Dabigatran Etexilate Adamed leaflet – Poland

How to use Dabigatran Etexilate Adamed

Leaflet accompanying the packaging: patient information

Dabigatran Etexilate Adamed, 75 mg, hard capsules

Dabigatranum etexilatum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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 only. 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, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What is Dabigatran Etexilate Adamed and what is it used for
2. Important information before taking Dabigatran Etexilate Adamed
3. How to take Dabigatran Etexilate Adamed
4. Possible side effects
5. How to store Dabigatran Etexilate Adamed
6. Contents of the pack and other information

1. What is Dabigatran Etexilate Adamed and what is it used for

Dabigatran Etexilate Adamed contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. Its action is to block a substance in the body responsible for the formation of blood clots.
Dabigatran Etexilate Adamed is used in adults to:

prevent the formation of blood clots in the veins after hip or knee replacement surgery.

Dabigatran Etexilate Adamed is used in children aged 8 years and older to:

treat blood clots and prevent recurrent blood clots.

2. Important information before taking Dabigatran Etexilate Adamed

When not to take Dabigatran Etexilate Adamed

if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
if you have severe kidney impairment.
if you are currently bleeding.
if you have a disease of any internal organ that increases the risk of major bleeding (e.g. stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
if you have an increased tendency to bleed. It may be congenital, of unknown cause, or caused by the use of other medicines.
if you are taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when changing anticoagulant treatment, introducing a catheter into a vein or artery, when heparin is administered to the catheter to maintain its patency or when restoring normal heart function through a procedure called catheter ablation in atrial fibrillation.
if you have severe liver impairment or liver disease that may lead to death.
if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
if you are taking oral cyclosporine, a medicine used to prevent transplant rejection.
if you are taking dronedarone, a medicine used to treat heart rhythm disorders.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have a mechanical heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting treatment with Dabigatran Etexilate Adamed, discuss it with your doctor.
If you have experienced symptoms or have undergone surgery during treatment with this medicine, consult your doctor.
The patient should inform the doctorif they have or have had any medical conditions or diseases, especially those listed below:

if you have an increased risk of bleeding, such as:
if you have recently had bleeding.
if you have had a surgical biopsy within the last month.
if you have had a serious injury (e.g. fracture, head injury, or any injury requiring surgical treatment).
if you have esophagitis or gastritis.
if you have gastroesophageal reflux disease.
if you are taking medicines that may increase the risk of bleeding. See also "Dabigatran Etexilate Adamed and other medicines" below.
if you are taking anti-inflammatory or pain-relieving medicines, such as diclofenac, ibuprofen, piroxicam.
if you have infective endocarditis (bacterial infection of the heart).
if you have reduced kidney function or are dehydrated (feeling thirsty and passing less dark, concentrated, or foamy urine).
if you are over 75 years old.
if you are an adult and weigh 50 kg or less.
only in the case of use in children: if the child has an infection around or in the brain.
in the case of a history of myocardial infarction or if you have been diagnosed with conditions that increase the risk of myocardial infarction.
if you have liver disease that affects blood test results. In this case, the use of this medicine is not recommended.

When to exercise special caution when taking Dabigatran Etexilate Adamed

if you need to undergo surgery: In this case, it is necessary to discontinue the use of Dabigatran Etexilate Adamed due to the increased risk of bleeding during and after surgery. It is very important to take Dabigatran Etexilate Adamed before and after surgery exactly as your doctor has instructed.
if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
It is very important to take Dabigatran Etexilate Adamed before and after surgery exactly as your doctor has instructed.
You should immediately inform your doctor if you experience numbness or weakness in your lower limbs or bowel or bladder problems after the anesthesia has worn off, as urgent medical attention is required.
if you have fallen or injured yourself during treatment, especially if you have injured your head. You should immediately seek medical attention. Your doctor will examine you to see if you may have an increased risk of bleeding.
if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

Dabigatran Etexilate Adamed and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
In particular, tell your doctor before taking Dabigatran Etexilate Adamed if you are taking any of the following medicines:

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin).
Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are used only on 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 Dabigatran Etexilate Adamed, depending on the condition for which it was prescribed. See also section 3.
Medicines used to prevent transplant rejection (e.g. tacrolimus, cyclosporine).
A combination product containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
Anti-inflammatory and pain-relieving medicines (e.g. aspirin, ibuprofen, diclofenac).
St. John's Wort, a herbal medicine used to treat depression.
Antidepressant medicines called selective serotonin reuptake inhibitors or selective norepinephrine 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

The effect of Dabigatran Etexilate Adamed on pregnancy and the unborn child is not known. Do not take this medicine during pregnancy unless your doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Dabigatran Etexilate Adamed.
Do not breastfeed while taking Dabigatran Etexilate Adamed.

Driving and using machines

Dabigatran Etexilate Adamed has no or negligible influence on the ability to drive and use machines.

3. How to take Dabigatran Etexilate Adamed

Dabigatran Etexilate Adamed capsules can be used in adults and children aged 8 years or older who can swallow capsules whole.
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.

Take Dabigatran Etexilate Adamed as follows:

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg each).
If kidney function is reducedby more than half or if you are 75 years old or older, the recommended dose is 150 mg once a day(taken as 2 capsules of 75 mg each).
In patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose of Dabigatran Etexilate Adamed is 150 mg once a day(taken as 2 capsules of 75 mg each).
Patient taking verapamil-containing medicines, with reduced kidney functionof more than half, should take a reduced dose of 75 mgof Dabigatran Etexilate Adamed due to increased risk of bleeding.
In both types of surgery, do not start treatment if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, start with a dose of 2 capsules once a day.
After knee replacement surgery
Start taking Dabigatran Etexilate Adamed with a dose of 1 capsule within 1 to 4 hours after the end of surgery. Then take 2 capsules once a day for a total of 10 days.
After hip replacement surgery
Start taking Dabigatran Etexilate Adamed with a dose of 1 capsule within 1 to 4 hours after the end of surgery. Then take 2 capsules once a day for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrent blood clots in children
Dabigatran Etexilate Adamed should be taken twice a day, one dose in the morning and one dose in the evening, at approximately the same time every day. The interval between doses should be approximately 12 hours.
The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue to take all other medicines unless your doctor tells you to stop taking them.
Table 1 shows the single and total daily doses of Dabigatran Etexilate Adamed in milligrams (mg). The doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1:
Dabigatran Etexilate Adamed dosing table

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

from 61 to less than 71 kg	from 8 to less than 18 years	300	600
from 71 to less than 81 kg	from 8 to less than 18 years	300	600
81 kg or more	from 10 to less than 18 years	300	600

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 Adamed

Dabigatran Etexilate Adamed 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.

Changing anticoagulant medicine

Do not change your anticoagulant medicine without getting detailed instructions from your doctor.

Taking a higher dose of Dabigatran Etexilate Adamed than recommended

Taking too much of this medicine increases the risk of bleeding. If you have taken too many capsules, contact your doctor immediately. Specific treatments are available.

Missing a dose of Dabigatran Etexilate Adamed

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
Continue taking the missed daily dose of Dabigatran Etexilate Adamed at the same time the next day.
Do not take a double dose to make up for a missed dose.
Treatment of blood clots and prevention of recurrent blood clots in children.
A missed dose can be taken up to 6 hours before the next scheduled dose.
If there are less than 6 hours until the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Dabigatran Etexilate Adamed

Dabigatran Etexilate Adamed should be taken as directed by your doctor. Do not stop taking this medicine without consulting your doctor first, as the risk of blood clots may be higher if treatment is stopped prematurely. Contact your doctor if you experience indigestion after taking Dabigatran Etexilate Adamed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dabigatran Etexilate Adamed affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding. Major or severe bleeding can occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of the location. In some cases, these bleedings may not be visible.
If you experience bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to monitor you closely or change your medicine.
If you experience a severe allergic reaction that can cause difficulty breathing or dizziness, contact your doctor immediately.
Side effects are listed below by frequency:

Frequent (may affect up to 1 in 10 people):
Decreased hemoglobin in the blood (a substance in red blood cells)
Abnormal liver function test results

Uncommon (may affect 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 urine discolored pink or red due to the presence of blood), from hemorrhoids, from the anus, bleeding under the skin, into a joint, due to injury or after surgery
Formation of hematomas or bruising after surgery
Blood in the stool, as detected by laboratory tests
Decreased red blood cell count in the blood
Decreased hematocrit
Allergic reaction
Vomiting
Frequent passage of loose or liquid stools
Nausea
Wound secretion
Increased liver enzyme activity
Jaundice of the skin or whites of the eyes due to liver or blood disease

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

Bleeding
Bleeding may occur into the brain, from the surgical wound, from the injection site, or from the catheter insertion site
Blood-tinged secretion from the catheter insertion site into a vein
Coughing up blood or sputum tinged with blood
Decreased platelet count in the blood
Decreased red blood cell count in the blood after surgery
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing facial or throat swelling
Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
Sudden change in skin color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulceration)
Esophagitis or gastritis
Gastroesophageal reflux disease
Abdominal pain or stomach pain
Indigestion
Difficulty swallowing
Wound secretion
Wound secretion after surgery

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

Difficulty breathing or wheezing
Decreased or absent white blood cell count (which help fight infections)
Hair loss

Treatment of blood clots and prevention of recurrent blood clots in children
Frequent (may affect up to 1 in 10 people):

Decreased red blood cell count in the blood
Decreased platelet count in the blood
Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
Sudden change in skin color and appearance
Formation of hematomas
Nosebleeds
Gastroesophageal reflux disease
Vomiting
Nausea
Frequent passage of loose or liquid stools
Indigestion
Hair loss
Increased liver enzyme activity

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

Decreased white blood cell count (which help fight infections)
Bleeding may occur into the stomach or intestines, brain, anus, penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
Decreased hemoglobin in the blood (a substance in red blood cells)
Decreased hematocrit
Itching
Coughing up blood or sputum tinged with blood
Abdominal pain or stomach pain
Esophagitis or gastritis
Allergic reaction
Difficulty swallowing
Jaundice of the skin or whites of the eyes due to liver or blood disease

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

Absent white blood cell count (which help fight infections)
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing facial or throat swelling
Difficulty breathing or wheezing
Bleeding
Bleeding may occur into a joint, from a wound, from the surgical wound, from the injection site, or from the catheter insertion site into a vein
Bleeding from hemorrhoids
Stomach or intestinal ulcer (including esophageal ulceration)
Abnormal liver function test results

Reporting side effects

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

5. How to store Dabigatran Etexilate Adamed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after "EXP" or "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original package to protect from light and moisture.
Medicines should 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 Dabigatran Etexilate Adamed contains

The active substance is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (as mesylate).
The other ingredients are: tartaric acid, arabic gum, dried dispersion, hypromellose 15cP, dimeticone, talc, and hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), purified water, and hypromellose.
The black ink used for printing contains shellac, iron oxide black (E172), and potassium hydroxide.

What Dabigatran Etexilate Adamed looks like and contents of the pack

Dabigatran Etexilate Adamed 75 mg is a hard capsule with a white, opaque cap with black printing "D75" and a white, opaque body, filled with yellowish pellets.
This medicine is available in packs containing 30 or 60 hard capsules in aluminum blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, M. Adamkiewicza 6A
05-152 Czosnów
phone: 22 732 77 00

Manufacturer

Adamed Pharma S.A.
Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:

Dabigatran Etexilate Adamed

Bulgaria:

Дабигатран етексилат Адамед 75 mg твърди капсули

Italy:

Dabigatran Etexilato Adamed

Spain:

Dabigatrán etexilato Adamed 75 mg cápsulas duras EFG

Portugal:

Dabigatrano etexilato Adamed

Croatia:

Dabigatraneteksilat Adamed 75 mg tvrde kapsule
Romania:
Dabigatran Etexilate Adamed 75 mg capsule
France:
Dabigatran Etexilate Adamed 75 mg gélule