Apinoptim

Patient Information Leaflet: Information for the Patient

Apinoptim, 2.5 mg, Film-Coated Tablets

Apixaban

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Apinoptim and what is it used for

Apinoptim contains the active substance apixaban and belongs to a group of so-called anticoagulant medications.
This medication helps prevent the formation of blood clots by blocking factor Xa, which is an essential element in the blood clotting process.
Apinoptim 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 legs to the lungs, it can block blood flow through the lungs, causing shortness of breath with 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, hindering blood flow to these organs (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.

Apinoptim is used in children from 28 days 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.
Information on body weight and recommended dose can be found in section 3.

2. Important information before taking Apinoptim

When not to take Apinoptim

• If the patient is allergicto apixaban or any of the other ingredients of this medication (listed in section 6),
• If the patient has excessive bleeding,
• If the patient has an organ diseasethat increases the risk of severe 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 anticoagulant medications(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 treatment, discuss with your doctor, pharmacist, or nurse if you have any of the following conditions:

• Increased risk of bleeding, such as:
• Bleeding disorders, including conditions that result in reduced platelet activity,
• Very high blood pressurethat is not controlled 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 medication 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 medication after 5 or more hours after catheter removal,
• If the patient has a heart valve prosthesis,
• If the doctor determines that the patient's blood pressure is unstable or plans other treatment or surgery to remove a blood clot from the lungs.

When to exercise special caution when taking Apinoptim

• 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 on possible treatment changes.

In case of surgery or a procedure that may cause bleeding, the doctor may ask the patient to temporarily stop taking this medication for a short time. If there is any uncertainty about whether a procedure may cause bleeding, the doctor should be consulted.

Children and adolescents

Apinoptim is not recommended for use in children and adolescents with a body weight below 35 kg.

Apinoptim and other medications

Tell your doctor, pharmacist, or nurse about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Some medications may enhance the effect of Apinoptim, and some may reduce its effect. The doctor will decide whether you should receive Apinoptim while taking other medications and how closely you should be monitored.
The following medications may enhance the effect of Apinoptim and increase the risk of unwanted bleeding:

• Certain antifungal medications(e.g., ketoconazole and others)
• Certain antiviral medications used to treat HIV/AIDS(e.g., ritonavir)
• Other medications used to reduce blood clotting(e.g., enoxaparin and others)
• Anti-inflammatoryor pain-relieving medications(e.g., acetylsalicylic acid or naproxen), especially if the patient is over 75 years old and taking acetylsalicylic acid, may be at increased risk of bleeding
• Medications used for high blood pressure or heart problems(e.g., diltiazem)
• Antidepressant medicationscalled selective serotonin reuptake inhibitorsor serotonin and norepinephrine reuptake inhibitors.

The following medications may reduce the ability of Apinoptim to prevent blood clot formation:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor, pharmacist, or nurse before taking this medication.
The effect of Apinoptim on pregnancy and the unborn child is unknown. This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
It is not known whether apixaban passes into breast milk. Before taking this medication while breastfeeding, consult your doctor, pharmacist, or nurse. You may be advised to stop breastfeeding or stop/restart taking this medication.

Driving and using machines

It has not been found that Apinoptim affects the ability to drive and use machines.

Apinoptim contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medication.
This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Apinoptim

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor, pharmacist, or nurse.

Dose

Swallow the tablet with water. Apinoptim can be taken with or without food.
To achieve the best treatment results, it is recommended to take the tablets at the same time every day.
If you have problems swallowing the tablets whole, discuss other ways of taking Apinoptim with your doctor. The tablet can be crushed and mixed with water or 5% glucose solution, juice, or apple puree before administration.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the entire powder to a suitable container and then mix it with a small amount of water or one of the above-mentioned liquids to prepare a mixture.
• Swallow (drink) 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 (drink) the rinse liquid. If necessary, the doctor may administer the crushed Apinoptim tablet mixed with 60 mL of water or 5% glucose solution through a nasogastric tube.

Apinoptim 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 Apinoptim 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 Apinoptim 5 mgtablet twice a day.
The recommended dose is one Apinoptim 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 reduced kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or higher),
• the patient is 80 years old or older,
• the patient weighs 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 to continue treatment.
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 twoApinoptim 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 oneApinoptim 5 mgtablet twice a day, for example, one tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after completing 6 months of treatment
The recommended dose is one Apinoptim 2.5 mgtablet twice a day, for example, one tablet in the morning and one in the evening.
The doctor will decide how long to continue treatment.
Use in children and adolescents
Treatment and prevention of recurrence of blood clots in the veins or in the blood vessels of the lungs.
This medication should always be taken or administered as recommended by the doctor or pharmacist. If you are unsure, consult your doctor, pharmacist, or nurse.
To achieve the best treatment results, try to take or administer the dose at the same time every day.
The dose of Apinoptim is based on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing 35 kg or more is four Apinoptim 2.5 mg tablets twice a day for the first 7 days, for example, four in the morning and four in the evening. After 7 days, the recommended dose is two Apinoptim 2.5 mg tablets twice a day, for example, two in the morning and two in the evening.
For parents and caregivers: observe the child to ensure they have taken the full dose.
It is essential to follow the scheduled doctor's visits, as the dose may need to be adjusted with changes in the patient's body weight.

The doctor may change the anticoagulant treatment as follows:

• Switching from Apinoptim to anticoagulant medicationsStop taking Apinoptim. Anticoagulant treatment (e.g., heparin) should be started at the time of the scheduled next dose of Apinoptim.
• Switching from anticoagulant medications to ApinoptimStop taking anticoagulant medications. Apinoptim treatment should be started at the time of the scheduled next dose of anticoagulant medication and then continue with the usual dosing schedule.
• Switching from anticoagulant treatment with a vitamin K antagonist (e.g., warfarin) to ApinoptimStop taking the vitamin K antagonist medication. The doctor will perform blood tests and inform you when to start taking Apinoptim.
• Switching from Apinoptim to anticoagulant treatment with a vitamin K antagonist (e.g., warfarin)

If the doctor informs you that you should start taking a vitamin K antagonist medication, you should continue taking Apinoptim for at least 2 days after taking the first dose of the vitamin K antagonist medication. The doctor will perform blood tests and inform you when to stop taking Apinoptim.

Patients undergoing cardioversion

Patients with irregular heart rhythm who require cardioversion to restore a normal heart rhythm should take this medication at the times specified by the doctor to prevent blood clot formation in the brain and other blood vessels.

Taking a higher dose of Apinoptim than recommended

If you have taken a higher dose of this medication than recommended, inform your doctor immediately.
Take the packaging with you, even if there are no tablets left.
If you have taken a higher dose of Apinoptim than recommended, you may be at increased risk of bleeding. If bleeding occurs, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Apinoptim

• If you miss a morning dose, take it as soon as you remember and you can take it with your evening dose.
• If you miss an evening dose, you can take it only on the same evening. Do not take two doses the next morning; instead, continue taking the medication the next day as recommended, twice a day.

In case of doubts about taking the medication or missing more than one dose

consult your doctor, pharmacist, or nurse.

Stopping Apinoptim treatment

Do not stop taking this medication without consulting your doctor, as stopping Apinoptim treatment prematurely may increase the risk of blood clot formation.
In case of any further doubts about taking this medication, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Apinoptim can cause side effects, although not everybody gets them.
Apinoptim can be used in three different medical conditions. Known side effects and their frequency may vary in each of these conditions and are listed separately below. In these conditions, the most common overall side effect of this medication is bleeding, which can potentially be life-threatening and may require immediate medical attention.
The following side effects may occur when taking Apinoptim to prevent blood clot formation after hip or knee replacement surgery.

Common side effects (may affect up to 1 in 10 people)

• Anemia, which can cause fatigue or pallor;
• Bleeding, including:
• subcutaneous hemorrhages (bruises) and swelling;
• Nausea (vomiting).

Uncommon side effects (may affect up to 1 in 100 people)

• Reduced platelet count (which can affect blood clotting);
• Bleeding:
• after surgery, including subcutaneous hemorrhages and swelling, bleeding or fluid leakage from the surgical wound/incision site or injection site;
• from the stomach, intestines, or bright red blood in the stool;
• blood in the urine;
• from the nose;
• from the vagina;
• 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;
• Itching.

Rare side effects (may affect up to 1 in 1000 people)

• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, as well as difficulty breathing. In case of any of these symptoms, contact your doctor immediately;
• Bleeding:
• into the muscle;
• into the eyes;
• from the gums and blood in sputum when coughing;
• from the rectum;
• Hair loss.

Frequency not known (cannot be estimated from the available data)

• Bleeding:
• into the brain or spinal cord;
• into the lungs or throat;
• into the abdominal cavity or into the space behind the abdominal cavity;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• A skin rash, which can form 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 elevated, flat, red, round patches under the skin surface, or bruising;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function disorder (nephropathy associated with anticoagulant administration).

The following side effects may occur when taking Apinoptim to prevent blood clot formation in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Common side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• into the eyes;
• from the stomach or intestines;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• subcutaneous hemorrhages (bruises) and swelling;
• Anemia, 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 side effects (may affect up to 1 in 100 people)

• Bleeding:
• into the brain or spinal cord;
• into the mouth or blood in sputum when coughing;
• into the abdominal cavity or from the vagina;
• bright red blood in the stool;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including subcutaneous hemorrhages and swelling, bleeding or fluid leakage from the surgical wound/incision site or injection site
• from hemorrhoids;
• Reduced 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;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, as well as difficulty breathing. Contact your doctor immediatelyif you notice any of these symptoms.

Rare side effects (may affect up to 1 in 1000 people)

• Bleeding:
• into the lungs or throat;
• into the space behind the abdominal cavity;
• into the muscle.

Frequency not known (cannot be estimated from the available data)

• Vasculitis (inflammation of blood vessels), which can cause skin rash or elevated, flat, red, round patches under the skin surface, or bruising;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function disorder (nephropathy associated with anticoagulant administration).

The following side effects may occur when taking Apinoptim 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 side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• from the nose;
• from the gums;
• blood in the urine;
• subcutaneous hemorrhages (bruises) and swelling;
• from the stomach, intestines, or rectum;
• from the mouth;
• from the vagina;
• Anemia, which can cause fatigue or pallor;
• Reduced platelet count (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) activity.

Uncommon side effects (may affect up to 1 in 100 people)

• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Bleeding:
• into the eyes;
• into the mouth or blood in sputum when coughing;
• bright red blood in the stool;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including subcutaneous hemorrhages and swelling, bleeding or fluid leakage from the surgical wound/incision site or injection site
• from hemorrhoids;
• into the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, as well as difficulty breathing. Contact your doctor immediatelyif you notice any of these symptoms;
• 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 side effects (may affect up to 1 in 1000 people)

• Bleeding:
• into the brain or spinal cord;
• into the lungs.

Frequency not known (cannot be estimated from the available data)

• Bleeding:
• into the abdominal cavity or into the space behind the abdominal cavity.
• A skin rash, which can form 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 elevated, flat, red, round patches under the skin surface, or bruising;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function disorder (nephropathy associated with anticoagulant administration).

Additional side effects in children and adolescents
If you notice any of the following symptoms, inform your doctor immediately:

• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, as well as difficulty breathing. The frequency of these side effects is "common" (may affect up to 1 in 10 people).

Generally, side effects reported in children and adolescents taking Apinoptim were similar to those observed in adults and were mostly mild or moderate. Side effects that occurred more frequently in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

• Bleeding, including:
• from the vagina;
• from the nose.

Common side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• from the gums;
• blood in the urine;
• subcutaneous hemorrhages (bruises) and swelling;
• from the intestines or rectum;
• bright red blood in the stool;
• bleeding after surgery, including subcutaneous hemorrhages and swelling, bleeding or fluid leakage from the surgical wound/incision site or injection site;
• Hair loss;
• Anemia, which can cause fatigue or pallor;
• Reduced platelet count (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Itching;
• 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.

Frequency not known (cannot be estimated from the available data)

• Bleeding:
• into the abdominal cavity or into the space behind the abdominal cavity;
• into the stomach;
• into the eyes;
• into the mouth;
• from hemorrhoids;
• into the mouth or blood in sputum when coughing;
• into the brain or spinal cord;
• into the lungs;
• into the muscle;
• A skin rash, which can form 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 elevated, 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 kidney, sometimes with blood in the urine, leading to kidney function disorder (nephropathy associated with anticoagulant administration).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Apinoptim

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medication.
Crushed tablets
Crushed Apinoptim tablets are stable in water, 5% glucose solution, apple juice, and apple puree for up to 4 hours.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Apinoptim contains

• The active substance is apixaban. Each film-coated tablet contains 2.5 mg of apixaban.
• The other ingredients are:
• Tablet core: microcrystalline cellulose (type 101), anhydrous lactose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate,
• Coating: hypromellose 2910, lactose monohydrate, titanium dioxide (E171), triacetin, yellow iron oxide (E172).

What Apinoptim looks like and contents of the pack

The film-coated tablets are yellow, round, and 6.0 mm ± 0.2 mm in diameter.
Blister pack (PVC/PVDC/Aluminum) in a cardboard box.
Package sizes: 20, 60 film-coated tablets.
Not all package sizes may be marketed.

Patient Alert Card: Information for use

A Patient Alert Card is attached to the packaging or your doctor may give you a similar card.
The Patient Alert Card contains information that is helpful to you and warns other doctors that you are taking Apinoptim. Always carry this card with you.

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

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. 607 696 231
e-mail: [email protected]

Manufacturer

PHARMADOX Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

Date of last revision of the leaflet:

July 2025