Package leaflet: Information for the patient

Apinoptim, 5 mg, coated tablets
Apixabanum
Please read the entire leaflet before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Apinoptim is and what it is used for
Important information before taking Apinoptim
How to take Apinoptim
Possible side effects
How to store Apinoptim
Contents of the pack and other information

1. What Apinoptim is and what it is used for

Apinoptim contains the active substance apixaban and belongs to a group of medicines called anticoagulants.
This medicine helps prevent blood clots by inhibiting factor Xa, an important component in the blood clotting process.
Apinoptim is used in adults:

to prevent formation of blood clots in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or to other organs, impairing blood flow to these organs (also known as systemic embolism). Stroke may be life-threatening and requires immediate medical attention.
to treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

Apinoptim is used in children aged from 28 days to below 18 years for the treatment of blood clots and prevention of recurrence of blood clots in veins or in the blood vessels of the lungs.
Information on body weight and recommended dosage can be found in section 3.

2. Important information before using Apinoptim

When not to use Apinoptim

if the patient is allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
if the patient has excessive bleeding,
if the patient has a disease of an organ that increases the risk of serious bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed intracranial bleeding),
if the patient has liver disease leading to an increased risk of bleeding (hepatic coagulopathy),
if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran or heparin), except in situations of switching anticoagulant therapy, when a venous or arterial line has been inserted and heparin is administered through this line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into the vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before starting this medicine if the patient has any of the following conditions:

increased risk of bleeding, for example:
conditions involving bleeding, including those resulting in reduced platelet activity,
very high blood pressure not controlled by medication,
if the patient is over 75 years of age,
if the patient weighs 60 kg or less,
severe kidney disease or if the patient is on dialysis,
liver disease or history of liver disease. This medicine should be used with caution in patients showing signs of liver function abnormalities.
a tube (catheter) or injection into the spine (anaesthetic or painkiller). In such a case, the doctor will advise taking this medicine 5 or more hours after removal of the catheter,
if the patient has a heart valve prosthesis,
if the doctor determines that the patient's blood pressure is unstable or if other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Apinoptim

if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

If surgery or a procedure that may cause bleeding is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If in doubt whether a particular procedure may cause bleeding, ask the doctor.

Children and adolescents

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

Apinoptim and other medicines

Tell your doctor, pharmacist or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Some medicines may enhance the effect of Apinoptim, while others may reduce its effect. The doctor will decide whether the patient should receive Apinoptim while taking other medicines and how closely monitoring should be performed.

The following medicines may enhance the effect of Apinoptim and increase the risk of unwanted bleeding:

certain medicines used to treat fungal infections (e.g. ketoconazole and others),
certain antiviral medicines used to treat HIV/AIDS infection (e.g. ritonavir),
other medicines used to reduce blood clotting (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 of age and taking acetylsalicylic acid, which may increase the risk of bleeding,
medicines used for high blood pressure or heart problems (e.g. diltiazem),
antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

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

medicines used to prevent epilepsy or seizures (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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor, pharmacist or nurse before using 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, she should contact her doctor immediately.

It is not known whether apixaban passes into human milk. Consult your doctor, pharmacist or nurse before using this medicine during breastfeeding. The patient may be advised to discontinue breastfeeding or to stop/avoid starting treatment with this medicine.

Driving and operating machinery

No effects of Apinoptim on the ability to drive or operate machinery have been observed.

Apinoptim contains lactose and sodium

If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Apinoptim

This medicine should always be taken as directed by a doctor or pharmacist. If you have any
doubts, consult your doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed with water. Apinoptim may be taken independently of
meals.
To achieve the best treatment results, it is recommended to take the tablets at the same
time each day.
If a patient has difficulty swallowing the tablets whole, discuss alternative methods of taking
Apinoptim with your doctor. The tablet may be crushed and mixed with water or 5% aqueous
glucose solution, juice, or apple puree immediately before administration.
Instructions for crushing tablets:

Crush the tablet with a pestle in a mortar.
Carefully transfer the entire powder to a suitable container, then mix it with a small amount (e.g., 30 mL [2 tablespoons]) of water or one of the liquids listed above to prepare a mixture.
Swallow (drink) the mixture.
Rinse the pestle and mortar used for crushing the tablets, as well as the container, with a small amount of water or another liquid (e.g., 30 mL), then swallow (drink) the rinsing liquid. If necessary, a doctor may administer crushed Apinoptim tablets mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.

Apinoptim should be taken as directed for the following indications:
Prevention of blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor
The recommended dose is one Apinoptim 5 mg tablet twice daily.
The recommended dose is one Apinoptim 2.5 mg tablet twice daily if:

the patient has severe renal impairment,
two or more of the following conditions are met:
laboratory blood tests suggest reduced kidney function (serum creatinine concentration of 1.5 mg/dL (133 micromoles/L) or higher),
the patient is 80 years of age or older,
the patient’s 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 treatment should continue.
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 two tablets of Apinoptim 5 mg 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 tablet of Apinoptim 5 mg twice daily, 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 daily, for example, one tablet in the morning and one in the evening.
Your doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrence of blood clots in veins or blood vessels of the lungs.
This medicine should always be taken or administered as directed by a doctor or pharmacist.
If in doubt, consult your doctor, pharmacist, or nurse.
To achieve the best treatment effect, doses should be taken or administered at the same time each day.
The dose of Apinoptim depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing at least 35 kg is two Apinoptim 5 mg tablets, administered twice daily for the first 7 days, for example, two in the morning and two in the evening. After 7 days, the recommended dose is one Apinoptim 5 mg tablet, administered twice daily, for example, one in the morning and one in the evening.
For parents and caregivers: observe the child to ensure the full dose has been taken.
It is important to attend scheduled doctor’s appointments, as dose adjustments may be necessary due to changes in body weight.
Your doctor may change anticoagulant treatment as follows:

Switching from Apinoptim to anticoagulant medicines Discontinue Apinoptim. Begin treatment with anticoagulant medicines (e.g., heparin) at the time the next tablet was scheduled to be taken.
Switching from anticoagulant medicines to Apinoptim Discontinue anticoagulant medicines. Begin Apinoptim treatment at the time the next dose of anticoagulant medicine was scheduled, then continue regular dosing.
Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Apinoptim Discontinue the vitamin K antagonist medicine. Your doctor must perform blood tests and will inform you when to start taking Apinoptim.
Switching from Apinoptim to anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apinoptim for at least 2 days after taking the first dose of the vitamin K antagonist medicine. Your doctor must perform blood tests and will inform you when to stop taking Apinoptim.

Patients undergoing cardioversion
Patients with an irregular heartbeat who require cardioversion to restore normal heart rhythm should take this medicine at the times specified by their doctor to prevent blood clots in the brain and other blood vessels.
Taking more than the recommended dose of Apinoptim
If a patient takes more than the recommended dose of this medicine, contact a doctor immediately. Bring the medicine packaging with you, even if no tablets remain.
If a patient takes more than the recommended dose of Apinoptim, the risk of bleeding may increase. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect directed against factor Xa may be required.
Missing a dose of Apinoptim
If a morning dose is missed, take it as soon as remembered, and it may be taken together with the evening dose.

A missed evening dose may be taken only on the same evening. Do not take two doses the next morning instead; continue taking the medicine the next day as directed, twice daily. If in doubt about use of the medicine or if more than one dose is missed, consult your doctor, pharmacist, or nurse.

Stopping Apinoptim
Do not stop taking this medicine without consulting your doctor, as the risk of developing a blood clot may be higher if Apinoptim is stopped prematurely.
If you have any further doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

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

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

Common side effects (may occur in less than 1 in 10 people)

Bleeding, including:
into the eyes;
into the stomach or intestine;
from the rectum;
blood in urine;
from the nose;
from the gums;
subcutaneous haemorrhage (bruising) and swelling;
Anaemia, which may cause fatigue or paleness;
Low blood pressure, which may lead to fainting or rapid heartbeat;
Nausea;
Blood test results may indicate:
increased gamma-glutamyl transferase (GGT) activity.

Uncommon side effects (may occur in less than 1 in 100 people)

Bleeding:
into the brain or spinal canal;
into the mouth or blood in coughed-up phlegm;
in the abdominal cavity or from the vagina;
bright red blood in stool;
bleeding after surgery, including bruising and swelling, leakage of blood or fluid
from the surgical wound/incision site (wound discharge) or injection site;
from haemorrhoids;
presence of blood in stool or urine detected in laboratory tests;
Decreased platelet count (which may 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, which may cause yellowing of the skin and eyes;
Skin rash;
Itching;
Hair loss;
Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, contact your doctor immediately.

Rare side effects (may occur in less than 1 in 1,000 people)

Bleeding:
into the lungs or throat;
into the retroperitoneal space (located at the back of the abdominal cavity);
into muscles.

Very rare side effects (may occur in less than 1 in 10,000 people)

Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

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

Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects may occur when taking Apinoptim to treat or prevent recurrent blood clots in the veins of the legs and blood clots in the blood vessels of the lungs.

Common side effects (may occur in less than 1 in 10 people)

Bleeding, including:
from the nose;
from the gums;
blood in urine;
subcutaneous haemorrhage (bruising) and swelling;
in the stomach, intestine, or from the rectum;
in the mouth;
from the vagina;
Anaemia, which may cause fatigue or paleness;
Decreased platelet count (which may affect blood clotting);
Nausea;
Skin rash;
Blood test results may indicate:
increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT) activity.

Uncommon side effects (may occur in less than 1 in 100 people)

Low blood pressure, which may lead to fainting or rapid heartbeat;
Bleeding:
into the eyes;
in the mouth or blood in coughed-up phlegm;
bright red blood in stool;
test results indicating blood in stool or urine;
bleeding after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
from haemorrhoids;
into muscles;
Itching;
Hair loss;
Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, contact your 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, which may cause yellowing of the skin and eyes.

Rare side effects (may occur in less than 1 in 1,000 people)

Bleeding:
into the brain or spinal canal;
into the lungs.

Frequency not known (cannot be estimated from available data)

Bleeding:
into the abdominal cavity or retroperitoneal space.
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising.
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional side effects in children and adolescents

If any of the following symptoms occur, contact your doctor immediately:

Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. The frequency of these side effects is classified as common (may occur in less than 1 in 10 people).

Generally, side effects observed in children and adolescents treated with Apinoptim were similar to those seen in adults and were mostly mild or moderate in severity. Side effects observed more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

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

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

Common side effects (may occur in less than 1 in 10 people)

Bleeding, including:
from the gums;
blood in urine;
subcutaneous haemorrhages (bruising) and swelling;
from the intestine or rectum;
bright red blood in stool;
postoperative bleeding, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood or fluid (discharge) from the surgical wound or injection site;
Hair loss;
Anaemia, which may cause fatigue or paleness;
Decreased platelet count (which may affect clotting);
Nausea;
Skin rash;
Itching;
Low blood pressure, which may cause fainting or rapid heartbeat;
Blood test results may indicate:
abnormal liver function;
increased activity of certain liver enzymes;
increased alanine aminotransferase (ALT).

Frequency not known (cannot be estimated from available data)

Bleeding:
into the abdominal cavity or retroperitoneal space;
in the stomach;
in the eyes;
in the mouth;
from haemorrhoids;
in the mouth or blood in coughed-up phlegm;
in the brain or spinal canal;
in the lungs;
in the muscle;
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Vasculitis, which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising;
Blood test results may indicate:
increased gamma-glutamyl transferase (GGT) activity;
presence of blood in stool or urine.
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorisation holder. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Apinoptim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Crushed tablets
Crushed Apinoptim tablets are stable in water, 5% glucose solution in water, apple juice, and apple puree for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Apinoptim contains

The active substance is apixaban. Each coated tablet contains 5 mg of apixaban.
The other ingredients are:
- Tablet core: microcrystalline cellulose (type 101), anhydrous lactose, sodium lauryl sulfate, sodium croscarmellose, 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, oblong coated tablets measuring 10.2 x 5.2 mm ± 0.2 mm.
Blister packs made of PVC/PVDC/Aluminium, in a cardboard box.
Pack sizes: 56, 60 coated tablets.

Not all pack sizes may be marketed.

Patient Alert Card: information for use
A Patient Alert Card is included in the packaging, or your physician may provide you with a similar card.
The Patient Alert Card contains helpful information for the patient and warns other physicians that the patient is taking Apinoptim. You should always carry this card with you.

Take the card.
Fill in the following details, or ask your doctor to complete them:
- Name:
- Date of birth:
- Indication:
- Dose: ......... mg twice daily
- Doctor's name:
- Doctor's telephone number:
Fold the card and always carry it with you.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
tel. +48 22 32 160 240

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

January 2026