Telexer

Package leaflet: Information for the patient

TELEXER, 110 mg, hard capsules
Dabigatranum etexilatum
Please read carefully all of this leaflet before taking this medicine because it contains
important information for you.

• Keep this leaflet as 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 personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Telexer is and what it is used for
2. What you need to know 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 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 clotting.
Telexer is used in adults to:

• prevent blood clots in veins after knee or hip replacement surgery.
• prevent blood clots in the brain (stroke) and in other blood vessels in 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 legs and lungs and to prevent recurrence of blood clots in the legs and lungs. 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 which increases the risk of major bleeding (e.g. peptic 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 which may lead to death.
• if the patient is taking oral ketoconazole or itraconazole, antifungal medications.
• 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 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 during treatment with this
medicine or if the patient has undergone a surgical procedure, you should also 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: if the patient has recently experienced bleeding; if the patient underwent a surgical tissue biopsy (biopsy) within the last month; if the patient has suffered a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment); if the patient has inflammation of the esophagus or stomach; 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 with other medicines"; if the patient is taking non-steroidal anti-inflammatory drugs such as diclofenac, ibuprofen, 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 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 heart attack or has conditions diagnosed to 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 special 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 both 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 legs 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 attention should be sought. 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 treatment needs to be changed.

Telexer with other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned
to be taken. In particular, tell your 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 only topically to the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing amiodarone, quinidine, or 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 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).
• 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 age
should avoid becoming pregnant while taking Telexer.
Breastfeeding should not be performed while taking 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 as prescribed by your doctor. If in doubt, consult your doctor.
Telexer should be taken according to the following recommendations:

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If renal function is reduced by 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*).
In patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose
of Telexer is 150 mg once daily (taken as 2 capsules of 75 mg*).
Patients taking medicines containing verapamil who also have reduced renal function
by more than half should receive a reduced dose of 75 mg* of dabigatran etexilate due to increased risk of bleeding.
In both types of surgery, treatment should not be started if there is active bleeding from the surgical site. If treatment cannot be initiated by the next day after surgery, it should be started with a dose of 2 capsules once daily.
*The 75 mg dose of Telexer is not available; therefore, it is not suitable for the above-mentioned patient groups. In these patients, alternative medicinal products containing dabigatran etexilate at a dose of 75 mg should be used.

After knee joint replacement surgery
Telexer treatment should be initiated by taking one capsule within 1 to 4 hours after completion of surgery. Then, two capsules should be taken once daily for a total of 10 days.

After hip joint replacement surgery
Telexer treatment should be initiated by taking one capsule within 1 to 4 hours after completion of surgery. Then, two capsules should be taken once daily for a total of 28 to 35 days.

Prevention of blood clots in the brain and other blood vessels by preventing clot formation due to irregular heart function, and treatment and prevention of recurrent blood clots in the legs and lungs
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 if the patient requires restoration of normal heart rhythm via 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 treatment with Telexer, once the doctor has confirmed adequate control of blood coagulation. Telexer should be taken as directed by the doctor.

Treatment and prevention of recurrent blood clots in children
Telexer should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The interval between doses should ideally be 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 continue to be taken unless the doctor advises otherwise.

Table 1 shows the single and total daily doses of Telexer in milligrams (mg). Doses depend on the patient's body weight in kilograms (kg) and age in years:
Table 1: Dosing table for Telexer capsules

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 along the perforated line.
Push the capsule through the foil of the blister pack.
Switching anticoagulant therapy
Do not switch anticoagulant therapy 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
Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Telexer at the usual 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 blood vessels of the brain and body by preventing formation of clots caused by 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
Use in children: Treatment of blood clots and prevention of recurrence of blood clots
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 the missed dose.
Stopping Telexer
Telexer should be taken exactly as prescribed by the doctor. Do not stop taking this medicine without consulting your doctor first, as the risk of developing a blood clot may be higher if treatment is stopped prematurely. Contact your doctor if you experience indigestion 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 are related to symptoms such as bruising or bleeding. Severe or extensive bleeding may occur, which is the most serious adverse effect and, regardless of location, may lead to disability, be life-threatening, or even fatal. In some cases, such bleeding may not be visible.
If bleeding occurs that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling) appear, contact your doctor immediately. The doctor may decide to place the patient under close observation or change the treatment.

In case of a serious allergic reaction, 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 clots after hip or knee replacement surgery

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

• Decrease in haemoglobin levels in the blood (the substance in red blood cells)
• Abnormal liver function test results in laboratory tests

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

• Bleeding may occur from the nose, stomach or intestines, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, from the rectum, under the skin, into joints, due to injury or after injury or surgery
• Formation of bruises or haematomas following surgery
• Blood in stool detected in laboratory tests
• Decrease in the number of red blood cells in the blood
• Decrease in blood cell fraction
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Presence of discharge from the wound (fluid oozing from the surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

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

• Bleeding
• Bleeding may occur into the brain, from the surgical incision site, from the injection site, or from the site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-tinged sputum
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery
• 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
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Discharge of fluid from the wound
• Discharge of fluid from the surgical wound

Frequency unknown (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

Prevention of blood vessel blockages in the brain and body by preventing clots caused by irregular heart function

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

• Bleeding may occur from the nose, stomach or intestines, from the penis/vagina or 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 affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur from haemorrhoids, from the rectum, or into the brain
• Formation of haematomas
• Coughing up blood or blood-tinged sputum
• Decrease in the number of platelets in the blood
• Decrease in haemoglobin levels in the blood (the substance in red blood cells)
• Allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results in laboratory tests

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

• Bleeding may occur into joints, from the surgical incision site, from a wound, from the injection site, or from the site of intravenous catheter insertion
• 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 blood cell fraction
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

Frequency unknown (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 with dabigatran etexilate was numerically higher 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 lungs

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

• Bleeding may occur from the nose, 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 affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur into joints or due to injury
• Bleeding may occur from haemorrhoids
• Decrease in the number of red blood cells in the blood
• Formation of haematomas
• Coughing up blood or blood-tinged sputum
• Allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (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 affect up to 1 in 1,000 people):

• Bleeding may occur from the surgical incision site, from the injection site, from the site of intravenous catheter insertion, or 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 unknown (cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in haemoglobin levels in the blood (the substance in red blood cells)
• Decrease in blood cell fraction
• 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 clinical studies, the incidence of heart attacks with dabigatran etexilate was numerically higher than with warfarin. The overall number of events was low. No difference in the incidence 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

Common (may affect 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 colour and appearance
• Formation of haematomas
• Nosebleeds
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

Uncommon (may affect 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 rectum, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decrease in haemoglobin levels in the blood (the substance in red blood cells)
• Decrease in blood cell fraction
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal pain or stomach pain
• Inflammation of the oesophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

Frequency unknown (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 joints, from wounds, from the surgical incision site, from the injection site, or from the site of intravenous catheter insertion
• Bleeding may occur from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results in laboratory tests

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the 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 110 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, lake (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 110 mg hard capsules with a blue cap and a blue body (approximately 19.4 mm in length). The company logo of Gedeon Richter is printed on the cap and the symbol "110" on the body.
The capsules are packed in blisters made of OPA/Aluminium/PE/Aluminium 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 Authorisation Holder
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
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 110 mg capsule hard
Czech Republic: TELEXER
Estonia: TELEXER
Hungary: TELEXER 110 mg keménykapszula
Latvia: TELEXER 110 mg cietās kapsulas
Lithuania: TELEXER 110 mg kietosios kapsulės
Poland: TELEXER
Romania: TELEXER 110 mg capsule
Slovakia: TELEXER 110 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
Poland
Tel.: +48 (22) 755 96 48
[email protected]