Apinoptim

Leaflet accompanying the packaging: patient information

Apinoptim, 5 mg, film-coated tablets

Apixaban

Read the leaflet carefully before taking the medicine, 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 medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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, they should tell their 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 packaging 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 medicines.
This medicine helps prevent the formation of blood clots by blocking factor Xa, which is an important element in the blood clotting process.
Apinoptim is used in adults:

• 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 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 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 bleeding into the brain),
• If the patient has liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy),
• If the patient is taking anticoagulant medicines(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is being switched, and the patient has a venous or arterial access line 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 their vein) due to irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting treatment, the patient should discuss the following conditions with their doctor, pharmacist, or nurse:

• Increased risk of bleeding, such as:
• Bleeding disorders, including conditions that result in decreased 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 medicine should be used with caution in patients with signs of liver function changes.
• A tube (catheter) or injection into the spine(anesthetic or pain-relieving). In such cases, the doctor will recommend taking the medicine after 5 or more hours after the catheter is removed,
• 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 their doctor, who will decide on possible changes to the treatment.

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

Children and adolescents

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

Apinoptim and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may enhance the effect of Apinoptim, and some may weaken its effect. The doctor will decide whether the patient should receive Apinoptim while taking other medicines and how closely they should be monitored.
The following medicines may enhance the effect of Apinoptim 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 anticoagulant medicines(e.g., enoxaparin and others)
• Anti-inflammatory or pain-relieving medicines(e.g., acetylsalicylic acid or naproxen), especially if the patient is over 75 years old and taking acetylsalicylic acid, they may be at increased risk of bleeding
• Medicines used to treat high blood pressure or heart problems(e.g., diltiazem)
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors.

The following medicines may reduce the ability of Apinoptim 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 for depression)
• Medicines used to treat tuberculosis or other infections(e.g., rifampicin).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before taking this medicine.
The effect of Apinoptim on pregnancy and the unborn child is unknown. This medicine should not be used during pregnancy. If the patient becomes pregnant while taking this medicine, they should contact their doctor immediately.
It is not known whether apixaban passes into breast milk. Before taking this medicine while breastfeeding, the patient should consult their doctor, pharmacist, or nurse. The patient may be advised to stop breastfeeding or stop/ not start taking this medicine.

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 the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Apinoptim

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

Dose

The tablet should be swallowed with water. Apinoptim can be taken with or without food.
To achieve the best treatment results, the patient should try to take the tablets at the same time every day.
The recommended dose is one Apinoptim 5 mg tablet twice a day.

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 (e.g., 30 mL or 2 tablespoons) 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 liquid after rinsing. 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 follows:

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
The recommended dose is one Apinoptim 5 mg tablet twice a day.
The recommended dose is one Apinoptim 2.5 mg tablet 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 indicate decreased 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'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 twoApinoptim 5 mg tablets 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 mg tablet 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 Apinoptim 2.5 mg 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.
Use in children and adolescents
Treatment and prevention of recurrence of blood clots in the veins or blood vessels of the lungs.
This medicine should always be taken or administered exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
To achieve the best treatment results, the dose should be taken or administered 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 two Apinoptim 5 mg tablets 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 one Apinoptim 5 mg tablet twice a day, for example, one tablet in the morning and one in the evening.
For parents and caregivers: the child should be observed to ensure they take the full dose.
It is essential to follow the scheduled doctor's appointments, 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 medicinesThe patient should stop taking Apinoptim. Anticoagulant treatment (e.g., heparin) should be started at the time of the scheduled intake of the next Apinoptim tablet.
• Switching from anticoagulant medicines to ApinoptimThe patient should stop taking anticoagulant medicines. Apinoptim treatment should be started at the time of the scheduled intake of the next dose of anticoagulant medicine and then continued as usual.
• Switching from treatment with a vitamin K antagonist (e.g., warfarin) to ApinoptimThe patient should stop taking the vitamin K antagonist. The doctor will perform blood tests and inform the patient when to start taking Apinoptim.
• Switching from Apinoptim to treatment with a vitamin K antagonist (e.g., warfarin)If the doctor informs the patient that they should start taking a vitamin K antagonist, the patient should continue taking Apinoptim for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor will perform blood tests and inform the patient 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 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.

Taking a higher dose of Apinoptim than recommended

If the patient has taken a higher dose of this medicine than recommended, they should immediately inform their doctor.
The patient should take the packaging with them, even if there are no tablets left.
If the patient has taken a higher dose of Apinoptim than recommended, they may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Apinoptim

In case of missing a morning dose, the patient should take it as soon as they remember and can take it together with the evening dose.

• A missed evening dose can only be taken on the same evening. The patient should not take two doses the next morning instead; they should continue taking the medicine the next day as recommended, twice a day.

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

The patient should consult their doctor, pharmacist, or nurse.

Stopping Apinoptim treatment

The patient should not stop taking this medicine without consulting their doctor, as the risk of blood clot formation may be higher if Apinoptim treatment is stopped prematurely.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Apinoptim can cause side effects, although not everybody gets them.
The most common general 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 Apinoptim to prevent the formation of blood clots 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:
• in the eyes;
• in the stomach or intestines;
• from the rectum
• blood in the urine;
• from the nose;
• from the gums;
• bruising (hematoma) 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:
• in the brain or spinal cord;
• in the mouth or blood in sputum when coughing;
• in the abdominal cavity or from the vagina;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• from hemorrhoids;
• blood in the stool or urine detected in laboratory tests;
• Decreased platelet count in the blood (which can affect blood clotting);
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a breakdown product of red blood cells that can cause yellowing of the skin and eyes;
• Rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling and difficulty breathing. If any of these symptoms are observed, the patient should contact their doctor immediately.

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

• Bleeding:
• in the lungs or throat;
• in the space behind the abdominal cavity;
• in the muscles.

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

• A rash that 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).

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

• Vasculitis (inflammation of blood vessels), which can cause a rash or raised, flat, red, round patches under the skin, or bruising;
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function impairment (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;
• bruising (hematoma) and swelling;
• in the stomach, intestines, or rectum;
• in the mouth;
• from the vagina;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count in the blood (which can affect blood clotting);
• Nausea (vomiting);
• 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:
• in the eyes;
• in the mouth or blood in sputum when coughing;
• bright red blood in the stool;
• blood in the stool or urine detected in laboratory tests;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• from hemorrhoids;
• itching;
• hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling and difficulty breathing. If any of these symptoms are observed, the patient should contact their doctor immediately;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a breakdown product of red blood cells that can cause yellowing of the skin and eyes.

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

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

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

• Bleeding:
• in the abdominal cavity or space behind the abdominal cavity.
• A rash that 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 a rash or raised, flat, red, round patches under the skin, or bruising.
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function impairment (nephropathy associated with anticoagulant administration).

Additional side effects in children and adolescents
If any of the following symptoms are observed, the patient should immediately inform their doctor:

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

Generally, the 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;
• bruising (hematoma) and swelling;
• in the intestines or rectum;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• hair loss;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count in the blood (which can affect blood clotting);
• Nausea (vomiting);
• rash;
• itching;
• low blood pressure, which can cause fainting or rapid heartbeat;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (ALT) activity.

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

• Bleeding
• in the abdominal cavity or space behind the abdominal cavity;
• in the stomach;
• in the eyes;
• in the mouth;
• from hemorrhoids;
• in the mouth or blood in sputum when coughing;
• in the brain or spinal cord;
• in the lungs;
• in the muscles;
• A rash that 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 a rash or raised, flat, red, round patches under the skin, 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 impairment (nephropathy associated with anticoagulant administration).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 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 can help gather more information on the safety of the medicine.

5. How to store Apinoptim

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after: EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Crushed tablets
Crushed Apinoptim tablets are stable in water, 5% glucose solution in water, apple juice, and apple sauce for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Apinoptim contains

• The active substance of Apinoptim is apixaban. Each film-coated tablet contains 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, iron oxide red (E172).

What Apinoptim looks like and contents of the pack

Pink, elongated film-coated tablets with dimensions of 10.0 x 5.0 mm ± 0.2 mm.
Blister pack with PVC/PVDC/Aluminum foil, in a cardboard box.
Pack sizes: 56, 60 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: information for use

A Patient Alert Card is included with the packaging or the doctor may provide the patient with a similar card.
The Patient Alert Card contains information that is helpful to the patient and warns other doctors that the patient is taking Apinoptim. The patient should always carry this card with them.

• 1. The patient should take the card.
• 2. The patient should fill in the following points or ask their 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. The patient should fold the card and always carry it with them.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
phone: 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