Axipio

Package Leaflet: Information for the User

AXIPIO, 2.5 mg, coated tablets

Apixaban

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What A is and what it is used for
• 2. What you need to know before you take A
• 3. How to take A
• 4. Possible side effects
• 5. How to store A
• 6. Contents of the pack and other information

1. What A is and what it is used for

A contains the active substance apixaban and belongs to a group of medicines called anticoagulants. It helps to prevent blood clots from forming by blocking Factor Xa, which is an important factor in blood clotting.

A is used in adults to:

• prevent blood clots from forming after hip or knee replacement surgery. After hip or knee surgery, you are at a higher risk of getting blood clots in your legs. This can lead to swelling of your legs, with or without pain. If a blood clot breaks loose from your leg, it can travel to your lungs, which can block the flow of blood in your lungs and cause difficulty breathing, chest pain, or even death.
• prevent blood clots from forming in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and travel to the brain, causing a stroke, or to other organs, reducing blood flow to these organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• 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 prevent new blood clots from forming in the deep veins of the legs and/or lungs.

2. What you need to know before you take A

Do not take A

• 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 a condition that increases the risk of severe bleeding(such as a recent stomach or intestinal ulcer, recent bleeding in the brain)
• if you have liver diseasethat leads to an increased risk of bleeding (liver coagulopathy)
• if you are taking other medicines to prevent blood clotting(such as warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is being switched, when a venous or arterial line is 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 heart rhythm (arrhythmia).

Warnings and precautions

Before taking this medicine, discuss with your doctor, pharmacist, or nurse if you have any of the following conditions:

• increased risk of bleeding, such as:
• bleeding disorders, including conditions that lead to decreased platelet activity
• very high blood pressure, uncontrolled by medication
• if you are over 75 years old
• if you weigh 60 kg or less
• severe kidney disease or if you are on dialysis
• liver disease or a history of liver disease
• this medicine should be used with caution in patients with signs of liver function changes
• spinal or epidural catheter(anesthesia or pain relief), in which case your doctor will advise you to take this medicine at least 5 hours after catheter removal
• artificial heart valve
• if your doctor determines that your blood pressure is unstable or if you are scheduled for another treatment or surgery to remove a blood clot from your lungs

When to be extra careful when taking A

• 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 surgeryor procedures that may cause bleeding, your doctor may ask you to temporarily stop taking this medicine for a short period. If you are unsure whether a procedure may cause bleeding, ask your doctor.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.

A and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Some medicines may increase the effect of A, while others may reduce its effect. Your doctor will decide whether you should take A while taking other medicines and how closely you should be monitored.

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

• certain antifungal medicines(such as ketoconazole)
• certain antiviral medicines used to treat HIV/AIDS(such as ritonavir)
• other medicines used to reduce blood clotting(such as enoxaparin)
• anti-inflammatory or pain-relieving medicines(such as 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 problems(such as diltiazem)
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors

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

• medicines used to prevent seizures or fits(such as phenytoin)
• St. John's Wort(a herbal supplement used for depression)
• medicines used to treat tuberculosis or other infections(such as rifampicin)

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

The effect of apixaban on pregnancy and the unborn child is not known. Do not take this medicine during pregnancy. If you become pregnant while taking this medicine, contact your doctor immediately.

Breastfeeding

It is not known whether apixaban passes into human 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/avoid taking this medicine.

Driving and using machines

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

A contains lactose and sodium

Lactose: If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

3. How to take A

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 whole with water. A can be taken with or without food.

To get the best effect, it is recommended 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 A. The tablet can be crushed just before taking and mixed with water or 5% 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 or 2 tablespoons) of water or another liquid mentioned above to make a mixture
• swallow the mixture
• rinsing 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 swallowing the rinse liquid. If necessary, your doctor may give you a crushed A tablet mixed with 60 mL of water or 5% glucose solution through a nasogastric tube.

A should be taken as follows for the following indications:

Prevention of blood clots after hip or knee replacement surgery

The recommended dose is one A 2.5 mg 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 you have had major hip surgery, you will usually take the tablets for 32 to 38 days.

If you have had major knee surgery, you will usually take the tablets for 10 to 14 days.

Prevention of blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor

The recommended dose is one A 5 mg tablet twice daily.

The recommended dose is one A 2.5 mg tablet twice daily if:

• you have severe kidney problems
• two or more of the following conditions apply:
• your blood test results indicate decreased kidney function (serum creatinine level of 1.5 mg/dL (133 micromole/L or higher)
• you are 80 years old or older
• 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 deep veins of the legs and blood clots in the blood vessels of the lungs

The recommended dose is twoA 5 mg tablets 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 oneA 5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.

Prevention of new blood clots after completing 6 months of treatment

The recommended dose is oneA 2.5 mg 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 switch your anticoagulant treatment as follows:

• Switching from A to other anticoagulants. Stop taking A. Start treatment with other anticoagulants (such as heparin) at the time of the next scheduled dose.
• Switching from other anticoagulants to A

Stop taking other anticoagulants. Start taking A at the time of the next scheduled dose of the other anticoagulant, and then continue with your usual dosing schedule.

• Switching from treatment with a vitamin K antagonist (such as warfarin) to A. Stop taking the vitamin K antagonist. Your doctor will perform blood tests and tell you when to start taking A.
• Switching from A to treatment with a vitamin K antagonist (such as warfarin). If your doctor tells you to start taking a vitamin K antagonist, you should continue taking A for at least 2 days after taking the first dose of the vitamin K antagonist. Your doctor will perform blood tests and tell you when to stop taking A.

Patients undergoing cardioversion

Patients who need to undergo a cardioversion procedure to restore a normal heart rhythm should take this medicine at the times specified by their doctor to prevent blood clots from forming in the blood vessels of the brain and other blood vessels.

What to do if you take more A than you should

If you take more A than you should, contact your doctor immediately. Take the package with you, even if it is empty.

If you take more A than you should, you may be at increased risk of bleeding. If you experience bleeding, you may need surgical treatment, blood transfusion, or other treatment to reverse the effect of Factor Xa inhibition.

What to do if you miss a dose of A

• Take the dose as soon as you remember and:
• take the next dose of A at the usual time
• then take A as you would normally

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse

Do not stop taking this medicine without talking to your doctor, as stopping A too early may increase the risk of blood clots. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. A can be used in three different medical conditions. The known side effects and their frequency may vary depending on the condition and are listed separately below. In these conditions, the most common overall side effect of this medicine is bleeding, which can be life-threatening and may require immediate medical attention.

The following side effects may occur when taking apixaban to prevent blood clots after hip or knee replacement surgery.

Common (may affect up to 1 in 10 people):

• anemia, which can cause tiredness or pale skin
• bleeding, including bruising and swelling
• nausea (feeling sick)

Uncommon (may affect up to 1 in 100 people):

• decreased platelet count (which can affect blood clotting)
• bleeding:
• after surgery, including bruising and swelling, bleeding or fluid leakage from the wound or surgical incision (wound discharge) or injection site
• from the stomach, intestines, or black stools
• blood in urine
• from the nose
• from the vagina
• low blood pressure, which can lead to fainting or rapid heartbeat
• blood test results may indicate:
• liver problems
• 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 (may affect up to 1 in 1,000 people):

• allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.
• bleeding:
• into the muscle
• into the eyes
• from the gums or coughing up blood
• from the anus
• hair loss

Unknown frequency (cannot be estimated from the available data):

• bleeding:
• into the brain or spinal cord
• into the lungs or throat
• into the mouth
• into the abdominal cavity or retroperitoneal space
• from hemorrhoids
• blood test results indicating blood in stool or urine
• 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.

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

Common (may affect up to 1 in 10 people):

• bleeding:
• into the eye
• from the stomach or intestines
• from the anus
• blood in urine
• from the nose
• from the gums
• bruising and swelling
• anemia, which can cause tiredness or pale skin
• low blood pressure, which can lead to fainting or rapid heartbeat
• nausea (feeling sick)
• blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity

Uncommon (may affect up to 1 in 100 people):

• bleeding:
• into the brain or spinal cord
• into the mouth or coughing up blood
• into the abdominal cavity or from the vagina
• black stools
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the wound or surgical incision (wound discharge) or injection site
• from hemorrhoids
• decreased platelet count (which can affect blood clotting)
• blood test results may indicate:
• liver problems
• 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
• skin rash
• itching
• hair loss
• allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.

Rare (may affect up to 1 in 1,000 people):

• bleeding:
• into the lungs or throat
• into the abdominal cavity or retroperitoneal space
• into the muscle

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 apixaban to treat or prevent new blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungs.

Common (may affect up to 1 in 10 people):

• bleeding:
• from the nose
• from the gums
• blood in urine
• bruising and swelling
• from the stomach or intestines
• from the anus
• in the mouth
• from the vagina
• anemia, which can cause tiredness or pale skin
• decreased platelet count (which can affect blood clotting)
• nausea (feeling sick)
• skin rash
• blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) activity

Uncommon (may affect up to 1 in 100 people):

• low blood pressure, which can lead to fainting or rapid heartbeat
• bleeding:
• into the eyes
• into the mouth 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 wound or surgical incision (wound discharge) or injection site
• from hemorrhoids
• into the muscle
• itching
• hair loss
• allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.
• blood test results may indicate:
• liver problems
• 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 (may affect up to 1 in 1,000 people):

• bleeding:
• into the brain or spinal cord
• into the lungs

Unknown frequency (cannot be estimated from the available data):

• bleeding:
• into the abdominal cavity or retroperitoneal space
• 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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +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 A

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

No special storage precautions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What A contains

The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.

The other ingredients are:

• tablet core: microcrystalline cellulose (type 101), sodium croscarmellose, sodium docusate, copolymer of polyvinyl acetate and polyvinylpyrrolidone, polyethylene glycol, magnesium stearate
• coating (Opadry II yellow): hypromellose 2910, 15mPas, lactose monohydrate, titanium dioxide (E 171), macrogol 3350, yellow iron oxide (E 172)

What A looks like and contents of the pack

The tablets are yellow, round, and biconvex.

• Blisters in a carton pack of 20, 60, and 90 coated tablets.
• Perforated unit dose blisters in a carton pack of 20 x 1, 60 x 1, and 90 x 1 coated tablets.

Not all pack sizes may be marketed.

Patient Alert Card: information for use

Inside the A package, next to the patient information leaflet, you will find a Patient Alert Card or your doctor may give you a similar card.

The Patient Alert Card contains information to help you and to alert other doctors that you are taking A. You should always carry this card with you.

• 1. Take the card
• 2. If necessary, separate the part written in the language you understand (this is made easier by the perforated edges)

• 3. Fill in the following sections or ask your doctor to fill them in:
• Name:
• Date of birth:
• Indication:
• Dose: ........ mg twice daily
• Doctor's name:
• Doctor's phone number:
• 4. Fold the card and keep it with you at all times

Marketing authorization holder

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany, Centrafarm Services B.V., Van de Reijtstraat 31 E, 4814NE Breda, Netherlands

For further information on this medicine, contact the local representative of the marketing authorization holder: Stada Pharm Sp. z o.o., ul. Krakowiaków 44, 02-255 Warsaw, Tel. +48 22 737 79 20

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: A, Croatia: A 2.5 mg / 5 mg film-coated tablets, Greece: A, Poland: A

Date of last revision of the leaflet: