Package leaflet: Information for the patient

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

Keep this leaflet to be able to read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual only. Do not share it with others. This medicine may harm other people, even if their symptoms are identical.
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 Poltixa is and what it is used for
Important information 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 known as anticoagulants.
This medicine helps prevent blood clots by inhibiting Factor Xa, a key component in the blood clotting process.
Poltixa is used in adults:

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 stroke, or to other organs, impairing blood flow to those 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), and to prevent recurrence of such clots in the veins of the legs and/or lungs.

Poltixa is used in children from 28 days to below 18 years of age for the treatment of blood clots
and prevention of recurrent blood clots in veins or in the blood vessels of the lungs.
The recommended body weight-adjusted dose is provided 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 a disease of an organ that increases the risk of serious bleeding (such as active or recently diagnosed stomach or intestinal ulcer, recently diagnosed bleeding into the brain)
if the patient has liver disease that 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 the case of switching anticoagulant therapy, when an intravenous or intra-arterial line has been inserted and heparin is administered through the 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
Before starting treatment with Poltixa, discuss with your doctor, pharmacist or
nurse if the patient has any of the following conditions:

increased risk of bleeding, for example:
conditions involving bleeding, including those leading to 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. This medicine 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 a
case, the doctor will advise taking this medicine at least 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 other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise special caution when using Poltixa:

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 involve bleeding is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If in doubt whether a procedure may involve bleeding, ask 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 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 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:

some medicines used to treat fungal infections (e.g. ketoconazole and others)
some 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 if the patient is over 75 years of age and taking acetylsalicylic acid, which may increase the risk of unwanted bleeding.
medicines used for high blood pressure or heart problems (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 her doctor, pharmacist or nurse before using this medicine.
The effect of Poltixa on pregnancy and the unborn child is unknown. Poltixa should not be taken during pregnancy. If a patient becomes pregnant while taking Poltixa, she should
contact her doctor immediately.
It is not known whether Poltixa 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 or not start taking Poltixa.

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

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

3. How to take Poltixa

This medicine should always be taken exactly as instructed by your doctor or pharmacist.
If you are unsure, consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with water. Poltixa can be taken independently of meals.
To achieve the best treatment results, it is recommended to take the tablets at the same times each day.
If you have difficulty swallowing the tablets whole, speak to your doctor about alternative ways of taking Poltixa. 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 powder to a suitable container and 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, mortar, and container used for crushing the tablets with a small amount of water or another liquid (e.g., 30 ml) and swallow the rinsing liquid.

If necessary, your doctor may administer crushed Poltixa tablets mixed with 60 ml of water or 5% aqueous glucose solution through a nasogastric tube.
Poltixa should be taken as directed in the following indications:
Prevention 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 Poltixa tablet 5 mg twice daily.
The recommended dose is one Poltixa tablet 2.5 mg twice daily if:

the patient has severe renal impairment
two or more of the following conditions are met:
blood test results indicate reduced kidney function (serum creatinine level 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 deep veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two tablets of Poltixa 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 Poltixa 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 Poltixa tablet 2.5 mg 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 in the blood vessels of the lungs.
This medicine should always be taken or administered exactly as directed by your doctor or pharmacist.
If you are unsure, consult your doctor, pharmacist, or nurse.
To achieve the best treatment outcome, try to take or administer the dose at the same time each day.
The dose of Poltixa depends on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents with a body weight of at least 35 kg is two tablets of Poltixa 5 mg, 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 tablet of Poltixa 5 mg, 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 with changes in body weight.
Your 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 Poltixa dose was scheduled.
Switching from anticoagulant medicines to Poltixa: Discontinue the anticoagulant medicine. Start Poltixa at the time the next anticoagulant dose was scheduled, and continue taking it as usual.
Switching from vitamin K antagonist anticoagulant therapy (e.g., warfarin) to Poltixa: Discontinue the vitamin K antagonist medicine. Your doctor will perform blood tests and inform you when to start taking Poltixa.
Switching from Poltixa to vitamin K antagonist anticoagulant therapy (e.g., warfarin): If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Poltixa for at least 2 days after taking the first dose of the vitamin K antagonist medicine. Your doctor will perform blood tests and inform you when to stop taking Poltixa.

Patients undergoing cardioversion
Patients with irregular heartbeat who require cardioversion to restore normal heart rhythm should take Poltixa at the times specified by their doctor to prevent formation of 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 you have taken more than the recommended dose of Poltixa, contact your doctor immediately.
Take the medicine packaging with you, even if it is empty.
If you have taken more than the recommended dose of Poltixa, your risk of bleeding may increase. If bleeding occurs, surgical treatment, blood transfusion, or other treatment to reverse the effects of factor Xa inhibition may be required.
Missing a dose of Poltixa

If you miss a morning dose, take it as soon as you remember, and you may take it together with your 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 directed, twice daily.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
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 taking Poltixa for
preventing blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Common (occur in less than 1 in 10 patients)

Bleeding, including:
into the eye
into the stomach or intestine
from the rectum
blood in urine
from the nose
from the gums
subcutaneous haemorrhage 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 (occur in less than 1 in 100 patients)

Bleeding:
into the brain or spinal canal
in the oral cavity or haemoptysis
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/tissue 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 (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 your doctor immediately.

Rare (occur in less than 1 in 1,000 patients)

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

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

Skin rash, during which blisters may form, resembling small target-like lesions (dark spots in the center 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, round spots under the skin surface, or bruising;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse effects may occur when taking Poltixa
for the treatment or prevention of recurrent venous blood clots
in the lower limbs and pulmonary embolism (blood clots in the blood vessels of the lungs).

Common (occur in less than 1 in 10 patients)

Bleeding, including:
from the nose
from the gums
blood in urine
subcutaneous haemorrhage and swelling
in the stomach, intestine, or from the rectum
in the oral cavity
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 (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 oral cavity or coughing up blood
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/tissue 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 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 (occur in less than 1 in 1,000 patients)

Bleeding:
into the brain or spinal canal
in the lungs

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

Bleeding:
into the abdominal cavity or retroperitoneal space.
Skin rash, during which blisters may form, resembling small target-like lesions (dark spots in the center 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, round spots under the skin surface, or bruising;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

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

Allergic reactions (hypersensitivity), 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 abnormal vaginal bleeding.

Very common (occur in more than 1 in 10 patients)

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

Common (occur in less than 1 in 10 patients)

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 in the child;
Blood test results may indicate:
abnormal liver function;
increased activity of certain liver enzymes;
increased alanine aminotransferase (AlAT) activity.

Frequency not known (cannot be estimated from available data)

Bleeding:
into the abdominal cavity or retroperitoneal space;
into the stomach;
into the eyes;
in the oral cavity;
from haemorrhoids;
in the oral cavity or blood in sputum when coughing;
into the brain or spinal canal;
into the lungs;
into muscles;
Skin rash, during which blisters may form, resembling small target-like lesions (dark spots in the center 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 under 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 adverse effects
If any adverse effects occur, including any not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Poltixa

Keep this medicine out of the sight and reach of children.
No special storage instructions 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 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 in use. Doing so helps protect the environment.

6. Contents of the pack and other information

What Poltixa contains

The active substance is apixaban. Each tablet contains 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, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172).

What Poltixa looks like and contents of the pack
Oblong, biconvex, film-coated pink tablets, 9.9–10.3 mm in length and 4.9–5.3 mm in width.
Poltixa is available in PVC/PVDC/Aluminium blisters packed in cardboard boxes.
The pack contains 14, 20, 28, 56, 60, 168 or 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdanski, Poland
Tel.: +48 22 364 61 01