Package leaflet: Information for the user

APIXABAN DOC 2.5 mg film-coated tablets

Equivalent 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
What APIXABAN DOC is and what it is used for
What you need to know before you take APIXABAN DOC
How to take APIXABAN DOC
Possible side effects
How to store APIXABAN DOC
Contents of the pack and other information

What APIXABAN DOC is and what it is used for

APIXABAN DOC contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots by blocking Factor Xa, an important component in blood clotting.

APIXABAN DOC 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 moves 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 can 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 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.

What you need to know before you take APIXABAN DOC

Do not take APIXABAN DOC 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 increases the risk of serious bleeding (such as a recent or active ulcer of the stomach or intestine, or recent bleeding in the brain);
you have liver disease that increases the risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood clots (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 a history of liver problems; This medicine will be used with caution in patients showing signs of impaired liver function.
you have a tube (catheter) or have had an injection into your spine (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 DOC

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 you need to change your therapy. 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 DOC

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Some medicines can increase the effect of APIXABAN DOC, while others can reduce it. Your doctor will decide whether you should be treated with APIXABAN DOC when taking these medicines and how closely you need to be monitored.

The following medicines can increase the effect of APIXABAN DOC 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 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 an increased 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 can reduce the effect of APIXABAN DOC in helping to prevent blood clots:

medicines for epilepsy or seizures (e.g., phenytoin, etc.);
St. John’s wort (a herbal product 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 or are planning to become pregnant, or if you are breastfeeding, consult your doctor, pharmacist or nurse before taking this medicine.
The effect of APIXABAN DOC during pregnancy and on the unborn child is 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 DOC 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 DOC has not shown effects on the ability to drive or use machines.

APIXABAN DOC contains lactose (a type of sugar) and sodium

If your doctor has told you that you have an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

How to take APIXABAN DOC

Take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor, pharmacist or nurse.

Dosage
Swallow the tablet with some water. APIXABAN DOC may be taken with or without food. Try to take the tablets at the same time each day to get the best effect from treatment.

If you have difficulty swallowing the whole tablet, ask your doctor about other ways to take APIXABAN DOC. The tablet can 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 solution.
If necessary, your doctor may also administer the crushed APIXABAN DOC tablet mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.

Take APIXABAN DOC as recommended:

To prevent the formation of blood clots after hip or knee replacement surgery:
The recommended dose is one APIXABAN DOC 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 major surgery on the hip, you will usually take the tablets for a period of 32 to 38 days.
If you have had major surgery on the knee, you will usually take the tablets for a period of 10 to 14 days.

To prevent the formation of blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor:
The recommended dose is one APIXABAN DOC 5 mg tablet twice daily.
The recommended dose is one APIXABAN DOC 2.5 mg tablet twice daily if:

you have severely reduced kidney function; or
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 APIXABAN DOC 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 DOC 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 DOC 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 modify your anticoagulant treatment as follows:

Switching from APIXABAN DOC to another anticoagulant medicine
Stop taking APIXABAN DOC. 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 DOC
Stop taking the anticoagulant medicine. Start treatment with APIXABAN DOC at the time you would have taken your next dose of the anticoagulant medicine, then continue taking it as usual.

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

Switching from APIXABAN DOC to an anticoagulant containing a vitamin K antagonist (e.g., warfarin)
If your doctor tells you to start taking a medicine containing a vitamin K antagonist, continue taking APIXABAN DOC 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 DOC.

Patients undergoing cardioversion

If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take this medicine at the times your doctor tells you to, to prevent blood clots in the blood vessels of the brain and other blood vessels in your body.

If you take more APIXABAN DOC than you should

Contact your doctor immediately if you have taken more than the prescribed dose of this medicine. Take the medicine pack with you, even if no tablets are left.
If you take more APIXABAN DOC 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 anti-Factor Xa anticoagulant activity.

If you forget to take APIXABAN DOC

Take the missed dose as soon as you remember and:

take your next dose of APIXABAN DOC 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 DOC

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

If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. APIXABAN DOC may be given for three different medical conditions. The known side effects and their frequency may differ for each of these conditions and are listed separately below. For these conditions, the most common general side effect of this medicine is bleeding, which can potentially be life-threatening and requires immediate medical attention.

The following side effects are known to occur when APIXABAN DOC 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, blood or fluid leakage from the surgical wound/incision (wound discharge) or from the injection site;
from the stomach, intestine or clear/red blood in stools;
blood in urine;
from the nose;
from the vagina;
Low blood pressure, which may cause weakness or a rapid heartbeat;
Blood tests may show:
abnormal liver function;
increase in some 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 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 any of these symptoms occur.
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;
tests showing blood in 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 small, flat, red, round spots under the skin surface or bruising.

The following side effects are known to occur when APIXABAN DOC 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;
blood in urine;
from the nose;
from the gums;
bruising and swelling;
Anaemia, which may cause tiredness or pale skin;
Low blood pressure, which may cause weakness or 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 stools;
bleeding occurring after surgery, including bruising and swelling, blood or fluid leakage from the surgical wound/incision (wound discharge) or from the injection site;
from haemorrhoids;
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;
increase in some 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 any of these symptoms occur.

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;
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 small, flat, red, round spots under the skin surface or bruising.

The following side effects are known to occur when APIXABAN DOC 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;
blood in 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 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 stools;
tests showing blood in stools or urine;
bleeding occurring after surgery, including bruising and swelling, blood or fluid leakage 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 any of these symptoms occur.
Blood tests may show:
abnormal liver function;
increase in some 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 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 small, flat, red, round spots under the skin surface or bruising.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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.

How to store APIXABAN DOC

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 and blister after "Exp" or "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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Contents of the pack and other information

What APIXABAN DOC contains
The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
The other ingredients are:
Tablet core: lactose monohydrate (see section 2), microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulphate, magnesium stearate, copovidone.
Coating: lactose monohydrate (see section 2), hypromellose, titanium dioxide, triacetin, yellow iron oxide.
See section 2 “APIXABAN DOC contains lactose (a type of sugar) and sodium”.

Description of the appearance of APIXABAN DOC and contents of the pack
The film-coated tablets are round, yellow, with “E23” engraved on one side and smooth on the other.

Available in blisters in cartons of 10, 14, 20, 28, 56, 60, 100, 168 or 200 film-coated tablets.
Available in bottles of 20, 30, 50, 60, 90, 100, 200, 250 or 500 film-coated tablets. Not all pack sizes may be marketed.

Patient Alert Card: managing information

Inside the APIXABAN DOC package, along with the package leaflet, you will find a Patient Alert Card or your doctor may give you a similar one.
This Patient Alert Card includes information that may be useful to you and alerts other doctors that you are taking APIXABAN DOC. You must always carry this card with you.
Take the card.
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 keep it with you at all times.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40, 20121 Milan, Italy

Manufacturer
TOWA Pharmaceutical Europe, S.L
C/ de Sant Martí, 75-97, Martorelles, 08107 Barcelona, Spain

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

| Member State | Name | |------------------|----------| | Germany | Apixaban TOWA Pharmaceutical Europe 2.5 mg Filmtabletten | | Italy | APIXABAN DOC | | France | Apixaban TOWA Pharmaceutical Europe 2.5 mg comprimé pelliculé |

Patient Information Leaflet: Information for the User

APIXABAN DOC 5 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any doubts, 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 effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
What APIXABAN DOC is and what it is used for
What you need to know before taking APIXABAN DOC
How to take APIXABAN DOC
Possible side effects
How to store APIXABAN DOC
Contents of the pack and other information
What APIXABAN DOC is and what it is used for
APIXABAN DOC contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots by blocking Factor Xa, an important component in blood clotting.
APIXABAN DOC is used in adults:

to prevent blood clots forming in the heart in patients with irregular heartbeat (atrial fibrillation) and with at least one additional risk factor. Blood clots can break loose and travel to the brain, causing stroke, or to other organs, blocking normal blood flow to these organs (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 blood clots from recurring in the veins of the legs and/or lungs.

What you need to know before taking APIXABAN DOC
Do not take APIXABAN DOC 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 a higher risk of serious bleeding (such as a recent or active ulcer of the stomach or intestine, or recent bleeding in the brain);
you have a liver disease that leads to a higher risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood clots (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 activity;
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 your blood pressure is unstable, or if another treatment or surgical procedure to remove a blood clot from the lungs is planned. Be especially careful with APIXABAN DOC
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 undergoing 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 DOC Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Some medicines can increase the effect of APIXABAN DOC and others can reduce it. Your doctor will decide whether you should be treated with APIXABAN DOC when taking these medicines and how closely you need to be monitored. The following medicines can increase the effect of APIXABAN DOC 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 medicines 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 can reduce the effect of APIXABAN DOC in helping to prevent blood clots:
medicines for 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).

12/18
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor, pharmacist or nurse for advice before taking this medicine.
The effect of APIXABAN DOC during pregnancy and on the unborn child is 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 DOC 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 DOC has not shown effects on the ability to drive or use machines.
APIXABAN DOC 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’.
How to take APIXABAN DOC
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 some water. APIXABAN DOC can be taken with or without food. Try to take the tablets at the same time each day to get the best effect from treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take APIXABAN DOC. The tablet can be crushed and mixed with water, 5% glucose 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 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 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 the crushed APIXABAN DOC tablet mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.
Take APIXABAN DOC as recommended:
To prevent blood clots forming in the heart in patients with irregular heartbeat and at least one additional risk factor.
The recommended dose is one APIXABAN DOC 5 mg tablet twice daily.
The recommended dose is one APIXABAN DOC 2.5 mg tablet twice daily if:
you have severely reduced kidney function;
you meet two or more of the following conditions:
13/18
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 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 deep veins of the legs and in the blood vessels of the lungs
The recommended dose is two tablets of APIXABAN DOC 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 DOC 5 mg twice daily, for example, one in the morning and one in the evening.
To prevent blood clots from recurring after completing 6 months of treatment.
The recommended dose is one APIXABAN DOC 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 DOC to another anticoagulant medicine
Stop taking APIXABAN DOC. 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 DOC
Stop taking the anticoagulant medicine. Start treatment with APIXABAN DOC at the time you would have taken the next dose of the anticoagulant medicine, then continue taking it normally.
Switching from a vitamin K antagonist anticoagulant (e.g., warfarin) to APIXABAN DOC
Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and instruct you on when to start treatment with APIXABAN DOC.
Switching from APIXABAN DOC 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 DOC for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will need to perform blood tests and instruct you on when to stop treatment with APIXABAN DOC.
Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take this medicine at the times your doctor tells you to, to prevent blood clots in the blood vessels of the brain and other blood vessels in your body.
If you take more APIXABAN DOC than you should
Contact your doctor immediately if you have taken more than the prescribed dose of this medicine. Take the medicine pack with you, even if no tablets remain.
If you take more APIXABAN DOC than recommended, you may have an increased risk of bleeding.
If bleeding occurs, you may need surgery, a blood transfusion or other treatments that
14/18
can neutralize the anti-Factor Xa activity.
If you forget to take APIXABAN DOC
Take the missed dose as soon as you remember and:
take your next dose of APIXABAN DOC at the usual time
then continue as scheduled.
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 DOC
Do not stop taking this medicine 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 doubts about how to use this medicine, contact your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effect with this medicine is bleeding, which can potentially be life-threatening and requires immediate medical attention.
The following side effects are known to occur when APIXABAN DOC 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 intestine;
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 cause weakness or 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 coughed-up phlegm;
in the abdomen or from the vagina;
bright/red blood in the stools;
bleeding occurring after surgery, including bruising and swelling, blood or fluid leakage from the surgical wound/incision (wound discharge) or from the injection site;
from haemorrhoids;
tests showing blood in the stools or urine;
Reduction in the number of platelets in the blood (which may affect clotting);
Blood tests may show:
liver function abnormalities;
15/18
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 breathing difficulties. Contact your doctor immediately if any of these symptoms occur.
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;
in the muscle.
Very rare side effects (may affect up to 1 in 10,000 people)
Skin rash that may blister and appear 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 present 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 DOC is taken to treat or prevent recurrence of blood clots in the deep 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;
blood in the urine;
bruising and swelling;
in the stomach, intestine, from the rectum;
in the mouth;
from the vagina;
Anaemia, which may cause tiredness or paleness;
Reduction in the number of platelets in the blood (which may affect 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 coughed-up phlegm;
bright/red blood in the stools;
tests showing blood in the stools or urine;
bleeding occurring after surgery, including bruising and swelling, blood or fluid leakage from the surgical wound/incision (wound discharge) or from the injection site;
from haemorrhoids;
16/18
in the 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 any of these symptoms occur.
Blood tests may show:
liver function abnormalities;
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 available data)
Bleeding:
in the abdomen or in the space behind the abdominal cavity.

Skin rash that may blister and appear 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 present as skin rashes or sharp, flat, red, round spots under the skin surface or bruising.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.
How to store APIXABAN DOC
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' or '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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.
Contents of the pack and other information
What APIXABAN DOC contains
The active substance is apixaban. Each tablet contains 5 mg of apixaban.
The other components are:
Tablet core: lactose monohydrate (see section 2), microcrystalline cellulose,
croscarmellose sodium, sodium lauryl sulphate, magnesium stearate, copovidone.
Coating: lactose monohydrate (see section 2), hypromellose, titanium dioxide, triacetin, red iron oxide, yellow iron oxide, black iron oxide.
See section 2 “APIXABAN DOC contains lactose (a type of sugar) and sodium”
17/18
Description of the appearance of APIXABAN DOC and contents of the pack
The film-coated tablets are oval, pink, with “E124” imprinted on one side and smooth on the other.

Available in blisters in cartons containing 10, 14, 20, 28, 56, 60, 100, 168 or 200 film-coated tablets.
Available in bottles containing 20, 30, 50, 60, 90, 100, 200, 250 or 500 film-coated tablets. Not all pack sizes may be marketed.

Patient Alert Card: managing information
Inside the pack of APIXABAN DOC, together with the package leaflet, you will find a Patient Alert Card or your doctor may give you a similar one.
This Patient Alert Card contains information that may be useful to you and alerts other doctors that you are taking APIXABAN DOC. You must always carry this card with you.
Take the card.
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 keep it with you at all times
Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40, 20121 Milano, Italy
Manufacturer
TOWA Pharmaceutical Europe, S.L
C/ de Sant Martí, 75-97, Martorelles, 08107 Barcelona, Spain
This medicine is authorised in the European Economic Area countries with the following
names:
Member State Name
Germany Apixaban TOWA Pharmaceutical Europe 5 mg Filmtabletten
Italy APIXABAN DOC
France Apixaban TOWA Pharmaceutical Europe 5 mg comprimé pelliculé
18/18

Apixaban Doc Generici