Dabigatran etexilate orion: detailed information

Package leaflet: information for the patient

Dabigatran etexilate Orion, 150 mg, hard capsules
Dabigatranum etexilatum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Dabigatran etexilate Orion is and what it is used for
What you need to know before taking Dabigatran etexilate Orion
How to take Dabigatran etexilate Orion
Possible side effects
How to store Dabigatran etexilate Orion
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 the brain (stroke) and in other blood vessels in the body in patients who have a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor
treat blood clots in the veins of the legs and lungs, and to prevent recurrence of such clots.

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 currently has bleeding
if the patient has a disease of any internal organ that 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 its patency, or restoring normal heart rhythm using a procedure called catheter ablation for atrial fibrillation
if the patient has severe liver function impairment 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 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 previously 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 a surgical tissue biopsy (biopsy) within the last month
if the patient has sustained 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 that 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 within the heart (bacterial endocarditis)
if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark (concentrated) or foamy 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 has been diagnosed with a condition increasing the risk of myocardial infarction
if the patient has liver disease affecting blood test results. In such cases, use of this medicine is not recommended.

When to exercise special caution when using Dabigatran etexilate Orion

if the patient needs to undergo surgery: In such cases, 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 before and after surgery.
if surgery requires insertion of a catheter or administration of an 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 before and after surgery.
The patient should immediately inform the doctor if numbness or weakness in the lower limbs or problems with the bowels 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 they injure their head. Immediate medical evaluation is required. The doctor will assess whether there is an increased risk of bleeding.
if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform their doctor, who will decide whether a change in treatment is necessary.

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, before taking Dabigatran etexilate Orion, tell the doctor 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 verapamil, the doctor may recommend a lower dose of Dabigatran etexilate Orion depending on the condition for which the medicine was prescribed. See section 3.
medicines used to prevent rejection of transplanted organs (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 or the unborn child. This medicine should not be taken during pregnancy unless the doctor considers it 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 effect or a 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. the 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 treating children under 8 years of age.
This medicine should always be taken according to the doctor's instructions. If in doubt, consult your doctor.
Take Dabigatran etexilate Orion exactly as directed below:
Prevention of blood clots in blood vessels of the brain and body by preventing clots that form due to irregular heart function, and treatment of blood clots in the legs and lungs, as well as prevention of recurrence of blood clots in the legs and lungs.
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
For patients aged 80 years or above, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
Patients taking medicines containing verapamil should receive a reduced dose of Dabigatran etexilate Orion of 220 mg taken as one 110 mg capsule twice daily due to a possible increased risk of bleeding.
For patients with potentially increased risk of bleeding, the doctor may recommend treatment with a dose of 220 mg taken as one 110 mg capsule twice daily.
Treatment with this medicine may be continued if the patient requires restoration of normal heart rhythm through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Dabigatran etexilate Orion should be taken according to the doctor's instructions.
In patients undergoing implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure known as percutaneous coronary intervention with stent implantation, treatment with Dabigatran etexilate Orion may be administered once the doctor has confirmed adequate control of blood coagulation. Dabigatran etexilate Orion should be taken according to the doctor's instructions.
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, 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 the dose during treatment. Continue taking all other medications unless your doctor advises otherwise.
Table 1 shows the single and total daily doses of Dabigatran etexilate Orion in milligrams (mg). Doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dosing table for Dabigatran etexilate Orion capsules

Body weight and age ranges		Single dose in mg	Total daily dose in mg
Body weight in kg	Age in years	Single dose in mg	Total daily dose in mg
from 11 to less than 13 kg	from 8 to less than 9 years	75	150
from 13 to less than 16 kg	from 8 to less than 11 years	110	220
from 16 to less than 21 kg	from 8 to less than 14 years	110	220
from 21 to less than 26 kg	from 8 to less than 16 years	150	300
from 26 to less than 31 kg	from 8 to less than 18 years	150	300
from 31 to less than 41 kg	from 8 to less than 18 years	185	370
from 41 to less than 51 kg	from 8 to less than 18 years	220	440
from 51 to less than 61 kg	from 8 to less than 18 years	260	520
from 61 to less than 71 kg	from 8 to less than 18 years	300	600
from 71 to less than 81 kg	from 8 to less than 18 years	300	600
81 kg or more	from 10 to less than 18 years	300	600

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 crush, 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 first obtaining detailed instructions from your doctor.

If you take more Dabigatran etexilate Orion than you should
Taking too high a dose of this medicine increases the risk of bleeding. If you have taken too many capsules, contact your doctor immediately. Specific treatment methods are available.

If you forget to take Dabigatran etexilate Orion
A missed dose may be taken if there are more than 6 hours before the next scheduled dose.
If less than 6 hours remain before the next scheduled dose, the missed dose should not be taken. Do not take a double dose to make up for a forgotten dose.

Stopping Dabigatran etexilate Orion
Dabigatran etexilate Orion should be taken as directed by your 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 you experience gastrointestinal discomfort after taking Dabigatran etexilate Orion.
If you have any further questions 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 will experience them.
Dabigatran etexilate Orion affects the blood clotting system, therefore most side effects involve symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious side 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 you experience bleeding that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to place you under close observation or change your treatment.

If you experience a serious allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

The possible side effects listed below are grouped according to their frequency of occurrence.

Prevention of blood clots in blood vessels in the brain and body by preventing the formation of clots that occur due to irregular heart function

Common (may occur in 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 pink or red urine due to presence of blood), or under the skin
decrease in the number of red blood cells in the blood
abdominal pain or stomach pain
indigestion
frequent passage of loose or liquid stools
nausea

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

bleeding
bleeding may occur from haemorrhoids, from the rectum, or into the brain
formation of bruises (haematomas)
coughing up blood or blood-stained sputum
decrease in the number of platelets in the blood
decrease in haemoglobin levels in the blood (a substance in red blood cells)
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 stomach contents into the oesophagus (reflux)
vomiting
difficulty swallowing
abnormal liver function test results in laboratory tests

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

bleeding may occur into a joint, from a surgical incision site, from a wound, from an injection site, or from the site where a venous catheter was inserted
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
decrease in the number of blood cells
increased liver enzyme activity
yellowing of the skin or whites of the eyes caused by liver or blood disease

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

difficulty breathing or wheezing
decrease in the number of, or even absence of, white blood cells (which help fight infections)
hair loss

In clinical trials, the number of heart attacks was numerically higher with dabigatran than with warfarin. However, the overall number of occurrences was low.

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

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

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

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

bleeding
bleeding may occur into a joint or following injury
bleeding may occur from haemorrhoids
decrease in the number of red blood cells in the blood
formation of bruises (haematomas)
coughing up blood or blood-stained sputum
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 stomach contents into the oesophagus (reflux)
nausea
vomiting
abdominal pain or stomach pain
frequent passage of loose or liquid stools
abnormal liver function test results in laboratory tests
increased liver enzyme activity

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

bleeding may occur from a surgical incision site, from an injection site, from the site where a venous catheter was inserted, or bleeding from the brain
decrease in the number of platelets in the blood
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
difficulty swallowing

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

difficulty breathing or wheezing
decrease in haemoglobin levels in the blood (a substance in red blood cells)
decrease in the number of blood cells
decrease in the number of, or even absence of, white blood cells (which help fight infections)
yellowing of the skin or whites of the eyes caused by liver or blood disease
hair loss

In clinical trials, the number of heart attacks was numerically higher with dabigatran than with warfarin. However, the overall number of occurrences was low. There was no observed difference in the number of heart attacks in patients treated with dabigatran compared to patients receiving placebo.

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

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

decrease in the number of red blood cells in the blood
decrease in the 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 (haematomas)
nosebleeds
regurgitation of stomach contents into the oesophagus (reflux)
vomiting
nausea
frequent passage of loose or liquid stools
indigestion
hair loss
increased liver enzyme activity

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

decrease in the number of white blood cells (which help fight infections)
bleeding may occur into the stomach or intestines, from the brain, from the anus, from the 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 (a substance in red blood cells)
decrease in the 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 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, from a surgical incision site, from an injection site, or from the site where a venous catheter was inserted
bleeding may occur from haemorrhoids
stomach or intestinal ulcer (including oesophageal ulceration)
abnormal liver function test results in laboratory tests

Reporting of side effects

If any 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 Monitoring of 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
Side effects can also be reported to the marketing authorisation holder.

By reporting side effects, you help provide 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 pack following:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. 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 mesilate, corresponding to 150 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), black iron oxide (E 172), and potassium hydroxide.

What Dabigatran etexilate Orion looks like and contents of the pack
Dabigatran etexilate Orion 150 mg is a white, opaque capsule, 21.5 mm in length and 7.6 mm in diameter, filled with pellets ranging in colour from white to pale yellow. The cap is printed in black ink with the mark "MD", and the body with the number "150".
Dabigatran etexilate Orion 150 mg is available in blisters made of Aluminium/Aluminium/LDPE/PES, packed in cardboard boxes containing 10, 30, 60, 100, or 180 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]