Dabigatran Etexilate Adamed

Package Leaflet: Information for the Patient

Dabigatran Etexilate Adamed, 150 mg, Hard Capsules

Dabigatranum etexilatum

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

• 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 that is responsible for the formation of blood clots.

Dabigatran Etexilate Adamed is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs and prevent 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 to:

• treat blood clots and prevent the recurrence of 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 disease.
• 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 into the brain, recent brain or eye surgery).
• if you have an increased tendency to bleed. It can 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 using a procedure called catheter ablation in atrial fibrillation.
• if you have severe liver disease or liver disease that can 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 organ rejection.
• if you are taking dronedarone, a medicine used to treat heart rhythm disorders.
• if you are taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have been fitted with an artificial heart valve that requires continuous anticoagulant treatment.

Warnings and precautions

Before starting treatment with Dabigatran Etexilate Adamed, discuss it with 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. bone 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 "Dabigatran Etexilate Adamed and other medicines" below.
• if you are taking anti-inflammatory medicines, such as diclofenac, ibuprofen, piroxicam.
• if you have an infection of the heart (bacterial endocarditis).
• if you have decreased kidney function or are dehydrated (feeling thirsty and passing less urine than usual).
• 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 the patient has 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 be particularly careful when taking Dabigatran Etexilate Adamed

• if you need to undergo surgery: In this case, it is necessary to discontinue treatment with 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 directed by your doctor.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for spinal or epidural anesthesia or to relieve pain):
• It is very important to take Dabigatran Etexilate Adamed before and after surgery exactly as directed by your doctor.
• You should immediately inform your doctor if you experience numbness or weakness in your lower limbs or problems with your intestines or bladder 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 if you are taking any of the following medicines:

• Anticoagulant medicines (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• 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 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 organ rejection (e.g. tacrolimus, cyclosporine).
• A combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• 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 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 use of Dabigatran Etexilate Adamed during pregnancy is not recommended. 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 taken by adults and children aged 8 years and older who can swallow capsules whole.

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor.

Take Dabigatran Etexilate Adamed exactly as follows:

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart function and treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs

The recommended dose is 300 mg taken as one 150 mg capsule twice daily.

For patients aged 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.

Patient taking medicines containing verapamilshould receive a reduced dose of Dabigatran Etexilate Adamed to 220 mg taken as one 110 mg capsule twice dailydue to the potential increased risk of bleeding.

For patients with a potentially increased risk of bleeding, the doctor may recommend a dose of 220 mg taken as one 110 mg capsule twice daily.

Treatment can be continued if the patient needs to restore normal heart function using a procedure called cardioversion or catheter ablation in atrial fibrillation. Dabigatran Etexilate Adamed should be taken exactly as directed by your doctor.

In the case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, the patient may receive treatment with Dabigatran Etexilate Adamed after the doctor has confirmed that adequate anticoagulation control has been achieved. Dabigatran Etexilate Adamed should be taken exactly as directed by your doctor.

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 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. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. All other medicines should be continued, unless the doctor recommends stopping any of 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.

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, washed down 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.

Changing anticoagulant medicine

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

Taking more than the recommended dose of Dabigatran Etexilate Adamed

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

Missing a dose of Dabigatran Etexilate Adamed

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 exactly 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 too early. 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, Dabigatran Etexilate Adamed 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. In some cases, these bleedings may not be visible.

If you experience bleeding that does not stop by itself or symptoms of excessive bleeding (exceptional weakness, fatigue, paleness, 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:

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart function

Common (may affect 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 urine discolored pink or red due to the presence of blood) or bleeding under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Nausea

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

• Bleeding
• Bleeding may occur from hemorrhoids, rectum or brain
• Hematoma
• Coughing up blood or sputum discolored with blood
• Decreased platelet count
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding may occur into a joint, from a surgical wound, from a wound, from an injection site or from a catheter insertion site
• 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
• Decreased white blood cell count
• Increased liver enzyme activity
• Jaundice or yellowing 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):

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

In clinical trials, the incidence of myocardial infarction with Dabigatran Etexilate Adamed was higher than with warfarin. The overall incidence was low.

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

Common (may affect up to 1 in 10 people):

• Bleeding may occur from the nose, into the stomach or intestines, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Indigestion

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

• Bleeding
• Bleeding may occur into a joint or due to injury
• Bleeding may occur from hemorrhoids
• Decreased red blood cell count
• Hematoma
• Coughing up blood or sputum discolored with blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding may occur from a surgical wound, from an injection site or from a catheter insertion site or brain bleeding
• Decreased platelet count
• 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
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Decreased white blood cell count (which help fight infections)
• Jaundice or yellowing of the skin or whites of the eyes due to liver or blood disease
• Hair loss

In clinical trials, the incidence of myocardial infarction with dabigatran was higher than with warfarin. The overall incidence was low. No difference in myocardial infarction was observed in patients treated with dabigatran compared to those treated with placebo.

Treatment of blood clots and prevention of recurrence of blood clots in children

Common (may affect up to 1 in 10 people):

• Decreased red blood cell count
• Decreased platelet count
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Hematoma
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent 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, rectum, penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Itching
• Coughing up blood or sputum discolored with blood
• Abdominal pain or stomach pain
• Esophagitis or gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice or yellowing 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):

• Absence of white blood cells (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 a surgical wound, from an injection site or from a catheter insertion site
• Bleeding may occur from hemorrhoids
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to:

Department for Monitoring of Adverse Reactions to Medicinal Products

Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

Al. Jerozolimskie 181C

02-222 Warszawa

Tel.: +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 "Expiry Date". 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Dabigatran Etexilate Adamed contains

• The active substance is dabigatran etexilate. 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 ink used for printing 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 with black printing "D150" and a white, opaque body, filled with yellow pellets.

This medicine is available in packs of 30, 60, 100 or 180 hard capsules in aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization 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 authorized in the Member States of the European Economic Area 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

Date of last revision of the package leaflet: