Apixaban Orion

Leaflet attached to the packaging: information for the user

Apixaban Orion, 2.5 mg, coated tablets

apixaban

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Apixaban Orion and what is it used for
• 2. Important information before taking Apixaban Orion
• 3. How to take Apixaban Orion
• 4. Possible side effects
• 5. How to store Apixaban Orion
• 6. Contents of the packaging and other information

1. What is Apixaban Orion and what is it used for

Apixaban Orion contains the active substance apixaban and belongs to a group of so-called anticoagulant medicines. This medicine helps prevent the formation of blood clots by blocking factor Xa, which is an important factor in blood clotting.
Apixaban Orion is used in adults:

• to prevent the formation of blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, the patient may have an increased risk of blood clots in the veins of the lower limbs. This can lead to swelling of the legs, with or without pain. If a blood clot moves from the lower limb to the lungs, it can block blood flow through the lungs, causing shortness of breath with a feeling of chest pain or without. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
• to prevent the formation of blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and move to the brain, leading to a stroke, or to other organs, making it difficult for these organs to receive blood (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• to treat blood clots in the veins of the lower limbs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the blood vessels of the lower limbs and/or lungs.

Apixaban Orion is used in children from 28 days of age to less than 18 years of age to treat and prevent the recurrence of blood clots in the veins or in the blood vessels of the lungs.
The recommended dose depends on body weight, see section 3.

2. Important information before taking Apixaban Orion

When not to take Apixaban Orion

• if the patient is allergicto apixaban or any of the other ingredients of this medicine (listed in section 6)
• if the patient has excessive bleeding
• if the patient has an organ diseasethat increases the risk of serious bleeding (such as active or recently diagnosed stomach or intestinal ulcersor recent brain bleeding)
• if the patient has liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy)
• if the patient is taking medicines that prevent blood clotting(e.g. warfarin, rivaroxaban, dabigatran or heparin), except in cases where the anticoagulant treatment is changed, when the patient has a venous or arterial access line and heparin is administered through this line to maintain its patency or when the patient is undergoing catheter ablation (a catheter is inserted into their vein) due to irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting to take Apixaban Orion, you should discuss with your doctor or pharmacist if you have any of the following conditions:

• increased risk of bleeding, for example:
• bleeding disorders, including those that result in reduced platelet activity
• very high blood pressure, uncontrolled with medication
• if the patient is over 75 years old
• if the patient weighs 60 kg or less
• severe kidney disease or if the patient is on dialysis
• liver disease or a history of liver disease
• this medicine should be used with caution in patients with signs of liver function changes
• tube (catheter) or injection into the spine(anesthetic or pain-relieving), in which case the doctor will recommend taking this medicine after 5 or more hours after the catheter is removed
• if the patient has a prosthetic heart valve
• if the doctor determines that the patient's blood pressure is unstable or other treatment or surgery is planned to remove a blood clot from the lungs.

When to be particularly careful when taking Apixaban Orion

• 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.

In case of need for surgery or a procedure that may be associated with bleeding, the doctor may ask the patient to temporarily stop taking this medicine for a short time. If there is any uncertainty as to whether a given procedure may be associated with bleeding, the doctor should be asked about it.

Children and adolescents

It is not recommended to use this medicine in children and adolescents with a body weight of less than 35 kg.

Apixaban Orion and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Some medicines may enhance the effect of Apixaban Orion, and some may weaken its effect.
The doctor will decide whether you should receive Apixaban Orion while taking other medicines and how closely you should be monitored.
The following medicines may enhance the effect of Apixaban Orion and increase the risk of unwanted bleeding:

• certain antifungal medicines(e.g. ketoconazole and others)
• certain antiviral medicines used to treat HIV/AIDS(e.g. ritonavir)
• other medicines used to reduce blood clotting(e.g. enoxaparin and others)
• anti-inflammatoryor pain-relieving medicines(e.g. acetylsalicylic acid or naproxen), especially if the patient is over 75 years old and takes acetylsalicylic acid, may be at increased risk of unwanted bleeding
• medicines used for high blood pressure or heart problems(e.g. diltiazem)
• antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and norepinephrine reuptake inhibitors.

The following medicines may reduce the ability of Apixaban Orion to prevent blood clot formation:

• medicines used to prevent seizures or convulsions(e.g. phenytoin and others)
• St. John's Wort(a herbal supplement used in depression)
• medicines used to treat tuberculosisor other infections(e.g. rifampicin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a child, you should ask your doctor or pharmacist for advice before taking this medicine.
The effect of Apixaban Orion on pregnancy and the unborn child is not known. You should not take this medicine during pregnancy. If you become pregnant while taking this medicine, you should contact your doctor immediately.
It is not known whether Apixaban Orion passes into breast milk. Before taking this medicine while breastfeeding, you should ask your doctor or pharmacist for advice. You may be advised to stop breastfeeding or stop/ not start taking this medicine.

Driving and using machines

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

Apixaban Orion contains lactose

This medicine contains 48 mg of lactose. If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Other excipients

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Apixaban Orion

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.

Dose

The tablet should be swallowed with water. Apixaban Orion can be taken with or without food. To get the best effect from the treatment, it is recommended to take the tablets at the same time every day.
If the patient has problems swallowing the tablets whole, they should talk to their doctor about other ways of taking Apixaban Orion. The tablet can be crushed just before taking and mixed with water or 5% glucose solution, juice or apple puree.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the powder to a suitable container, then mix it with a small amount, e.g. 30 mL (2 tablespoons), of water or another liquid mentioned above to prepare a mixture.
• Swallow the mixture.
• Rinse the pestle and mortar used to crush the tablets and the container with a small amount of water or another liquid (e.g. 30 mL) and swallow the liquid after rinsing.

If necessary, the doctor may administer a crushed Apixaban Orion tablet mixed with 60 mL of water or 5% glucose solution through a nasogastric tube.

Apixaban Orion should be taken as recommended in the following indications:

Prevention of blood clot formation after hip or knee replacement surgery
The recommended dose is one Apixaban Orion 2.5 mg tablet twice a day. For example, one tablet in the morning and one in the evening.
The first tablet should be taken 12 to 24 hours after surgery.
If the patient has undergone major hip replacement surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee replacement surgery, they will usually take the tablets for 10 to 14 days.
Prevention of blood clot formation in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor
The recommended dose is one Apixaban Orion 5 mgtablet twice a day.
The recommended dose is one Apixaban Orion 2.5 mgtablet twice a day, if:

• the patient has severe kidney problems
• two or more of the following conditions are met:
• the patient's blood test results suggest impaired kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or more)
• the patient is 80 years old or older
• the patient's body weight is 60 kg or less.

The recommended dose is one tablet twice a day, for example one tablet in the morning and one in the evening. The doctor will decide how long the treatment should be continued.
Treatment of blood clots in the veins of the lower limbs and blood clots in the blood vessels of the lungs
The recommended dose is twoApixaban Orion 5 mgtablets twice a day for the first 7 days, for example two tablets in the morning and two in the evening.
After 7 days, the recommended dose is oneApixaban Orion 5 mgtablet twice a day, for example one tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after completion of 6-month treatment
The recommended dose is one Apixaban Orion 2.5 mgtablet twice a day, for example one tablet in the morning and one in the evening. The doctor will decide how long the treatment should be continued.

Use in children and adolescents

Treatment and prevention of recurrence of blood clots in the veins or in the blood vessels of the lungs
The medicine should always be taken or administered as recommended by the doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
To get the best effect from the treatment, it is recommended to take the tablets at the same time every day.
The dose of Apixaban Orion depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents with a body weight of at least 35 kg is fourApixaban Orion 2.5 mgtablets twice a day for the first 7 days, for example four tablets in the morning and four in the evening.
After 7 days, the recommended dose is twoApixaban Orion 2.5 mgtablets twice a day, for example two tablets in the morning and two in the evening.
Recommendations for parents and caregivers: you should observe the child and make sure they have taken the full dose.
It is important to follow the doctor's recommendations for visits, as if the child's weight changes, the dose of the medicine may need to be adjusted.

The doctor may change the anticoagulant treatment as follows:

Change from Apixaban Orion to anticoagulant medicines
You should stop taking Apixaban Orion. Anticoagulant treatment (e.g. heparin) should be started at the time of the planned intake of the next tablet.
Change from anticoagulant medicines to Apixaban Orion
You should stop taking anticoagulant medicines. Apixaban Orion treatment should be started at the time of the planned intake of the next dose of anticoagulant medicine, and then its usual intake should be continued.
Change from anticoagulant treatment including a vitamin K antagonist (e.g. warfarin) to Apixaban Orion
You should stop taking the vitamin K antagonist medicine. The doctor must perform blood tests and inform the patient when to start taking Apixaban Orion.
Change from Apixaban Orion to anticoagulant treatment including a vitamin K antagonist (e.g. warfarin)
If the doctor informs the patient that they should start taking a vitamin K antagonist medicine, they should continue to take Apixaban Orion for at least 2 days after taking the first dose of the vitamin K antagonist medicine. The doctor must perform blood tests and inform the patient when to stop taking Apixaban Orion.

Patients undergoing cardioversion

Patients who need to undergo a cardioversion procedure to restore a normal heart rhythm should take this medicine at the times specified by the doctor to prevent the formation of blood clots in the blood vessels of the brain and other blood vessels in the body.

Taking a higher dose of Apixaban Orion than recommended

If you have taken a higher dose of this medicine than recommended, you should immediately inform your doctor.
You should take the packaging of the medicine with you, even if it is empty.
If you have taken a higher dose of Apixaban Orion than recommended, you may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion or other treatment that can reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Apixaban Orion

• If you miss a morning dose, you should take it as soon as you remember and you can take it together with the evening dose.
• If you miss an evening dose, you can take it only on the same evening. You should not take two doses the next morning instead, but continue taking the medicine the next day as recommended, twice a day.

In case of doubts about taking the medicine or if you have missed more than

one dose, you should ask your doctor or pharmacist.

Stopping Apixaban Orion treatment

You should not stop taking this medicine without consulting your doctor, as the risk of blood clot formation may be higher if you stop taking Apixaban Orion too early.
If you have any further doubts about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Apixaban Orion can be used in three different medical conditions. The known side effects and their frequency in each of these medical conditions may be different and are listed separately below. In these conditions, the most common overall side effect of this medicine is bleeding, which can potentially be life-threatening and may require immediate medical attention.
The following side effects may occur when taking Apixaban Orion to prevent blood clot formation after hip or knee replacement surgery.
Common ( may affect up to 1 in 10 people):

• anaemia, which can cause fatigue or pallor
• bleeding, including bruising and swelling
• nausea (vomiting).

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

• decreased platelet count (which can affect blood clotting)
• bleeding after any surgery, including bruising and swelling, discharge or other fluid from the wound/incision or injection site, gastrointestinal bleeding, rectal bleeding, haematuria, epistaxis, vaginal bleeding
• low blood pressure, which can lead to fainting or rapid heartbeat
• blood test results may indicate liver function disorders, increased activity of certain liver enzymes, increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes
• pruritus.

Rare ( may affect up to 1 in 1000 people):

• allergic reactions (hypersensitivity), which can cause facial swelling, lip swelling, mouth swelling, tongue swelling and/or throat swelling and difficulty breathing. If you notice any of these symptoms, you should immediately contact your doctor.
• bleeding into the muscle, into the eyes, from the gums or haemoptysis, rectal bleeding
• hair loss.

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

• bleeding into the brain or spinal cord, lungs, or abdominal cavity, or into the space behind the abdominal cavity, gastrointestinal tract, eye, mouth or haemoptysis, from haemorrhoids, bleeding into the brain or spinal cord, lungs, or muscles
• rash, which can cause blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme)
• vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin surface, or bruising
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant medicines).

The following side effects may occur when taking Apixaban Orion to prevent blood clot formation in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor.
Common ( may affect up to 1 in 10 people):

• bleeding into the eye, gastrointestinal tract, rectum, haematuria, epistaxis, bleeding from the gums
• anaemia, which can cause fatigue or pallor
• low blood pressure, which can lead to fainting or rapid heartbeat
• nausea (vomiting)
• blood test results may indicate increased gamma-glutamyltransferase (GGT) activity.

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

• bleeding into the brain or spinal cord, mouth or haemoptysis, gastrointestinal tract, rectal bleeding, blood in the urine, bleeding after surgery, including bruising and swelling, discharge or other fluid from the wound/incision or injection site, bleeding from haemorrhoids, bleeding into the muscle
• decreased platelet count (which can affect blood clotting)
• blood test results may indicate liver function disorders, increased activity of certain liver enzymes, increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes
• rash
• pruritus
• hair loss
• allergic reactions (hypersensitivity), which can cause facial swelling, lip swelling, mouth swelling, tongue swelling and/or throat swelling and difficulty breathing. If you notice any of these symptoms, you should immediately contact your doctor.

Rare ( may affect up to 1 in 1000 people):

• bleeding into the lungs or throat, into the space behind the abdominal cavity, into the muscle.

Very rare ( may affect up to 1 in 10,000 people):

• rash, which can cause blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme).

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

• vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin surface, or bruising
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant medicines).

The following side effects may occur when taking Apixaban Orion to treat or prevent the recurrence of blood clots in the veins of the lower limbs and blood clots in the blood vessels of the lungs.
Common ( may affect up to 1 in 10 people):

• epistaxis, bleeding from the gums, haematuria, bruising and swelling, gastrointestinal tract bleeding, rectal bleeding, bleeding from the mouth, vaginal bleeding
• anaemia, which can cause fatigue or pallor
• decreased platelet count (which can affect blood clotting)
• nausea (vomiting)
• rash
• Blood test results may indicate increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) activity.

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

• low blood pressure, which can lead to fainting or rapid heartbeat
• bleeding into the eye, mouth or haemoptysis, gastrointestinal tract, rectal bleeding, blood in the urine, bleeding after surgery, including bruising and swelling, discharge or other fluid from the wound/incision or injection site, bleeding from haemorrhoids, bleeding into the muscle
• pruritus
• hair loss
• allergic reactions (hypersensitivity), which can cause facial swelling, lip swelling, mouth swelling, tongue swelling and/or throat swelling and difficulty breathing. If you notice any of these symptoms, you should immediately contact your doctor.
• blood test results may indicate liver function disorders, increased activity of certain liver enzymes, increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes.

Rare ( may affect up to 1 in 1000 people):

• bleeding into the brain or spinal cord, lungs.

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

• bleeding into the abdominal cavity or into the space behind the abdominal cavity
• rash, which can cause blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme)
• vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin surface, or bruising
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant medicines).

Additional side effects occurring in children and adolescents
You should immediately inform your doctor if your child experiences any of the following symptoms:

• allergic reaction (hypersensitivity), which can cause facial swelling, lip swelling, mouth swelling, tongue swelling and/or throat swelling and difficulty breathing. These side effects are common (may affect up to 1 in 10 people).

Generally, the side effects observed in children and adolescents treated with Apixaban Orion were similar to those observed in adults, and their severity was mild or moderate. The side effects observed more frequently in children and adolescents were nosebleeds and abnormal vaginal bleeding.
Very common ( may affect more than 1 in 10 people):

• vaginal bleeding, nosebleeds.

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

• bleeding from the gums, haematuria, bruising and swelling, gastrointestinal tract bleeding, rectal bleeding, bleeding from the mouth, bleeding after surgery, including bruising and swelling, discharge or other fluid from the wound/incision or injection site
• hair loss
• anaemia, which can cause fatigue or pallor
• decreased platelet count (which can affect blood clotting)
• nausea (vomiting)
• rash
• pruritus
• low blood pressure, which can lead to fainting or rapid heartbeat
• blood test results may indicate liver function disorders, increased activity of certain liver enzymes, increased alanine aminotransferase (ALT) activity.

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

• bleeding into the abdominal cavity or into the space behind the abdominal cavity, gastrointestinal tract, eye, mouth or haemoptysis, from haemorrhoids, bleeding into the brain or spinal cord, lungs, or muscles
• rash, which can cause blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme)
• vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin surface, or bruising
• blood test results may indicate increased gamma-glutamyltransferase (GGT) activity, blood in the stool or urine
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant medicines).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 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 can help provide more information on the safety of this medicine.

5. How to store Apixaban Orion

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated on the carton and blister after Lot.
There are no special storage precautions for this medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Apixaban Orion contains

• The active substance of the medicine is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other ingredients are: Tablet core: lactose, microcrystalline cellulose (102), croscarmellose sodium, magnesium stearate, sodium lauryl sulfate. Tablet coating: hypromellose (HPMC 2910) - 5mPas, lactose monohydrate, titanium dioxide (E 171), triacetin, yellow iron oxide (E 172).

What Apixaban Orion looks like and contents of the pack

Yellow, round, biconvex, film-coated tablets with a diameter of 6 mm, with the inscription "I1" on one side and smooth on the other side.
Pack sizes:
Blister: 10, 20, 60, 100, 168 and 200 film-coated tablets.
HDPE bottle with child-resistant closure: 30, 200 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: information for use

Inside the Apixaban Orion packaging, next to the patient information leaflet, there is a Patient Alert Card or the doctor may give the patient a similar card.
The Patient Alert Card contains information that is useful for the patient and warns other doctors that the patient is taking Apixaban Orion. You should always carry this card with you.

• 1. Take the card and tear off the relevant language.
• 2. Fill in the following points or ask your doctor to fill them in:
• Name and surname:
• Date of birth:
• Indication:
• Dose: mg twice a day
• Doctor's name and surname:
• Doctor's phone number:
• 3. Fold the card and always carry it with you.

Marketing authorisation holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer/Importer

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, you should contact the local representative of the marketing authorisation holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

Date of last revision of the leaflet: 04/2025