Dabigatran etexilate orion

Package leaflet: Information for the patient

Dabigatran etexilate Orion, 75 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Dabigatran etexilate Orion is and what it is 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 Dabigatran etexilate Orion is and what it is used for

Dabigatran etexilate Orion 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 responsible for blood clot formation.
Dabigatran etexilate Orion is used in adults to:

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

Dabigatran etexilate Orion is used in children to:

• treat blood clots and to 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 impairment
• if the patient is currently experiencing bleeding
• if the patient has a disease of any internal organ which increases the risk of major bleeding (e.g. gastric ulcer, brain injury or intracranial haemorrhage, 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 where heparin is administered through the catheter to maintain patency, or restoring normal heart rhythm using a procedure called catheter ablation in atrial fibrillation
• if the patient has severe liver function impairment or liver disease which 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 had a mechanical heart valve implanted, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran etexilate Orion, discuss this with your doctor. If symptoms occur during treatment with this medicine or if the patient has undergone surgery, 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 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 a surgical tissue biopsy (biopsy) within the last month
• if the patient has suffered a serious injury (e.g. bone fracture, head injury or any injury requiring surgical treatment)
• if the patient has oesophagitis or gastritis
• if the patient has gastro-oesophageal reflux (acid reflux into the oesophagus)
• if the patient is taking medicines which may increase the risk of bleeding. See below “Dabigatran etexilate Orion and other medicines”
• if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam
• if the patient has an infection in or around 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 heart attack or if the patient has been diagnosed with a condition 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 particular caution when taking Dabigatran etexilate Orion

• if the patient needs to undergo surgery: In such a case, temporary discontinuation of Dabigatran etexilate Orion is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate Orion exactly as directed by the doctor both before and after surgery.
• if surgery requires insertion of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
• It is very important to take Dabigatran etexilate Orion exactly as directed by the doctor both before and after surgery.
• The patient should immediately inform the doctor if numbness or

weakness in the lower limbs or problems with the bowel or bladder occur after the anaesthesia wears off, as urgent medical attention is required.

• if the patient falls or injures themselves during treatment, especially if the head is injured. Immediate medical attention should be sought. The doctor will assess whether there may be an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system 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 Orion and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, tell the doctor before taking Dabigatran etexilate Orion 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 only to 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 condition for which the medicine was prescribed. See also section 3.
• medicines used to prevent organ rejection after transplantation (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-noradrenaline 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 Orion has on pregnancy and 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 Orion.
Breastfeeding should not be undertaken during treatment with Dabigatran etexilate Orion.
Driving and operating machinery
Dabigatran etexilate Orion has no or negligible effect on the ability to drive and operate machinery.
Excipients
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "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 are able to swallow capsules whole.
Other age-appropriate formulations are available for the treatment of children under 8 years of age.
This medicine should always be taken as prescribed by the doctor. In case of doubt, consult your doctor.
Take Dabigatran etexilate Orion exactly as directed below:

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 kidney 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 Orion is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking verapamil-containing medicines who also have reduced kidney function
(by more than half) should take a reduced dose of 75 mg of Dabigatran etexilate Orion due to an
increased risk of bleeding.

In both types of surgery, treatment should not be started if there is active bleeding from the surgical site.
If treatment cannot be initiated by 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 initiated by taking one capsule within 1 to 4 hours
after the end of the surgical procedure. Then, take two capsules once daily for a total of 10 days.

After hip replacement surgery
Treatment with Dabigatran etexilate Orion should be initiated by taking one capsule within 1 to 4 hours
after the end of the surgical procedure. Then, take two capsules once daily for a total of 28 to 35 days.

Treatment and prevention of recurrence of blood clots in children
Dabigatran etexilate Orion 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 be as close as possible to 12 hours.

The recommended dose depends on body weight and age. The doctor will determine the correct dose and may adjust it during treatment. Continue taking all other prescribed medicines unless your doctor advises otherwise.

Table 1 shows the single and total daily doses of Dabigatran etexilate Orion in milligrams (mg).
The doses depend on the patient's body weight in kilograms (kg) and age in years.

Table 1: Dosing table for Dabigatran etexilate Orion capsules

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: as two 110 mg capsules
185 mg: as one 75 mg capsule and one 110 mg capsule
150 mg: as 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 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.
Taking more Dabigatran etexilate Orion than prescribed
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 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 on the following day. Do not take a double dose to make up for the missed dose.
Treatment and prevention of recurrence of blood clots in children
A missed dose may be taken up to 6 hours before the next scheduled dose. If less than 6 hours remain 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 directed by the doctor. Do not stop taking this medicine without first consulting your doctor, 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 Orion.
If you have any further questions regarding 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 Orion 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, it may lead to disability, be life-threatening, or even result in death. In some cases, these bleedings 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), 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 affect up to 1 in 10 people):

• Decrease in haemoglobin levels in the blood (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, penis/vagina or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, rectum, under the skin, into a joint, following injury or after a surgical procedure
• Formation of bruises or bruising after a surgical procedure
• Blood in stool detected in laboratory tests
• Decrease in number of red blood cells in the blood
• Decrease in number of blood cells
• Allergic reaction
• Vomiting
• Frequent passage of loose or liquid 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 caused by liver or blood disease

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

• Bleeding
• Bleeding may occur into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion
• Blood-stained discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-stained sputum
• Decrease in number of platelets in the blood
• Decrease in 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 food from the stomach into the oesophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Discharge of fluid from the wound
• Discharge of fluid from the surgical wound

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

• Difficulty breathing or wheezing
• Decrease in number or complete absence of white blood cells (which help fight infections)
• Hair loss

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

• Decrease in number of red blood cells in the blood
• Decrease in 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 bruises
• Nosebleeds
• Regurgitation of food from the stomach into the oesophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decrease in number of white blood cells (which help fight infections)
• Bleeding may occur from the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decrease in haemoglobin levels in the blood (substance in red blood cells)
• Decrease in number of blood cells
• Itching
• Coughing up blood or blood-stained 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 caused by liver or blood disease

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 swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur into a joint, from a wound, surgical incision site, injection site, or site of intravenous catheter insertion
• Bleeding may occur from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results

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 the 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate Orion

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 after:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to properly dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information What does Dabigatran etexilate Orion contain

• The active substance is dabigatran etexilate. Each hard capsule contains dabigatran etexilate in the form of mesilate, equivalent 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 printing ink 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 white, opaque hard capsules of 17.5 mm in length and 6.4 mm in diameter, filled with pellets ranging from white to pale yellow. The cap is printed in black ink with the mark "MD", and the body with the number "75".
Dabigatran etexilate Orion 75 mg is available in blisters made of Aluminium/Aluminium/LDPE/PES, packed in cardboard boxes containing 10, 30, or 60 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation 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
For more detailed information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]