Dabigatran etexilate adamed: detailed information

Package leaflet: Information for the patient

Dabigatran Etexilate Adamed, 150 mg, hard capsules
Dabigatranum etexilatum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, 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 others, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Dabigatran Etexilate Adamed is and what it is used for
What you need to know before taking Dabigatran Etexilate Adamed
How to take Dabigatran Etexilate Adamed
Possible side effects
How to store Dabigatran Etexilate Adamed
Contents of the pack and other information

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

Dabigatran Etexilate Adamed 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 responsible for blood clot formation.
Dabigatran Etexilate Adamed is used in adults for:

preventing the formation of blood clots in the brain (stroke) and in other blood vessels of the body in patients with a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor.
treating blood clots in the veins of the legs and lungs, and preventing the recurrence of blood clots in the veins of the legs and lungs.

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

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

2. Important information before taking Dabigatran Etexilate Adamed

When not to take Dabigatran Etexilate Adamed

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 any internal organ that increases the risk of major bleeding (e.g. gastric ulcer, brain injury 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 taking other medicines.
if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant therapy, during insertion of a venous or arterial catheter when heparin is administered through the catheter to maintain its patency, or during a procedure called catheter ablation for atrial fibrillation to restore normal heart rhythm.
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 an artificial heart valve that requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran Etexilate Adamed, discuss this with your doctor.
If symptoms have occurred during treatment with this medicine or if the patient has undergone a surgical procedure, consult a doctor.
The patient should inform the doctor if they currently have or have had in the past 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 (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 Adamed 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 of the heart (bacterial endocarditis).
if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark [concentrated] or 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 previously had a 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 to exercise particular caution when taking Dabigatran Etexilate Adamed

if the patient needs to undergo surgery: In such a case, temporary discontinuation of Dabigatran Etexilate Adamed is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran Etexilate Adamed exactly as directed by the doctor both before and after surgery.
if surgery requires insertion of a catheter or administration of an injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
It is very important to take Dabigatran Etexilate Adamed exactly as directed by the doctor both before and after surgery.
The patient should immediately inform the doctor if, after the anaesthesia wears off, they experience numbness or weakness in the legs or problems with the bowels or bladder, as urgent medical care is required.
if the patient falls or injures themselves during treatment, especially if they injure their head. Immediate medical attention should be sought. The doctor will assess whether there may be an increased risk of bleeding.
if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform their doctor, who will decide whether a change in treatment is necessary.

Dabigatran Etexilate Adamed and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, before taking Dabigatran Etexilate Adamed, the patient should tell the doctor
if they are taking any of the following medicines:

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless these medicines are applied only to the skin.
Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing verapamil, the doctor may recommend a lower dose of Dabigatran Etexilate Adamed depending on the condition for which the medicine was prescribed. See 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 called 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 Adamed 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 Adamed.
Breastfeeding must not be undertaken during treatment with Dabigatran Etexilate Adamed.

Driving and operating machinery
Dabigatran Etexilate Adamed has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to take Dabigatran Etexilate Adamed

Dabigatran Etexilate Adamed capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole.
This medicine should always be taken according to the doctor's instructions. If in doubt, consult the doctor.
Dabigatran Etexilate Adamed should be taken as follows:
Prevention of blood clots in blood vessels of the brain and body by preventing the formation of 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 such clots
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 Adamed 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 via a procedure called cardioversion or via a procedure called catheter ablation for atrial fibrillation. Dabigatran Etexilate Adamed should be taken according to the doctor's instructions.
In 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 Adamed after the doctor confirms adequate control of blood coagulation. Dabigatran Etexilate Adamed should be taken according to the doctor's instructions.
Treatment of blood clots and prevention of recurrent blood clots in children
Dabigatran Etexilate Adamed 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 body weight and age. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. All other medications should be continued unless the doctor advises otherwise.
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: Dosing table for Dabigatran Etexilate Adamed

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

Single doses requiring combination of more than one capsule:
300 mg: two capsules of 150 mg or four capsules of 75 mg
260 mg: one capsule of 110 mg and one capsule of 150 mg
or one capsule of 110 mg and two capsules of 75 mg
220 mg: two capsules of 110 mg
185 mg: one capsule of 75 mg and one capsule of 110 mg
150 mg: one capsule of 150 mg or two capsules of 75 mg

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 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.

Accidental overdose of Dabigatran Etexilate Adamed
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 Adamed
A missed dose may be taken if there is still 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.

Stopping treatment with Dabigatran Etexilate Adamed
Dabigatran Etexilate Adamed should be taken according to the doctor's instructions. Do not stop taking this medicine without consulting your doctor first, as the risk of blood clot formation 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 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 everybody will experience them.
Dabigatran Etexilate Adamed affects the blood clotting system; therefore, most of the adverse reactions are related to symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse effect. Regardless of the site, such bleeding may lead to disability, be life-threatening, or even result in death. In some cases, this bleeding may not be visible.
If you experience bleeding that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to place you under close monitoring or change your treatment.
In case of a serious allergic reaction, which may cause difficulty breathing or dizziness, seek immediate medical attention.

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

Prevention of blood clots in blood vessels of 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 discoloration of urine due to presence of blood), or under the skin
Decrease in the number of red blood cells in the blood
Abdominal pain or stomach pain
Indigestion
Frequent passage of loose or watery stools
Nausea

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

Bleeding
Bleeding may occur from haemorrhoids, from the rectum, or into the brain
Formation of bruises (bruising)
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in haemoglobin levels in the blood (a substance in red blood cells)
Allergic reaction
Sudden change in skin color 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 into a joint, from a surgical incision site, from a wound, from an injection site, or from the site of intravenous catheter insertion
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash characterized by dark red, raised, itchy bumps due to an allergic reaction
Decrease in blood cell count
Increased liver enzyme activity
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):

Difficulty breathing or wheezing
Decrease in the number or even absence of white blood cells (which help fight infections)
Hair loss

In clinical trials, the number of heart attacks was numerically higher with Dabigatran Etexilate Adamed than with warfarin. The overall number of events was low.

Treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in the legs and lungs

Common (may 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 discoloration of 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
Decrease in the number of red blood cells in the blood
Formation of bruises (bruising)
Coughing up blood or blood-stained sputum
Allergic reaction
Sudden change in skin color and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulceration)
Inflammation of the oesophagus and stomach
Regurgitation of stomach contents into the oesophagus (reflux)
Nausea
Vomiting
Abdominal pain or stomach pain
Frequent passage of loose or watery stools
Abnormal liver function test results in laboratory tests
Increased liver enzyme activity

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

Bleeding from a surgical incision site, or from an injection site, or from the site of intravenous catheter insertion, or bleeding into the brain
Decrease in the number of platelets in the blood
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash characterized by dark red, raised, itchy bumps due to an allergic reaction
Difficulty swallowing

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

Difficulty breathing or wheezing
Decrease in haemoglobin levels in the blood (a substance in red blood cells)
Decrease in blood cell count
Decrease in the number or even absence of white blood cells (which help fight infections)
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 was numerically higher with dabigatran 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 who received 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 characterized by dark red, raised, itchy bumps due to an allergic reaction
Sudden change in skin color and appearance
Formation of bruises (bruising)
Nosebleeds
Regurgitation of stomach contents into the oesophagus (reflux)
Vomiting
Nausea
Frequent passage of loose or watery stools
Indigestion
Hair loss
Increased liver enzyme activity

Uncommon (may 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 discoloration of urine due to presence of blood), or under the skin
Decrease in haemoglobin levels in the blood (a 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
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 site, from an injection site, or from the site of intravenous catheter insertion
Bleeding may occur from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulceration)
Abnormal liver function test results in laboratory tests

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can also be reported directly to:
Department for Monitoring of Adverse Drug Reactions
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
Reporting side effects helps 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 stated on the carton or blister after:
"Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C. Keep in the original packaging in order to protect from light and moisture.
Medicines must not be disposed of via the sewage system. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 150 mg of dabigatran etexilate (as mesylate).
The other ingredients are: tartaric acid, arabic gum, dried dispersion, hypromellose 15cP, dimethicone, talc and hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171), indigo carmine (E 132), purified water and hypromellose.
The black printing ink contains shellac, iron oxide black (E 172) and potassium hydroxide.

What Dabigatran Etexilate Adamed looks like and contents of the pack
Dabigatran Etexilate Adamed 150 mg is a hard capsule with a blue, opaque cap printed in black with "D150" and a white, opaque body, filled with yellowish pellets.
This medicine is available in packs containing 30, 60, 100 or 180 hard capsules in aluminum blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. 22 732 77 00

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

This medicine is authorised in the European Economic Area countries under the following names:
Poland: Dabigatran Etexilate Adamed
Bulgaria: Дабигатран етексилат Адамед 150 mg твърди капсули
Italy: Dabigatran Etexilato Adamed
Spain: Dabigatrán etexilato Adamed 150 mg cápsulas duras
Portugal: Dabigatrano etexilato Adamed
Croatia: Dabigatraneteksilat Adamed 150 mg tvrde kapsule
Romania: Dabigatran Etexilate Adamed 150 mg capsule
France: Dabigatran Etexilate Adamed 150 mg gélule
Austria: Dabigatran Etexilate Adamed 150 mg Hartkapseln
Netherlands: Dabigatran Etexilaat Adamed 150 mg harde capsules