Axipio

Package Leaflet: Information for the User

AXIPIO, 5 mg, film-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 and other information

• 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 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 and block the 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 veins of the legs (deep vein thrombosis) and blood clots in the blood vessels of the lungs (pulmonary embolism), as well as prevent new blood clots from forming in the blood vessels 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 active or recently diagnosed stomach or intestinal ulcers, recent bleeding in the brain)
• if you have liver diseasethat increases the risk of bleeding (hepatic 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 access line is inserted and heparin is administered to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into the vein) due to irregular heartbeat (arrhythmia).

line in order 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 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 reduced 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 dysfunction
• artificial heart valve
• if your doctor has determined that your blood pressure is unstable or if you are scheduled for 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 you need to undergo surgeryor a procedure that may be associated with bleeding, your doctor may ask you to temporarily stop taking this medicine for a short period of time. If you are unsure whether a procedure may be associated with bleeding, you should 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.

• Some antifungal medicines(such as ketoconazole)
• Some antiviral medicines used to treat HIV/AIDS(such as ritonavir)
• Other medicines used to reduce blood clotting(such as enoxaparin)
• Pain relievers or anti-inflammatory 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 bleeding
• Medicines used to treat high blood pressure or heart problems(such as diltiazem)
• Antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and norepinephrine reuptake inhibitors.

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

• Medicines used to treat epilepsy or seizures(such as phenytoin)
• St. John's Wort(a herbal supplement used to treat 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. You should not take this medicine during pregnancy. If you become pregnant while taking this medicine, you should immediatelycontact your doctor.

Breastfeeding

It is not known whether apixaban 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/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 with water. You can take A with or without food. To get the best results, it is recommended to take the tablets at the same time every day.

If you have problems swallowing the tablets whole, talk to your doctor about other ways to take A. The tablet can be crushed and mixed with water or 5% glucose solution, juice, or apple sauce immediately before taking.

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.
• 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 water. 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 directed in the following indications:

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 are met:
• your blood test results indicate reduced 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 veins of the legs and blood clots in the blood vessels of the lungs

The recommended dose is two A 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 one A 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 one A 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 anticoagulantsStop taking A. Start treatment with other anticoagulants (e.g., heparin) at the time of the next scheduled dose of A.
• Switching from other anticoagulants to AStop taking other anticoagulants. Start taking A at the time of the next scheduled dose of the other anticoagulant, and then continue with the usual dosing of A.
• Switching from treatment with a vitamin K antagonist (e.g., warfarin) to AStop 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 (e.g., 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 require cardioversion 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 parts of the body.

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. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

If you forget to take A

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

If you have any further questions on the use of this product, or if you have missed more than one dose

contact your doctor, pharmacist, or nurse.

If you stop taking A

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.

The most common 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 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:
• 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 (may affect up to 1 in 100 people):

• bleeding:
• in the brain or spinal cord
• in the mouth or coughing up blood
• in the abdomen or from the vagina
• red blood in the stool
• bleeding after surgery, including bruising and swelling, fluid leakage from the surgical wound or tissue incision site, or injection site
• from hemorrhoids
• in the muscles
• itching
• hair loss
• allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.
• blood test results may indicate:
• liver dysfunction
• 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 (may affect up to 1 in 1000 people):

• bleeding:
• in the lungs or throat
• in the abdominal cavity or retroperitoneal space
• in the muscles

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

• a skin rash that may form 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 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 the urine
• bruising and swelling
• in the stomach or intestine
• from the rectum
• in the mouth
• from the vagina
• anemia, which can cause fatigue or pale skin
• reduced platelet count, which can affect blood clotting
• nausea (vomiting)
• 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:
• in the eyes
• in the mouth or coughing up blood
• red blood in the stool
• blood test results indicating blood in the stool or urine
• bleeding after surgery, including bruising and swelling, fluid leakage from the surgical wound or tissue incision site, or injection site
• from hemorrhoids
• in the muscles
• itching
• hair loss
• allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.
• blood test results may indicate:
• liver dysfunction
• 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 (may affect up to 1 in 1000 people):

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

Not known (frequency cannot be estimated from the available data):

• bleeding:
• in the abdominal cavity or retroperitoneal space
• a skin rash that may form 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 directly to the Department of Medicinal Product Monitoring, 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, or to the marketing authorization holder.

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 5 mg of apixaban.

The other ingredients are:

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

What A looks like and contents of the pack

The film-coated tablets are pink, oval, and have a dividing line on one side.

• Blisters in a carton containing 56, 60, and 90 film-coated tablets.
• Perforated unit-dose blisters in a carton containing 56 x 1, 60 x 1, and 90 x 1 film-coated tablets.

Not all pack sizes may be marketed.

A Patient Alert Card is included in the package of A, along with the patient information leaflet, or your doctor may give you a similar card.

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

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

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: