Dabigatran etexilate g.l.

Package leaflet: Information for the patient

Dabigatran etexilate G.L., 75 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

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

Contents of the leaflet

1. What Dabigatran etexilate G.L. is and what it is used for
2. Important information 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 package 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 in the body a substance responsible for blood clot formation.
Dabigatran etexilate G.L. is used in adults for:

• prevention of blood clots in veins following hip or knee replacement surgery.

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

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

2. Information before using Dabigatran etexilate G.L.

When Dabigatran etexilate G.L. must not be used

• 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 impairment of kidney function.
• 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. peptic ulcer disease, brain trauma or intracranial haemorrhage, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by 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 through the catheter to maintain its patency, or during a catheter ablation procedure for atrial fibrillation.
• if the patient has severe liver 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 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 lifelong anticoagulant therapy.

Warnings and precautions
Before starting treatment with Dabigatran etexilate G.L., discuss this with your doctor. If you experience any symptoms while taking this medicine or have undergone surgery, you should consult your doctor.
The patient should inform the doctor if they have or have previously had any medical conditions or diseases, especially the following:

• 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 tissue 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 anti-inflammatory medicines 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), 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 previous heart attack or has conditions diagnosed that increase the risk of heart attack.
• if the patient has liver disease affecting blood test results. In such a case, use of this medicine is not recommended.

When special caution is needed when using Dabigatran etexilate G.L.

• if the patient needs to undergo surgery: In such a case, 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. before and after surgery exactly as directed by the doctor.
• if the surgical procedure requires insertion of a catheter or administration of an 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. before and after surgery exactly as directed by the doctor.
• the patient should inform the doctor immediately if they experience numbness or weakness in the lower limbs or problems with bowel or bladder function 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 is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

Dabigatran etexilate G.L. and other medicines
You must tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take. In particular, you must tell your 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, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless these are applied topically 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 organ rejection after transplantation (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 called selective serotonin reuptake inhibitors or selective serotonin and noradrenaline reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medicines used to treat AIDS (e.g. ritonavir).
• Some medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breast-feeding
It is not known what effect Dabigatran etexilate G.L. has on pregnancy and the unborn child. This medicine should not be used during pregnancy unless the doctor considers it safe. Women of childbearing potential should avoid becoming pregnant while taking Dabigatran etexilate G.L.
Breast-feeding must not be undertaken during treatment with Dabigatran etexilate G.L.

Driving and using machines
Dabigatran etexilate G.L. has no effect or a negligible effect on the ability to drive and use machines.

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 directed by the doctor. In case of doubt, consult your doctor.
Dabigatran etexilate G.L. should always be taken according to the following instructions:

Prevention of blood clots after surgery (joint replacement) of the hip or knee
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg each).
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 each).
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 each).
Patients taking medications containing verapamil who also have reduced renal function by more than half should receive a reduced dose of 75 mg of this medicine 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 by 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 1 to 4 hours after completion 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 1 to 4 hours after completion of the surgical procedure. Then, two capsules should be taken once daily for a total duration of 28 to 35 days.

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

The recommended dose depends on age and body weight. The doctor will determine the correct dose and may adjust it during treatment. Continue taking all other prescribed medications unless your doctor advises otherwise.

Table 1 shows the 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 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 crush, chew or empty the pellets from the capsule, as this may increase the risk of bleeding.
Switching anticoagulant medication
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 surgery (joint replacement) of the hip or knee
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.
Treatment and prevention of recurrent blood clots in children
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 the missed dose.
Stopping treatment with Dabigatran etexilate G.L.
Dabigatran etexilate G.L. should be taken according to the doctor's instructions. Do not stop taking this medicine without prior consultation with your doctor, as the risk of blood clot formation may increase if treatment is stopped prematurely. Contact your doctor if you experience gastrointestinal discomfort after taking Dabigatran etexilate G.L.
If you have any further questions 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 of the adverse reactions relate to symptoms such as bruising or bleeding.
Severe or major 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 medication.
In case 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 (joint replacement) of the hip or knee
Common (may occur in up to 1 in 10 people):

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

Uncommon (may occur in 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, following injury or after surgical procedures
• Formation of bruises or haematomas occurring after surgery
• Blood in stool detected in laboratory tests
• Decreased number of red blood cells in blood
• Decreased proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent passage of loose or liquid stools
• Nausea
• Discharge from wound (leakage of fluid from surgical wound)
• Increased liver enzyme activity
• Yellowing 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 into the brain, from the surgical incision site, injection site, or from the site where a venous catheter was inserted
• Blood-tinged discharge from the site where a venous catheter was inserted
• Coughing up blood or blood-tinged sputum
• Decreased platelet count in blood
• Decreased number of red blood cells in 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 nodules occurring as a result of 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 wound
• Discharge of fluid from surgical wound

Not known (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

Treatment 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 blood
• Decreased platelet count in blood
• Skin rash consisting of dark red, raised, itchy nodules occurring as a result of an allergic reaction
• Sudden change in skin colour and appearance
• Formation of bruises
• 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, brain, rectum, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decreased haemoglobin levels in blood (a substance in red blood cells)
• Decreased proportion of blood cells
• 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 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 into joints, from wounds, surgical incision sites, injection sites, or sites where a venous catheter was inserted
• Bleeding from haemorrhoids may occur
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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 reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Dabigatran etexilate G.L.

Keep this medicine out of 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 conditions required.
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 provided on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such practices 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 75 mg of dabigatran etexilate.

Other ingredients are:

• Capsule contents: tartaric acid (in the form of pellets), hypromellose, hydroxypropylcellulose and talc.
• Capsule shell: 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 18.0 mm, with a white, opaque cap and a white,
opaque body, size “2”, filled with granules ranging in colour from white to yellowish.
The capsules are packed in aluminum 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 desiccant made of silica gel in the cap (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

To obtain 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]