Package leaflet: Information for the patient

Apixaban Torrent 2.5 mg film-coated tablets

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

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

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

Apixaban Torrent 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 Torrent 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 veins of your leg. This can cause swelling of the legs, with or without pain. If a blood clot moves from the leg to the lungs, it can block blood flow, causing shortness of breath, with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
to prevent the formation of blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and travel to the brain, causing a stroke, or reach other organs and block normal blood flow to those organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
to treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent blood clots from recurring in the blood vessels of the legs and/or lungs.

2. What you need to know before taking Apixaban Torrent

Do not take Apixaban Torrent 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 an organ disease that leads to an increased risk of serious bleeding (such as a recent or active stomach or intestinal ulcer, recent bleeding in the brain);
you have a liver disease that leads to an increased risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood 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 this medicine if you have any of the following conditions:

an increased risk of bleeding, such as:
- bleeding disorders, including conditions leading to reduced platelet function
- very high blood pressure not controlled by medical treatment
- if you are over 75 years old
- if you weigh 60 kg or less
- severe kidney disease or 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 had a tube (catheter) or 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 Apixaban Torrent

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.

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 time. If you are unsure whether a procedure may cause bleeding, ask your doctor.

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

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

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

certain medicines for fungal infections (e.g., ketoconazole, etc.);
certain antiviral medicines for HIV/AIDS (e.g., ritonavir);
other medicines used to reduce blood clotting (e.g., enoxaparin, etc.);
anti-inflammatory 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 Torrent 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, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.

The effect of Apixaban Torrent 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 Apixaban Torrent 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 Torrent has not shown effects on the ability to drive or use machines.

Apixaban Torrent contains lactose
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.

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

3. How to take Apixaban Torrent

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 Torrent 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 Torrent. The tablet can be crushed and mixed with water, 5% glucose in water,
apple juice, or apple puree, immediately before administration.
Instructions for crushing the tablet:

Crush the tablets 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 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 Torrent tablet mixed
with 60 mL of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Torrent as recommended:
To prevent blood clots after hip or knee replacement surgery.
The recommended dose is one tablet of Apixaban Torrent 2.5 mg 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 32 to 38 days.
If you have undergone major knee surgery, you will usually take the tablets for 10 to 14 days.
To prevent blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor.
The recommended dose is one tablet of Apixaban Torrent 5 mg twice daily.
The recommended dose is one tablet of Apixaban Torrent 2.5 mg 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 (deep vein thrombosis and pulmonary embolism).
The recommended dose is two tablets of Apixaban Torrent 5 mg twice daily for the first 7 days, for example, two in the morning and two in the evening.
After 7 days, the recommended dose is one tablet of Apixaban Torrent 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 tablet of Apixaban Torrent 2.5 mg 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 Torrent to anticoagulant medicines Stop taking Apixaban Torrent. Start treatment with anticoagulant medicines (e.g., heparin) at the time you would have taken your next tablet.
Switching from anticoagulant medicines to Apixaban Torrent Stop taking the anticoagulant medicine. Start taking Apixaban Torrent at the time you would have taken your next dose of anticoagulant, then continue taking it as usual.
Switching from vitamin K antagonist anticoagulant therapy (e.g., warfarin) to Apixaban Torrent Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to start Apixaban Torrent.
Switching from Apixaban Torrent to vitamin K antagonist anticoagulant therapy (e.g., warfarin) If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban Torrent for at least 2 days after the first dose of the vitamin K antagonist. Your doctor will need to perform blood tests and advise you when to stop Apixaban Torrent.

Patients undergoing cardioversion
If your abnormal heart rhythm needs to be corrected 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 elsewhere in the body.
If you take more Apixaban Torrent 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 Apixaban Torrent than recommended, you may have an increased risk of bleeding. If bleeding occurs, you may require surgery, a blood transfusion, or other treatments to reverse the anticoagulant effect on factor Xa.
If you forget to take Apixaban Torrent

Take the missed dose as soon as you remember and:
take your next dose of Apixaban Torrent at the 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 Torrent
Do not stop taking this medicine without first talking to your doctor, as your risk of developing a blood clot may be higher if you stop treatment too early.
If you have any questions about 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 everyone gets them. Apixaban Torrent may be given for three different medical conditions. The known side effects and how frequently they occur may differ depending on these conditions and are listed separately below. For these conditions, the most common general side effect with this medicine is bleeding, which can potentially be life-threatening and requires immediate medical attention.

The following side effects are known to occur when Apixaban Torrent 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:
- 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 or intestine, or clear/red blood in faeces
- 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 the available data)

Bleeding:
- in the brain or spinal cord
- in the lungs or throat
- in the mouth
- in the abdomen or in the space behind the abdominal cavity
- from haemorrhoids
- blood tests showing blood in faeces or urine
Skin rash which may blister and appear 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 Apixaban Torrent 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 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) levels

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 faeces
- 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 faeces or urine
Reduction in the number of platelets in the blood (which may affect 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
- in 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 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 the available data)

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

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

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

Bleeding, including:
- from the nose
- from the gums
- in urine
- bruising and swelling
- in the stomach, intestine, or from the rectum
- in the mouth
- from the vagina
Anaemia, which may cause tiredness or pale skin
Reduction in the number of platelets in the blood (which may affect clotting)
Nausea (feeling unwell)
Skin rash
Blood tests may show:
- increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT) levels

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 faeces
- blood tests showing blood in faeces or urine
- 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 the available data)

Bleeding:
- in the abdomen or in the space behind the abdominal cavity
Skin rash which may blister and appear 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, pharmacist, or nurse. 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 Torrent

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 on the blister after Exp. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
For the 60-tablet bottle pack:
Apixaban Torrent must not be used more than 30 days after first opening the bottle.
For the 500-tablet bottle pack:
Apixaban Torrent must not be used more than 90 days after first opening the bottle.
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 Torrent contains
• The active substance is apixaban.
Each Apixaban Torrent 2.5 mg film-coated tablet contains 2.5 mg of apixaban.
• The other components are:
Tablet core:
Anhydrous lactose, microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate
Film coating: hypromellose (E464), monohydrate lactose, titanium dioxide (E171), triacetin, iron oxide yellow (E172)

Description of the appearance of Apixaban Torrent and package contents
Apixaban Torrent 2.5 mg film-coated tablets are yellow, round, biconvex, film-coated tablets with bevelled edges, marked with "H6" on one side and smooth on the other.
Apixaban Torrent 2.5 mg film-coated tablets are available in Alu/Alu blisters containing 20 and 200 film-coated tablets or in HDPE bottles with child-resistant closure/continuous thread and induction seal containing 60 or 500 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: managing information
Inside the Apixaban Torrent package, 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 Torrent. You must always carry this card with you.

Take the card.
Separate the section in your language if necessary (this is made easier by the perforated edges).
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
Torrent Pharma (Malta) Ltd.
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914,
Malta
Manufacturer
Torrent Pharma (Malta) Ltd
Central Business Centre, Level 2,
Triq Hal Tarxien, Il
Gudja GDJ 1907
Malta

Patient information leaflet

Apixaban Torrent 5 mg film-coated tablets

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet
What Apixaban Torrent is and what it is used for

What you need to know before taking Apixaban Torrent
How to take Apixaban Torrent
Possible side effects
How to store Apixaban Torrent
Contents of the pack and other information

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

Apixaban Torrent 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, an important component in blood coagulation.
Apixaban Torrent is used in adults:

to prevent the formation of blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or reach other organs, impairing 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 Torrent

Do not take Apixaban Torrent 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 leads to an increased 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 leads to 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 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 this medicine if you have any of the following conditions:

an increased risk of bleeding, such as:
- bleeding disorders, including conditions leading to reduced platelet function
- very high blood pressure not controlled by medical treatment
- if you are over 75 years old
- if you weigh 60 kg or less
- severe kidney disease or 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 Torrent

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

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

certain medicines for fungal infections (e.g., ketoconazole, etc.);
certain antiviral medicines for HIV/AIDS (e.g., ritonavir);
other medicines used to reduce blood clotting (e.g., enoxaparin, etc.);
anti-inflammatory 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 Torrent 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, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
The effect of Apixaban Torrent 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 Torrent 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 vehicles or use machinery.
Apixaban Torrent contains lactose
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
Apixaban Torrent contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Apixaban Torrent

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 Torrent may be taken with or without food.
Try to take your tablets at the same time each day to get the best effect from
treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take
Apixaban Torrent. 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 listed above to prepare a mixture.
Swallow the mixture.
Rinse the mortar and pestle used to crush the tablet and the container with a small amount of water (e.g., 30 mL) or one of the other liquids, and swallow the rinse.

If necessary, your doctor may also administer crushed Apixaban Torrent tablets
mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Torrent as recommended:
To prevent blood clots forming in the heart in patients with irregular heartbeat and at least one additional
risk factor.
The recommended dose is one tablet of Apixaban Torrent 5 mg twice daily.
The recommended dose is one tablet of Apixaban Torrent 2.5 mg 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 tablets of Apixaban Torrent 5 mg twice daily for the first 7
days, for example, two in the morning and two in the evening.
After 7 days, the recommended dose is one tablet of Apixaban Torrent 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 tablet of Apixaban Torrent 2.5 mg 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 Torrent to anticoagulant medicines Stop taking Apixaban Torrent. 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 Torrent Stop taking the anticoagulant medicine. Start treatment with Apixaban Torrent at the time you would have taken your next dose of anticoagulant medicine, then continue taking it as usual.
Switching from treatment with a vitamin K antagonist (e.g., warfarin) to Apixaban Torrent 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 Torrent.
Switching from Apixaban Torrent to treatment with a vitamin K antagonist (e.g., warfarin) If your doctor tells you to start taking the vitamin K antagonist medicine, continue taking Apixaban Torrent 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 taking Apixaban Torrent.

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
prevent blood clots in blood vessels of the brain and elsewhere in your body.
If you take more Apixaban Torrent than you should
Inform your doctor immediately if you have taken more than the prescribed dose of Apixaban Torrent. Bring the
medicine pack with you, even if no tablets remain.
If you take more Apixaban Torrent than recommended, you may have an increased risk of
bleeding. If bleeding occurs, surgery, a blood transfusion, or other treatments that can reverse the anticoagulant effect on factor Xa may be required.
If you forget to take Apixaban Torrent

Take the missed dose as soon as you remember and:
take your next dose of Apixaban Torrent at the usual time.
then continue as prescribed. 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 Torrent
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 everyone gets them. The most common general side effect with 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 Torrent 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 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 coughed-up phlegm 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 fluids from the surgical wound/incision (wound discharge) or from the injection site;
- from haemorrhoids;
- tests showing blood in the stools or urine;
Reduced platelet count in the blood (which may affect 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;
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;
- in the muscle.

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

Rash that may blister and appear as small target-like 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 present as skin rashes or small, flat, red, round spots under the skin surface or bruising.

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

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

Bleeding, including:
- from the nose;
- from the gums;
- blood in the urine;
- bruising and swelling;
- in the stomach, intestines, or from the rectum;
- in the mouth;
- from the vagina;
Anaemia, which may cause tiredness or pale skin;
Reduced platelet count in the blood (which may affect clotting);
Nausea (feeling unwell);
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 when coughing;
- bright red blood in the stools;
- tests showing blood in the 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:
- 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 the available data)

Bleeding:
- in the abdomen or behind the abdominal cavity.
Rash that may blister and appear 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 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 Apixaban Torrent

6. Package contents and other information

What Apixaban Torrent contains

The active substance is apixaban. Each 5 mg film-coated tablet of Apixaban Torrent contains 5 mg of apixaban.
The other components are: Tablet core: anhydrous lactose, microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate.

Film coating: hypromellose (E464), monohydrate lactose, titanium dioxide (E171), triacetin,
red iron oxide (E172).

Description of the appearance of Apixaban Torrent and package contents
Apixaban Torrent 5 mg film-coated tablets are pink, oval-shaped, biconvex, film-coated tablets with bevelled edges, marked with "H5" on one side and smooth on the other side.
Apixaban Torrent 5 mg film-coated tablets are available in Alu/Alu blisters containing 20 or 200 film-coated tablets, or in HDPE bottles with child-resistant continuous thread cap and induction seal containing 60 or 500 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: managing information
Inside the package of Apixaban Torrent, 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 physicians that you are taking Apixaban Torrent.
You must always carry this card with you.

Take the card.
Separate the section in your language if necessary (this is made easier by the perforated edges).
Complete the following sections or ask your doctor to do so:
* Name:
* Date of birth:
* Indication:
* Dose: ......mg twice daily
* Doctor's name:
* Doctor's telephone number:
Fold the card and always keep it with you.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Torrent Pharma (Malta) Ltd.
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914,
Malta

Manufacturer
Torrent Pharma (Malta) Ltd
Central Business Centre, Level 2,
Triq Hal Tarxien, Il
Gudja GDJ 1907
Malta