Package leaflet: Information for the patient

TELEXER, 150 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Telexer is and what it is used for
Important information before taking Telexer
How to take Telexer
Possible side effects
How to store Telexer
Contents of the pack and other information

1. What Telexer is and what it is used for

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

prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body in patients with a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor.
treat blood clots in the veins of the legs and lungs, and to prevent recurrence of such clots.
Telexer is used in children to:
treat blood clots and to prevent 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 medicine (listed in section 6).
if the patient has severe kidney function impairment.
if the patient is currently experiencing bleeding.
if the patient has a disease of any internal organ that increases the risk of major bleeding (e.g. gastric ulcer, brain injury or intracranial hemorrhage, recent brain or eye surgery).
if the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by taking other medicines.
if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy, inserting a venous or arterial catheter where heparin is administered through the catheter to maintain patency, or restoring normal heart rhythm using a procedure called catheter ablation in atrial fibrillation.
if the patient has severe liver function impairment or liver disease that may lead to death.
if the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
if the patient is taking oral cyclosporine, a medicine used to prevent rejection of a transplanted organ.
if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
if the patient is taking a fixed-dose combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
if the patient has had a mechanical heart valve implanted, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting Telexer, discuss this with your doctor. If symptoms occur or the patient has undergone surgery during treatment with this medicine, consult your doctor.
The patient should inform the doctor if they currently have or have previously had any medical conditions or diseases, especially those listed below:

if the patient has an increased risk of bleeding, such as: recent bleeding episodes. if the patient underwent a surgical tissue biopsy within the last month. if the patient has experienced a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment). if the patient has esophagitis or gastritis. if the patient has gastroesophageal reflux (acid reflux into the esophagus). if the patient is taking medicines that may increase the risk of bleeding. See below "Telexer and other medicines". if the patient is taking nonsteroidal anti-inflammatory drugs such as diclofenac, ibuprofen, piroxicam. if the patient has an infection in the heart (bacterial endocarditis). if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark [concentrated] or foamy urine). if the patient is over 75 years of age. if the patient is an adult weighing 50 kg or less. only when used in children: if the child has an infection around or within the brain.
if the patient has had 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, use of this medicine is not recommended.

When to exercise particular caution when taking Telexer

if the patient needs to undergo surgery: In such cases, temporary discontinuation of Telexer is necessary due to increased risk of bleeding during and immediately after surgery. It is very important to take Telexer exactly as directed by the doctor before and after surgery.
if surgery requires insertion of a catheter or administration of an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief): it is very important to take Telexer exactly as

directed by the doctor.
the patient should immediately inform the doctor if numbness or weakness in the lower limbs or problems with bowel or bladder function occur after the anesthesia wears off, as urgent medical care is required.

if the patient falls or sustains an injury during treatment, especially if the head is injured. Immediate medical evaluation is necessary. The doctor will assess whether there may be an increased risk of bleeding.
if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is needed.

Telexer and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. In particular, tell the doctor before taking Telexer if the patient is 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 these medicines are applied topically to the skin only.
Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing verapamil, the doctor may recommend a lower dose of Telexer depending on the condition for which the medicine was prescribed. See section 3.
Medicines used to prevent rejection of transplanted organs (e.g. tacrolimus, cyclosporine).
A fixed-dose combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C virus infection).
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 known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.
Rifampicin or clarithromycin (both antibiotics).
Antiviral medicines used to treat HIV/AIDS (e.g. ritonavir).
Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
It is unknown what effect Telexer has on pregnancy and the unborn child. This medicine should not be taken during pregnancy unless the doctor determines it is safe. Women of childbearing potential should avoid becoming pregnant while taking Telexer.
Breastfeeding should not be performed during treatment with Telexer.

Driving and operating machinery
Telexer has no effect on the ability to drive or operate machinery.

3. How to take Telexer

Telexer capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole.
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult your doctor.
Telexer should be taken according to the following recommendations:
Prevention of blood vessel blockages in the brain and body by preventing the formation of blood clots that occur due to irregular heart function, and treatment of blood clots in the veins of the legs and lungs, as well as prevention of recurrence of such clots.
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
In patients aged 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
Patients taking medicines containing verapamil should receive Telexer at a reduced dose of 220 mg taken as one 110 mg capsule twice daily due to the potential increased risk of bleeding.
In patients with potentially increased risk of bleeding, the doctor may recommend treatment with a dose of 220 mg taken as one 110 mg capsule twice daily.
Treatment with this medicine may be continued in patients who require restoration of normal heart rhythm through a procedure called cardioversion or catheter ablation for atrial fibrillation. Telexer should be taken exactly as prescribed by the doctor.
In patients undergoing implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure known as percutaneous coronary intervention with stent placement, treatment with Telexer may be initiated once the doctor has confirmed adequate control of blood coagulation. Telexer should be taken exactly as prescribed by the doctor.
Treatment of blood clots and prevention of recurrent blood clots in children
Telexer should be taken twice daily, one dose in the morning and one dose in the evening, approximately at the same time each day. The interval between doses should be as close as possible to 12 hours.
The recommended dose depends on body weight and age. The doctor will determine the correct dose and may adjust it during treatment. All other medications should be continued unless the doctor advises otherwise.
Table 1 shows the single and total daily doses of Telexer in milligrams (mg). The doses depend on the patient's body weight in kilograms (kg) and age in years:
Table 1: Dosing table for Telexer capsules

Body weight and age ranges		Single dose in mg	Total daily dose in mg
Body weight in kg	Age in years	Single dose in mg	Total daily dose in mg
from 11 to less than 13 kg	8 to less than 9 years	75*	150
from 13 to less than 16 kg	8 to less than 11 years	110	220
from 16 to less than 21 kg	8 to less than 14 years	110	220
from 21 to less than 26 kg	8 to less than 16 years	150	300
from 26 to less than 31 kg	8 to less than 18 years	150	300
from 31 to less than 41 kg	8 to less than 18 years	185*	370
from 41 to less than 51 kg	8 to less than 18 years	220	440
from 51 to less than 61 kg	8 to less than 18 years	260	520
from 61 to less than 71 kg	8 to less than 18 years	300	600
from 71 to less than 81 kg	8 to less than 18 years	300	600
81 kg or more	10 to less than 18 years	300	600

Single doses requiring 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: as two 110 mg capsules
185* mg: as one 75* mg capsule and one 110 mg capsule
150 mg: as one 150 mg capsule or
two 75* mg capsules
*The 75 mg dose of Telexer is not available; therefore, it is not suitable for the above-mentioned
patient groups. Other medicinal products containing dabigatran etexilate in a 75 mg dose should be used in these patients.
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. Do not break, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.
Instructions for opening blister packs
For perforated foil: Detach the single dose from the blister pack along the perforated line.
Push the capsules through the foil of the blister pack.
Switching anticoagulant therapy
Do not switch anticoagulant medication without receiving detailed instructions from your doctor.
Taking more Telexer than prescribed
Taking too high a dose of this medicine increases the risk of bleeding. If a patient has taken too many capsules, contact a doctor immediately. Specific treatment methods are available.
Missed dose of Telexer
A missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next scheduled dose, the missed dose should not be taken. Do not take a double dose to make up for a missed dose.
Stopping treatment with Telexer
Telexer should be taken exactly as prescribed by the doctor. Do not stop taking this medicine without first consulting your doctor, as the risk of blood clot formation may be higher if treatment is stopped prematurely. Contact your doctor if dyspepsia occurs after taking Telexer.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Telexer affects the blood clotting system; therefore, most adverse effects involve symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse effect. Regardless of location, it may lead to disability, be life-threatening, or even result in death. In some cases, such bleeding may not be visible.
If you experience bleeding that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to place you under close monitoring or change your treatment.
If a serious allergic reaction occurs, which may cause difficulty breathing or dizziness, contact your doctor immediately.

The possible adverse effects listed below are grouped according to their frequency of occurrence.

Prevention of blood vessel blockages in the brain and body by preventing clots from forming due to irregular heart function

Common (may occur in up to 1 in 10 people):

Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina, or from the urinary tract (including pink or red urine due to presence of blood), or under the skin
Decrease in the number of red blood cells in the blood
Abdominal pain or stomach pain
Indigestion
Frequent passage of loose or watery stools
Nausea

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

Bleeding
Bleeding may occur from hemorrhoids, from the rectum, or into the brain
Formation of bruises (bruising)
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in hemoglobin levels in the blood (a substance in red blood cells)
Allergic reaction
Sudden change in skin color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulceration)
Inflammation of the esophagus and stomach
Regurgitation of stomach contents into the esophagus (reflux)
Vomiting
Difficulty swallowing
Abnormal liver function test results in laboratory tests

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

Bleeding into a joint, from a surgical incision site, from a wound, from an injection site, or from the site where a venous catheter was inserted
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
Decrease in the proportion of blood cells
Increased liver enzyme activity
Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

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

Difficulty breathing or wheezing
Decrease in the number of, or even absence of, white blood cells (which help fight infections)
Hair loss

In a clinical study, the incidence of heart attacks was numerically higher with dabigatran etexilate than with warfarin. The overall number of events was low.

Treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in the legs and (or) lungs

Common (may occur in up to 1 in 10 people):

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

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

Bleeding
Bleeding may occur into a joint or following injury
Bleeding may occur from hemorrhoids
Decrease in the number of red blood cells in the blood
Formation of bruises (bruising)
Coughing up blood or blood-stained sputum
Allergic reaction
Sudden change in skin color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulceration)
Inflammation of the esophagus and stomach
Regurgitation of stomach contents into the esophagus (reflux)
Nausea
Vomiting
Abdominal pain or stomach pain
Frequent passage of loose or watery stools
Abnormal liver function test results in laboratory tests
Increased liver enzyme activity

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

Bleeding from a surgical incision site, from an injection site, from the site where a venous catheter was inserted, or bleeding into the brain
Decrease in the number of platelets in the blood
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
Difficulty swallowing

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

Difficulty breathing or wheezing
Decrease in hemoglobin levels in the blood (a substance in red blood cells)
Decrease in the proportion of blood cells
Decrease in the number of, or even absence of, white blood cells (which help fight infections)
Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders
Hair loss

In a clinical study, the incidence of heart attacks was numerically higher with dabigatran etexilate than with warfarin. The overall number of events was low. No difference in the incidence of heart attacks was observed between patients treated with dabigatran and those who received placebo.

Treatment and prevention of recurrence of blood clots in children

Common (may occur in up to 1 in 10 people):

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
Sudden change in skin color and appearance
Formation of bruises (bruising)
Nosebleeds
Regurgitation of stomach contents into the esophagus (reflux)
Vomiting
Nausea
Frequent passage of loose or watery stools
Indigestion
Hair loss
Increased liver enzyme activity

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

Decrease in the number of white blood cells (which help fight infections)
Bleeding may occur into the stomach or intestines, into the brain, from the anus, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
Decrease in hemoglobin levels in the blood (a substance in red blood cells)
Decrease in the proportion of blood cells
Itching
Coughing up blood or blood-stained sputum
Abdominal pain or stomach pain
Inflammation of the esophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

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

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Difficulty breathing or wheezing
Bleeding
Bleeding may occur into a joint, from a wound, from a surgical incision site, from an injection site, or from the site where a venous catheter was inserted
Bleeding may occur from hemorrhoids
Stomach or intestinal ulcer (including esophageal ulceration)
Abnormal liver function test results in laboratory tests

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

5. How to store the medicine Telexer

Keep the medicine out of sight and reach of children.
There are no special requirements regarding the storage temperature of the 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 stated month.
Medicines must 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 is dabigatran etexilate. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
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, lac (E 132), hypromellose.
The black printing ink contains: shellac (E 904), black iron oxide (E 172), propylene glycol (E 1520), concentrated ammonium hydroxide (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 a white body (approximately 21.7 mm in length). The company logo of Gedeon Richter is printed on the cap and the symbol "150" on the body.
Blister packs made of OPA/Aluminium/PE/Aluminium foil with a desiccant, containing 10 hard capsules. Each carton contains 10, 30 or 60 hard capsules.
A multipack containing 3 packs of 60 hard capsules (180 hard capsules). Each individual pack in the multipack contains 6 blisters of OPA/Aluminium/PE/Aluminium foil with a desiccant, each blister containing 10 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised 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 keménykapszula
Latvia: TELEXER 150 mg cietās kapsulas
Lithuania: TELEXER 150 mg kietosios kapsulės
Poland: TELEXER
Romania: TELEXER 150 mg capsule
Slovakia: TELEXER 150 mg tvrdé kapsuly

For further information about this medicinal product, 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]