POLTIXA 2.5 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Poltixa, 2.5 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Poltixa and what is it used for
4. Important information before taking Poltixa
   1. When not to take Poltixa
   2. Warnings and precautions
   3. Children and adolescents
   4. Poltixa and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Poltixa contains lactose
   8. Poltixa contains sodium
5. How to take Poltixa
   1. Dose
   2. Instructions for crushing tablets:
   3. Poltixa should be taken as recommended in the following indications:
   4. The doctor may change the anticoagulant treatment as follows:
   5. Patients undergoing cardioversion
   6. Taking a higher dose of Poltixa than recommended
   7. Missing a dose of Poltixa
   8. If the patient has any doubts about taking the medicine or has missed more than
   9. Stopping treatment with Poltixa
6. Possible side effects
   1. Common (occurring in less than 1 in 10 patients)
   2. Uncommon (occurring in less than 1 in 100 patients)
   3. Rare (occurring in less than 1 in 1000 patients)
   4. Frequency not known (cannot be estimated from the available data)
   5. Common (occurring in less than 1 in 10 patients)
   6. Uncommon (occurring in less than 1 in 100 patients)
   7. Rare (occurring in less than 1 in 1000 patients)
   8. Very rare (may occur in up to 1 in 10,000 patients)
   9. Frequency not known (cannot be estimated from the available data)
   10. Common (occurring in less than 1 in 10 patients)
   11. Uncommon (occurring in less than 1 in 100 patients)
   12. Rare (occurring in less than 1 in 1000 patients)
   13. Frequency not known (cannot be estimated from the available data)
   14. Reporting side effects
7. How to store Poltixa
8. Package contents and other information
   1. What Poltixa contains
   2. What Poltixa looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Poltixa, 2.5 mg, film-coated tablets

Apixaban

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Poltixa and what is it used for
• 2. Important information before taking Poltixa
• 3. How to take Poltixa
• 4. Possible side effects
• 5. How to store Poltixa
• 6. Package contents and other information

1. What is Poltixa and what is it used for

Poltixa 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 factor in blood clotting.
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, the patient may be at increased risk of developing 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 lower limb 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, making it difficult for blood to reach those 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.

2. Important information before taking Poltixa

When not to take Poltixa

• 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 recently diagnosed brain bleeding)
• If the patient has liver diseasethat leads to an increased risk of bleeding (liver coagulopathy)
• If the patient is taking anticoagulant medicines(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 with Poltixa, the patient should discuss the following conditions with their doctor, pharmacist or nurse:

• Increased risk of bleeding, for example:
• Bleeding disorders, including cases that result in decreased platelet activity
• Very high blood pressure, uncontrolled with medication
• If the patient is over 75 years old
• If the patient's body weight is 60 kg or less
• Severe kidney disease or if the patient is on dialysis
• Liver disease or a history of liver dysfunction, Poltixa should be used with caution in patients with signs of liver dysfunction
• A tube (catheter) or injection into the spine(anesthetic or pain-relieving), in which case the doctor will recommend taking Poltixa at least 5 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 be particularly careful when taking Poltixa:

• 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 whether to change the treatment.

If surgery or a procedure that may be associated with bleeding is necessary, the doctor may ask the patient to temporarily stop taking this medicine for a short time. If there is any doubt as to whether a given procedure may be associated with bleeding, the doctor should be consulted.

Children and adolescents

Poltixa is not recommended for use in children and adolescents under 18 years of age.

Poltixa 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 Poltixa, and some may weaken its effect. The doctor will decide whether the patient should receive Poltixa while taking other medicines and how closely they should be monitored.
The following medicines may enhance the effect of Poltixa and increase the risk of unwanted bleeding:

• Some antifungal medicines(e.g. ketoconazole and others)
• Some antiviral medicines used to treat HIV/AIDS(e.g. ritonavir)
• Other medicines used to reduce blood clotting(e.g. enoxaparin and others)
• Anti-inflammatoryor analgesic 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 unwanted bleeding.
• Medicines used for high blood pressure or heart disease(e.g. diltiazem)
• Antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and noradrenaline reuptake inhibitors.

The following medicines may reduce the ability of Poltixa 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 in depression)
• Medicines used to treat tuberculosisor 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 Poltixa on pregnancy and the unborn child is unknown. Poltixa should not be taken during pregnancy. If the patient becomes pregnant while taking Poltixa, they should contact their doctor immediately.
It is not known whether Poltixa passes into breast milk. Before taking this medicine during breastfeeding, the patient should consult their doctor, pharmacist or nurse. The patient may be advised to stop breastfeeding or stop or not start taking Poltixa.

Driving and using machines

Poltixa has no or negligible influence on the ability to drive and use machines.

Poltixa contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Poltixa contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Poltixa

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

Dose

The tablet should be swallowed with water. Poltixa 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 the patient has difficulty swallowing the tablets whole, they should discuss other ways of taking Poltixa with their doctor. The tablet can be crushed immediately before taking and mixed with water or 5% aqueous glucose solution, juice or apple sauce.

Instructions for crushing tablets:

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

If necessary, the doctor may administer a crushed Poltixa tablet mixed with 60 ml of water or 5% aqueous glucose solution through a nasogastric tube.

Poltixa 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 2.5 mg Poltixa 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 5 mg Poltixa tablet twice a day.
The recommended dose is one 2.5 mg Poltixa tablet twice a day if:

• the patient has severe kidney dysfunction
• two or more of the following conditions are met:
• the patient's blood test results suggest impaired kidney function (serum creatinine level of 1.5 mg/dl (133 micromole/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 two 5 mg Poltixa tabletstwice a day for the first 7days, for example two tablets in the morning and two in the evening.
After 7days, the recommended dose is one 5 mg Poltixa tablettwice a day, for example one tablet in the morning and one in the evening.
Prevention of recurrent blood clot formation after completing 6 months of treatment
The recommended dose is one 2.5 mg Poltixa 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.

The doctor may change the anticoagulant treatment as follows:

• Change from Poltixa to anticoagulant medicines The patient should stop taking Poltixa. Anticoagulant treatment (e.g. heparin) should be started at the time of the scheduled intake of the next Poltixa tablet.
• Change from anticoagulant medicines to Poltixa The patient should stop taking anticoagulant medicines. Poltixa treatment should be started at the time of the scheduled intake of the next dose of anticoagulant medicine, and then continued as usual.
• Change from anticoagulant treatment including a vitamin K antagonist (e.g. warfarin) to Poltixa The patient should stop taking the vitamin K antagonist. The doctor will perform blood tests and inform the patient when to start taking Poltixa.
• Change from Poltixa to anticoagulant treatment including a vitamin K antagonist (e.g. warfarin) If the doctor informs the patient that they should start taking a vitamin K antagonist, they should continue taking Poltixa 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 Poltixa.

Patients undergoing cardioversion

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

Taking a higher dose of Poltixa than recommended

If the patient has taken a higher dose of Poltixa than recommended, they should contact their doctor immediately.
The patient should take the packaging with them, even if it is empty.
If the patient has taken a higher dose of Poltixa than recommended, they may be at increased risk of bleeding. If bleeding occurs, surgical treatment or blood transfusion or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Poltixa

• The patient should take the dose as soon as they remember and:
• take the next dose of Poltixa at the usual time
• then continue taking the medicine as before.

If the patient has any doubts about taking the medicine or has missed more than

one dose, they should consult their doctor, pharmacist or nurse.

Stopping treatment with Poltixa

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

4. Possible side effects

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

Common (occurring in less than 1 in 10 patients)

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

Uncommon (occurring in less than 1 in 100 patients)

• Decreased platelet count (which can affect blood clotting)
• Bleeding:
• after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision site (wound exudate) or injection site
• from the stomach, intestines or black stools
• blood in urine
• from the nose
• from the genital tract
• Low blood pressure, which can lead to fainting or rapid heartbeat
• Blood test results may indicate:
• liver dysfunction
• 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 (occurring in less than 1 in 1000 patients)

• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling and/or throat swelling, as well as difficulty breathing. If any of these symptoms are observed, the patient should contact their doctor immediately.
• Bleeding:
• into the muscle
• into the eyes
• from the gums and coughing up blood
• 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 stool or urine
• A skin rash, which 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 skin rash or elevated, flat, red, round patches under the skin surface, or bruising.

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

Common (occurring in less than 1 in 10 patients)

• Bleeding, including:
• into the eye
• into the stomach or intestines
• from the rectum
• blood in urine
• from the nose
• from the gums
• 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 (occurring in less than 1 in 100 patients)

• Bleeding:
• into the brain or spinal cord
• into the mouth or throat or coughing up blood
• into the abdominal cavity or from the genital tract
• black stools
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision site (wound exudate) or injection site
• from hemorrhoids
• into the muscle
• Itching
• Hair loss
• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling and/or throat swelling, as well as difficulty breathing. If any of these symptoms are observed, the patient should contact their doctor immediately.
• Blood test results may indicate:
• liver dysfunction
• 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 (occurring in less than 1 in 1000 patients)

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

Very rare (may occur in up to 1 in 10,000 patients)

• A skin rash, which 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 skin rash or elevated, flat, red, round patches under the skin surface, or bruising.

The following side effects may occur when taking Poltixa to treat or prevent recurrent blood clot formation in the veins of the lower limbs and blood clots in the blood vessels of the lungs.

Common (occurring in less than 1 in 10 patients)

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

Uncommon (occurring in less than 1 in 100 patients)

• Low blood pressure, which can lead to fainting or rapid heartbeat
• Bleeding:
• into the eyes
• into the mouth or throat or coughing up blood
• black stools
• blood test results indicating blood in stool or urine
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision site (wound exudate) or injection site
• from hemorrhoids
• into the muscle
• Itching
• Hair loss
• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling and/or throat swelling, as well as difficulty breathing. If any of these symptoms are observed, the patient should contact their doctor immediately.
• Blood test results may indicate:
• liver dysfunction
• 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 (occurring in less than 1 in 1000 patients)

• 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 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 skin rash or elevated, flat, red, round patches under the skin surface, or bruising.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Poltixa

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for the medicine.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents 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, croscarmellose sodium, 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 what the package contains

Round, biconvex, yellow film-coated tablets, 5.9-6.3 mm in diameter.
Poltixa is available in PVC/PVDC/Aluminum blisters in a cardboard box.
The package contains 10, 20, 60, 168 or 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of last revision of the leaflet: