Apixaban Teva Italia: detailed information

Package leaflet: Information for the user

Apixaban Teva Italia 2.5 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, because 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 Teva Italia is and what it is used for
What you need to know before taking Apixaban Teva Italia
How to take Apixaban Teva Italia
Possible side effects
How to store Apixaban Teva Italia
Contents of the pack and other information

1. What Apixaban Teva Italia is and what it is used for

Apixaban Teva Italia 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 Teva Italia 2.5 mg 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, the risk of developing blood clots in the leg veins may be higher. This can cause leg swelling, 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, causing a stroke, or may reach other organs, blocking normal blood supply 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 leg veins (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 need to know before taking Apixaban Teva Italia

Do not take Apixaban Teva Italia 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 an organ of the body that leads to an increased risk of serious bleeding (such as an active or recent ulcer of the stomach or intestine, or recent bleeding in the brain),
you have a liver disease that increases the 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 having a venous or arterial catheter and receiving heparin through it to keep it open, or if a catheter is inserted into a blood vessel (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 a history of liver problems; Apixaban Teva Italia will be used with caution in patients showing signs of impaired liver function;
you have a tube (catheter) or have had an injection into the spine (for anaesthesia or pain relief). Your doctor will instruct you to take Apixaban Teva Italia at least 5 hours or more after catheter removal;
you have a prosthetic heart valve;
if your doctor finds your blood pressure to be unstable, or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

Take special care with Apixaban Teva Italia

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 therapy needs to be changed.

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 might cause bleeding, ask your doctor.
Children and adolescents
Apixaban is not recommended for children and adolescents under 18 years of age.
Other medicines and Apixaban Teva Italia
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, while others can reduce them. Your doctor will decide whether you should be treated with apixaban when taking these medicines and how closely you should be monitored.
The following medicines may increase the effects of apixaban 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 or pain-relieving medicines (e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years of age 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 in helping to prevent blood clots:

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, suspect 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 during pregnancy and on the unborn child are unknown. You must not take apixaban if you are pregnant. Contact your doctor immediately if you become pregnant while taking apixaban.
It is not known whether Apixaban Teva Italia 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 discontinue/avoid starting treatment with apixaban.
Driving and using machines
Apixaban has not shown effects on the ability to drive or operate machinery.
Apixaban Teva Italia contains lactose (a type of sugar) and sodium
If your doctor has diagnosed you with 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 Teva Italia

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with some water. Apixaban Teva Italia 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 you can take
Apixaban Teva Italia. The tablet may be crushed and mixed with water, 5% dextrose in
water, apple juice, or apple puree, immediately before taking.
Instructions for crushing the tablet:

Crush the tablets with a mortar and pestle.
Carefully transfer all of 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 Apixaban Teva Italia as crushed tablets
mixed with 60 mL of water or 5% dextrose in water through a nasogastric tube.
Take Apixaban Teva Italia as recommended:
To prevent blood clots after hip or knee replacement surgery
The recommended dose is one 2.5 mg Apixaban Teva Italia 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 5 mg Apixaban Teva Italia tablet twice daily.
The recommended dose is one 2.5 mg Apixaban Teva Italia tablet twice daily if:

you have severely reduced kidney function;
or if you meet two or more of the following conditions:
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 5 mg Apixaban Teva Italia 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 5 mg Apixaban Teva Italia tablet 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 2.5 mg Apixaban Teva Italia 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 Teva Italia to another anticoagulant medicine Stop taking Apixaban Teva Italia. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you would have taken the next tablet.
Switching from another anticoagulant medicine to Apixaban Teva Italia

Stop taking the anticoagulant medicine. Start treatment with Apixaban Teva
Italia at the time you would have taken the next dose of the anticoagulant, then continue taking it as usual.

Switching from a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Teva Italia Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to start treatment with Apixaban Teva Italia.
Switching from Apixaban Teva Italia 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 Teva Italia 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 Teva Italia.

Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Apixaban Teva Italia exactly as your doctor instructs, to prevent blood clots in the blood vessels of the brain and other blood vessels in your body.
If you take more Apixaban Teva Italia than you should
Contact your doctor immediately if you have taken more than the prescribed dose of Apixaban Teva Italia.
Bring the medicine pack with you, even if no tablets remain.
If you take more Apixaban Teva Italia than recommended, you may have an increased risk of
bleeding. If bleeding occurs, surgery, a blood transfusion, or other treatments to reverse anti-factor Xa activity may be required.
If you forget to take Apixaban Teva Italia
Take the missed dose as soon as you remember and:

take your next dose of Apixaban Teva Italia at your 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 Teva Italia
DO NOT stop taking Apixaban Teva Italia without first talking to your doctor, because the
risk of developing a blood clot may be higher 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. Apixaban can be administered for three different medical conditions. The known side effects and how often they occur may differ and are listed separately below. For these conditions, the most common general side effect of apixaban is bleeding, which can potentially be life-threatening and requires immediate medical attention.

The following side effects are known to occur when apixaban 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 blood 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, intestine, or clear/red blood in the stools
- In the urine
- From the nose
- From the vagina
Low blood pressure, which may cause you to feel faint or have a rapid heartbeat
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
Itching

Rare side effects (may affect up to 1 in 1000 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:
- In the 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 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 the stools or urine
Skin rash that may form blisters and appears as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
Inflammation of blood vessels (vasculitis), which may appear as skin rashes or sharp, flat, red, round spots under the skin surface or bruising.

The following side effects are known to occur when apixaban 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 intestine
- 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 cause you to feel faint or have a rapid heartbeat
Nausea (feeling unwell)
Blood tests may show:
- An increase in gamma-glutamyltransferase (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 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 the stools or urine
Reduction 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 1000 people)

Bleeding:
- In the lungs or throat
- In the space behind the abdominal cavity
- In the muscle

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

Skin rash that may form blisters and appears as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)

Not known (frequency cannot be estimated from available data)

Inflammation of blood vessels (vasculitis), which may appear as skin rashes or sharp, flat, red, round spots under the skin surface or bruising.

The following side effects are known to occur when apixaban 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
- In the urine
- Bruising and swelling
- In the stomach, intestine, 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 blood clotting)
Nausea (feeling unwell)
Skin rash
Blood tests may show:
- An increase in gamma-glutamyltransferase (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 sputum when coughing
- Clear/red blood in the stools
- Blood tests showing blood in the 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
- In the 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 1000 people)

Bleeding:
- In the brain or spinal cord
- In the lungs

Not known (frequency cannot be estimated from available data)

Bleeding:
- In the abdomen or in the space behind the abdominal cavity
Skin rash that may form blisters and appears as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
Inflammation of blood vessels (vasculitis), which may appear as skin rashes or sharp, flat, red, round spots under the skin surface or bruising.

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 the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Apixaban Teva Italia

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 carton, bottle, 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Apixaban Teva Italia contains

The active substance is apixaban. Each film-coated tablet contains 2.5 mg of apixaban.
The excipients are:
Tablet core: lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate [vegetable].
Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, red iron oxide (E172). See section 2 “Apixaban Teva Italia contains lactose (a type of sugar) and sodium.

Description of the appearance of Apixaban Teva Italia and contents of the pack
Apixaban Teva Italia film-coated tablets are round, biconvex, yellow in colour, with a diameter of approximately 6 mm and a thickness of 3 mm.
Apixaban Teva Italia is available in:
Blister packs: 10, 20, 21, 60, 63, 100, 168 or 200 film-coated tablets.
Unit dose divisible blisters: 10x1, 20x1, 60x1, 100x1 or 168x1 film-coated tablets.
Bottle with child-resistant cap: 60 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: managing information
Inside the package of Apixaban Teva Italia, together with the package leaflet, you will find a Patient Alert Card or your doctor may provide you with a similar one.
This Patient Alert Card includes important information that may be useful to you and alerts other doctors that you are taking Apixaban Teva Italia. You must always carry this card with you.

Take the card (attached to the inside of the carton).
Tear off the text in your language as needed (this will be facilitated by the pre-perforated edge).
Complete the following sections or ask your doctor to do so:
- Name:

Date of birth:
Indication:
Dose: ........ mg twice daily
Doctor’s name:
Doctor’s telephone number: 4. Fold the card and always keep it with you.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan
Manufacturer
Combino Pharm (Malta) Ltd
60 Qasam Industrijali Hal Far
Hal Far Birzebbuga
BBG3000 - Malta

Package leaflet: information for the user

Apixaban Teva Italia 5 mg film-coated tablets

Generic medicine
Please 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 their symptoms are the same as yours, because it could 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 Teva Italia is and what it is used for
What you need to know before taking Apixaban Teva Italia
How to take Apixaban Teva Italia
Possible side effects
How to store Apixaban Teva Italia
Contents of the pack and other information

1. What Apixaban Teva Italia is and what it is used for

Apixaban Teva Italia 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 Teva Italia 5 mg 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 dislodge and travel to the brain, causing a stroke, or may travel to other organs, blocking 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 Teva Italia

Do not take Apixaban Teva Italia 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 an organ disease that leads to an increased risk of serious bleeding (such as an active or recent ulcer of the stomach or intestine, or a 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 having a venous or arterial catheter and receiving heparin through this route to keep it open, or if a catheter is inserted into a blood vessel (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 are on dialysis;
liver problems or a history of liver problems; Apixaban Teva Italia 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.

Use special caution with Apixaban Teva Italia

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.

Children and adolescents

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

Other medicines and Apixaban Teva Italia

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, while others can reduce them. Your doctor will decide whether you should be treated with apixaban when taking these medicines and how closely you should be monitored.

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

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

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

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, planning to become pregnant, or 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 apixaban if you are pregnant. Contact your doctor immediately if you become pregnant while taking apixaban.

It is not known whether Apixaban Teva Italia 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 apixaban.

Driving and using machines

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

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

If your doctor has diagnosed you with 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 Teva Italia

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor, pharmacist, or nurse.
Dose
Swallow the tablet with water. Apixaban Teva Italia 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 Teva Italia. The tablet may be crushed and mixed with water, 5% dextrose 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 of 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 crushed Apixaban Teva Italia tablets mixed with 60 mL of water or 5% dextrose in water through a nasogastric tube.
Take Apixaban Teva Italia as recommended:
To prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor
The recommended dose is one 5 mg Apixaban Teva Italia tablet twice daily.
The recommended dose is one 2.5 mg Apixaban Teva Italia 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 5 mg Apixaban Teva Italia 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 5 mg Apixaban Teva Italia 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 2.5 mg Apixaban Teva Italia 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 modify your anticoagulant treatment as follows:

Switching from Apixaban Teva Italia to another anticoagulant medicine Stop taking Apixaban Teva Italia. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you would have taken the next tablet.
Switching from another anticoagulant medicine to Apixaban Teva Italia Stop taking the anticoagulant medicine. Start treatment with Apixaban Teva Italia at the time you would have taken the 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 Teva Italia Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you on when to start treatment with Apixaban Teva Italia.
Switching from Apixaban Teva Italia to treatment with a vitamin K antagonist anticoagulant (e.g., warfarin) If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban Teva Italia 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 on when to stop treatment with Apixaban Teva Italia.

Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal rhythm by a procedure called cardioversion, take Apixaban Teva Italia at the times your doctor instructs you to take it, to prevent blood clots in the blood vessels of the brain and other blood vessels in your body.
If you take more Apixaban Teva Italia than you should
Contact your doctor immediately if you have taken more than the prescribed dose of Apixaban Teva Italia.
Bring the medicine pack with you, even if no tablets remain.
If you take more Apixaban Teva Italia than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery, transfusion, or other treatments that can reverse anti-factor Xa activity may be required.
If you forget to take Apixaban Teva Italia
Take the missed dose as soon as you remember and:

take your next dose of Apixaban Teva Italia 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 Teva Italia
DO NOT stop taking Apixaban Teva Italia without first talking to your doctor, because your risk of developing a blood clot may be higher 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 serious side effect of 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 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;
blood in the urine;
from the nose;
from the gums;
bruising and swelling;
Anaemia, which may cause tiredness or pale skin;
Low blood pressure, causing dizziness or a rapid heartbeat;
Nausea (feeling sick);
Blood tests may show:
increased gamma-glutamyltransferase (GGT).

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

Bleeding:
in the brain or spinal column;
in the mouth or blood in coughed-up phlegm when coughing;
in the abdomen or from the vagina;
bright red blood in 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;
blood tests showing blood in stools or urine;
Decreased platelet count 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;
Rash;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. 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;
in muscle.

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

Skin rash that 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).

Not known (frequency cannot be estimated from available data)

Inflammation of blood vessels (vasculitis), which may present as skin rashes or small, flat, red, round spots under the skin surface or bruising.

The following side effects are known to occur when apixaban 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 pale skin;
Decreased platelet count in the blood (which may affect blood clotting);
Nausea (feeling sick);
Rash;
Blood tests may show:
increased gamma-glutamyltransferase (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 phlegm when coughing;
bright red blood in stools;
blood tests showing blood in 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;
in muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. 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 column;
in the lungs.

Not known (frequency cannot be estimated from available data)

Bleeding:
in the abdomen or behind the abdominal cavity;
Skin rash that 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);
Inflammation of blood vessels (vasculitis), which may present as skin rashes or small, flat, red, round spots under the skin surface or bruising.

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 the national reporting system at 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 Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, container, 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Apixaban Teva Italia contains

The active substance is apixaban. Each film-coated tablet contains 5 mg of apixaban.
The excipients are:
Tablet core: lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate [vegetable].
Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, red iron oxide (E172). See section 2 “Apixaban Teva Italia contains lactose (a type of sugar) and sodium.”

Description of the appearance of Apixaban Teva Italia and package contents
The film-coated tablets of Apixaban Teva Italia are oval-shaped, pink in colour,
biconvex, approximately 10 mm in length, 5.4 mm in width and 4 mm in thickness.
Apixaban Teva Italia is available in:
Blister packs: 14, 20, 28, 30, 56, 60, 100, 105, 168 or 200 film-coated tablets
Unit-dose divisible blisters: 28x1, 56x1, 60x1, 100x1 or 168x1 film-coated tablets.
Bottle with child-resistant cap: 60 film-coated tablets
Not all pack sizes may be marketed.

Patient Alert Card: managing information
Inside the Apixaban Teva Italia package, together with the package leaflet, you will find a Patient Alert Card, or your doctor may have given you a similar one.
This Patient Alert Card contains important information that may be helpful to you and alerts other physicians that you are taking Apixaban Teva Italia. You must always carry this card with you.

Take the card (attached to the inside of the carton).
Separate the text in your language as needed (this will be facilitated by the pre-perforated edge).
Complete the following sections or ask your doctor to do so:
- Name:
- Date of birth:
- Indication:
- Dose: ........ mg twice daily
- Doctor’s name:
- Doctor’s telephone number:
Fold the card and always keep it with you.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturer
Combino Pharm (Malta) Ltd
60 Qasam Industrijali Hal Far
Hal Far Birzebbuga
BBG3000 - Malta