Apixaban Bruno Farmaceutici: detailed information

Patient Information Leaflet

Apixaban Bruno Farmaceutici 2.5 mg film-coated tablets

apixaban
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 give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Apixaban Bruno Farmaceutici is and what it is used for

Apixaban Bruno Farmaceutici 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 Bruno Farmaceutici is used in adults:

to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. Following hip or knee surgery, there is an increased risk of developing blood clots in the veins of the leg. This may cause leg swelling, with or without pain. If a blood clot travels from the leg to the lungs, it can block blood flow, causing shortness of breath, with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
to prevent the formation of blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and reach the brain, leading to stroke, or may 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 such blood clots from recurring in the blood vessels of the legs and/or lungs.

2. What you need to know before taking Apixaban Bruno Farmaceutici

Do not take Apixaban Bruno Farmaceutici if:

you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
you are bleeding excessively;
you have a disease in an organ of the body that increases the risk of serious bleeding (such as a recent or active ulcer of 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 an intravenous 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 Apixaban Bruno Farmaceutici 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
- 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 should be used with caution in patients showing signs of impaired liver function.
you have a tube (catheter) or have recently 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;
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 Bruno Farmaceutici

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

Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.

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

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

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

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

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

The effect of apixaban 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 passes into breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine while breastfeeding. They will advise whether you should discontinue breastfeeding or discontinue/avoid starting treatment with this medicine.

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

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

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

3. How to take Apixaban Bruno Farmaceutici

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 Bruno Farmaceutici may be taken with
or without food. Try to take the tablets at the same time each day to achieve the best
effect from treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about alternative ways to take
Apixaban Bruno Farmaceutici. The tablet may be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before administration.
Instructions for crushing the tablet:

Crush the tablets with a mortar and pestle.
Carefully transfer all the powder into a suitable container and then mix the powder with a small amount, e.g., 30 mL (2 tablespoons), of water or one of the other liquids 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 Bruno Farmaceutici tablet mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Bruno Farmaceutici as recommended:
To prevent blood clots after hip or knee replacement surgery.
The recommended dose is one 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 formation of blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.
The recommended dose is one 5 mg tablet twice daily.
The recommended dose is one 2.5 mg tablet twice daily if:

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

The recommended dose is one tablet twice daily, for example, one in the morning and one in the evening. Your doctor will decide how long you should continue treatment.
To treat blood clots in the veins of the legs and in the blood vessels of the lungs
The recommended dose is two 5 mg tablets of Apixaban Bruno Farmaceutici twice daily for the first 7 days, for example, two in the morning and two in the evening.
After 7 days, the recommended dose is one 5 mg tablet of Apixaban Bruno Farmaceutici twice daily, for example, one in the morning and one in the evening.
To prevent recurrence of blood clots after completion of 6 months of treatment
The recommended dose is one 2.5 mg tablet of Apixaban Bruno Farmaceutici 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 Bruno Farmaceutici to anticoagulant medicines Stop taking Apixaban Bruno Farmaceutici. Start treatment with anticoagulant medicines (e.g., heparin) at the time you would have taken the next tablet.
Switching from anticoagulant medicines to Apixaban Bruno Farmaceutici Stop taking anticoagulant medicines. Start treatment with Apixaban Bruno Farmaceutici at the time you would have taken the next dose of anticoagulant medicine, then continue taking it as usual.
Switching from treatment with a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Bruno Farmaceutici Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to start treatment with Apixaban Bruno Farmaceutici.
Switching from Apixaban Bruno Farmaceutici to treatment with a vitamin K antagonist anticoagulant (e.g., warfarin) If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban Bruno Farmaceutici 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 Bruno Farmaceutici.

Patients undergoing cardioversion
If your abnormal heart rhythm needs to be restored to normal by a procedure called cardioversion, take this medicine exactly as your doctor instructs, to prevent blood clots in blood vessels in the brain and other blood vessels in your body.
If you take more Apixaban Bruno Farmaceutici 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 Apixaban Bruno Farmaceutici than recommended, you may have an increased risk of bleeding. If bleeding occurs, you may require surgery, a blood transfusion, or other treatments that can reverse the anticoagulant activity against factor Xa.
If you forget to take Apixaban Bruno Farmaceutici
Take the missed dose as soon as you remember and:

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

Do not take a double dose to make up for a forgotten dose.
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 Bruno Farmaceutici
Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Apixaban Bruno Farmaceutici may be given for three different medical conditions. The known side effects and how frequently they occur may differ for 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 is taken to prevent blood clots after hip or knee replacement surgery.

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

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

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

Reduction in the number of platelets in the blood (which may affect blood clotting)
Bleeding:
- occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site
- 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
- increased levels of certain liver enzymes
- increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes
Itching

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

Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. 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:
- into the brain or spinal cord
- into the lungs or throat
- in the mouth
- in the abdomen or into the space behind the abdominal cavity
- from haemorrhoids
- blood tests showing blood in stools or urine
Skin rash which may blister and appear as small target-like spots (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Inflammation of blood vessels (vasculitis), which may present as skin rashes or sharp, flat, red, round spots under the skin surface or bruising
Bleeding in the kidney, sometimes with blood in urine, leading to the kidneys being unable to function properly (anticoagulant-related nephropathy)

The following side effects are known to occur when apixaban 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 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 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 sputum when coughing
- in the abdomen or from the vagina
- clear/red blood in stools
- occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site
- from haemorrhoids
- blood tests showing blood in stools or urine
Reduction in the number of platelets in the blood (which may affect blood clotting)
Blood tests may show:
- abnormal liver function
- increased levels of certain liver enzymes
- increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes
Skin rash
Itching
Hair loss
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and 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
- into the space behind the abdominal cavity
- into the muscle

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

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

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
Bleeding in the kidney, sometimes with blood in urine, leading to the kidneys being unable to function properly (anticoagulant-related nephropathy)

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

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

Bleeding, including:
- from the nose
- from the gums
- blood in 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 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 dizziness or a rapid heartbeat
Bleeding:
- in the eyes
- in the mouth or blood in sputum when coughing
- clear/red blood in stools
- blood tests showing blood in stools or urine
- occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site
- from haemorrhoids
- into 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 you experience any of these symptoms.
Blood tests may show:
- abnormal liver function
- increased levels of certain liver enzymes
- increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes

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

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

Not known (frequency cannot be estimated from available data)

Bleeding:
- in the abdomen or into the space behind the abdominal cavity
Skin rash which may blister and appear as small target-like spots (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Inflammation of blood vessels (vasculitis), which may present as skin rashes or sharp, flat, red, round spots under the skin surface or bruising
Bleeding in the kidney, sometimes with blood in urine, leading to the kidneys being unable to function properly (anticoagulant-related nephropathy)

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 Apixaban Bruno Farmaceutici

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.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Apixaban Bruno Farmaceutici contains

The active substance is apixaban. Each film-coated tablet contains 2.5 mg of apixaban.
The other components are:
• Tablet core: Cellactose 80 (Lactose monohydrate (75%) and cellulose (25%)), croscarmellose sodium (E468), sodium lauryl sulfate (E487), magnesium stearate (E470b).
• Film coating: Macrogol, talc, titanium dioxide (E171), glycerol monocaprylocaprate type I, polyvinyl alcohol (E1203), yellow iron oxide (E172).

Description of the appearance of Apixaban Bruno Farmaceutici and contents of the pack
Yellow, round, biconvex, film-coated tablets (6 mm in diameter) with "C28" engraved on one side.
Available in blister packs of 60 tablets in a box.

Patient Alert Card: managing information
Inside the packaging of Apixaban Bruno Farmaceutici, together with the package leaflet, you will find a Patient Alert Card, or your doctor may provide you with a similar one.
This Patient Alert Card includes information that may be useful to you and alerts other healthcare professionals that you are taking Apixaban Bruno Farmaceutici. 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 always keep it with you.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare Srl
Via Marghera, 29
20149 - Milan, Italy
Manufacturer
Coripharma ehf
Reykjavíkurvegur 78-80
220 Hafnarfjörður
Iceland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country	Name
Italy	Apixaban Bruno Farmaceutici

Patient information leaflet

Apixaban Bruno Farmaceutici 5 mg film-coated tablets

apixaban
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may 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 Apixaban Bruno Farmaceutici is and what it is used for
What you need to know before taking Apixaban Bruno Farmaceutici
How to take Apixaban Bruno Farmaceutici
Possible side effects
How to store Apixaban Bruno Farmaceutici
Contents of the pack and other information

1. What Apixaban Bruno Farmaceutici is and what it is used for

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

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 detach 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 recurrence of blood clots in the blood vessels of the legs and/or lungs.

2. What you need to know before taking Apixaban Pharmacare

Do not take Apixaban Bruno Farmaceutici if:

you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
you are bleeding excessively;
you have a disease in an organ of the body that increases the risk of serious bleeding (such as a recent or active ulcer of 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 having a venous or arterial catheter and 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 Apixaban Bruno Farmaceutici if you have any of the following conditions:

an increased risk of bleeding, such as:
bleeding disorders, including conditions leading to reduced platelet function;
very high blood pressure not controlled by medical treatment;
if you are over 75 years old;
if you weigh 60 kg or less;
a serious kidney disease or if you are on dialysis;
liver problems or a history of liver problems; this medicine will be used with caution in patients showing signs of impaired liver function;
you have a prosthetic heart valve;
if your doctor finds that your blood pressure is unstable or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

Take special care with Apixaban Pharmacare

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 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 Pharmacare
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 Bruno Farmaceutici, while others can reduce them. Your doctor will decide whether you should be treated with Apixaban Bruno Farmaceutici when taking these medicines and how closely you need to be monitored.
The following medicines may increase the effects of Apixaban Bruno Farmaceutici 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). 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 Apixaban Bruno Farmaceutici 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 to treat 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, consult your doctor, pharmacist, or nurse before taking this medicine.
The effect of apixaban 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 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 has not shown effects on the ability to drive or operate machinery.
Apixaban Bruno Farmaceutici contains lactose (a type of sugar) and sodium
If your doctor has informed you of an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Apixaban Pharmacare

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 some water. Apixaban Bruno Farmaceutici may be taken with
or without food. Try to take the tablets at the same time each day to achieve the best
effect from treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take
Apixaban Pharmacare. The tablet may be crushed and mixed with water, or 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 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.

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 mg/dL (133 micromoles/L) or higher); you are 80 years of age or older; your body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one in the morning and one in the evening. Your doctor will decide how long you should continue treatment.
To treat blood clots in the veins of the legs and in the blood vessels of the lungs
The recommended dose is two 5 mg tablets of Apixaban Bruno Farmaceutici twice daily for
the first 7 days, for example, two in the morning and two in the evening.
After 7 days, the recommended dose is one 5 mg tablet of Apixaban Bruno Farmaceutici twice
daily, for example, one in the morning and one in the evening.
To prevent recurrence of blood clots after completion of 6 months of treatment
The recommended dose is one 2.5 mg tablet of Apixaban Bruno Farmaceutici 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 Bruno Farmaceutici to other anticoagulant medicines Stop taking Apixaban Pharmacare. Start treatment with anticoagulant medicines (e.g., heparin) at the time you would have taken your next tablet.
Switching from an anticoagulant medicine to Apixaban Pharmacare Stop taking the anticoagulant medicine. Start treatment with Apixaban Bruno Farmaceutici at the time you would have taken your next dose of the anticoagulant medicine, then continue taking it as usual.
Switching from treatment with a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Pharmacare
Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you on when to start treatment with Apixaban Pharmacare.
Switching from Apixaban Bruno Farmaceutici to treatment with a vitamin K antagonist anticoagulant (e.g., warfarin)
If your doctor tells you to start taking a vitamin K antagonist medicine, continue taking Apixaban Bruno Farmaceutici for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you on when to stop treatment with Apixaban Pharmacare.

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 instructs you to take it, to prevent blood clots in the blood vessels of the brain and other blood vessels in your body.
If you take more Apixaban Bruno Farmaceutici 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 Apixaban Bruno Farmaceutici than recommended, you may have an increased risk
of bleeding. If bleeding occurs, you may require surgery, a blood transfusion, or other treatments that can reverse the anticoagulant activity against factor Xa.
If you forget to take Apixaban Pharmacare
Take the missed dose as soon as you remember and:

take your next dose of Apixaban Bruno Farmaceutici at the usual time, then continue as prescribed.

Do not take a double dose to make up for the missed dose.
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 Pharmacare
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 doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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 apixaban is taken to prevent blood clots forming in the heart in patients with irregular heartbeat and at least one additional risk factor.

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

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

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

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

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

Bleeding:
- in the lungs or throat;
- behind the abdominal cavity (retroperitoneal haemorrhage);
- 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 "target" lesions (central dark 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 beneath 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 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 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;
Decrease in the number of platelets in the blood (which may affect blood clotting);
Nausea (feeling sick);
Skin rash;
Blood tests may show:
- increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT).

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

Low blood pressure, which may cause dizziness or a rapid heartbeat;
Bleeding:
- in the eyes;
- in the mouth or blood in coughed-up phlegm;
- bright red blood in the stools;
- blood tests showing blood in the stools or urine;
- 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;
- 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 certain liver enzymes;
- increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.

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

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

Not known (frequency cannot be estimated from available data)

Bleeding:
- in the abdomen or behind the abdominal cavity (retroperitoneal haemorrhage);
Skin rash that may blister and appear as small "target" lesions (central dark 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 beneath the skin surface or bruising;
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 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 Apixaban Pharmacare

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 Pharmacare contains

The active substance is apixaban. Each film-coated tablet contains 5 mg of apixaban.
The other components are:
Tablet core: Cellactose 80 (Lactose monohydrate (75%) and cellulose (25%)), croscarmellose sodium (E468), sodium lauryl sulfate (E487), magnesium stearate (E470b).
Film coating: Macrogol, talc, titanium dioxide (E171), glycerol monocaprylocaprate type I, polyvinyl alcohol (E1203), iron oxide red (E172).

Description of the appearance of Apixaban Bruno Farmaceutici and pack contents
Pink, oval, biconvex, film-coated tablets (size 5.2 x 10 mm) with "C29" engraved on one side.
Available in blister packs of 60 film-coated tablets in a carton.

Patient Alert Card: information management
Inside the packaging of Apixaban Pharmacare, together with the package leaflet, you will find a Patient Alert Card, or your doctor may provide you with a similar one.
This Patient Alert Card includes information that may be helpful to you and alerts other physicians that you are taking Apixaban Pharmacare.
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 always keep it with you.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country	Name
Italy	Apixaban Pharmacare