Dabigatran etexilate Orion

Patient Information Leaflet: Information for the Patient

Dabigatran etexilate Orion, 150 mg, hard capsules

Dabigatran etexilate

Read the leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine 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 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. Its action is to block a substance in the body that is responsible for the formation of blood clots.

Dabigatran etexilate Orion is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a form of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem and at least one additional risk factor
• treat blood clots in the veins of the legs and lungs and prevent the recurrence of blood clots in the veins of the legs and lungs.

Dabigatran etexilate Orion is used in children to:

• treat blood clots and prevent the recurrence of blood clots.

2. Important information before taking Dabigatran etexilate Orion

When not to take Dabigatran etexilate Orion

• 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. It may be congenital, of unknown cause or caused by the use of other medicines
• if you are taking anticoagulant medicines (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 the catheter to maintain its 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, medicines used to treat fungal infections
• if you are taking oral cyclosporine, a medicine used to prevent organ rejection
• if you are taking dronedarone, a medicine used to treat heart rhythm disorders
• if you are taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
• if you have been fitted with an artificial heart valve that requires continuous anticoagulant treatment.

Warnings and precautions

Before starting treatment with Dabigatran etexilate Orion, discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment with this medicine, consult your doctor.

You should inform your doctorif you 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 had bleeding
• if you have had a surgical biopsy within the last month
• if you have had a serious injury (e.g. 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 medicines that may increase the risk of bleeding. See "Dabigatran etexilate Orion and other medicines" below
• if you are taking anti-inflammatory medicines, such as diclofenac, ibuprofen, piroxicam
• if you have an infection of the heart (bacterial endocarditis)
• if you have reduced kidney function or are dehydrated (feeling thirsty and passing less urine than usual)
• 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 heart attack or if you have been diagnosed with a disease that increases the risk of a heart attack.
• if you have liver disease that affects blood test results. In this case, the use of this medicine is not recommended.

When to be particularly careful when taking Dabigatran etexilate Orion

• if you need to undergo surgery: In this case, it is necessary to discontinue treatment with 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 your doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine

(e.g. for spinal anesthesia or pain relief):

• It is very important to take Dabigatran etexilate Orion 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 during treatment, especially if you have injured your head. You should seek medical attention immediately. Your doctor will examine you to see if you may have an increased risk of bleeding.
• if you have a condition called 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 Orion and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take. In particular, tell your doctor if you are taking

any of the following medicines before taking Dabigatran etexilate Orion:

• medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin)
• 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 verapamil, the doctor may recommend a reduced dose of Dabigatran etexilate Orion, depending on the disease for which it was prescribed. See 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)
• anti-inflammatory and pain-relieving medicines (e.g. aspirin, 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. You should not take this medicine during pregnancy unless your 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 that 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 medicine should always be taken exactly as your doctor has instructed.

In case of doubt, consult your doctor.

Take Dabigatran etexilate Orion exactly as follows:

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart rhythm and treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs

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

For patients aged 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice a day.

Patient taking medicines containing verapamilshould receive a reduced dose of Dabigatran etexilate Orion to 220 mg taken as one 110 mg capsule twice a daydue to the potential increased risk of bleeding.

For patients with a potentially increased risk of bleeding, the doctor may recommend a reduced dose of 220 mg taken as one 110 mg capsule twice a day.

Treatment can be continued if the patient needs to restore normal heart function using a procedure called cardioversion or catheter ablation in atrial fibrillation. Dabigatran etexilate Orion should be taken exactly as your doctor has instructed.

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 Orion after the doctor has confirmed that normal blood clotting control has been achieved. Dabigatran etexilate Orion should be taken exactly as your doctor has instructed.

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

Dabigatran etexilate Orion should be taken twice a day, 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 body weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment.

Continue to take all other medicines unless your 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 body weight in kilograms (kg) and age in years.

Table 1: Dabigatran etexilate Orion dosing table in capsule form

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:

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 your 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

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 a missed dose.

Stopping treatment with Dabigatran etexilate Orion

Dabigatran etexilate Orion should be taken exactly as your doctor has instructed. 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 indigestion after taking Dabigatran etexilate Orion.

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

4. Possible side effects

Like all medicines, 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 heavy bleeding can occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of location and may not be visible.

If you experience bleeding that does not stop on its own or symptoms of excessive bleeding (extreme weakness, tiredness, paleness, dizziness, headache or unexplained swelling), contact your doctor immediately.

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

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

The following side effects are grouped by frequency:

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal 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 (including urine discolored pink or red due to the presence of blood) or bleeding under the skin
• reduced 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, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• hematoma formation
• coughing up blood or sputum discolored with blood
• reduced platelet count
• reduced hemoglobin levels in the blood (a substance in red blood cells)
• 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 a joint, from a wound, from a surgical incision, from an injection site, or from a catheter insertion site
• severe allergic reaction causing difficulty breathing 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
• reduced white blood cell count
• increased liver enzyme activity
• jaundice of the skin or whites of the eyes due to liver or blood disease

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

• difficulty breathing or wheezing
• reduced white blood cell count (which help fight infections)
• hair loss

Treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of 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 (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• indigestion

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

• bleeding
• bleeding may occur into a joint or due to injury
• bleeding may occur from hematomas
• reduced red blood cell count
• hematoma formation
• 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
• increased liver enzyme activity

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

• bleeding may occur from a surgical incision, from an injection site, or from a catheter insertion site or from the brain
• reduced platelet count
• severe allergic reaction causing difficulty breathing 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
• difficulty swallowing

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

• difficulty breathing or wheezing
• reduced hemoglobin levels in the blood (a substance in red blood cells)
• reduced white blood cell count
• reduced white blood cell count (which help fight infections)
• jaundice of the skin or whites of the eyes due to liver or blood disease
• hair loss

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

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

• reduced red blood cell count
• reduced platelet count
• skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• sudden change in skin color or appearance
• hematoma formation
• nosebleeds
• gastroesophageal reflux disease
• vomiting
• nausea
• diarrhea
• indigestion
• hair loss
• increased liver enzyme activity

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

• reduced white blood cell count (which help fight infections)
• bleeding may occur into the stomach or intestines, from the brain, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• reduced hemoglobin levels in the blood (a substance in red blood cells)
• reduced white blood cell 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 whites of the 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 a joint, from a wound, from a surgical incision, from an injection site, or from a 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 the Department of Drug Safety, 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.

By reporting side effects, you can 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 which is stated on the carton or blister after "EXP". The expiry date refers to the last day of that month.

Store in a temperature not exceeding 25°C.

Medicines should not be disposed of via wastewater or household waste.

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 mesylate, equivalent to 150 mg dabigatran etexilate.
• The other ingredients are: tartaric acid, hypromellose, talc, hydroxypropylcellulose, 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 pack

Dabigatran etexilate Orion 150 mg is a white, opaque capsule with a length of 21.5 mm and a diameter of 7.6 mm, filled with white to light yellow pellets. The cap is printed with "MD" in black ink, and the body is printed with "150".

Dabigatran etexilate Orion 150 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 medicine, please 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: