PACKAGE LEAFLET

Package leaflet: Information for the user

Apixaban Mylan 2.5 mg film-coated tablets

apixaban
Please read this entire 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 questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Apixaban Mylan is and what it is used for
What you need to know before taking Apixaban Mylan
How to take Apixaban Mylan
Possible side effects
How to store Apixaban Mylan
Contents of the pack and other information

1. What Apixaban Mylan is and what it is used for

Apixaban Mylan contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent the formation of blood clots by blocking Factor Xa, which is an important component in blood clotting.
Apixaban Mylan is used in adults:

to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After surgery on the hip or knee, you may be at increased risk of developing blood clots in the veins of your legs. This can cause swelling of the legs, with or without pain. If a blood clot travels from the leg to the lungs, it can block blood flow, causing shortness of breath, with or without chest pain. 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 heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, leading to stroke, or to other organs, blocking normal blood supply 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), and to prevent blood clots from recurring in the blood vessels of the legs and/or lungs.

2. What you need to know before taking Apixaban Mylan

Do not take Apixaban Mylan if:

you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
you have excessive bleeding;
you have a disease in a body organ that leads to an increased risk of serious bleeding (such as active or recent ulcer of the stomach or intestine, or recent bleeding in the brain);
you have a liver disease that leads to an increased risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while you have a venous or arterial catheter and are receiving heparin through it to keep it open, or if a catheter is inserted into one of your blood vessels (transcatheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine if you have any of the following conditions:

an increased risk of bleeding, such as:
bleeding disorders, including conditions leading to reduced platelet function;
very high blood pressure not controlled by medical treatment;
if you are over 75 years of age;
if you weigh 60 kg or less;
severe kidney disease or if you are on dialysis;
liver problems or history of liver problems; This medicine will be used with caution in patients showing signs of impaired liver function.
you have had a tube (catheter) or an injection in the spinal column (for anaesthesia or pain relief). Your doctor will advise you to take this medicine at least 5 hours or more after removal of the catheter;
you have a prosthetic heart valve;
if your doctor finds that your blood pressure is unstable, or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

Take special care with Apixaban Mylan

if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

If you are due to undergo surgery or a procedure that may cause bleeding, your doctor may ask you to temporarily stop taking this medicine for a short time. 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.

Other medicines and Apixaban Mylan
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Some medicines can increase the effects of Apixaban Mylan, while others can reduce them. Your doctor will decide whether you should be treated with Apixaban Mylan when taking these medicines and how closely you need to be monitored.

The following medicines may increase the effects of Apixaban Mylan and increase the risk of unwanted bleeding:

certain medicines for fungal infections (e.g., ketoconazole, etc.);
certain antiviral medicines for HIV/AIDS (e.g., ritonavir);
other medicines used to reduce blood clotting (e.g., enoxaparin, etc.);
anti-inflammatory drugs or painkillers (e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years of age and taking acetylsalicylic acid, you may have a higher risk of bleeding;
medicines for high blood pressure or heart problems (e.g., diltiazem);
antidepressants known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

The following medicines may reduce the effects of Apixaban Mylan in helping to prevent blood clots:

medicines used to prevent epilepsy or seizures (e.g., phenytoin, etc.);
St. John’s wort (a herbal remedy used for depression);
medicines used to treat tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.

The effects of apixaban during pregnancy and on the unborn child are unknown. You must not take this medicine if you are pregnant. Contact your doctor immediately if you become pregnant while taking this medicine.

It is not known whether Apixaban Mylan passes into breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine while breastfeeding. They will advise you whether to stop breastfeeding or to stop or not start treatment with this medicine.

Driving and using machines
Apixaban Mylan has not shown any effects on the ability to drive or use machinery.

Apixaban Mylan contains lactose (a type of sugar) and sodium.
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Apixaban Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with some water. Apixaban Mylan may be taken with or without food.
Try to take the tablets at the same time each day to achieve the best effect from treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take Apixaban Mylan. The tablet may be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before administration.
Instructions for crushing the tablet:

Crush the tablets with a mortar and pestle.
Carefully transfer all the powder into a suitable container and then mix the powder with a small amount, e.g., 30 ml (2 tablespoons), of water or one of the other liquids listed above to prepare a mixture.
Swallow the mixture.
Rinse the mortar and pestle used to crush the tablet and the container with a small amount of water (e.g., 30 ml) or one of the other liquids, and swallow the rinse.

If necessary, your doctor may also administer the crushed Apixaban Mylan tablet mixed with 60 ml of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Mylan as recommended:
To prevent blood clots after hip or knee replacement surgery.
The recommended dose is one Apixaban Mylan 2.5 mg tablet twice daily, for example, one in the morning and one in the evening.
You should take the first tablet 12 to 24 hours after surgery.
If you have had hip surgery, you will usually take the tablets for a period of 32 to 38 days.
If you have had knee surgery, you will usually take the tablets for a period of 10 to 14 days.
To prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.
The recommended dose is one Apixaban Mylan 5 mg tablet twice daily.
The recommended dose is one Apixaban Mylan 2.5 mg tablet twice daily if:

you have severely reduced kidney function;
you meet two or more of the following criteria:
- blood test results suggest poor kidney function (serum creatinine level is 1.5 mg/dl (133 micromoles/l) or higher);
- you are 80 years of age or older;
- your body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one in the morning and one in the evening. Your doctor will decide how long you should continue treatment.
To treat blood clots in the veins of the legs and in the blood vessels of the lungs
The recommended dose is two tablets of Apixaban Mylan 5 mg 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 Apixaban Mylan 5 mg twice daily, for example, one in the morning and one in the evening.
To prevent recurrence of blood clots after completing 6 months of treatment
The recommended dose is one Apixaban Mylan 2.5 mg tablet twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.
Your doctor may adjust your anticoagulant treatment as follows:

Switching from Apixaban Mylan to another anticoagulant medicine Stop taking Apixaban Mylan. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you would have taken your next dose.
Switching from another anticoagulant medicine to Apixaban Mylan Stop taking the anticoagulant medicine. Start treatment with Apixaban Mylan at the time you would have taken your next dose of the anticoagulant medicine, then continue taking it as usual.
Switching from treatment with a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Mylan
Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to start treatment with Apixaban Mylan.
Switching from Apixaban Mylan to treatment with a vitamin K antagonist anticoagulant (e.g., warfarin)
If your doctor tells you to start taking a vitamin K antagonist medicine, continue taking Apixaban Mylan for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to stop treatment with Apixaban Mylan.

Patients undergoing cardioversion
If your abnormal heart rhythm needs to be restored to normal by a procedure called cardioversion, take this medicine exactly as your doctor instructs, to prevent blood clots in blood vessels of the brain and other parts of your body.
If you take more Apixaban Mylan than you should
Contact your doctor immediately if you have taken more than the prescribed dose of this medicine. Bring the medicine pack with you, even if no tablets remain.
If you take more Apixaban Mylan than recommended, you may have an increased risk of bleeding. If bleeding occurs, you may require surgery, a blood transfusion, or other treatments that can reverse the anticoagulant effect on factor Xa.
If you forget to take Apixaban Mylan
Do not take a double dose to make up for a forgotten dose.
Take the missed dose as soon as you remember and:

take your next dose of Apixaban Mylan at the usual time
then continue as directed.

If you are unsure what to do or if you have missed more than one dose, consult your doctor, pharmacist, or nurse.
If you stop taking Apixaban Mylan
Do not stop taking this medicine without first talking to your doctor, as your risk of developing a blood clot may increase if you stop treatment too early.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Apixaban Mylan may be given for three different medical conditions. The known side effects and how frequently they occur may differ and are listed separately below. For these conditions, the most common general side effect with this medicine is bleeding, which could potentially be life-threatening and requires immediate medical attention.

The following side effects are known to occur when Apixaban Mylan is taken to prevent blood clots after hip or knee replacement surgery.

Common side effects (may affect up to 1 in 10 people)

Anaemia, which may cause tiredness or pale skin;
Bleeding, including:
- bruising and swelling;
Nausea (feeling unwell).

Uncommon side effects (may affect up to 1 in 100 people)

Reduction in the number of platelets in the blood (which may affect clotting);
Bleeding:
- occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- in the stomach or intestines, or clear/red blood in the stools;
- in the urine;
- from the nose;
- from the vagina;
Low blood pressure, which may make you feel faint or give you a rapid heartbeat;
Blood tests may show:
- abnormal liver function;
- increased levels of certain liver enzymes;
- increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
Itching.

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

Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
Bleeding:
- into a muscle;
- in the eyes;
- from the gums and blood in sputum when coughing;
- from the rectum;
Hair loss.

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

Bleeding:
- in the brain or spinal cord;
- in the lungs or throat;
- in the mouth;
- in the abdomen or in the space behind the abdominal cavity;
- from haemorrhoids;
- blood tests showing blood in stools or urine;
Skin rash which may blister and appear as small target-like spots (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme).

The following side effects are known to occur when Apixaban Mylan is taken to prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common side effects (may affect up to 1 in 10 people)

Bleeding, including:
- in the eyes;
- in the stomach or intestines;
- from the rectum;
- in the urine;
- from the nose;
- from the gums;
- bruising and swelling;
Anaemia, which may cause tiredness or pale skin;
Low blood pressure, which may make you feel faint or give you a rapid heartbeat;
Nausea (feeling unwell);
Blood tests may show:
- increased gamma-glutamyl transferase (GGT) levels;

Uncommon side effects (may affect up to 1 in 100 people)

Bleeding: ‐ in the brain or spinal cord; ‐ in the mouth or blood in sputum when coughing; ‐ in the abdomen or from the vagina; ‐ clear/red blood in the stools; ‐ occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site; ‐ from haemorrhoids; ‐ blood tests showing blood in stools or urine;
Reduction in the number of platelets in the blood (which may affect clotting);
Blood tests may show:
- abnormal liver function;
- increased levels of certain liver enzymes;
- increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
Skin rash;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.

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

Bleeding:
- in the lungs or throat;
- in the space behind the abdominal cavity;
- into a muscle.

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

Skin rash which may blister and appear as small target-like spots (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme).

The following side effects are known to occur when Apixaban Mylan is taken to treat or prevent recurrence of blood clots in the veins of the legs and in the blood vessels of the lungs.

Common side effects (may affect up to 1 in 10 people)

Bleeding, including: ‐ from the nose; ‐ from the gums; ‐ in the urine; ‐ bruising and swelling;
- in the stomach, intestines, or from the rectum;
- in the mouth;
- from the vagina;
Anaemia, which may cause tiredness or pale skin;
Reduction in the number of platelets in the blood (which may affect clotting);
Nausea (feeling unwell);
Skin rash;
Blood tests may show:
- increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT) levels.

Uncommon side effects (may affect up to 1 in 100 people)

Low blood pressure, which may cause weakness or a rapid heartbeat;
Bleeding: ‐ in the eyes; ‐ in the mouth or blood in sputum when coughing; ‐ clear/red blood in the stools; ‐ blood tests showing blood in stools or urine; ‐ occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site; ‐ from haemorrhoids; ‐ into a muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
Blood tests may show:
- abnormal liver function;
- increased levels of certain liver enzymes;
- increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.

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

Bleeding:
- in the brain or spinal cord;
- in the lungs.

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

Bleeding:
- in the abdomen or in the space behind the abdominal cavity.
Skin rash which may blister and appear as small target-like spots (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apixaban Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Apixaban Mylan contains

The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
The other components are:
‐ Tablet core: lactose (see section 2), microcrystalline cellulose (E460), croscarmellose sodium, sodium lauryl sulfate, magnesium stearate (E470b);
‐ Coating: monohydrate lactose (see section 2), hypromellose (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172).

Description of the appearance of Apixaban Mylan and packaging contents
The film-coated tablets are yellow, round (approximately 6 mm in diameter), biconvex (curved outward on both sides), with "IU1" engraved on one side and smooth on the other.
Apixaban Mylan is available in:

Blister packs in cartons containing 10, 20, 56, 60, 100, 168 or 200 tablets, or
Divided unit-dose blisters in cartons containing 10x1, 20x1, 56x1, 60x1, 100x1, 168x1 or 200x1 tablets, or
Bottles containing 60, 180 or 1,000 tablets. The bottles containing 60 film-coated tablets have a child-resistant screw cap.

Not all pack sizes may be marketed.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani, 20 - 20124 Milan, Italy
Manufacturer
McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352, Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Apixaban Mylan 2.5 mg Filmtabletten
Belgium Apixaban Mylan 2.5 mg filmomhulde tabletten
Bulgaria Apixaban Mylan 2.5 mg film-coated tablets
Cyprus Apixaban / Mylan 2.5 mg film-coated tablets
Czech Republic Apixaban Mylan
Denmark Apixaban Mylan
Estonia Apixaban Mylan
Finland Apixaban Mylan
France Apixaban Mylan 2.5 mg comprimé pelliculé
Germany Apixaban Mylan 2.5 mg Filmtabletten
Greece Apixaban / Mylan 2.5 mg film-coated tablets
Hungary Apixaban 2.5 mg filmtabletta
Iceland Apixaban Mylan
Ireland Apixaban Mylan 2.5 mg film-coated tablets
Italy Apixaban Mylan
Latvia Apixaban Mylan 2.5 mg apvalkotās tablets
Lithuania Apixaban Mylan 2.5 mg plėvele dengtos tabletės
Luxembourg Apixaban Mylan 2.5 mg comprimés pelliculés
Malta Apixaban Mylan 2.5 mg film-coated tablets
Norway Apixaban Mylan
Portugal Apixabano Mylan
Slovakia Apixaban Mylan 2.5 mg
Spain Apixaban Mylan comprimidos recubiertos con película EFG
Sweden Apixaban Mylan
Netherlands Apixaban Mylan 2.5 mg, filmomhulde tabletten
United Kingdom (Northern Ireland) Apixaban Mylan 2.5 mg film-coated tablets

Package leaflet: Information for the user

Apixaban Mylan 5 mg film-coated tablets

apixaban
Read 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 questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Apixaban Mylan is and what it is used for
What you need to know before taking Apixaban Mylan
How to take Apixaban Mylan
Possible side effects
How to store Apixaban Mylan
Contents of the pack and other information

1. What Apixaban Mylan is and what it is used for

Apixaban Mylan contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent the formation of blood clots by inhibiting Factor Xa, an important component in blood coagulation.
Apixaban Mylan is used in adults:

to prevent the formation of blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or reach other organs and block normal blood flow to those organs (also known as systemic embolism). A stroke can 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 the recurrence of blood clots in the blood vessels of the legs and/or lungs.

2. What you should know before taking Apixaban Mylan

Do not take Apixaban Mylan if:

you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
you have excessive bleeding;
you have a disease in a body organ that leads to an increased risk of serious bleeding (such as an active or recent ulcer of the stomach or intestine, recent bleeding in the brain);
you have a liver disease that leads to an increased risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while you have a venous or arterial catheter and are receiving heparin through such a catheter to keep it open, or if a catheter is inserted into one of your blood vessels (transcatheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine if you have any of the following conditions:

an increased risk of bleeding, such as:
bleeding disorders, including conditions leading to reduced platelet function;
very high blood pressure not controlled by medical treatment;
if you are over 75 years old;
if you weigh 60 kg or less;
severe kidney disease or if you are on dialysis;
liver problems or a history of liver problems; This medicine will be used with caution in patients showing signs of impaired liver function.
you have a prosthetic heart valve;
if your doctor finds that your blood pressure is unstable or if another treatment or surgical procedure to remove a blood clot from the lungs is planned. Exercise particular caution with Apixaban Mylan.
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

If you are scheduled for surgery or a procedure 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.

Other medicines and Apixaban Mylan

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

The following medicines may increase the effects of Apixaban Mylan and increase the risk of unwanted bleeding:

certain medicines for fungal infections (e.g., ketoconazole, etc.);
certain antiviral medicines for HIV/AIDS (e.g., ritonavir);
other medicines used to reduce blood clotting (e.g., enoxaparin, etc.);
anti-inflammatory drugs or painkillers (e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years old and taking acetylsalicylic acid, your risk of bleeding may be higher;
medicines for high blood pressure or heart problems (e.g., diltiazem);
antidepressants known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

The following medicines may reduce the effects of Apixaban Mylan in helping to prevent clot formation:

medicines to prevent epilepsy or seizures (e.g., phenytoin, etc.);
St. John’s wort (a herbal remedy used for depression);
medicines to treat tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.

The effects of Apixaban Mylan on pregnancy and the unborn child are unknown. You must not take this medicine if you are pregnant. Contact your doctor immediately if you become pregnant while taking this medicine.

It is not known whether Apixaban Mylan passes into breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine during breastfeeding. They will advise you whether to stop breastfeeding or to stop or not start treatment with this medicine.

Driving and using machines

Apixaban Mylan has not shown effects on the ability to drive or use machines.

Apixaban Mylan contains lactose (a type of sugar) and sodium.

If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Apixaban Mylan

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor, pharmacist, or nurse.

Dosage
Swallow the tablet with a glass of water. Apixaban Mylan may be taken with or without food.
Try to take the tablets at the same time each day to achieve the best effect from treatment.

If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take Apixaban Mylan. The tablet may be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before administration.

Instructions for crushing the tablet:

Crush the tablets using a mortar and pestle.
Carefully transfer all the powder into a suitable container and mix it with a small amount, e.g., 30 ml (2 tablespoons), of water or one of the other liquids mentioned above to prepare a mixture.
Swallow the mixture.
Rinse the mortar and pestle used to crush the tablet and the container with a small amount of water (e.g., 30 ml) or one of the other liquids, and swallow the rinse.
If necessary, your doctor may also administer crushed Apixaban Mylan tablets mixed with 60 ml of water or 5% glucose in water through a nasogastric tube.

Take Apixaban Mylan as recommended:
To prevent blood clots from forming in the heart in patients with irregular heartbeat and at least one additional risk factor:
The recommended dose is one Apixaban Mylan 5 mg tablet twice daily.
The recommended dose is one Apixaban Mylan 2.5 mg tablet twice daily if:

you have severely reduced kidney function;
you meet two or more of the following criteria:
- blood test results suggest poor kidney function (serum creatinine level is 1.5 mg/dl (133 micromoles/l) or higher);
- you are 80 years of age or older;
- your body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one in the morning and one in the evening. Your doctor will decide how long you should continue treatment.

To treat blood clots in the veins of the legs and in the blood vessels of the lungs:
The recommended dose is two Apixaban Mylan 5 mg tablets 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 Apixaban Mylan 5 mg tablet twice daily, for example, one in the morning and one in the evening.

To prevent recurrence of blood clots after completion of 6 months of treatment:
The recommended dose is one Apixaban Mylan 2.5 mg tablet twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.

Your doctor may adjust your anticoagulant treatment as follows:

Switching from Apixaban Mylan to another anticoagulant medicine: Stop taking Apixaban Mylan. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you would have taken your next tablet.
Switching from another anticoagulant medicine to Apixaban Mylan: Stop taking the anticoagulant medicine. Start taking Apixaban Mylan at the time you would have taken your next dose of the anticoagulant medicine, then continue taking it as usual.
Switching from a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Mylan: Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to start treatment with Apixaban Mylan.
Switching from Apixaban Mylan to a vitamin K antagonist anticoagulant (e.g., warfarin): If your doctor tells you to start taking a vitamin K antagonist medicine, continue taking Apixaban Mylan for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to stop treatment with Apixaban Mylan.

Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal through a procedure called cardioversion, take this medicine exactly as directed by your doctor to prevent blood clots in the blood vessels of the brain and other parts of your body.

If you take more Apixaban Mylan than you should
Contact your doctor immediately if you have taken more than the prescribed dose of Apixaban Mylan. Bring the medicine pack with you, even if no tablets are left.
If you take more Apixaban Mylan than recommended, you may have an increased risk of bleeding. If bleeding occurs, you may require surgery, a blood transfusion, or other treatments that can reverse the anticoagulant effect on factor Xa.

If you forget to take Apixaban Mylan
Do not take a double dose to make up for the forgotten dose.
Take the missed dose as soon as you remember and:

take your next dose of Apixaban Mylan at the usual time;
then continue as directed.

If you are unsure what to do or if you have missed more than one dose, consult your doctor, pharmacist, or nurse.

If you stop taking Apixaban Mylan
Do not stop taking this medicine without first talking to your doctor, as your risk of developing a blood clot may increase if you stop treatment too early.

If you have any questions about how to use this medicine, 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 general side effect with this medicine is bleeding, which may potentially be life-threatening and requires immediate medical attention.

The following side effects are known to occur when Apixaban Mylan is taken to prevent blood clots forming in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common side effects (may affect up to 1 in 10 people)

Bleeding, including:
- in the eyes;
- in the stomach or intestines;
- from the rectum;
- blood in the urine;
- from the nose;
- from the gums;
- bruising and swelling;
Anaemia, which may cause tiredness or paleness;
Low blood pressure, which may make you feel faint or cause a rapid heartbeat;
Nausea (feeling unwell);
Blood tests may show:
- increased gamma-glutamyl transferase (GGT).

Uncommon side effects (may affect up to 1 in 100 people)

Bleeding:
- in the brain or spinal cord;
- in the mouth or blood in coughed-up mucus (sputum) when coughing;
- in the abdomen or from the vagina;
- bright red blood in the stools;
- bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- from haemorrhoids;
- tests showing blood in the stools or urine;
- Decrease in the number of platelets in the blood (which may affect blood clotting);
- Blood tests may show:
  - abnormal liver function;
  - increase in certain liver enzymes;
  - increase in bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.
- Skin rash;
- Itching;
- Hair loss;
- Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.

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

Bleeding:
- in the lungs or throat;
- behind the abdominal cavity (retroperitoneal space);
- into a muscle.

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

Skin rash that may blister and appears as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).

The following side effects are known to occur when Apixaban Mylan is taken to treat or prevent recurrence of blood clots in the veins of the legs and blood vessels of the lungs.

Common side effects (may affect up to 1 in 10 people)

Bleeding, including:
- from the nose;
- from the gums;
- blood in the urine;
- bruising and swelling;
- in the stomach, intestines, or from the rectum;
- in the mouth;
- from the vagina;
Anaemia, which may cause tiredness or paleness;
Decrease in the number of platelets in the blood (which may affect blood clotting);
Nausea (feeling unwell);
Skin rash;
Blood tests may show:
- increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT).

Uncommon side effects (may affect up to 1 in 100 people)

Low blood pressure, which may cause weakness or a rapid heartbeat;
Bleeding:
- in the eyes;
- in the mouth or blood in coughed-up mucus (sputum) when coughing;
- bright red blood in the stools;
- tests showing blood in the stools or urine;
- bleeding occurring after any surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- from haemorrhoids;
- into a muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms;
Blood tests may show:
- abnormal liver function;
- increase in certain liver enzymes;
- increase in bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.

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

Bleeding:
- in the brain or spinal cord;
- in the lungs.

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

Bleeding:
- in the abdomen or in the space behind the abdominal cavity (retroperitoneal space).
Skin rash that may blister and appears as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apixaban Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Apixaban Mylan contains

The active substance is apixaban. Each tablet contains 5 mg of apixaban.
The excipients are:
- Tablet core: lactose ( see section 2), microcrystalline cellulose (E460), croscarmellose sodium, sodium lauryl sulfate, magnesium stearate (E470b);
- Coating: monohydrate lactose ( see section 2), hypromellose (E464), titanium dioxide (E171), triacetin, red iron oxide (E172).

Description of the appearance of Apixaban Mylan and package contents
The film-coated tablets are pink, oval-shaped (approximately 5.2 x 9.8 mm), biconvex (curved outwards on both sides), with "IU2" engraved on one side and smooth on the other.
Apixaban Mylan is available in:

Blister packs in boxes containing 14, 20, 28, 56, 60, 100, 168 or 200 tablets; or
Unit dose divisible blisters in boxes containing 14x1, 20x1, 28x1, 56x1, 60x1, 100x1, 168x1 or 200x1 tablets; or
Bottles containing 60, 180 or 1,000 tablets. The bottles containing 60 film-coated tablets are equipped with a child-resistant screw cap. Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani, 20 - 20124 Milano
Manufacturer
McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Apixaban Mylan 5 mg Filmtabletten
Belgium Apixaban Mylan 5 mg filmomhulde tabletten
Bulgaria Apixaban Mylan 5 mg film-coated tablets
Cyprus Apixaban / Mylan 5 mg film-coated tablets
Czech Republic Apixaban Mylan
Denmark Apixaban Mylan
Estonia Apixaban Mylan
Finland Apixaban Mylan
France Apixaban Mylan 5 mg comprimé pelliculé
Germany Apixaban Mylan 5 mg Filmtabletten
Greece Apixaban / Mylan 5 mg film-coated tablets
Hungary Apixaban 5 mg filmtabletta
Iceland Apixaban Mylan
Ireland Apixaban Mylan 5 mg film-coated tablets
Italy Apixaban Mylan
Latvia Apixaban Mylan 5 mg apvalkotās tablets
Lithuania Apixaban Mylan 5 mg plėvele dengtos tabletės
Luxembourg Apixaban Mylan 5 mg comprimés pelliculés
Malta Apixaban Mylan 5 mg film-coated tablets
Norway Apixaban Mylan
Portugal Apixabano Mylan
Slovak Republic Apixaban Mylan 5 mg
Spain Apixaban Mylan comprimidos recubiertos con película EFG
Sweden Apixaban Mylan
Netherlands Apixaban Mylan 5 mg, filmomhulde tabletten
United Kingdom (Northern Ireland) Apixaban Mylan 5 mg film-coated tablets