Dabigatran etexilate Orion

Package Leaflet: Information for the Patient

Dabigatran Etexilate Orion, 110 mg, Hard Capsules

Dabigatranum Etexilatum

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

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this package leaflet, inform the doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Dabigatran Etexilate Orion and What is it Used For
• 2. Important Information Before Taking Dabigatran Etexilate Orion
• 3. How to Take Dabigatran Etexilate Orion
• 4. Possible Side Effects
• 5. How to Store Dabigatran Etexilate Orion
• 6. Package Contents and Other Information

1. What is Dabigatran Etexilate Orion and What is it Used For

Dabigatran Etexilate Orion contains dabigatran etexilate as the active substance and belongs to a group of medications called anticoagulants. Its action involves blocking a substance in the body responsible for blood clot formation.
Dabigatran Etexilate Orion is used in adults to:

• prevent blood clots in veins after hip or knee replacement surgery
• prevent 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 blood clots in the veins of the legs and lungs and prevent repeated blood clots in the veins of the legs and lungs.

Dabigatran Etexilate Orion is used in children to:

• treat blood clots and prevent repeated blood clots.

2. Important Information Before Taking Dabigatran Etexilate Orion

When Not to Take Dabigatran Etexilate Orion

• if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medication (listed in section 6)
• if the patient has severe kidney problems
• if the patient is currently bleeding
• if the patient has a disease of any internal organ that increases the risk of significant bleeding (e.g., stomach ulcer disease, brain injury or bleeding into the brain, recent brain or eye surgery)
• if the patient has an increased tendency to bleed. This may be inherited, of unknown cause, or caused by the use of other medications
• if the patient is taking anticoagulant medications (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment, introducing a catheter into a vein or artery, when heparin is administered to maintain catheter patency or when restoring normal heart rhythm using a procedure called catheter ablation in atrial fibrillation
• if the patient has severe liver problems or liver disease that may lead to death
• if the patient is taking oral ketoconazole or itraconazole, medications used to treat fungal infections
• if the patient is taking oral cyclosporine, a medication used to prevent organ rejection
• if the patient is taking dronedarone, a medication used to treat heart rhythm disorders
• if the patient is taking a combination medication containing glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C
• if the patient has a mechanical heart valve that requires ongoing anticoagulation therapy.

Warnings and Precautions

Before starting Dabigatran Etexilate Orion, discuss it with your doctor. If symptoms occurred during treatment with this medication or the patient underwent surgery, consult a doctor.
The patient should inform the doctorif they have or have had any medical conditions or diseases, especially those listed below:

• if the patient has an increased risk of bleeding, such as:
• if the patient has recently experienced bleeding
• if the patient has undergone surgical biopsy within the last month
• if the patient has had a serious injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment)
• if the patient has esophagitis or gastritis
• if the patient has gastroesophageal reflux disease
• if the patient is taking medications that may increase the risk of bleeding. See "Dabigatran Etexilate Orion and Other Medications" below
• if the patient is taking anti-inflammatory medications, such as diclofenac, ibuprofen, or piroxicam
• if the patient has an infection of the heart (infective endocarditis)
• if the patient has decreased kidney function or is dehydrated (feeling thirsty and producing less urine)
• if the patient is over 75 years old
• if the patient is an adult and weighs 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 previous heart attack or if the patient has been diagnosed with a disease that increases the risk of heart attack.
• if the patient has liver disease that affects blood test results. In such cases, the use of this medication is not recommended.

When to Exercise Particular Caution When Taking Dabigatran Etexilate Orion

• if the patient needs to undergo surgery: In such cases, it is necessary to temporarily discontinue Dabigatran Etexilate Orion due to the increased risk of bleeding during and after surgery. It is very important to take Dabigatran Etexilate Orion before and after surgery exactly as the doctor has instructed.

After surgery, take Dabigatran Etexilate Orion as instructed by the 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 reduce pain):
• It is very important to take Dabigatran Etexilate Orion before and after surgery exactly as the doctor has instructed.
• The patient should immediately inform the doctor if they experience numbness or weakness in the lower limbs or problems with the intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if the patient has fallen or injured themselves during treatment, especially if they have injured their head. The patient should immediately seek medical attention. The doctor will examine the patient to determine if there is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide whether to change the treatment.

Dabigatran Etexilate Orion and Other Medications

Tell the doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
In particular, the patient should tell the doctor before taking Dabigatran Etexilate Orion if they are taking any of the following medications:

• medications that reduce blood clotting (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 Orion, depending on the disease for which the medication 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 medications (e.g., aspirin, ibuprofen, diclofenac)
• St. John's Wort, a herbal medication 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 Orion on pregnancy and the unborn child is not known. This medication should not be taken during pregnancy unless the doctor decides it is safe.
Women of childbearing age should avoid becoming pregnant while taking Dabigatran Etexilate Orion.
During treatment with Dabigatran Etexilate Orion, breastfeeding should be avoided.

Driving and Operating Machines

Dabigatran Etexilate Orion has no or negligible influence on the ability to drive and operate machines.

Excipients

This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to Take Dabigatran Etexilate Orion

Dabigatran Etexilate Orion capsules can be used in adults and children aged 8 years or older who can swallow capsules whole.
There are other age-appropriate formulations for the treatment of children under 8 years of age.
This medication should always be taken exactly as instructed by the doctor. In case of doubts, consult a doctor.

Take Dabigatran Etexilate Orion 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 kidney function is reduced by more than half or the patient is 75 years old or older, 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 receive a reduced dose of Dabigatran Etexilate Orion, 150 mg once daily (taken as 2 capsules of 75 mg each).
Patients taking medications containing verapamil, with reduced kidney function by more than half, should take a reduced dose of Dabigatran Etexilate Orion, 75 mg, due to the increased risk of bleeding.
In both types of surgery, treatment should not be started if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, it should be started with a dose of 2 capsules once daily.
After knee replacement surgery
Dabigatran Etexilate Orion treatment should be started with a single capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once daily for a total of 10 days.
After hip replacement surgery
Dabigatran Etexilate Orion treatment should be started with a single capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once daily for a total of 28 to 35 days.
Prevention of blood clots in the brain and body due to irregular heart rhythm and treatment of blood clots in the veins of the legs and lungs and prevention of repeated blood clots in the veins of the legs and lungs
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 medications containing verapamil should receive a reduced dose of Dabigatran Etexilate Orion, 220 mg taken as one 110 mg capsule twice daily, due to the increased risk of bleeding.
Patients with potentially increased risk of bleeding may be prescribed a dose of 220 mg taken as one 110 mg capsule twice daily by their doctor.
Treatment can be continued if the patient needs to restore normal heart rhythm using a procedure called cardioversion. Dabigatran Etexilate Orion should be taken as instructed by the 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 Dabigatran Etexilate Orion treatment after the doctor has confirmed that blood clotting is under control. Dabigatran Etexilate Orion should be taken as instructed by the doctor.
Treatment of blood clots and prevention of repeated blood clots in children
Dabigatran Etexilate Orion should be taken twice daily, one dose in the morning and one dose in the evening, approximately at the same time every 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 Orion in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Table 1: Dabigatran Etexilate Orion Capsule Dosing Table

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 Orion

Dabigatran Etexilate Orion can be taken with or without food. The capsules should be swallowed whole with a glass of water to facilitate passage into the stomach. They should not be broken, chewed, or the pellets emptied from the capsule, as this may increase the risk of bleeding.

Changing Anticoagulant Medication

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

Taking More Than the Recommended Dose of Dabigatran Etexilate Orion

Taking too much of this medication increases the risk of bleeding. If the patient has taken too many capsules, they should immediately contact a doctor. Specific treatments are available.

Missing a Dose of Dabigatran Etexilate Orion

Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Dabigatran Etexilate Orion at the same time the next day. Do not take a double dose to make up for the missed dose.
Use in adults: Prevention of blood clots in the brain and body due to irregular heart rhythm and treatment of blood clots in the veins of the legs and lungs and prevention of repeated blood clots in the veins of the legs and lungs
Use in children: Treatment of blood clots and prevention of repeated blood clots
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 the missed dose.

Stopping Dabigatran Etexilate Orion Treatment

Dabigatran Etexilate Orion should be taken as instructed by the doctor. Do not stop taking this medication without consulting a doctor first, as the risk of blood clots may be higher if treatment is stopped prematurely. Contact a doctor if nausea occurs after taking Dabigatran Etexilate Orion.
In case of further doubts about the use of this medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, Dabigatran Etexilate Orion can cause side effects, although not everybody gets them.
Dabigatran Etexilate Orion affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding. Severe or significant bleeding may occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of location. In some cases, these bleedings may not be visible.
In case of bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), immediately contact a doctor. The doctor may decide to closely monitor the patient or change the medication.
In case of a severe allergic reaction that may cause difficulty breathing or dizziness, immediately contact a doctor.
Side effects are grouped by frequency below.

• Prevention of blood clots after hip or knee replacement surgery
  Common (may affect up to 1 in 10 people):
• decrease in 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, into the 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
• decrease in red blood cell count
• decrease in platelet count
• allergic reaction
• vomiting
• diarrhea
• nausea
• wound secretion
• increased liver enzyme activity
• jaundice of the skin or eyes due to liver or blood disease. Rare (may affect up to 1 in 1,000 people):
• bleeding
• bleeding may occur into the joint, from the surgical site, from the 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
• decrease in platelet count
• increase in liver enzyme activity
• jaundice of the skin or eyes due to liver or blood disease. Unknown frequency (cannot be estimated from the available data):
• difficulty breathing or wheezing
• decrease in or absence of white blood cells (which help fight infections)
• hair loss.

Prevention of blood clots in the brain and body due to irregular heart rhythm
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, or bleeding under the skin
• decrease in red blood cell count
• abdominal pain or stomach pain
• nausea
• diarrhea. Uncommon (may affect up to 1 in 100 people):
• bleeding
• bleeding may occur from the hematomas, from the rectum, or into the brain
• formation of hematomas
• coughing up blood or sputum discolored with blood
• decrease in platelet count
• decrease in 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 site, from the 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
• decrease in platelet count
• increase in liver enzyme activity
• jaundice of the skin or eyes due to liver or blood disease. Unknown frequency (cannot be estimated from the available data):
• difficulty breathing or wheezing
• decrease in or absence of white blood cells (which help fight infections)
• hair loss.

Treatment of blood clots in the veins of the legs and lungs and prevention of repeated 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, or bleeding under the skin
• nausea.

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

• bleeding
• bleeding may occur into the joint or due to injury
• bleeding may occur from the hematomas
• decrease in red blood cell count
• formation of hematomas
• coughing up blood or sputum discolored with blood
• 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
• increase in liver enzyme activity.

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

• bleeding may occur from the surgical site, from the wound, from the injection site, or from the catheter insertion site, or bleeding into the brain
• decrease in 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. Unknown frequency (cannot be estimated from the available data):
• difficulty breathing or wheezing
• decrease in hemoglobin levels in the blood
• decrease in platelet count
• decrease in or absence of white blood cells (which help fight infections)
• jaundice of the skin or eyes 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 small.

Treatment of blood clots and prevention of repeated blood clots in children
Common (may affect up to 1 in 10 people):

• decrease in red blood cell count
• decrease in 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
• nausea
• hair loss
• increase in liver enzyme activity. Uncommon (may affect up to 1 in 100 people):
• decrease in white blood cell count (which help fight infections)
• bleeding may occur into the stomach or intestines, into the brain, from the rectum, from the penis/vagina or urinary tract, or bleeding under the skin
• decrease in hemoglobin levels in the blood
• decrease in platelet count
• itching
• coughing up blood or sputum discolored with blood
• abdominal pain or stomach pain
• esophagitis or gastritis
• allergic reaction
• difficulty swallowing
• jaundice of the skin or eyes due to liver or blood disease. Unknown 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 site, from the injection site, or from the catheter insertion site
• bleeding may occur from the hematomas
• stomach or intestinal ulcers (including esophageal ulcers)
• abnormal liver function test results.

Reporting Side Effects

If side effects occur, including those not listed in this package leaflet, inform the doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Dabigatran Etexilate Orion

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the package or blister after "Expiration Date (EXP)". The expiration date refers to the last day of the month stated.
There are no special storage instructions for this medication.
Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Dabigatran Etexilate Orion Contains

• The active substance is dabigatran etexilate. Each hard capsule contains dabigatran etexilate mesilate, equivalent to 110 mg of dabigatran etexilate.
• The other ingredients are tartaric acid, hypromellose, talc, hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate
• The capsule shell contains titanium dioxide (E 171) and hypromellose.
• The black ink used for printing contains shellac, propylene glycol (E 1520), iron oxide black (E 172), and potassium hydroxide.

What Dabigatran Etexilate Orion Looks Like and Contents of the Package

Dabigatran Etexilate Orion 110 mg is a white, non-transparent capsule with a length of 19.4 mm and a diameter of 6.9 mm, filled with white to light yellow pellets. The cap is printed with "MD" in black ink, and the body is printed with "110".
Dabigatran Etexilate Orion 110 mg is available in aluminum/aluminum/LDPE/PES blisters in cardboard boxes, containing 10, 30, 60, 100, or 180 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Importer/Manufacturer

Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation, Orion Pharma
Joensuunkatu 7
24100 Salo
Finland
To obtain more detailed information on this medication, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl

Date of Last Revision of the Package Leaflet: