Banxan: detailed information

Patient Information Leaflet: Information for the User

BANXAN

2.5 mg film-coated tablets
Equivalent medicine
Please read this leaflet carefully before taking this medicine as 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, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet
What BANXAN is and what it is used for
What you need to know before taking BANXAN
How to take BANXAN
Possible side effects
How to store BANXAN
Contents of the pack and other information

1. What BANXAN is and what it is used for

BANXAN 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 the blood clotting process.
This medicine 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 with 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 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 veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

2. What you should know before taking BANXAN

Do not take BANXAN:

if you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
if you are experiencing excessive bleeding;
if you have a disease in a body organ that leads to an increased risk of severe bleeding (such as a recent or active ulcer of the stomach or intestine, or recent bleeding in the brain);
if you have a liver disease that increases the risk of bleeding (hepatic coagulopathy);
if 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 that 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 an increased risk of bleeding, such as:
bleeding disorders, including conditions leading to reduced platelet function;
very high blood pressure, uncontrolled by medical treatment;
if you are over 75 years old;
if you weigh 60 kg or less;
if you have severe kidney disease or are on dialysis;
if you have liver problems or a history of liver problems. This medicine will be used with caution in patients showing signs of impaired liver function;
if you have a tube (catheter) or have received 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;
if 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 BANXAN

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 might ask you to temporarily stop taking this medicine for a short period. If you are unsure whether a procedure might cause bleeding, consult your doctor.
Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.
Other medicines and BANXAN
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 BANXAN, while others can reduce it. Your doctor will decide whether you should be treated with BANXAN when taking these medicines and how closely you should be monitored.
The following medicines may increase the effect of BANXAN 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-relieving medicines (e.g., acetylsalicylic acid or naproxen). Particularly 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 effect of BANXAN 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 for treating tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
The effect of this medicine on pregnancy and 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 this medicine 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
It has not been demonstrated that this medicine affects the ability to drive or use machinery.
BANXAN 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 BANXAN

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor, pharmacist, or nurse.

Dosage

Swallow the tablet with a little water. This medicine can 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 BANXAN. 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 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 pestle, mortar, and container used for crushing the tablet 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 BANXAN tablets mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.

Take BANXAN as recommended:

To prevent blood clots after hip or knee replacement surgery.

The recommended dose is one BANXAN 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 undergone major hip surgery, you will usually take the tablets for a period of 32 to 38 days.
If you have undergone major 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 BANXAN 5 mg tablet twice daily.
The recommended dose is one BANXAN 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 g/dL (133 micromol/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 BANXAN 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 BANXAN 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 BANXAN 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 BANXAN to another anticoagulant medicine

Stop taking BANXAN. 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 BANXAN

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

Switching from treatment with a vitamin K antagonist anticoagulant (e.g., warfarin) to BANXAN

Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you on when to start treatment with BANXAN.

Switching from BANXAN 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 BANXAN 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 BANXAN.

Use in 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 the blood vessels of the brain and other parts of the body.

If you take more BANXAN 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 BANXAN than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery, blood transfusion, or other treatments that can reverse the anti-factor Xa activity may be required.

If you forget to take BANXAN

Take the missed dose as soon as you remember and:
take your next dose of BANXAN 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 BANXAN

Do not stop taking this medicine without first talking to your doctor, as 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. BANXAN may be given for three different medical conditions. The known side effects and how frequently they occur may differ for each of these medical conditions and are listed separately below. For these conditions, the most common general 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 BANXAN is taken to prevent blood clots after hip or knee replacement surgery.

Common (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 (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;
from the stomach, intestine, or clear/red blood in faeces;
in the 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;
increased levels of some liver enzymes;
increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
Itching.

Rare (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 the muscle;
into 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 faeces or urine;
Skin rash which may form blisters and appears as small targets (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.

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

Common (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 weakness or a rapid heartbeat;
Nausea (feeling unwell);
Blood tests may show increased levels of gamma-glutamyl transferase (GGT).

Uncommon (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 faeces;
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 faeces or urine;
Reduction in the number of platelets in the blood (which may affect blood clotting);
Blood tests may show:
abnormal liver function;
increased levels of some 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 (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 (may affect up to 1 in 10,000 people)
Skin rash which may form blisters and appears as small targets (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 BANXAN 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 (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 increased levels of gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT).

Uncommon (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 faeces;
tests showing blood in faeces 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;
increased levels of some liver enzymes;
increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.

Rare (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 which may form blisters and appears as small targets (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 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.

5. How to store BANXAN

Keep this medicine out of the sight and reach of children.
8/18
Do not use this medicine after the expiry date stated on the carton and blister after Scad. 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.

6. Package contents and other information

What BANXAN contains
The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
The other components are:
Tablet core: monohydrate lactose (see section 2 “BANXAN contains lactose (a type of sugar) and sodium”), microcrystalline cellulose (E460), povidone K30, crospovidone (type A), sodium lauryl sulfate, sodium stearyl fumarate.
Coating: monohydrate lactose (see section 2 “BANXAN contains lactose (a type of sugar) and sodium”), hypromellose, titanium dioxide (E171), triacetin (1518), yellow iron oxide (E172).
Description of the appearance of BANXAN and package contents
The film-coated tablets are yellow, round, and have a diameter of 6.1 mm.
They are available in perforated unit-dose blisters made of aluminum PVC/PVdC, packed in cardboard boxes.
Pack sizes of 10 x 1, 20 x 1 or 60 x 1 film-coated tablets (in unit-dose perforated blisters).
Not all pack sizes may be marketed.
Marketing Authorization Holder
Morganceutical S.r.l. - Viale Varese 39 - 22100 Como – Italy
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA3000
Malta
Adalvo Ltd.
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings,
San Gwann, SGN 3000
Malta
This medicinal product is authorized in the European Economic Area Member States under the following
names:
Member State Name
Italy BANXAN
9/18

Package leaflet: information for the user

BANXAN 5 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine as 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 their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
What BANXAN is and what it is used for
What you need to know before taking BANXAN
How to take BANXAN
Possible side effects
How to store BANXAN
Contents of the pack and other information

7. What BANXAN is and what it is used for

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

to prevent blood clots forming in the heart of patients with irregular heartbeat (atrial fibrillation) who have at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or travel to other organs and block normal blood flow to those organs (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 re-forming in the blood vessels of the legs and/or lungs.

8. What you should know before taking BANXAN

Do not take BANXAN:

if you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
if you are experiencing excessive bleeding;
if 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 bleeding in the brain);
if you have a liver disease that increases the risk of bleeding (hepatic coagulopathy);
if 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 that 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 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;
if you have severe kidney disease or are on dialysis;
if you have liver problems or a history of liver problems. This medicine will be used with caution in patients showing signs of impaired liver function;
if 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 particular caution with BANXAN

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 necessary.

If you are scheduled for surgery or a procedure that may cause bleeding, your doctor might ask you to temporarily stop taking this medicine for a short period. If you are unsure whether a procedure could cause bleeding, consult your doctor.
Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.
Other medicines and BANXAN
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 BANXAN, while others can reduce it. Your doctor will decide whether you should be treated with BANXAN when taking these medicines and how closely you need to be monitored.
The following medicines can increase the effect of BANXAN and increase the risk of unwanted bleeding:

certain antifungal medicines (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). Particularly 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 BANXAN 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 used 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 effect of this medicine 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 this medicine 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
It has not been shown that this medicine affects the ability to drive or operate machinery.
BANXAN 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’.

9. How to take BANXAN

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. This medicine can be taken with or without food. Try to take the tablets at the same time each day to achieve the best effect from treatment.

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 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 BANXAN tablets mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.

Take BANXAN as recommended:
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 BANXAN 5 mg tablet twice daily.

The recommended dose is one BANXAN 2.5 mg tablet twice daily if:
you have severely reduced kidney function;
you meet two or more of the following conditions:
blood test results suggest poor kidney function (serum creatinine level is 1.5 g/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 BANXAN 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 BANXAN 5 mg 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 BANXAN 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 BANXAN to another anticoagulant medicine
Stop taking BANXAN. 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 BANXAN
Stop taking the anticoagulant medicine. Start taking BANXAN 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 BANXAN
Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to start treatment with BANXAN.

Switching from BANXAN 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 BANXAN 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 BANXAN.

Use in 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 your brain and other blood vessels in your body.

If you take more BANXAN than you should
Inform 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 are left.

If you take more BANXAN than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery, transfusion, or other treatments that can reverse the anti-factor Xa anticoagulant activity may be required.

If you forget to take BANXAN
Take the missed dose as soon as you remember and:
take your next dose of BANXAN 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 BANXAN
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, consult your doctor, pharmacist, or nurse.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. The most common general 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 BANXAN is taken to prevent blood clots from forming in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common (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, which may cause weakness or a rapid heartbeat;
Nausea (feeling unwell);
Blood tests may show an increase in gamma-glutamyl transferase (GGT).

Uncommon (may affect up to 1 in 100 people)
Bleeding:
in the brain or spinal cord;
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;
tests showing blood in stools or urine;
Reduction in the number of platelets in the blood (which may affect blood clotting);
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;
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 (may affect up to 1 in 1,000 people)
Bleeding:
in the lungs or throat;
in the space behind the abdominal cavity (retroperitoneal haemorrhage);
in the muscle.

Very rare (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 BANXAN is taken to treat or prevent recurrence of blood clots in the veins of the legs and blood vessels of the lungs.

Common (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;
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-glutamyl transferase (GGT) or alanine aminotransferase (ALT).

Uncommon (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;
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 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:
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 (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 (retroperitoneal haemorrhage);
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);
Inflammation of blood vessels (vasculitis), which may present as skin rashes or small, flat, red, round spots beneath 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 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 help provide more information on the safety of this medicine.

11. How to store BANXAN

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 Scad. or 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.

12. Contents of the pack and other information

What BANXAN contains
The active substance is apixaban. Each tablet contains 5 mg of apixaban.
The other components are:
Tablet core: lactose monohydrate (see section 2 “BANXAN contains lactose (a type of sugar) and sodium”), microcrystalline cellulose (E460), povidone K30, crospovidone (type A), sodium lauryl sulfate, sodium stearyl fumarate.
Coating: lactose monohydrate (see section 2 “BANXAN contains lactose (a type of sugar) and sodium”), hypromellose, titanium dioxide (E171), triacetin (1518), red iron oxide (E172).
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Description of the appearance of BANXAN and the contents of the pack
The film-coated tablets are pink, oblong, 5.2 mm wide and 10.3 mm long.
They are available in perforated unit-dose blisters made of PVC/PVdC-aluminum, packed in cardboard boxes.
Pack sizes: 28 x 1 or 60 x 1 film-coated tablets (in unit-dose perforated blisters).
Not all pack sizes may be marketed.
Marketing Authorization Holder
Morganceutical S.r.l. - Viale Varese 39 - 22100 Como, Italy
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA3000
Malta
Adalvo Ltd.
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings,
San Gwann, SGN 3000
Malta
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Member State Name
Italy BANXAN
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