Dabigatran etexilate Orion

Leaflet accompanying the packaging: patient information

Dabigatran etexilate Orion, 75 mg, hard capsules

Dabigatranum etexilatum

Read the leaflet carefully before taking the medicine, 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 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. Contents of the pack 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 medicines called anticoagulants. Its action involves blocking a substance in the body responsible for the formation of blood clots.

Dabigatran etexilate Orion is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery.

Dabigatran etexilate Orion is used in children to:

• treat blood clots and prevent recurrence of 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 medicine (listed in section 6)
• if the patient has severe kidney function disorders
• 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, brain injury or bleeding into the brain, recent brain or eye surgery)
• if the patient has an increased tendency to bleed. It may be congenital, of unknown cause, or caused by the use of other medicines
• if the patient is taking anticoagulant medicines (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid), except when changing anticoagulant treatment, introducing a catheter into a vein or artery, or when heparin is administered to the catheter to maintain its patency or to restore normal heart function through a procedure called catheter ablation in atrial fibrillation
• if the patient has severe liver function disorders 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 organ rejection
• 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
• if the patient has a prosthetic heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting treatment with Dabigatran etexilate Orion, discuss it with your doctor. If symptoms occurred during treatment with this medicine 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 had bleeding
• if the patient has had a surgical biopsy within the last month
• if the patient has had a serious injury (e.g. 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 medicines that may increase the risk of bleeding. See below "Dabigatran etexilate Orion and other medicines"
• if the patient is taking non-steroidal anti-inflammatory medicines, such as diclofenac, ibuprofen, piroxicam
• if the patient has infective endocarditis (bacterial infection of the heart)
• if the patient has decreased kidney function or is dehydrated (feeling thirsty and producing a small amount of dark, concentrated 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 history of myocardial infarction or if the patient has been diagnosed with a disease that increases the risk of myocardial infarction.
• if the patient has liver disease that affects blood test results. In this case, the use of this medicine is not recommended.

When to exercise special caution when taking Dabigatran etexilate Orion

• if the patient needs to undergo surgery: In this case, it is necessary to discontinue the use of 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.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for epidural or spinal 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 of 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 hit their head, they should seek medical attention immediately. 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 medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

In particular, tell your doctor before taking Dabigatran etexilate Orion if you are taking any of the following medicines:

• medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless 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 amiodarone, quinidine, or verapamil, the doctor may recommend a lower dose of Dabigatran etexilate Orion, depending on the disease for which the medicine was prescribed. See also 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)
• non-steroidal 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 effect of Dabigatran etexilate Orion on pregnancy and the unborn child is not known. This medicine should not be taken during pregnancy unless the doctor considers it safe.

Women of childbearing age should avoid becoming pregnant while taking Dabigatran etexilate Orion.

Do not breastfeed while taking Dabigatran etexilate Orion.

Driving and using machines

Dabigatran etexilate Orion has no or negligible influence on the ability to drive and use machines.

Excipients

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine 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 the capsules whole.

There are other age-appropriate pharmaceutical forms for the treatment of children under 8 years of age.

This medicine should always be taken exactly as the doctor has instructed.

In case of doubt, consult the 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 reducedby more than half or in patients aged 75 or over,

the recommended dose is 150 mg once daily(taken as 2 capsules of 75 mg each).

In patients taking medicines containing amiodarone, quinidine, or verapamil,

the recommended dose of Dabigatran etexilate Orion is 150 mg once daily(taken as 2 capsules of 75 mg each).

Patient taking verapamil-containing medicines, with reduced kidney function

by more than half, should take a reduced dose of 75 mgof Dabigatran etexilate Orion 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

Treatment with Dabigatran etexilate Orion should be started with a dose of 1 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

Treatment with Dabigatran etexilate Orion should be started with a dose of 1 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.

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

Dabigatran etexilate Orion 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 the patient's weight and age.

The doctor will determine the correct dose.

The doctor may adjust the dose during treatment.

Continue to take all other medicines unless the doctor instructs you to stop taking them.

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.

Do not crush, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.

Changing anticoagulant medicine

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

Taking a higher dose of Dabigatran etexilate Orion than recommended

Taking too much of this medicine 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 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.

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

The 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 treatment with Dabigatran etexilate Orion

Dabigatran etexilate Orion should be taken as instructed by the 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 prematurely.

Contact your doctor if you experience nausea after taking Dabigatran etexilate Orion.

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

4. Possible side effects

Like all medicines, this medicine 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 massive bleeding can occur, which can lead to disability, be life-threatening, or even fatal.

In some cases, these bleeds may not be visible.

If bleeding occurs that does not stop on its own, or if there are symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately.

The doctor may decide to monitor the patient closely or change the medicine.

If a serious allergic reaction occurs that can cause breathing difficulties or dizziness, contact your doctor immediately.

Side effects are listed below by frequency of occurrence.

Prevention of blood clots after hip or knee replacement surgery

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

• decrease in hemoglobin 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 the presence of blood), or from hemorrhoids, from the rectum, 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 (oozing of fluid from the surgical wound)
• increased liver enzyme activity
• jaundice (yellowing of the skin or whites of the eyes 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
• secretion from the catheter insertion site discolored with blood
• coughing up blood or sputum discolored with blood
• decrease in platelet count
• decrease in red blood cell count after surgery
• severe allergic reaction causing breathing difficulties 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
• sudden change in skin color and appearance
• itching
• stomach or intestinal ulcers (including esophageal ulcers)
• esophagitis and gastritis
• gastroesophageal reflux disease
• abdominal pain or stomach pain
• nausea
• difficulty swallowing
• wound secretion
• wound secretion from the surgical wound

Unknown ( frequency cannot be estimated from the available data):

• difficulty breathing or wheezing
• decrease in or lack of white blood cells (which help fight infections)
• hair loss

Treatment of blood clots and prevention of recurrent 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 in the form of dark red, raised, itchy bumps due to an allergic reaction
• sudden change in skin color and appearance
• formation of hematomas
• nosebleeds
• gastroesophageal reflux disease
• vomiting
• nausea
• diarrhea
• nausea
• hair loss
• increased 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, brain, rectum, penis/vagina or urinary tract (including urine discoloration due to the presence of blood), or under the skin
• decrease in hemoglobin in the blood (a substance in red blood cells)
• decrease in blood cell count
• itching
• coughing up blood or sputum discolored with blood
• abdominal pain or stomach pain
• esophagitis and gastritis
• allergic reaction
• difficulty swallowing
• jaundice (yellowing of the skin or whites of the eyes due to liver or blood disease)

Unknown ( frequency cannot be estimated from the available data):

• lack of white blood cells (which help fight infections)
• severe allergic reaction causing breathing difficulties 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 hemorrhoids
• stomach or intestinal ulcers (including esophageal ulcers)
• abnormal liver function test results

Reporting side effects

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

Side effects can be reported directly to the Department of Drug Safety Monitoring, 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

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 medicine.

5. How to store Dabigatran etexilate Orion

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or blister after "EXP".

The expiry date refers to the last day of the month stated.

No special precautions for storage are necessary.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use.

This will help protect the environment.

6. Contents of the pack and other information

What Dabigatran etexilate Orion contains

• The active substance is dabigatran etexilate.
• Each hard capsule contains dabigatran etexilate in the form of mesylate, which corresponds to 75 mg of dabigatran etexilate.
• The other ingredients are: tartaric acid, hypromellose, talc, hydroxypropylcellulose, sodium croscarmellose, 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 pack

Dabigatran etexilate Orion 75 mg is a white, opaque capsule with a length of 17.5 mm and a diameter of 6.4 mm, filled with white to light yellow pellets.

The capsule is printed with black ink, with "MD" on the cap and "75" on the body.

Dabigatran etexilate Orion 75 mg is available in aluminum/aluminum/LDPE/PES blisters in cardboard boxes, containing 10, 30, or 60 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 medicine, contact the local representative of the marketing authorization holder:

Orion Pharma Poland Sp. z o.o.

[email protected]

Date of last revision of the leaflet: