Apixaban Orion

Package Leaflet: Information for the User

Apixaban Orion, 5 mg, film-coated tablets

apixaban

Read all of this leaflet carefully before taking this medicine because 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Apixaban Orion contains the active substance apixaban and belongs to a group of medicines called anticoagulants. It helps to prevent blood clots from forming by blocking factor Xa, which is important for blood clotting.

Apixaban Orion is used in adults to:

• prevent 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 travel to the brain, causing a stroke, or to other organs, blocking blood flow to these organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as prevent new blood clots from forming in the blood vessels of the legs 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 new blood clots from forming in the veins or lungs.

2. What you need to know before you take Apixaban Orion

Do not take Apixaban Orion

• if you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6)
• if you have excessive bleeding
• if you have a condition that increases the risk of serious bleeding(such as active or recently diagnosed stomach or intestinal ulcer, recent bleeding in the brain)

Bleeding in the brain

• if you have liver diseasethat increases the risk of bleeding (hepatic coagulopathy)
• if you are taking other medicines to prevent blood clotting(such as warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is being switched, when a venous or arterial access line has been inserted and heparin is being administered through this line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into a vein) for irregular heart rhythm (arrhythmia).

Warnings and precautions

Before taking Apixaban Orion, tell your doctor or pharmacist if you have any of the following conditions:

• increased risk of bleeding, such as:
• bleeding disorders, including those that result in decreased platelet activity
• very high blood pressurethat is not controlled with medication
• if you are over 75 years old
• if you weigh 60 kg or less
• severe kidney disease or if you are 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
• if you have a heart valve replacement
• if your doctor has determined that your blood pressure is unstable or if other treatment or surgery is planned to remove a blood clot from the lungs

When to be extra careful when taking Apixaban Orion

• 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.

If you need to have surgery or a procedure that may cause bleeding, your doctor may ask you to stop taking this medicine for a short time. If you are unsure whether a procedure may cause bleeding, you should ask your doctor.

Children and adolescents

This medicine should not be used in children and adolescents with a body weight of less than 35 kg.

Apixaban Orion and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including:

• some antifungal medicines(such as ketoconazole and others)
• some antiviral medicines used to treat HIV/AIDS(such as ritonavir)
• other medicines that reduce blood clotting(such as enoxaparin and others)
• anti-inflammatory or pain-relieving medicines(such as aspirin or naproxen), especially if you are over 75 years old and taking aspirin

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

• medicines used to prevent seizures or fits(such as phenytoin and others)
• St. John's Wort(a herbal supplement used for depression)
• medicines used to treat tuberculosis or other infections(such as rifampicin)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, 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, ask your doctor or pharmacist for advice. You may be advised to stop breastfeeding or stop/avoid 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 97 mg of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Other excipients

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially sodium-free.

3. How to take Apixaban Orion

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Dose

Swallow the tablet with water. Apixaban Orion can be taken with or without food. To get the best results, take the tablets at the same time every day.

If you have trouble swallowing the tablets whole, talk to your doctor about other ways to take Apixaban Orion. The tablet can be crushed and mixed with water or 5% glucose solution, juice, or apple sauce just before taking.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the powder to a suitable container and mix it with a small amount (e.g., 30 mL or 2 tablespoons) of water or another liquid mentioned above to make 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 rinse liquid.

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

Take Apixaban Orion as follows:

Prevention of blood clots 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 mg tablet twice daily.

The recommended dose is one Apixaban Orion 2.5 mg tablet twice daily if:

• you have severe kidney problems
• two or more of the following conditions are met:
• your blood test results indicate decreased kidney function (serum creatinine level of 1.5 mg/dL or more)
• you are 80 years old or older
• your body weight is 60 kg or less

The recommended dose is one tablet twice daily, for example, one tablet in the morning and one in the evening. Your doctor will decide how long you should continue treatment.

Treatment of blood clots in the veins of the legs and blood clots in the lungs

The recommended dose is two Apixaban Orion 5 mg tablets twice daily for the first 7 days, for example, two tablets in the morning and two in the evening.

After 7 days, the recommended dose is one Apixaban Orion 5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.

Prevention of new blood clots after completing 6 months of treatment

The recommended dose is one Apixaban Orion 2.5 mg tablet twice daily, for example, one tablet in the morning and one in the evening. Your doctor will decide how long you should continue treatment.

Use in children and adolescents

Treatment and prevention of new blood clots in the veins or lungs

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

To get the best results, take the tablets at the same time every day.

The dose of Apixaban Orion depends on body weight and will be calculated by your doctor.

The recommended dose for children and adolescents with a body weight of 35 kg or more is two Apixaban Orion 5 mg tablets twice daily for the first 7 days, for example, two tablets in the morning and two in the evening.

After 7 days, the recommended dose is one Apixaban Orion 5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.

Recommendations for parents and caregivers: observe the child and ensure they take the full dose.

It is essential to follow the doctor's recommendations for visits, as the dose of the medicine may need to be adjusted if the child's weight changes.

Switching from Apixaban Orion to other anticoagulants

Switching from Apixaban Orion to other anticoagulants

Stop taking Apixaban Orion. Start treatment with other anticoagulants (such as heparin) when the next dose of Apixaban Orion is scheduled.

Switching from other anticoagulants to Apixaban Orion

Stop taking other anticoagulants. Start treatment with Apixaban Orion when the next dose of the other anticoagulant is scheduled, and then continue with the usual dosing schedule.

Switching from treatment with a vitamin K antagonist (such as warfarin) to Apixaban Orion

Stop taking the vitamin K antagonist. Your doctor will perform blood tests and inform you when to start taking Apixaban Orion.

Switching from Apixaban Orion to treatment with a vitamin K antagonist (such as warfarin)

If your doctor tells you to start taking a vitamin K antagonist, you should continue taking Apixaban Orion for at least 2 days after taking the first dose of the vitamin K antagonist. Your doctor will perform blood tests and inform you when to stop taking Apixaban Orion.

Patients undergoing cardioversion

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

If you take more Apixaban Orion than you should

If you take more Apixaban Orion than you should, contact your doctor immediately. Take the package with you, even if it is empty.

If you take more Apixaban Orion than you should, you may be at increased risk of bleeding. If bleeding occurs, you may need surgical treatment, blood transfusion, or other treatment to reverse the effect of Apixaban Orion.

If you forget to take Apixaban Orion

• If you miss a morning dose, take it as soon as you remember and take the evening dose as scheduled.
• If you miss an evening dose, you can take it only on the same evening. Do not take two doses on the next day, instead, continue with your regular dosing schedule, twice daily.

If you have any further questions on the use of this product, or if you have missed more than one dose

ask your doctor or pharmacist.

Stopping Apixaban Orion

Do not stop taking this medicine without talking to your doctor first, as the risk of blood clots may be higher if you stop taking Apixaban Orion too early.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common side effect of this medicine is bleeding, which can be life-threatening and may require immediate medical attention.

The following side effects may occur when taking Apixaban Orion to prevent blood clots 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 in the eye, stomach, or intestine, bleeding from the rectum, blood in the urine, nosebleeds, bleeding from the gums, bruising, and swelling
• anaemia, which can cause tiredness or paleness
• low blood pressure, which can cause dizziness or fainting
• nausea (feeling sick)
• abnormal liver function tests, which can indicate liver damage

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

• bleeding in the brain or spinal cord, bleeding in the mouth or throat, coughing up blood, bleeding in the abdomen or retroperitoneal space, bleeding from haemorrhoids, bleeding after surgery, including bruising and swelling, discharge from the wound or injection site
• decreased platelet count, which can affect blood clotting
• abnormal liver function tests, including increased liver enzymes, increased bilirubin levels, which can cause yellowing of the skin and eyes
• skin rash
• itching
• hair loss
• allergic reactions (hypersensitivity), which can cause swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.

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

• bleeding in the lungs or throat, bleeding in the muscles

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

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

Not known (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, or bruising
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulants)

The following side effects may occur when taking Apixaban Orion to treat or prevent new blood clots in the veins of the legs and lungs:

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

• bleeding from the nose, gums, blood in the urine, bruising, and swelling, bleeding in the stomach or intestine, bleeding from the rectum, vaginal bleeding
• anaemia, which can cause tiredness or paleness
• decreased platelet count, which can affect blood clotting
• nausea (feeling sick)
• skin rash
• abnormal liver function tests, including increased liver enzymes

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

• low blood pressure, which can cause dizziness or fainting
• bleeding in the eye, mouth, or throat, coughing up blood, blood in the stool or urine, bleeding after surgery, including bruising and swelling, discharge from the wound or injection site, bleeding from haemorrhoids, bleeding in the muscles
• itching
• hair loss
• allergic reactions (hypersensitivity), which can cause swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.
• abnormal liver function tests, including increased liver enzymes, increased bilirubin levels, which can cause yellowing of the skin and eyes

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

• bleeding in the brain or spinal cord, bleeding in the lungs

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

• bleeding in the abdomen or retroperitoneal space
• skin rash with blisters, which can resemble 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, or bruising
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulants)

Additional side effects in children and adolescents

Tell your doctor immediatelyif your child experiences any of the following symptoms:

• allergic reaction (hypersensitivity), which can cause swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. This side effect is common (may affect up to 1 in 10 people).

Generally, the side effects seen in children and adolescents treated with Apixaban Orion were similar to those seen in adults, and were mild or moderate in severity. The side effects seen 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, blood in the urine, bruising, and swelling, bleeding in the intestine or rectum, blood in the stool; bleeding after surgery, including bruising and swelling, discharge from the wound or injection site
• hair loss
• anaemia, which can cause tiredness or paleness
• decreased platelet count, which can affect blood clotting
• nausea (feeling sick)
• skin rash
• itching
• low blood pressure, which can cause dizziness or fainting
• abnormal liver function tests, including increased liver enzymes

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

• bleeding in the abdomen or retroperitoneal space, bleeding in the stomach, eye, mouth, or throat, coughing up blood, bleeding from haemorrhoids, bleeding in the brain or spinal cord, bleeding in the lungs, bleeding in the muscles
• skin rash with blisters, which can resemble 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, or bruising
• abnormal liver function tests, including increased liver enzymes, blood in the stool or urine
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulants)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the national reporting system listed below.

You can also report side effects directly via the national reporting system.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apixaban 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 and blister after EXP. The expiry date refers to the last day of that month.

The batch number is stated on the carton and blister after Lot.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Apixaban Orion contains

• The active substance is apixaban. Each tablet contains 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) - 5 mPas, lactose monohydrate, titanium dioxide (E 171), triacetin, iron oxide red (E 172)

What Apixaban Orion looks like and contents of the pack

Pink, oval, biconvex, film-coated tablets, 10 mm in length and 5 mm in width, with "I2" engraved on one side and plain on the other.

Available in blister packs of 14, 20, 28, 56, 60, 100, 168, and 200 film-coated tablets.

HDPE bottles with child-resistant closure: 30, 200, and 500 film-coated tablets.

Not all pack sizes may be marketed.

Patient Alert Card: Information for the User

Inside the Apixaban Orion package, next to the patient leaflet, you will find a Patient Alert Card or your doctor may give you a similar card.

The Patient Alert Card contains information that will help you and alert other doctors that you are taking Apixaban Orion. Always carry this card with you.

• 1. Take the card and tear off the relevant language.
• 2. Fill in the following or ask your doctor to fill them in:
• Name:
• Date of birth:
• Indication:
• Dose: mg twice daily
• Doctor's name:
• Doctor's phone number:
• 3. Fold the card and keep it with you at all times.

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

For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

Orion Pharma Poland Sp. z o. o.

kontakt@orionpharma.info.pl

Date of last revision of the leaflet: 04/2025