Apixaban PensA: detailed information

Patient Information Leaflet

Apixaban Pensa 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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Apixaban Pensa 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, which is an important component in blood coagulation.
Apixaban Pensa 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, there may be an increased risk of developing blood clots in the leg veins. This can cause swelling in the legs, with or without pain. If a blood clot travels from the leg to the lungs, it may 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 a blood clot in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose, travel to the brain and cause a stroke, or reach other organs and block normal blood flow to that organ (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 blood clots from recurring in the blood vessels of the legs and/or lungs.

2. What you need to know before taking Apixaban Pensa

Do not take Apixaban Pensa 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 increases the risk of serious bleeding (e.g. active or recent ulcer in the stomach or intestine, 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 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 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 causing reduced platelet function;
- very high blood pressure not controlled by medical treatment;
- you are over 75 years of age;
- your body weight is equal to or less than 60 kg;
- you have severe kidney disease or are on dialysis;
- you have a liver problem or a history of liver problems.

This medicine should be used with caution in patients showing signs of impaired liver function.

you have a tube (catheter) or have received an injection into the spinal column (for anaesthesia or pain relief); your doctor will advise you when to start taking this medicine, usually at least 5 hours after catheter removal;
if 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 Pensa

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 adjustment is needed.

If you are scheduled for surgery or a procedure that may cause bleeding, your doctor may ask you to temporarily stop taking this medicine for a short period. If you are unsure whether a procedure 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 Apixaban Pensa
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 Pensa, while others may reduce its effects. Your doctor will decide whether you should be treated with Apixaban Pensa while taking these medicines and how closely you need to be monitored.

The following medicines may increase the effects of Apixaban Pensa 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, 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 (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs).

The following medicines may reduce the effect of Apixaban Pensa in helping to prevent blood clots:

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

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

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

It is not known whether Apixaban Pensa passes into human 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 Apixaban Pensa impairs the ability to drive or use machinery.

Apixaban Pensa contains lactose (a type of sugar) and sodium
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Apixaban Pensa

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with some water. Apixaban Pensa may be taken with or without food. To
achieve the best effect from treatment, try to take the tablets at the same time each day.
If you have difficulty swallowing the whole tablet, ask your doctor for alternative ways to take Apixaban
Pensa. The tablet may be crushed and mixed with water, 5% glucose in water,
or 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, 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 (e.g. 30 mL) of water or one of the other liquids and swallow the rinse liquid.

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

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

The recommended dose is one tablet twice daily, for example, one tablet in the morning
and one in the evening. Your doctor will decide how long you should continue treatment.
To treat blood clots in the veins of the legs and in the blood vessels of the lungs
The recommended dose is two tablets of Apixaban Pensa 5 mg twice daily for the first 7
days, for example, two tablets in the morning and two in the evening.
After 7 days, the recommended dose is one tablet of Apixaban Pensa 5 mg twice daily,
for example, one tablet in the morning and one in the evening.
To prevent recurrence of blood clots after completing 6 months of treatment
The recommended dose is one Apixaban Pensa 2.5 mg tablet twice daily, for example, one
tablet in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.
Your doctor may adjust your anticoagulant treatment in these cases:
Switching from Apixaban Pensa to anticoagulant medicines
Stop taking Apixaban Pensa. Start treatment with anticoagulant medicines (e.g.,
heparin) at the time you would have taken the next tablet.
Switching from anticoagulant medicines to Apixaban Pensa
Stop taking the anticoagulant medicines. Start taking Apixaban Pensa at the time you would have taken the next dose of anticoagulant medicine,
and then continue taking it normally.
Switching from treatment with vitamin K antagonist anticoagulants (e.g.,
warfarin) to Apixaban Pensa
Stop taking the medicine containing a vitamin K antagonist. Your doctor will perform blood tests and tell you when to start taking Apixaban Pensa.
Switching from Apixaban Pensa to treatment with a vitamin K antagonist anticoagulant (e.g.,
warfarin)
If your doctor tells you to start taking a medicine containing a vitamin K antagonist, continue taking Apixaban Pensa for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will perform blood tests and tell you when to stop taking Apixaban Pensa.
Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal rhythm by a procedure called cardioversion, take this medicine at the times indicated by your doctor to prevent the formation of blood clots in the blood vessels of the brain and in other blood vessels of the body.
If you take more Apixaban Pensa than you should
Inform your doctor immediately if you have taken more than the prescribed dose of this medicine. Bring the medicine packaging with you, even if the tablets are finished.
If you take more Apixaban Pensa than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgical interventions, blood transfusions, or other treatments that can reverse the anticoagulant activity of factor Xa may be required.
If you forget to take Apixaban Pensa
Take the missed dose as soon as you remember and:

take the next dose of Apixaban Pensa at your usual time;
then continue taking it as usual.

If you are unsure what to do or if you have missed more than one dose, ask your doctor, pharmacist, or
nurse.
If you stop taking Apixaban Pensa
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 further questions about the use of this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Apixaban Pensa may be administered for three different medical conditions. The known side effects and how often they occur for each of these medical conditions may differ 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.

If you are taking Apixaban Pensa to prevent blood clots after hip or knee replacement surgery, the following side effects are known:

Common side effects (may affect up to 1 in 10 people)
Anaemia, which may cause tiredness or paleness;
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, loss of blood or fluid from the surgical wound/incision (wound discharge) or from the injection site;
in the stomach, intestine, or bright red blood in the stool;
in the urine;
from the nose;
from the vagina;
Low blood pressure, which may cause fainting or a rapid heartbeat;
Blood tests may show:
abnormalities in liver function;
an increase in certain liver enzymes;
an increase in bilirubin, a breakdown product of red blood cells, 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 breathing difficulties. Contact your doctor immediately if you experience any of these symptoms.
Bleeding:
into a muscle;
in the eyes;
from the gums and blood in sputum when coughing;
from the rectum;
Hair loss.

Not known (frequency cannot be estimated from available data)

Bleeding:
in the brain or spinal cord;
in the lungs or throat;
in the mouth;
in the abdomen or behind the abdominal cavity;
from haemorrhoids;
tests showing blood in the stool or urine;
Skin rash which may form blisters and appear as small 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 cause skin rashes or small, flat, red, round spots under the skin surface or bruising.
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects are known to occur when Apixaban Pensa 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;
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 sputum when coughing;
in the abdomen or from the vagina;
bright red blood in the stool;
bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision (wound discharge) or from the injection site;
from haemorrhoids;
tests showing blood in the stool or urine;
Reduction in the number of platelets in the blood (which may affect clotting);
Blood tests may show:
abnormalities in liver function;
increase in certain liver enzymes;
increase in bilirubin, a breakdown product of red blood cells, 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 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;
into a muscle.

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

Skin rash which may form blisters and appear as small spots (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 cause bruising or skin rashes or raised, flat, red, round spots under the skin surface.
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

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

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

Bleeding, including:
from the nose;
from the gums;
in the urine;
bruising and swelling;
in the stomach, intestine, or 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 sputum when coughing;
bright red blood in the stool;
tests showing blood in the stool or urine;
bleeding occurring after any surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision (wound discharge) or from the injection site;
from haemorrhoids;
into a muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. Contact your doctor immediately if you experience any of these symptoms.
Blood tests may show:
abnormalities in liver function;
an increase in certain liver enzymes;
an increase in bilirubin, a breakdown product of red blood cells, 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 behind the abdominal cavity;
Skin rash which may form blisters and appear as small 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 cause bruising or skin rashes or small, raised, flat, red, round spots under the skin surface.
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

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 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 Apixaban Pensa

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

6. Package contents and other information

What Apixaban Pensa contains

The active substance is apixaban. Each film-coated tablet contains 2.5 mg of apixaban.
The other components are: Tablet core: monohydrate lactose; microcrystalline cellulose; croscarmellose sodium; sodium lauryl sulfate; magnesium stearate; copovidone. See section 2 “Apixaban Pensa contains lactose (a type of sugar) and sodium”. Tablet coating: monohydrate lactose; hypromellose; titanium dioxide; triacetin; yellow iron oxide.

Description of the appearance of Apixaban Pensa and package contents
The film-coated tablets are yellow, round (6.1 mm in diameter), with “E23” engraved on one side and smooth on the other side.

Available in blisters in packs of 10, 20 and 60 film-coated tablets.
Available in bottles in packs of 10, 20 and 60 film-coated tablets.

Not all pack sizes may be marketed.
Patient Alert Card: managing information
Inside the cardboard box of Apixaban Pensa, together with the package leaflet, you will find a Patient Alert Card, or your doctor may have provided you with a similar one.
The Patient Alert Card contains information that will be useful to you and will alert other physicians that you are taking Apixaban Pensa. You must always carry this card with you.
Remove the card from the cardboard box.
Separate the text in your language as needed (this is facilitated by perforated edges).
Complete the following sections or ask your doctor to do so:
Name:
Date of birth:
Therapeutic indication:
Dose: ____ mg, twice daily
Name of physician:
Physician’s telephone number:
Fold the card and keep it with you at all times.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan – Italy
Manufacturer
Towa Pharmaceutical Europe, SL
c/ de Sant Martí 75-97
08107 Martorelles, Barcelona
Spain
This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Apixaban Pensa
Portugal: Apixabano toLife
Spain: APIXABAN PENSA 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG

Package leaflet: Information for the user

Apixaban Pensa 5 mg film-coated tablets

Generic 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 they have the same symptoms as you, because it could 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 Apixaban Pensa is and what it is used for
What you need to know before taking Apixaban Pensa
How to take Apixaban Pensa
Possible side effects
How to store Apixaban Pensa
Contents of the pack and other information

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

Apixaban Pensa contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots by inhibiting factor Xa, an important component in the blood clotting process.
Apixaban Pensa is used in adults:
to prevent the formation of blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) who have at least one additional risk factor. Blood clots may break loose, travel to the brain and cause a 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 recurrence of blood clots in the blood vessels of the legs and/or lungs.

2. What you should know before taking Apixaban Pensa

Do not take Apixaban Pensa 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 increases the risk of life-threatening bleeding (such as, for example, an active or recent ulcer in the stomach or intestine, or a recent bleeding in the brain);
you have a liver disease that causes an increased risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant treatment, 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 involving reduced platelet function;
- very high blood pressure not controlled by medical treatment;
- you are over 75 years old;
- your body weight is equal to or less than 60 kg;
- you have severe kidney disease or are on dialysis;
- you have a liver problem 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.

Take special care with Apixaban Pensa

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 your treatment needs to be adjusted.

If you are scheduled for surgery or a procedure that may cause bleeding, your doctor may ask you to temporarily and briefly stop taking this medicine. 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 Pensa
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

The following medicines may increase the effects of Apixaban Pensa 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, your risk of bleeding may be higher if you are over 75 years old and taking acetylsalicylic acid;
medicines for high blood pressure or heart problems (e.g. diltiazem);
antidepressants known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs).

The following medicines may reduce the effect of Apixaban Pensa 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 for the treatment of tuberculosis or other infections (e.g. rifampicin).

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

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

It is not known whether Apixaban Pensa passes into human breast milk. Ask your doctor, pharmacist, or nurse for advice before taking this medicine during breastfeeding. They will advise you whether to stop breastfeeding or to stop/avoid starting treatment with this medicine.

Driving and using machines
It has not been demonstrated that Apixaban Pensa impairs the ability to drive or use machines.

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

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

3. How to take Apixaban Pensa

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor, pharmacist, or nurse.
Dose
Swallow the tablet with a glass of water. Apixaban Pensa 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 alternative ways of
taking Apixaban Pensa. The tablet may be crushed and mixed with water, 5% glucose in water,
or apple juice or apple puree, immediately before administration.
Instructions for crushing tablets:

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

If necessary, your doctor may also administer crushed Apixaban Pensa tablets mixed in 60 mL of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Pensa as recommended in the following cases:
To prevent blood clots forming in the heart in patients with irregular heartbeat and
with at least one other risk factor.
The recommended dose is one tablet of Apixaban Pensa 5 mg twice daily.
The recommended dose is one tablet of Apixaban Pensa 2.5 mg twice daily if:

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

The recommended dose is one tablet twice daily, for example, one tablet in the morning and
one in the evening.
Your doctor will decide how long you should continue treatment.
For the treatment of blood clots in the veins of the legs and in the blood vessels of the lungs
The recommended dose is two tablets of Apixaban Pensa 5 mg twice daily for the first 7
days, for example two tablets in the morning and two in the evening.
After 7 days, the recommended dose is one tablet of Apixaban Pensa 5 mg twice daily,
for example one tablet 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 tablet of Apixaban Pensa 2.5 mg twice daily, for example one
tablet in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.
Your doctor may adjust anticoagulant treatment in these cases:
Switching from Apixaban Pensa to anticoagulant medicines
Stop taking Apixaban Pensa. Start treatment with anticoagulant medicines (e.g. heparin) at the time you would have taken the next tablet.
Switching from anticoagulant medicines to Apixaban Pensa
Stop taking anticoagulant medicines. Start treatment with Apixaban Pensa at the time you would have taken the next dose of anticoagulant medicine, then continue as usual.
Switching from vitamin K antagonist anticoagulant treatment (e.g.
warfarin) to Apixaban Pensa
Stop taking the vitamin K antagonist medicine. Your doctor will perform blood tests and advise you when to start taking Apixaban Pensa.
Switching from Apixaban Pensa to a vitamin K antagonist anticoagulant treatment (e.g. warfarin)
If your doctor tells you to start taking a vitamin K antagonist medicine, continue taking Apixaban Pensa for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will perform blood tests and advise you when to stop taking Apixaban Pensa.
Patients undergoing cardioversion
If your heartbeat is irregular and needs to be restored to normal by a procedure called cardioversion, take this medicine at the times indicated by your doctor to prevent blood clots forming in blood vessels of the brain and other blood vessels in the body.
If you take more Apixaban Pensa 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 the tablets are finished.
If you take more Apixaban Pensa than recommended, you may have an increased risk of
bleeding. If bleeding occurs, surgical procedures, blood transfusions, or other treatments that can reverse the factor Xa anticoagulant activity may be required.
If you forget to take Apixaban Pensa
Take the missed dose as soon as you remember and:

take the next dose of Apixaban Pensa at your usual time;
then continue taking it as normal.

If you are unsure what to do or if you have missed more than one dose, ask your doctor, pharmacist, or
nurse.
If you stop taking Apixaban Pensa
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 further questions about the use of this medicine, ask your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common general side effect of this medicine is bleeding, which may be potentially life-threatening and requires immediate medical attention.

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

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

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

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

Bleeding:
- in the brain or spinal cord;
- in the mouth or blood in coughed-up mucus when coughing;
- in the abdomen or from the vagina;
- bright red blood in the stools;
- bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid 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 blood clotting);
Blood tests may show:
- abnormalities in liver function;
- increase in some liver enzymes;
- increase in bilirubin, a breakdown product of red blood cells, 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 difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.

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

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

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

Rash which may blister and appear as small spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).

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

Inflammation of blood vessels (vasculitis) which may cause bruising or skin rashes or flat, raised, red, round spots under the skin surface.
Bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys being unable to function properly (anticoagulant-related nephropathy).

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

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

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

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

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

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

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

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

Bleeding:
- in the abdomen or behind the abdominal cavity;
Rash which may blister and appear as small 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 cause bruising or skin rashes or flat, raised, red, round spots under the skin surface;
Bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys being unable to function properly (anticoagulant-related nephropathy).

5. How to store Apixaban Pensa

6. Package Contents and Other Information

What Apixaban Pensa Contains

The active substance is apixaban. Each film-coated tablet contains 5 mg of apixaban.
The other components are: Tablet core: monohydrate lactose; microcrystalline cellulose; sodium croscarmellose; sodium lauryl sulfate; magnesium stearate; copovidone. See section 2 “Apixaban Pensa contains lactose (a type of sugar) and sodium”. Tablet coating: monohydrate lactose; hypromellose; titanium dioxide; triacetin; red iron oxide; yellow iron oxide; ferrosoferric oxide/black iron oxide.

Description of the Appearance of Apixaban Pensa and Contents of the Package
The film-coated tablets are yellow, round (6.1 mm in diameter), with “E23” engraved on one side and smooth on the other.

Available in blisters in boxes of 20, 28, and 60 film-coated tablets.
Available in bottles in boxes of 20, 28, and 60 film-coated tablets.

Not all pack sizes may be marketed.

Patient Alert Card: Managing Information
Inside the cardboard box of Apixaban Pensa, together with the package leaflet, you will find a Patient Alert Card, or your doctor may provide you with a similar one.
The Patient Alert Card contains information that will be useful to you and will alert other physicians that you are taking APIXABAN PENSA. You must always carry this card with you.

Take the card out of the cardboard box.
Separate the text in your language as needed (this is facilitated by perforated edges).
Complete the following sections or ask your doctor to do so:
- Name:
- Date of birth:
- Therapeutic indication:
- Dose: ____ mg twice daily
- Physician’s name:
- Physician’s telephone number:
Fold the card and keep it with you at all times.

Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan – Italy

Manufacturer
Towa Pharmaceutical Europe, SL
c/ de Sant Martí 75-97
08107 Martorelles, Barcelona
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Apixaban Pensa
Portugal: Apixabano toLife
Spain: APIXABAN PENSA 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG