Dabigatran etexilate adamed

Package leaflet: Information for the patient

Dabigatran Etexilate Adamed, 110 mg, hard capsules
Dabigatranum etexilatum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any 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 someone else, 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.

Leaflet contents

1. What Dabigatran Etexilate Adamed is and what it is used for
2. What you need to know 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 called anticoagulants. It works by blocking a substance in the body that is involved in blood clot formation.
Dabigatran Etexilate Adamed is used in adults to:

• prevent the formation of blood clots in veins after hip or knee replacement surgery.
• prevent the formation of blood clots in the brain (stroke) and in other blood vessels in the body in patients with a type of irregular heartbeat 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 such clots.

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

• treat blood clots and to prevent 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 any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe renal 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 hemorrhage, 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 into the catheter to maintain its patency, or during a procedure called catheter ablation for atrial fibrillation.
• if the patient has severe hepatic 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 a prosthetic heart valve requiring continuous anticoagulant therapy.

Warnings and precautions
Before starting treatment with Dabigatran Etexilate Adamed, discuss this with your doctor.
If symptoms occur 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 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 inflammation of the esophagus or stomach.
• if the patient has gastroesophageal reflux (acid reflux into the esophagus).
• 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 nonsteroidal anti-inflammatory drugs such as diclofenac, ibuprofen, piroxicam.
• if the patient has an infection within 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 had a myocardial infarction or if the patient has been diagnosed with conditions increasing the risk of myocardial infarction.
• if the patient has liver disease affecting blood test results. In such a case, 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 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 prescribed by the doctor before and after surgery.

• if surgery involves 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 exactly as prescribed by the doctor before and after surgery.
• The patient should immediately inform the doctor if numbness or weakness in the legs, or problems with bowel or bladder function occur after the anesthesia 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 evaluation is necessary. 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 causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is needed.

Dabigatran Etexilate Adamed 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,
the patient should inform the doctor before taking Dabigatran Etexilate Adamed 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 applied topically to the skin 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 Adamed depending on the condition for which the medicine was prescribed. See 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-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-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
It is not known what effect Dabigatran Etexilate Adamed has on pregnancy or 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 should 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 as prescribed by the doctor. If in doubt, consult the doctor.
Dabigatran Etexilate Adamed should be taken according to the following recommendations:

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 started if there is bleeding from the surgical site. If treatment cannot be initiated by the next day after surgery, it should be started with a dose of 2 capsules once daily.

After knee replacement surgery
Treatment with Dabigatran Etexilate Adamed should begin with one capsule taken within 1 to 4 hours after completion of surgery. Then, two capsules once daily should be taken for a total of 10 days.

After hip replacement surgery
Treatment with Dabigatran Etexilate Adamed should begin with one capsule taken within 1 to 4 hours after completion of surgery. Then, two capsules once daily should be taken for a total of 28 to 35 days.

Prevention of thromboembolism in blood vessels of the brain and body by preventing clot formation due to irregular heart function, treatment of blood clots in the legs and lungs, and 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 Dabigatran Etexilate Adamed at a reduced dose of 220 mg, taken as one 110 mg capsule twice daily, due to a possible increased risk of bleeding.
In patients with a 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 using a procedure called cardioversion. Dabigatran Etexilate Adamed should be taken as directed by the doctor.

In patients undergoing implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure known as percutaneous coronary intervention with stent implantation, treatment with Dabigatran Etexilate Adamed may be administered after the doctor confirms adequate control of blood coagulation. Dabigatran Etexilate Adamed should be taken as directed by the doctor.

Treatment 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 ideally be 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 be continued 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 break, 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.

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
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 following day.
Do not take a double dose to make up for a missed dose.

Use in adults: Prevention of blood clots in blood vessels of the brain and body by preventing formation of clots caused by irregular heart rhythm, and treatment of blood clots in the veins of the legs and lungs, as well as prevention of recurrence of such clots.
Use in children: Treatment of blood clots and prevention of recurrent blood clots.
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 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.

Discontinuation of Dabigatran Etexilate Adamed
Dabigatran Etexilate Adamed should be taken as directed by the doctor. Do not stop taking this medicine without consulting your doctor first, 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 about 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 everyone will experience them.
Dabigatran Etexilate Adamed affects the blood coagulation 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 hip or knee replacement surgery
Common (may occur in up to 1 in 10 people):

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

Uncommon (may occur in 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 pink or red urine due to presence of blood), from haemorrhoidal nodules, from the rectum, under the skin, into a joint, following injury or after a surgical procedure
• Formation of haematomas or bruises following a surgical procedure
• Blood in stool detected in laboratory tests
• Decreased number of red blood cells in the blood
• Decreased proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Presence of discharge from the wound (fluid oozing from the surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to 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, from the 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 number of platelets in the blood
• Decreased number of red blood cells in the blood after a 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 due to 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
• Fluid discharge from the wound
• Fluid discharge from the surgical wound

Frequency unknown (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

Prevention of blood clots in blood vessels of the brain and body by preventing clots caused by 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
• Decreased 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 haemorrhoidal nodules, from the rectum, or into the brain
• Formation of haematomas
• Coughing up blood or blood-tinged sputum
• Decreased number of platelets in the blood
• Decreased haemoglobin levels in the blood (a 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 analyses

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

• Bleeding may occur into a joint, from the surgical incision site, from a wound, from the injection site, or from the site where a venous catheter was inserted
• 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 due to an allergic reaction
• Decreased proportion of blood cells
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disease

Frequency unknown (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

In clinical studies, the number of heart attacks with dabigatran was numerically higher 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 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 haemorrhoidal nodules
• Decreased number of red blood cells in the blood
• Formation of haematomas
• Coughing up blood or blood-tinged 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 watery stools
• Abnormal liver function test results in laboratory analyses
• Increased liver enzyme activity

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

• Bleeding may occur from the surgical incision site, from the injection site, from the site where a venous catheter was inserted, or into the brain
• Decreased 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 consisting of dark red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing

Frequency unknown (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decreased haemoglobin levels in the blood (a substance in red blood cells)
• Decreased proportion of blood cells
• Decreased number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes due to liver or blood disease
• Hair loss

In clinical studies, the number of heart attacks with dabigatran 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 recurrent blood clots in children
Common (may occur in up to 1 in 10 people):

• Decreased number of red blood cells in the blood
• Decreased number of platelets in the blood
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Formation 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):

• Decreased 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
• Decreased haemoglobin levels in the 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 due to liver or blood disease

Frequency unknown (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 the surgical incision site, from the injection site, or from the site where a venous catheter was inserted
• Bleeding may occur from haemorrhoidal nodules
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results in laboratory analyses

Reporting of adverse effects
If any adverse effects occur, including any 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 to 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 must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Dabigatran Etexilate Adamed contains

• The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
• The other ingredients are: tartaric acid, arabic gum, dried dispersion, hypromellose 5 cP, 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, black iron oxide (E 172) and potassium hydroxide.

What Dabigatran Etexilate Adamed looks like and contents of the pack
Dabigatran Etexilate Adamed 110 mg is a hard capsule with a blue, opaque cap printed in black with "D110" and a blue, opaque body, filled with yellowish pellets.
This medicinal product is available in packs containing 10, 30, 60, 100 or 180 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 medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Dabigatran Etexilate Adamed
Bulgaria: Дабигатран етексилат Адамед 110 mg твърди капсули
Italy: Dabigatran Etexilato Adamed
Spain: Dabigatrán etexilato Adamed 110 mg cápsulas duras EFG
Portugal: Dabigatrano etexilato Adamed
Croatia: Dabigatraneteksilat Adamed 110 mg tvrde kapsule
Romania: Dabigatran Etexilate Adamed 110 mg capsule
France: Dabigatran Etexilate Adamed 110 mg gélule
Austria: Dabigatran Etexilate Adamed 110 mg Hartkapseln
Netherlands: Dabigatran Etexilaat Adamed 110 mg harde capsules