Poltixa

Package Leaflet: Information for the Patient

Poltixa, 5 mg, Film-Coated Tablets

Apixaban

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

• Keep this leaflet, 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 those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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. Contents of the pack 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 blood clots by blocking factor Xa, which is an important factor in blood clotting.
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 can break loose and move to the brain, leading to a stroke, or to other organs, hindering blood flow to these organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• to treat blood clots in the veins of the legs (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 legs and (or) lungs.

2. Important information before taking Poltixa

When not to take Poltixa

• if you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6)
• if you have excessive bleeding
• if you have organ diseasethat increases the risk of serious bleeding (such as active or recently diagnosed stomach or intestinal ulcersor recent brain bleeding)
• if you have liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy)
• if you are taking medicines that prevent blood clotting(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the anticoagulant treatment is changed or when a 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, discuss with your doctor, pharmacist, or nurse if you have any of the following conditions:

• increased risk of bleeding, such as:
• bleeding disorders, including those that result in decreased platelet activity
• very high blood pressurethat is not controlled with medication
• if you are over 75 years old
• if your body weight is 60 kg or less
• severe kidney disease or if you are on dialysis
• liver disease or a history of liver function disorders, Poltixa should be used with caution in patients with signs of liver function changes
• if you have a prosthetic heart valve
• if your doctor determines that your blood pressure is unstable or if other treatment or surgery is planned to remove a blood clot from the lungs.

When to be particularly cautious when taking Poltixa:

• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

In case of surgery or a procedure that may be associated with bleeding, your doctor may ask you to temporarily stop taking this medicine for a short time. If you are unsure whether a procedure may be associated with bleeding, you should ask your doctor.

Children and adolescents

Poltixa should not be used in children and adolescents under 18 years of age.

Poltixa and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or might take.
Some medicines may increase the effect of Poltixa, and some may reduce its effect. Your doctor will decide whether you should receive Poltixa while taking other medicines and how closely you should be monitored.
The following medicines may increase 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(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 you are over 75 years old and taking acetylsalicylic acid, you may be at increased risk of unwanted bleeding.
• medicines used to treat 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 clots:

• medicines used to prevent seizures or fits(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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
The effect of Poltixa on pregnancy and the unborn child is not known. You should not take Poltixa if you are pregnant. If you become pregnant while taking Poltixa, you should contact your doctor immediately.
It is not known whether Poltixa passes into breast milk. Before taking this medicine while breastfeeding, ask your doctor, pharmacist, or nurse for advice. You 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 you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Poltixa contains sodium

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

3. How to take Poltixa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

Dose

Swallow the tablet with water. Poltixa can be taken with or without food.
To get the best results from your treatment, try to take the tablets at the same time every day.
If you have difficulty swallowing the tablets whole, talk to your doctor about other ways to take Poltixa. The tablet can be crushed and mixed with water or 5% glucose solution, juice, or apple puree just before taking.

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 or 2 tablespoons) of water or another liquid mentioned above to make 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 rinse liquid.

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

Poltixa should be taken as follows:

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

• you have severe kidney problems
• two or more of the following conditions are met:
• your blood test results suggest decreased kidney function (serum creatinine level of 1.5 mg/dl or more)
• you are 80 years old or more
• your 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 you should continue treatment.
Treatment of blood clots in the veins of the legs and blood clots in the lungs
The recommended dose is two5 mg Poltixa tablets twice daily for the first 7days, for example, two tablets in the morning and two in the evening.
After 7days, the recommended dose is one5 mg Poltixa tablet twice daily, for example, one tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after completing 6 months of 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.
Your doctor will decide how long you should continue treatment.

Your doctor may change your anticoagulant treatment as follows:

• Changing from Poltixa to other anticoagulant medicines: Stop taking Poltixa. Treatment with other anticoagulant medicines (e.g., heparin) should be started at the time of the planned intake of the next Poltixa tablet.
• Changing from other anticoagulant medicines to Poltixa: Stop taking other anticoagulant medicines. Treatment with Poltixa should be started at the time of the planned intake of the next dose of the other anticoagulant medicine, and then continue with the usual intake.
• Changing from treatment with a vitamin K antagonist (e.g., warfarin) to Poltixa: Stop taking the vitamin K antagonist. Your doctor will perform blood tests and inform you when to start taking Poltixa.
• Changing from Poltixa to treatment with a vitamin K antagonist (e.g., warfarin): If your doctor informs you that you should start taking a vitamin K antagonist, you should continue taking Poltixa for at least 2 days after taking the first dose of the vitamin K antagonist. Your doctor will perform blood tests and inform you 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 clots in the brain and other blood vessels.

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 package with you, even if it is empty.
If you have taken more than the recommended dose of Poltixa, you may be at increased risk of bleeding. If bleeding occurs, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Poltixa

• Take the dose as soon as you remember and:
• take the next dose of Poltixa at the usual time
• then continue taking the medicine as before.

If you have any doubts about taking the medicine or if you have missed more than

one dose, ask your doctor, pharmacist, or nurse.

Stopping treatment with Poltixa

Do not stop taking Poltixa without consulting your doctor, as the risk of blood clots may be higher if you stop taking Poltixa too early.
If you have any further doubts about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Poltixa can cause side effects, although not everybody gets them.
The most common 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 clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Common (affecting less than 1 in 10 people)

• Bleeding, including:
• in the eye
• in the stomach or intestine
• from the rectum
• blood in the urine
• from the nose
• from the gums
• bruising and swelling
• Anemia, which can cause fatigue or pale skin
• Low blood pressure, which can lead to fainting or rapid heartbeat
• Nausea (vomiting)
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity

Uncommon (affecting less than 1 in 100 people)

• Bleeding:
• in the brain or spinal cord
• in the mouth or coughing up blood
• in the abdomen or from the reproductive organs
• red blood in the stool
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or injection site
• from hemorrhoids
• presence of blood in the stool or urine detected in laboratory tests
• Decreased platelet count in the blood (which can 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 that can cause yellowing of the skin and eyes
• Skin rash
• Itching
• Hair loss
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and (or) throat, as well as difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.

Rare (affecting less than 1 in 1000 people)

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

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

• 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 raised, flat, red, round patches under the skin, or bruising.

The following side effects may occur when taking Poltixa for the treatment or prevention of recurrence of blood clots in the veins of the legs and blood clots in the lungs.

Common (affecting less than 1 in 10 people)

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

Uncommon (affecting less than 1 in 100 people)

• Low blood pressure, which can lead to fainting or rapid heartbeat
• Bleeding:
• in the eyes
• in the mouth or coughing up blood
• red blood in the stool
• presence of blood in the stool or urine detected in laboratory tests
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or injection site
• from hemorrhoids
• in the muscles
• Itching
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and (or) throat, as well as difficulty breathing. If you notice any of these symptoms, 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 that can cause yellowing of the skin and eyes

Rare (affecting less than 1 in 1000 people)

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

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

• Bleeding:
• in the abdominal cavity or in the space behind the abdominal cavity
• 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 raised, flat, red, round patches under the skin, or bruising.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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, you can help 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.
There are no special storage instructions for this 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. 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 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, 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, pink film-coated tablets, 9.9-10.3 mm in length and 4.9-5.3 mm in width.
Poltixa is available in PVC/PVDC/Aluminum blisters in a cardboard box.
The pack contains 14, 20, 28, 56, 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 package leaflet: