Dabigatran etexilate adamed

Package leaflet: Information for the patient

Dabigatran Etexilate Adamed, 75 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before taking 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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Dabigatran Etexilate Adamed is and what it is 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 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 known as anticoagulants. It works by blocking a substance in the body that is responsible for blood clot formation.
Dabigatran Etexilate Adamed is used in adults for:

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

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 currently has active bleeding.
• if the patient has a disease of any 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. 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, inserting 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 a mechanical heart valve, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran Etexilate Adamed, the patient should discuss this with their doctor.
If symptoms occur during treatment with this medicine or if the patient undergoes a surgical procedure, the patient should consult their doctor.
The patient should inform their doctor if they currently 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 disease (acid reflux into the oesophagus).
• if the patient is taking medicines which 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) and/or foamy 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 to 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 exercise special caution when taking Dabigatran Etexilate Adamed

• if the patient needs to undergo surgery: In such cases, treatment with Dabigatran Etexilate Adamed must be temporarily discontinued 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 before and after surgery.
• if surgery requires insertion of a catheter or 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 before and after surgery.
• The patient should immediately inform their doctor if they experience numbness or weakness in the legs, or problems with bowel or bladder function after the anaesthesia wears off, as urgent medical care may be needed.
• if the patient falls or injures themselves during treatment, especially if they injure their head. The patient should seek immediate medical attention. 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 their doctor, who will decide whether a change in treatment is necessary.

Dabigatran Etexilate Adamed and other medicines
The patient should inform their doctor or pharmacist about all medicines they are currently taking, have recently taken, or plan to take. In particular, the patient should
inform their doctor before taking Dabigatran Etexilate Adamed 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 used only topically 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 the medicine has been prescribed. See also section 3.
• Medicines used to prevent rejection of transplanted organs (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 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-norepinephrine 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 breastfeeding
It is not known what effect Dabigatran Etexilate Adamed has on pregnancy or on the unborn child. This medicine should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing potential should avoid becoming pregnant while taking Dabigatran Etexilate Adamed.
Breastfeeding is not recommended during treatment with Dabigatran Etexilate Adamed.

Driving and using machines
Dabigatran Etexilate Adamed has no effect or has a negligible effect 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 are able to swallow capsules whole.
This medicine should always be taken as prescribed by the doctor. In case of doubt, consult the doctor.
Dabigatran Etexilate Adamed should be taken according to the following instructions:
Prevention of blood clots after surgery (hip or knee replacement)
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 older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
In patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose of Dabigatran Etexilate Adamed is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking medicines containing verapamil, who also have renal function reduced by more than half, should take a reduced dose of 75 mg of Dabigatran Etexilate Adamed due to an increased risk of bleeding.
In both types of surgery, treatment should not be initiated if there is bleeding at the surgical site. If treatment cannot be started on the day following surgery, it should be initiated with a dose of 2 capsules once daily.
After knee replacement surgery
Treatment with Dabigatran Etexilate Adamed should begin with one capsule taken 1 to 4 hours after the end of surgery. Then, two capsules should be taken once daily for a total of 10 days.
After hip replacement surgery
Treatment with Dabigatran Etexilate Adamed should begin with one capsule taken 1 to 4 hours after the end of surgery. Then, two capsules should be taken once daily for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrence of 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 and may adjust it during treatment. All other medications should continue to be taken unless the doctor advises otherwise.
Table 1 shows the single and total daily doses of Dabigatran Etexilate Adamed 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 Adamed

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 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.

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

Taking more Dabigatran Etexilate Adamed than prescribed
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
Prevention of blood clots after hip or knee replacement surgery:
Continue taking the missed daily dose of Dabigatran Etexilate Adamed at the usual time on the next day.
Do not take a double dose to make up for a missed dose.

Treatment and prevention of recurrence of 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 before 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 Dabigatran Etexilate Adamed
Dabigatran Etexilate Adamed should be taken exactly as prescribed by the doctor. Do not stop taking this medicine without first consulting your doctor, 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 Adamed.

If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Dabigatran Etexilate Adamed affects the blood clotting system; therefore, most adverse effects involve symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse 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, 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, which may cause difficulty breathing or dizziness, contact your doctor immediately.

The possible adverse effects 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):

• Decrease in haemoglobin levels in blood (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, 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, due to injury or after injury or surgical procedure
• Development of haematomas or bruising following a surgical procedure
• Blood in stool detected in laboratory tests
• Decrease in number of red blood cells in blood
• Decrease in blood cell count
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Presence of discharge from wound (fluid leakage from surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver or blood disease

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

• Bleeding
• Bleeding may occur into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-tinged sputum
• Decrease in number of platelets in blood
• Decrease in number of red blood cells in blood after surgical procedure
• 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 bumps 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

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

• Difficulty breathing or wheezing
• Decrease in number or complete 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):

• Decrease in number of red blood cells in blood
• Decrease in number of platelets in blood
• Skin rash consisting of dark red, raised, itchy bumps occurring as a result of an allergic reaction
• Sudden change in skin colour and appearance
• Development of haematomas
• 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 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
• Decrease in haemoglobin levels in blood (substance in red blood cells)
• Decrease in blood cell count
• 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 or blood disease

Frequency not known (frequency cannot be estimated from the 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 joints, from wounds, surgical incision sites, injection sites, or sites of intravenous catheter insertion
• Bleeding may occur from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring 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 adverse effects helps provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorisation holder.

5. How to store Dabigatran Etexilate Adamed

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following:
"Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C. Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to properly dispose of medicines no longer in use. 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 (in the form of mesilate).
• The other ingredients are: tartaric acid, dried dispersion, hypromellose 15cP, dimethicone, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), purified water and hypromellose.
• The black printing ink 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 aluminium 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 for sale in 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
Austria: Dabigatran Etexilate Adamed 75 mg Hartkapseln
Netherlands: Dabigatran Etexilaat Adamed 75 mg harde capsules