Dabigatran Etexilate Adamed

Patient Information Leaflet: Information for the Patient

Dabigatran Etexilate Adamed, 110 mg, Hard Capsules

Dabigatranum etexilatum

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medication 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Dabigatran Etexilate Adamed contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. Its action is to block a substance in the body 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 veins after hip or knee replacement surgery.
• 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 heart valve problems and at least one additional risk factor.
• treat and prevent blood clots in the veins of the legs and lungs.

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

• treat and prevent 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 problems.
• 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. This can be inherited, of unknown cause, or caused by the use of other medications.
• if you are taking anticoagulant medications (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 maintain catheter patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.
• if you have severe liver problems or liver disease that can lead to death.
• if you are taking oral ketoconazole or itraconazole, medications used to treat fungal infections.
• if you are taking oral cyclosporine, a medication used to prevent organ rejection.
• if you are taking dronedarone, a medication used to treat heart rhythm disorders.
• if you are taking a combination medication containing glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C.
• if you have been fitted with an artificial heart valve that requires ongoing anticoagulant treatment.

Warnings and Precautions

Before starting treatment with Dabigatran Etexilate Adamed, discuss it with your doctor.

If you have experienced symptoms or undergone surgery during treatment with this medication, consult your doctor.

The patient should inform the doctorif they have or have had any medical conditions or diseases, especially those listed below:

• if you have an increased risk of bleeding, such as:
• if you have recently experienced 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 medications that may increase the risk of bleeding. See "Dabigatran Etexilate Adamed and other medications" below.
• if you are taking anti-inflammatory medications such as diclofenac, ibuprofen, or piroxicam.
• if you have infective endocarditis (bacterial infection of the heart).
• if you have reduced kidney function or are dehydrated (feeling thirsty and producing less urine).
• if you are over 75 years old.
• if you are an adult and weigh 50 kg or less.
• only in the case of use in children: if the child has an infection around or in the brain.
• in the case of a history of myocardial infarction or if 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 such cases, the use of this medication 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 Dabigatran Etexilate Adamed due to the increased risk of bleeding during and after surgery.

It is very important to take Dabigatran Etexilate Adamed before and after surgery exactly as your doctor has instructed.

• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for spinal or epidural anesthesia or to relieve pain):
• It is very important to take Dabigatran Etexilate Adamed before and after surgery exactly as your doctor has instructed.
• You should immediately inform your doctor if you experience numbness or weakness in your lower limbs or problems with your bowels or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if you have fallen or injured yourself while being treated, especially if you have injured your head. You should immediately seek medical attention. Your doctor will examine you to determine if there is an increased risk of bleeding.
• if you have 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 Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

In particular, you should tell your doctor before taking Dabigatran Etexilate Adamed if you are taking any of the following medications:

• Anticoagulant medications (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin).
• Medications used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are used only on the skin.
• Medications used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medications containing amiodarone, quinidine, or verapamil, the doctor may recommend a lower dose of Dabigatran Etexilate Adamed, depending on the condition for which it was prescribed. See section 3.
• Medications used to prevent organ rejection (e.g. tacrolimus, cyclosporine).
• A combination medication containing glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitis C).
• Anti-inflammatory and pain-relieving medications (e.g. aspirin, ibuprofen, diclofenac).
• St. John's Wort, a herbal remedy used to treat depression.
• Antidepressant medications called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medications used to treat AIDS (e.g. ritonavir).
• Certain medications used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and Breastfeeding

The effect of Dabigatran Etexilate Adamed on pregnancy and the unborn child is not known. You should not take this medication during pregnancy unless your doctor considers it safe.

Women of childbearing age should avoid becoming pregnant while taking Dabigatran Etexilate Adamed.

Do not breastfeed while taking Dabigatran Etexilate Adamed.

Driving and Using Machines

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

3. How to Take Dabigatran Etexilate Adamed

Dabigatran Etexilate Adamed capsules can be taken by adults and children aged 8 years and older who can swallow capsules whole.

This medication should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor.

Take Dabigatran Etexilate Adamed as Follows:

Prevention of blood clots after hip or knee replacement surgery

The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg each).

If you have reduced kidney function or are over 75 years old, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg each).

Patients taking medications containing amiodarone, quinidine, or verapamil should take a dose of 150 mg once daily (taken as 2 capsules of 75 mg each).

Prevention of blood clots in the brain and body due to irregular heartbeat and treatment of blood clots in the legs and lungs

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

Patients over 80 years old or taking medications containing verapamil should take a dose of 220 mg taken as one 110 mg capsule twice daily.

Patients with potentially increased risk of bleeding may be prescribed a dose of 220 mg taken as one 110 mg capsule twice daily.

Continuation of treatment is possible if the patient needs to restore normal heart function using a procedure called cardioversion. Dabigatran Etexilate Adamed should be taken as instructed 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 determined that adequate blood clotting control has been achieved. Dabigatran Etexilate Adamed should be taken as instructed by your doctor.

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 dose in the evening, at approximately the same time each day. The interval between doses should be approximately 12 hours.

The recommended dose depends on the patient's 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 instructs otherwise.

Table 1 shows the single and total daily doses of Dabigatran Etexilate Adamed in milligrams (mg) based on the patient's 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 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 Medication

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

Taking More than the Recommended Dose of Dabigatran Etexilate Adamed

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

Missing a Dose of Dabigatran Etexilate Adamed

Prevention of blood clots after hip or knee replacement surgery

Continue taking the missed daily dose of Dabigatran Etexilate Adamed at the same time the next day.

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

Prevention of blood clots in the brain and body due to irregular heartbeat and treatment of blood clots in the legs and lungs

A missed dose can be taken up to 6 hours before the next scheduled dose.

If it is 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 the missed dose.

Stopping Treatment with Dabigatran Etexilate Adamed

Dabigatran Etexilate Adamed should be taken as instructed by your doctor. Do not stop taking this medication without consulting your doctor first, as the risk of blood clots may be higher if treatment is stopped prematurely.

Contact your doctor if you experience indigestion after taking Dabigatran Etexilate Adamed.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, 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 bleeding or bruising.

Severe or life-threatening bleeding can occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal.

In some cases, this bleeding may not be visible.

If you experience bleeding that does not stop on its own or signs of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately.

Your doctor may decide to monitor you closely or change your medication.

If you experience a severe allergic reaction that can cause difficulty breathing or dizziness, contact your doctor immediately.

The following side effects are listed by frequency:

Prevention of blood clots after hip or knee replacement surgery

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

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

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

• Bleeding may occur from the nose, stomach, or intestines, from the penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Formation of hematomas or bruising after surgery
• Blood in the stool as detected by laboratory tests
• Decreased red blood cell count
• Decreased hematocrit
• Allergic reaction
• Vomiting
• Diarrhea
• Nausea
• Wound secretion
• Increased liver enzyme activity
• Jaundice due to liver or blood disease

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

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

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

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

Prevention of blood clots in the brain and body due to irregular heartbeat

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

• Bleeding may occur from the nose, stomach, or intestines, from the penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Indigestion
• Diarrhea
• Nausea

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

• Bleeding
• Bleeding may occur from hematomas, from the rectum, or into the brain
• Formation of hematomas
• Coughing up blood or blood-tinged sputum
• Decreased platelet count
• Decreased hemoglobin levels in the blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcers (including esophageal ulcers)
• 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 the joint, from the surgical wound, from the injection site, or from the catheter insertion site
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash with red, raised, itchy bumps due to an allergic reaction
• Decreased hematocrit
• Increased liver enzyme activity
• Jaundice 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 helps fight infections)
• Hair loss

Treatment of blood clots in the legs and lungs and prevention of recurrent blood clots

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

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

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

• Bleeding
• Bleeding may occur into the joint or due to injury
• Bleeding may occur from hematomas
• Decreased red blood cell count
• Formation of hematomas
• Coughing up blood or blood-tinged sputum
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcers (including esophageal ulcers)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Diarrhea
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding may occur from the surgical wound, from the injection site, or from the catheter insertion site, or bleeding into the brain
• Decreased platelet count
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash with 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
• Decreased hematocrit
• Decreased white blood cell count (which helps fight infections)
• Jaundice due to liver or blood disease
• Hair loss

In clinical trials, the number of heart attacks in patients taking dabigatran was higher than in those taking warfarin. The overall number of events was low.

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

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

• Decreased red blood cell count
• Decreased platelet count
• Skin rash with red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Diarrhea
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decreased white blood cell count (which helps fight infections)
• Bleeding may occur into the stomach, brain, rectum, penis/vagina, or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood
• Decreased hematocrit
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal pain or stomach pain
• Esophagitis or gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice 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 the joint, from the wound, from the surgical wound, from the injection site, or from the catheter insertion site
• Bleeding may occur from hematomas
• Stomach or intestinal ulcers (including esophageal ulcers)
• Abnormal liver function test results

Reporting Side Effects

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

Side effects can be reported directly to:

Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Jerozolimskie Avenue 181C

02-222 Warsaw

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 medication.

Side effects can also be reported to the marketing authorization holder.

5. How to Store Dabigatran Etexilate Adamed

Keep the medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging or blister after "Expiration Date" or "EXP". The expiration date refers to the last day of the month stated.

Do not store above 30°C. Store in the original packaging to protect from light and moisture.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. 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 110 mg of dabigatran etexilate (as mesylate).
• The other ingredients are tartaric acid, arabic gum, dried dispersion, hypromellose 5cP, dimeticone, 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 110 mg is a hard capsule with a blue, opaque cap with black printing "D110" and a blue, opaque body, filled with yellow pellets.

This medication is available in packs containing 10, 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 Medication is Authorized in the Member States of the European Economic Area 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

Date of Last Revision of the Leaflet: