Package leaflet: Information for the patient

Poltixa, 2.5 mg, coated tablets
Apixabanum
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Poltixa is and what it is used for
What you need to know before taking Poltixa
How to take Poltixa
Possible side effects
How to store Poltixa
Contents of the pack and other information

1. What Poltixa is and what it is used for

Poltixa 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.
Poltixa 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, patients have an increased risk of developing blood clots in the veins of the legs. This may lead to leg swelling, with or without pain. If a blood clot travels from the leg to the lungs, it may block blood flow through the lungs, causing breathlessness with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
to prevent blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing a stroke, or to other organs, impairing blood supply to these organs (also known as systemic embolism). Stroke can be life-threatening and requires immediate medical treatment.
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 veins of the legs and/or lungs.

Poltixa is used in children aged from 28 days to below 18 years for the treatment of blood clots and to prevent recurrence of blood clots in veins or in the blood vessels of the lungs.
The recommended dose adjusted for body weight is given in section 3.

2. Important information before using Poltixa

When not to use Poltixa

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 an organ disease that increases the risk of serious bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed intracranial haemorrhage)
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 access 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 a vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions
Before starting Poltixa, discuss with a doctor, pharmacist or
nurse 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, uncontrolled with medication
if the patient is over 75 years of age
if the patient’s body weight is 60 kg or less
severe kidney disease or if the patient is on dialysis
liver problems or history of liver problems
Poltixa should be used with caution in patients showing signs of liver function abnormalities.
a spinal catheter or spinal injection (anaesthetic or pain relief). In such cases, the doctor will advise taking Poltixa 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 other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Poltixa:

if the patient has a disorder called antiphospholipid syndrome (an autoimmune 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 associated with bleeding risk is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If unsure whether a procedure may involve bleeding risk, consult the doctor.
Children and adolescents
Poltixa is not recommended for use in children and adolescents with body weight below 35 kg.
Poltixa and other medicines
Tell the 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 Poltixa, while others may reduce its effect. The doctor will decide whether the patient should receive Poltixa while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Poltixa and increase the risk of unwanted bleeding:

certain antifungal medicines (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). Particularly when the patient is over 75 years of age and taking acetylsalicylic acid, the risk of unwanted bleeding may be increased.
medicines used for high blood pressure or heart conditions (e.g. diltiazem)
antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs).

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

medicines used to prevent epilepsy or seizures (e.g. phenytoin and others)
St John’s wort (an 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 a doctor, pharmacist or nurse before using this medicine.
The effect of Poltixa during pregnancy and on the unborn child is unknown. Poltixa should not be taken during pregnancy. If the patient becomes pregnant while taking Poltixa, she should contact her doctor immediately.
It is not known whether Poltixa passes into human milk. Before using this medicine during breastfeeding, consult a doctor, pharmacist or nurse. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting this medicine.
Driving and operating machinery
Poltixa has no effect or negligible effect on the ability to drive
motor vehicles and operate machinery.
This medicine contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Poltixa

This medicine should always be used according to the instructions given by the doctor or pharmacist. If in doubt,
consult the doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed with water. Poltixa 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, they should discuss alternative methods of taking Poltixa with their doctor. The tablet may be crushed immediately before administration and mixed with water or 5% aqueous glucose solution, juice, or apple puree.
Instructions for crushing tablets:

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

If necessary, the doctor may administer crushed Poltixa tablets mixed with 60 ml of water or 5% aqueous glucose solution through a nasogastric tube.
Poltixa should be used as recommended for the following indications:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one 2.5 mg Poltixa tablet twice daily.
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 surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee surgery, they will usually take the tablets for 10 to 14 days.
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 5 mg Poltixa tablet twice daily.
The recommended dose is one 2.5 mg Poltixa tablet twice daily if:

the patient has severe renal impairment
two or more of the following conditions are met:
the patient's blood test results 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 in the morning and one in the evening. The doctor will decide how long treatment should continue.
Treatment of blood clots in the veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two 5 mg Poltixa tablets 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 5 mg Poltixa tablet twice daily, for example, one in the morning and one in the evening.
Prevention of recurrent blood clots after completion of 6-month treatment
The recommended dose is one 2.5 mg Poltixa tablet twice daily, for example, one tablet in the morning and one in the evening.
The doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrent blood clots in veins or in the blood vessels of the lungs.
This medicine should always be taken or administered according to the instructions of the doctor or pharmacist.
If in doubt, consult the doctor, pharmacist, or nurse.
To achieve the best treatment outcome, the dose should be taken or administered at the same time each day.
The dose of Poltixa depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents with a body weight of at least 35 kg is four 2.5 mg Poltixa tablets, taken twice daily for the first 7 days, for example, four in the morning and four in the evening. After 7 days, the recommended dose is two 2.5 mg Poltixa tablets, taken twice daily, for example, two in the morning and two 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 with changes in the patient's body weight.
The doctor may change anticoagulant therapy as follows:

Switching from Poltixa to other anticoagulant medicines: Discontinue Poltixa. Start anticoagulant treatment (e.g., heparin) at the time the next tablet was scheduled to be taken.
Switching from anticoagulant medicines to Poltixa: Discontinue the anticoagulant medicines. Start Poltixa at the time the next dose of anticoagulant medicine was scheduled to be taken, then continue regular dosing.
Switching from vitamin K antagonist anticoagulant therapy (e.g., warfarin) to Poltixa: Discontinue the vitamin K antagonist medicine. The doctor must perform blood tests and will inform the patient when to start taking Poltixa.
Switching from Poltixa to vitamin K antagonist anticoagulant therapy (e.g., warfarin): If the doctor informs the patient that they should start taking a vitamin K antagonist medicine, Poltixa should be continued for at least 2 days after the first dose of the vitamin K antagonist medicine is taken. The doctor must perform blood tests and inform the patient when to discontinue Poltixa.

Patients undergoing cardioversion
Patients with irregular heartbeat who require a cardioversion procedure to restore normal heart rhythm should take Poltixa at the times specified by the doctor to prevent blood clots in the blood vessels of the brain and other blood vessels in the body.
Taking more than the recommended dose of Poltixa
If a patient takes more than the recommended dose of Poltixa, they should immediately inform their doctor.
Bring the medicine packaging, even if it is empty.
If a patient takes more than the recommended dose of Poltixa, there may be an increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect directed against factor Xa may be necessary.
Missing a dose of Poltixa

If a morning dose is missed, take it as soon as remembered, and it may be taken at the same time as the evening dose.
A missed evening dose may only be taken on the same evening. Do not take two doses the next morning instead; continue taking the medicine the next day as recommended, twice daily.

If in doubt about using the medicine or if more than one dose is missed, consult the doctor, pharmacist, or nurse.
Stopping Poltixa
Do not stop taking Poltixa without consulting the doctor, as stopping Poltixa prematurely may increase the risk of blood clots.
If there are any further doubts about using this medicine, consult the doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Poltixa can be used in three different medical conditions. Known adverse effects and their frequency of occurrence may differ for each of these medical conditions and are listed separately below. In these conditions, the most common general adverse effect of Poltixa is bleeding, which may potentially be life-threatening and may require immediate medical attention.

The following adverse effects may occur when Poltixa is used to prevent blood clots after hip or knee replacement surgery.

Common (occur in less than 1 in 10 patients)

Anaemia, which may cause fatigue or paleness
Bleeding including:
subcutaneous haemorrhages and swelling
Nausea (feeling sick)

Uncommon (occur in less than 1 in 100 patients)

Reduced number of platelets in the blood (which may affect blood clotting)
Bleeding:
after surgery, including bruising and swelling, leakage of blood or other fluid from the surgical wound/incision site (wound discharge) or injection site
from the stomach, intestines, or bright red blood in stool
blood in urine
nosebleeds
vaginal bleeding
Low blood pressure, which may lead to fainting or rapid heartbeat
Blood test results may indicate:
liver function abnormalities
increased activity of certain liver enzymes
increased bilirubin levels, a product formed from destroyed red blood cells, which may cause yellowing of the skin and eyes
Itching

Rare (occur in less than 1 in 1000 patients)

Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, contact a doctor immediately.
Bleeding:
into muscle
into the eyes
from gums and coughing up blood
from the rectum
Hair loss

Frequency unknown (cannot be estimated from available data)

Bleeding:
into the brain or spinal cord
in the lungs or throat
in the mouth
into the abdominal cavity or retroperitoneal space
from haemorrhoids
test results indicating presence of blood in stool or urine
Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme)
Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, round spots beneath the skin surface, or bruising
Kidney bleeding, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-associated nephropathy)

The following adverse effects may occur when Poltixa is used to prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common (occur in less than 1 in 10 patients)

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

Uncommon (occur in less than 1 in 100 patients)

Bleeding:
into the brain or spinal cord
in the mouth or haemoptysis (coughing up blood)
in the abdominal cavity or from genital tract
bright red blood in stool
postoperative bleeding, including bruising and swelling, leakage of blood or fluid from 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 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 (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, contact a doctor immediately.

Rare (occur in less than 1 in 1000 patients)

Bleeding:
in the lungs or throat
into the retroperitoneal space
into muscles

Very rare (occur in less than 1 in 10,000 patients)

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

Frequency unknown (cannot be estimated from available data)

Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, round spots beneath the skin surface, or bruising
Kidney bleeding, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-associated nephropathy)

The following adverse effects may occur when Poltixa is used to treat or prevent recurrence of blood clots in the veins of the lower limbs and blood clots in the blood vessels of the lungs.

Common (occur in less than 1 in 10 patients)

Bleeding, including:
nosebleeds
from gums
blood in urine
subcutaneous haemorrhage 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 clotting)
Nausea (feeling sick)
Skin rash
Blood test results may indicate:
increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT) activity

Uncommon (occur in less than 1 in 100 patients)

Low blood pressure, which may lead to fainting or rapid heartbeat
Bleeding:
into the eyes
in the mouth or coughing up blood
bright red blood in stool
test results indicating blood in stool or urine
postoperative bleeding, including bruising and swelling, leakage of blood or fluid from surgical wound/incision site (wound discharge) or injection site
from haemorrhoids
into muscles
Itching
Hair loss
Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, contact a 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 (occur in less than 1 in 1000 patients)

Bleeding:
into the brain or spinal cord
in the lungs

Frequency unknown (cannot be estimated from available data)

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

Additional adverse effects in children and adolescents
If any of the following symptoms occur, contact a doctor immediately:

Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. The frequency of these adverse effects is classified as "common" (may occur in up to 1 in 10 people). Generally, adverse effects observed in children and adolescents after administration of Poltixa were similar to those seen in adults and were mostly mild or moderate in severity. Adverse effects occurring more frequently in children and adolescents include nosebleeds and unusual vaginal bleeding.

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

Bleeding, including:
from the vagina
nosebleeds

Common (may occur in up to 1 in 10 people)

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

Frequency unknown (cannot be estimated from available data)

Bleeding:
into the abdominal cavity or retroperitoneal space
into the stomach
into the eyes
in the mouth
from haemorrhoids
in the mouth or blood in sputum when coughing
into the brain or spinal cord
in the lungs
into muscles
Skin rash, which may develop blisters and resembles 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, round 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
Kidney bleeding, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-associated nephropathy)

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can 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.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Poltixa

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Poltixa contains

The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
The other ingredients are:
- Tablet core: mannitol, microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate;
- Tablet coating: hypromellose type 2910, titanium dioxide (E 171), lactose monohydrate, macrogol 3350, triacetin, yellow iron oxide (E 172).

What Poltixa looks like and contents of the pack
Round, biconvex, film-coated tablets, light yellow in colour, 5.9–6.3 mm in diameter.
Poltixa is available in PVC/PVDC/aluminum blisters in a cardboard carton.
Pack sizes contain 10, 20, 60, 168 or 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel.: +48 22 364 61 01