Dabigatran etexilate g.l.: detailed information

Package leaflet: Information for the patient

Dabigatran etexilate G.L., 150 mg, hard capsules
Dabigatranum etexilatum
Please read carefully this leaflet before taking the medicine, because 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 person. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What is Dabigatran etexilate G.L. and what is it used for
Important information before taking Dabigatran etexilate G.L.
How to take Dabigatran etexilate G.L.
Possible side effects
How to store Dabigatran etexilate G.L.
Contents of the pack and other information

1. What is Dabigatran etexilate G.L. and what is it 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 to:

prevent formation of blood clots in the brain (stroke) and in other blood vessels of the body in patients with an irregular heart rhythm 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 blood clots in the veins of the legs and lungs.

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

treat blood clots and to prevent recurrence of blood clots.

2. Information before using Dabigatran etexilate G.L.

When not to use Dabigatran etexilate G.L.

if the patient is allergic to dabigatran etexilate or to 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 internal organs that increases the risk of major bleeding (e.g. peptic ulcer of the stomach, brain trauma 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 through the catheter to maintain its patency, or during a catheter ablation procedure for atrial fibrillation to restore normal heart rhythm.
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 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 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 tissue biopsy within the last month.
if the patient has sustained 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 (regurgitation of stomach acid 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 affecting 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 aged 75 years or older.
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 be especially careful when using Dabigatran etexilate G.L.

if the patient needs to undergo surgery: In such cases, treatment with Dabigatran etexilate G.L. must be temporarily discontinued 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 surgery requires insertion of a catheter or 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 the bowel or bladder after the anaesthesia 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 that increases the 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
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, tell 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, ticagrelor, rivaroxaban, acetylsalicylic acid).
Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless these medicines are used topically on the skin only.
Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). For 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 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-noradrenaline reuptake inhibitors.
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 age should avoid becoming pregnant while taking Dabigatran etexilate G.L.
Breastfeeding should not be undertaken during treatment with 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 the treatment of children under 8 years of age.
This medicine should always be taken according to the doctor's instructions. In case of doubt, consult your doctor.
Dabigatran etexilate G.L. should be taken according to the following recommendations:
Prevention of thromboembolic events in blood vessels of 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 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 older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
Patients taking medicines 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 the 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 function through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Dabigatran etexilate G.L. should be taken according to the doctor's instructions.
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 Dabigatran etexilate G.L. after the doctor has confirmed adequate control of blood coagulation. Dabigatran etexilate G.L. should be taken according to the doctor's instructions.
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, 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 age and body weight. The doctor will determine the correct dose and may adjust it during treatment. All other medications should continue to be used unless the doctor advises otherwise.
Table 1 shows the single and total daily doses of dabigatran etexilate in milligrams (mg). The 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

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	from 8 to less than 9	75	150
from 13 to less than 16	from 8 to less than 11	110	220
from 16 to less than 21	from 8 to less than 14	110	220
from 21 to less than 26	from 8 to less than 16	150	300
from 26 to less than 31	from 8 to less than 18	150	300
from 31 to less than 41	from 8 to less than 18	185	370
from 41 to less than 51	from 8 to less than 18	220	440
from 51 to less than 61	from 8 to less than 18	260	520
from 61 to less than 71	from 8 to less than 18	300	600
from 71 to less than 81	from 8 to less than 18	300	600
81 or more	from 10 to less than 18	300	600

Single doses requiring 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. They must not be broken, chewed, or emptied, 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, they should contact their doctor immediately. Specific treatment methods are available.

Missed dose of Dabigatran etexilate G.L.
A missed dose may be taken if it is at least 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.

Discontinuing Dabigatran etexilate G.L.
Dabigatran etexilate G.L. should be taken according to the doctor's instructions. Do not discontinue treatment without consulting your doctor first, as the risk of blood clots may increase 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Dabigatran etexilate G.L. affects the blood clotting system, therefore most of the side effects relate to symptoms such as bruising or bleeding.

Severe or major bleeding may occur, which is the most common side effect 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) appear, you should 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 causing difficulty in breathing or dizziness, contact your doctor immediately.

The possible side effects listed below are grouped according to their frequency of occurrence:

Prevention of blood clots in blood vessels in the brain and body by preventing the formation of clots that occur 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 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 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 bruises (haematomas)
Coughing up blood or blood-stained 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 occur in up to 1 in 1,000 people):

Bleeding may occur into a joint, from a surgical incision, from a wound, from an injection site, or from the site of insertion of a venous catheter
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
Decrease in blood cell count
Increased liver enzyme activity
Jaundice (yellowing of the skin or whites of the eyes) caused by liver or blood disease

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 clinical trials, the number of heart attacks 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 from haemorrhoids may occur
Decrease in the number of red blood cells in the blood
Formation of bruises (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 a surgical incision, from an injection site, from the site of insertion of a venous catheter, or from 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 appearing as dark red, raised, itchy bumps due to an allergic reaction
Difficulty swallowing

Not known (frequency 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 count
Decrease in the number of, or even absence of, white blood cells (which help fight infections)
Jaundice (yellowing of the skin or whites of the eyes) caused by liver or blood disease
Hair loss

In clinical trials, the number of heart attacks 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):

Decrease in the number of red blood cells in the blood
Decrease in the 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 bruises (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):

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 haemoglobin levels in the blood (the substance in red blood cells)
Decrease in blood cell count
Itching
Coughing up blood or blood-stained sputum
Abdominal pain or stomach pain
Inflammation of the oesophagus and stomach
Allergic reaction
Difficulty swallowing
Jaundice (yellowing of the skin or whites of the eyes) caused by liver or blood disease

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, from an injection site, or from the site of insertion of a venous catheter
Bleeding from haemorrhoids may occur
Stomach or intestinal ulcer (including oesophageal ulceration)
Abnormal liver function test results in laboratory tests

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also 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
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this 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 specified month.
Blister foil: Aluminium with moisture-absorbing layer – Aluminium (OPA/Alu/PE//PE/Alu/LDPE):
No special storage instructions 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 indicated on the packaging.
Medicines must not be disposed of via the sewage system 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 150 mg of dabigatran etexilate.

The 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 22.0 mm, with a light blue, opaque cap and a white,
opaque body, size "0", 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 a screw cap (PP).
Pack sizes:
Blisters containing: 10, 30, 30x1 (single-dose blister), 60, 60x1 (single-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 on this medicinal product, the contact is to be made with the local 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]