Dabigatran etexilate g.l.

Package leaflet: Information for the patient

Dabigatran etexilate G.L., 110 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before using this medicine, because it contains
important information for you.

• 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 personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Dabigatran etexilate G.L. is and what it is used for
2. What you need to know before taking Dabigatran etexilate G.L.
3. How to take Dabigatran etexilate G.L.
4. Possible side effects
5. How to store Dabigatran etexilate G.L.
6. Contents of the pack and other information

1. What Dabigatran etexilate G.L. is and what it is used for

Dabigatran etexilate G.L. 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.
Dabigatran etexilate G.L. is used in adults for:

• preventing the formation of blood clots in veins after hip or knee replacement surgery.
• preventing the formation of blood clots in the brain (stroke) and in other blood vessels in the body in patients who have an irregular heart rhythm known as non-valvular atrial fibrillation and at least one additional risk factor.
• treating blood clots in the veins of the legs and lungs, and preventing recurrence of such clots.

Dabigatran etexilate G.L. is used in children for:

• treatment of blood clots and prevention of recurrence of blood clots.

2. Important information before using Dabigatran etexilate G.L.

When not to use Dabigatran etexilate G.L.

• 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 an internal organ which increases the risk of major bleeding (e.g. stomach ulcer, brain injury or intracranial haemorrhage, recent brain or eye surgery);
• if the patient has an increased tendency to bleed, which 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, when heparin is administered via the catheter to maintain its patency, or during catheter ablation procedures for 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, 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 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 treatment with Dabigatran etexilate G.L., discuss this with your doctor. If symptoms occur during treatment with this medicine or if the patient has undergone surgery, medical advice should be sought.
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 has undergone a surgical 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 oesophagitis or gastritis;
• if the patient has gastro-oesophageal reflux (acid reflux into the oesophagus);
• if the patient is taking medicines that may increase the risk of bleeding. See below “Dabigatran etexilate G.L. and other medicines”;
• if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam;
• if the patient has an infection within the heart (bacterial endocarditis);
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark (concentrated), frothy 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 if conditions increasing the risk of heart attack have been diagnosed;
• 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 using Dabigatran etexilate G.L.

• if the patient needs to undergo surgery: In such cases, temporary discontinuation of Dabigatran etexilate G.L. is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate G.L. exactly as prescribed by the doctor before and after surgery.
• if the surgical procedure requires insertion of a catheter or injection into the spinal canal (e.g. for epidural or spinal anaesthesia or for pain relief):
• it is very important to take Dabigatran etexilate G.L. exactly as prescribed by the doctor before and after surgery;
• the patient should immediately inform the doctor if numbness or weakness in the lower limbs, or problems with the bowels or bladder occur after the anaesthesia wears off, as urgent medical care is required.
• if the patient falls or injures themselves during treatment, especially if they injure their head. Immediate medical help 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 an increased risk of blood clots), the patient should inform their doctor, who will decide whether a change in treatment is necessary.

Dabigatran etexilate G.L. and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, inform the doctor before taking Dabigatran etexilate G.L. if the patient is taking any of the following medicines:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, tikagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless these 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 amiodarone, quinidine or verapamil, the doctor may recommend a lower dose of Dabigatran etexilate G.L., depending on the condition for which the medicine was prescribed. See also section 3.
• Medicines used to prevent rejection of a transplanted organ (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 (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs).
• 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
It is not known what effect Dabigatran etexilate G.L. 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 Dabigatran etexilate G.L.
Breastfeeding should not be undertaken while taking Dabigatran etexilate G.L.

Driving and operating machinery
Dabigatran etexilate G.L. has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to take Dabigatran etexilate G.L.

Dabigatran etexilate G.L. capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole.
Other age-appropriate strengths and pharmaceutical forms are available for treating children under 8 years of age.
This medicine should always be taken as prescribed by the doctor. If in doubt, consult your doctor.
Dabigatran etexilate G.L. should be taken according to the following instructions:

Prevention of blood clots after surgery (joint replacement) of the hip or knee joint
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 above, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
In patients taking medications containing amiodarone, quinidine, or verapamil, the recommended dose of Dabigatran etexilate G.L. is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking medications containing verapamil who also have renal function reduced by more than half should take a reduced dose of 75 mg of Dabigatran etexilate G.L. due to an increased risk of bleeding.

In both types of surgery, treatment should not be initiated if there is active bleeding from the surgical site. If treatment cannot be started within the next day after surgery, it should be initiated with a dose of 2 capsules once daily.

After knee joint replacement surgery
Treatment with Dabigatran etexilate G.L. should begin with one capsule taken within 1 to 4 hours after the end of the surgical procedure. Then, two capsules should be taken once daily for a total of 10 days.

After hip joint replacement surgery
Treatment with Dabigatran etexilate G.L. should begin with one capsule taken within 1 to 4 hours after the end of the surgical procedure. Then, two capsules should be taken once daily for a total of 28 to 35 days.

Prevention of thromboembolism in blood vessels of the brain and body by preventing clot formation occurring due to irregular heart function, and treatment and prevention of recurrence of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg, taken as one 150 mg capsule twice daily.
In patients aged 80 years or above, the recommended dose is 220 mg, taken as one 110 mg capsule twice daily.
Patients taking medications containing verapamil should receive a reduced dose of Dabigatran etexilate G.L. of 220 mg, taken as one 110 mg capsule twice daily, due to a possible 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 using a procedure called cardioversion. Dabigatran etexilate G.L. should be taken as directed by the doctor.

In cases where a medical device (stent) is implanted into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, the patient may receive treatment with Dabigatran etexilate G.L., after the doctor has confirmed adequate control of blood coagulation. Dabigatran etexilate G.L. should be taken as directed by the doctor.

Treatment and prevention of recurrence of blood clots in children
Dabigatran etexilate G.L. should be taken twice daily, one dose in the morning and one in the evening, preferably at the same time each day. The interval between doses should be approximately 12 hours.

The recommended dose depends on age and body weight. 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 single and total daily doses of dabigatran etexilate in milligrams (mg). Doses depend on the patient's body weight in kilograms (kg) and age in years.

Table 1: Dosing table for dabigatran etexilate in capsule form

Single 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

How to take Dabigatran etexilate G.L.
Dabigatran etexilate G.L. may be used in adults and children aged at least 8 years who are able to swallow capsules whole.
Dabigatran etexilate G.L. 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.

Switching anticoagulant therapy
Do not switch anticoagulant medication without receiving detailed instructions from your doctor.

Taking more than the recommended dose of Dabigatran etexilate G.L.
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 Dabigatran etexilate G.L.
Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Dabigatran etexilate G.L. at the same time on the following day. Do not take a double dose to make up for the missed dose.

Use in adults: Prevention of thromboembolic events in blood vessels of the brain and body by preventing clot formation 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
Use in children: Treatment of blood clots and prevention of recurrent blood clots
A missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain until the next scheduled dose, the missed dose should not be taken. Do not take a double dose to make up for a missed dose.

Discontinuation of Dabigatran etexilate G.L.
Dabigatran etexilate G.L. 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 gastrointestinal discomfort occurs after taking Dabigatran etexilate G.L.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not in everyone.
Dabigatran etexilate G.L. affects the blood coagulation system, therefore most adverse reactions are related to symptoms such as bruising or bleeding.
Severe or extensive bleeding may occur, which is the most common adverse reaction and, regardless of location, may lead to disability, be life-threatening, or even result in death.
In some cases, such bleeding may not be visible.
If bleeding that does not stop spontaneously occurs, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. The doctor may decide to place the patient under close observation or change the treatment.
In the event of a serious allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

The possible adverse reactions listed below are grouped according to their frequency of occurrence:

Prevention of blood clots after surgery (hip or knee replacement)
Common (may occur in up to 1 in 10 people):

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

Uncommon (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 pink or red urine due to presence of blood), from haemorrhoids, from the rectum, under the skin, into joints, following injury or after surgical procedures
• Formation of haematomas or bruising occurring after surgery
• Blood in stool detected in laboratory tests
• Decreased number of red blood cells in the blood
• Decreased proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent passage of loose or liquid stools
• Nausea
• Presence of discharge from the wound (oozing of fluid from the surgical wound)
• Increased liver enzyme activity
• Jaundice of the skin or whites of the eyes caused by liver disease or blood disorders

Rare (may occur in 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 venous catheter insertion
• Blood-tinged discharge from the site of venous catheter insertion
• Coughing up blood or blood-stained sputum
• Decreased number of platelets in the blood
• Decreased 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 appearing as 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
• Fluid discharge from the wound
• Fluid discharge from the surgical wound

Unknown (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decreased number or even absence of white blood cells (which help fight infections)
• Hair loss

Prevention of thromboembolism in blood vessels of the brain and body by preventing formation of clots arising from irregular heart rhythm
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 urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decreased number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent passage of loose or liquid stools
• Nausea

Uncommon (may occur in 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-stained sputum
• Decreased number of platelets in the blood
• Decreased haemoglobin levels in the blood (a 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 occur in up to 1 in 1,000 people):

• Bleeding may occur into a joint, from the surgical incision site, from a wound, from the injection site, or from the site of venous catheter insertion
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash appearing as dark red, raised, itchy bumps due to an allergic reaction
• Decreased proportion of blood cells
• Increased liver enzyme activity
• Jaundice of the skin or whites of the eyes caused by liver disease or blood disorders

Unknown (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decreased number or even absence of white blood cells (which help fight infections)
• Hair loss

In clinical studies, the number of heart attacks observed with Dabigatran etexilate G.L. was numerically higher than with warfarin. The overall number of events was small.
Treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in the legs and 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 haemorrhoids
• Decreased number of red blood cells in the blood
• Formation of haematomas
• Coughing up blood or blood-stained 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 liquid 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 may occur from the surgical incision site, from the injection site, from the site of venous catheter insertion, or into the brain
• Decreased 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 appearing as dark red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing

Unknown (frequency cannot be estimated from available data):

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

In clinical studies, the number of heart attacks observed with Dabigatran etexilate G.L. was numerically higher than with warfarin. The overall number of events was low.
No difference in the number of heart attacks was observed between patients treated with dabigatran and those receiving placebo.
Treatment of blood clots and prevention of recurrence of blood clots in children
Common (may occur in up to 1 in 10 people):

• Decreased number of red blood cells in the blood
• Decreased number of platelets in the blood
• Skin rash appearing as 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 liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decreased 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
• Decreased haemoglobin levels in the blood (a substance in red blood cells)
• Decreased proportion of blood cells
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal pain or stomach pain
• Inflammation of the oesophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Jaundice 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 the surgical incision site, from the injection site, or from the site of venous 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dabigatran etexilate G.L.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle label following: EXP. The expiry date refers to the last day of the stated month.
Blister foil: Aluminium with moisture-absorbing layer – Aluminium (OPA/Alu/PE//PE/Alu/LDPE):
No special storage instructions apply.
Blister foil: Aluminium – Aluminium (blister oPA/Alu/PVC//Alu): Do not store above 30°C.
White HDPE bottle: Store in the original packaging to protect from moisture.
Storage conditions are given on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Dabigatran etexilate G.L. contains

• The active substance is dabigatran etexilate. Each capsule contains dabigatran etexilate in the form of mesilate equivalent to 110 mg of dabigatran etexilate.

Other ingredients are:

• Capsule contents: tartaric acid (in the form of pellets), hypromellose, hydroxypropylcellulose, and talc.
• Capsule shell: indigo carmine, aluminium lake (E 132), carrageenan, potassium chloride, titanium dioxide (E 171), and hypromellose.

What Dabigatran etexilate G.L. looks like and contents of the pack
Capsules with a diameter of approximately 19.0 mm, with a light blue, opaque cap and a light blue, opaque body, size “1”, filled with granules ranging in colour from white to yellowish.
The capsules are packed in aluminium blisters with a moisture-absorbing layer – Aluminium (OPA/Alu/PE//PE/Alu/LDPE) and Aluminium-Aluminium (blisters oPA/Alu/PVC//Alu), or in a plastic bottle with a container containing a moisture-absorbing agent (silica gel) in the closure (PP).
Pack sizes
Blisters containing: 10, 10x1 (unit dose blister), 30, 30x1 (unit dose blister), 60, 60x1 (unit dose blister), 100 and 180 hard capsules.
White bottle containing 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer
Laboratorios Liconsa, S.A.
Avda. Miralcampo 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]