by blood
• Decreased platelet count
• Decreased red blood cell count after surgery
• 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 due to an allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophageal or gastric inflammation
• Gastroesophageal reflux disease
• Abdominal pain or stomach pain
• Difficulty swallowing
• Wound exudate
• Wound exudate from the surgical wound

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

• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infections)
• Hair loss

Prevention of blood clots in the brain and body due to irregular heartbeat

• Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discoloration due to blood), or under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Nausea

Infrequent (may occur in up to 1 in 100 people):

• Bleeding
• Bleeding may occur from hematomas, from the rectum, or into the brain
• Formation of hematomas
• Coughing up blood or sputum discolored by blood
• Decreased platelet count
• Decreased hemoglobin levels 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 or gastric inflammation
• Gastroesophageal reflux disease
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding may occur into the joint, from the surgical wound, from the injection site, or from the 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 due to an allergic reaction
• Decreased hematocrit
• Increased liver enzyme activity
• Jaundice 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):

• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infections)
• Hair loss

Treatment of blood clots in the legs and lungs and prevention of recurrence of blood clots in the legs and lungs

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

Infrequent (may occur in up to 1 in 100 people):

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

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

• Bleeding may occur from the surgical wound, from the injection site, or from the catheter insertion site, or into the 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 due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Decreased white blood cell count (which helps fight infections)
• Jaundice of the skin or whites of the eyes due to liver or blood disease
• Hair loss

In clinical trials, 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. No difference in the frequency of heart attacks was observed in patients treated with dabigatran compared to patients receiving placebo.
Treatment of blood clots and prevention of recurrence of blood clots in children

• Decreased red blood cell count
• Decreased platelet count
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

Infrequent (may occur in up to 1 in 100 people):

• Decreased white blood cell count (which helps 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 discoloration due to blood), or under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Itching
• Coughing up blood or sputum discolored by blood
• Abdominal pain or stomach pain
• Esophageal or gastric inflammation
• Allergic reaction
• Difficulty swallowing
• Jaundice 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
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur into the joint, from the wound, from the surgical wound, from the injection site, or from the catheter insertion site
• Bleeding may occur from hematomas
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Telexer

The medication should be stored out of sight and reach of children.
There are no special storage temperature requirements for this medication.
The medication should be stored in its original packaging to protect it from moisture.
Do not use this medication after the expiration date stated on the blister and carton after "EXP" / "Expiration Date (EXP)". The expiration date refers to the last day of the month stated.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. 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 110 mg of dabigatran etexilate (as mesylate).
• The other ingredients are: tartaric acid, hypromellose, dimethicone 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, 110 mg, hard capsules with a blue cap and blue body (approximately 19.4 mm in length). The cap is printed with the company logo, and the body is printed with the symbol "110".

• Blisters of OPA/Aluminum/PE/Aluminum foil with a desiccant, containing 10 hard capsules.

Each carton contains 10, 30, or 60 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o.
Poniatowskiego 5 Street
05-825 Grodzisk Mazowiecki

Manufacturer

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

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

Bulgaria:
TELEXER 110 mg hard capsules
Czech Republic:
TELEXER
Estonia:
TELEXER
Hungary:
TELEXER 110 mg hard capsules
Latvia: TELEXER 110 mg hard capsules
Lithuania:
TELEXER 110 mg hard capsules
Poland: TELEXER
Romania:
TELEXER 110 mg capsules
Slovakia:
TELEXER 110 mg hard capsules
To obtain more detailed information on this medication, please contact:
Gedeon Richter Polska Sp. z o.o.
Medical Department
Poniatowskiego 5 Street
05-825 Grodzisk Mazowiecki
phone: +48 (22) 755 96 48
email: lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet: