Apixaban Teva

Package leaflet: Information for the user

Apixaban Teva 2.5 mg film-coated tablets

apixaban
Generic medicine
Read this entire 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 pass it on 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, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Apixaban Teva is and what it is used for
2. What you need to know before taking Apixaban Teva
3. How to take Apixaban Teva
4. Possible side effects
5. How to store Apixaban Teva
6. Contents of the pack and other information

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

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

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

Apixaban Teva is used in children aged from 28 days up to but less than 18 years to treat blood clots and to prevent blood clots from recurring in the veins or blood vessels of the lungs.
For the appropriate recommended dose according to body weight, see section 3.

2. What you need to know before taking Apixaban Teva

Do not take Apixaban Teva 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 leads to a higher risk of serious bleeding (such as an active or recent ulcer of the stomach or intestine, or a 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 clotting (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while having a venous or arterial catheter and receiving heparin through that catheter 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 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 an injection in the spinal column (for anaesthesia or pain relief). Your doctor will instruct you to take this medicine at least 5 hours or more after removal of the catheter.
• you have a prosthetic heart valve
• if your doctor finds that your blood pressure is unstable, or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

Take special care with Apixaban Teva

• 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 period. If you are unsure whether a procedure could cause bleeding, consult your doctor.

Children and adolescents
This medicine is not recommended for children and adolescents weighing less than 35 kg.

Other medicines and Apixaban Teva
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 Teva, while others can reduce them. Your doctor will decide whether treatment with Apixaban Teva is appropriate when you are taking these medicines and how closely you should be monitored.

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

• certain antifungal medicines (e.g., ketoconazole, etc.),
• certain antiviral medicines for HIV/AIDS (e.g., ritonavir),
• other medicines used to reduce blood clotting (e.g., enoxaparin, etc.),
• anti-inflammatory or pain-relieving medicines (e.g., acetylsalicylic acid or naproxen). 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),
• antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

The following medicines may reduce the effects of Apixaban Teva 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 to treat tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
The effects of apixaban during pregnancy and on the unborn child 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 Teva 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 Teva has not shown effects on the ability to drive or use machines.

Apixaban Teva contains lactose (a type of sugar) and sodium.
If your doctor has diagnosed you with 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 Teva

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor, pharmacist, or nurse.

Dose
Swallow the tablet with some water. Apixaban Teva can be taken with or without food.
Try to take the tablets at the same time each day to achieve the best effect from treatment.

If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take Apixaban Teva. 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 for crushing 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 Teva tablet mixed with 60 ml of water or 5% glucose in water through a nasogastric tube.

Take Apixaban Teva 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 dose 12 to 24 hours after surgery.
If you had surgery on the hip, you will usually take the tablets for 32 to 38 days.
If you had surgery on the knee, you will usually take the tablets for 10 to 14 days.

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

• you have severely reduced kidney function, or
• you meet two or more of the following conditions:
  • blood test results suggest poor kidney function (serum creatinine value 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 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 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 2.5 mg tablet twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.

Use in children and adolescents
To treat blood clots and to prevent recurrence of blood clots in veins or in blood vessels of the lungs.
Take or administer this medicine exactly as instructed by your doctor, the child’s doctor, or pharmacist. If you have any doubts, consult your doctor, the child’s doctor, pharmacist, or nurse. Try to take or administer the dose at the same time each day to achieve the best effect from treatment.

The dose of Apixaban Teva depends on body weight and will be calculated by the doctor. The recommended dose for children and adolescents with a body weight of at least 35 kg is four tablets of Apixaban Teva 2.5 mg twice daily for the first 7 days, for example, four in the morning and four in the evening. After 7 days, the recommended dose is two tablets of Apixaban Teva 2.5 mg twice daily, for example, two in the morning and two in the evening.

For parents or caregivers: Observe the child to ensure the full dose has been taken. It is important to attend scheduled medical appointments, as the dose may need to be adjusted as body weight changes.

Your doctor may adjust your anticoagulant treatment as follows:

• Switching from Apixaban Teva to another anticoagulant medicine
  Stop taking Apixaban Teva. Start treatment with the other anticoagulant medicine (e.g., heparin) at the time you would have taken your next tablet.

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

• Switching from a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Teva
  Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you on when to start Apixaban Teva.

• Switching from Apixaban Teva to a vitamin K antagonist anticoagulant (e.g., warfarin)
  If your doctor tells you to start taking a vitamin K antagonist medicine, continue taking Apixaban Teva 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 on when to stop Apixaban Teva.

Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal through a procedure called cardioversion, take this medicine exactly as your doctor instructs, to prevent blood clots in blood vessels of the brain and other parts of your body.

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

If you forget to take Apixaban Teva

• If you forget to take your morning dose, take it as soon as you remember, and you may take it together with your evening dose.
• A forgotten evening dose may only be taken the same evening. Do not take two doses the next morning; instead, continue with your regular twice-daily dosing schedule the following day.

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

If you have any questions about using 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. Apixaban Teva may be administered for three different medical conditions. The known side effects and their frequency may vary 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 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, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or injection site
  • In the stomach, intestines, or clear/red blood in stools
  • In the urine
  • From the nose
  • From the vagina
• Low blood pressure, which may cause dizziness 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 any of these symptoms occur.
• 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
  • In the lungs or throat
  • In the mouth
  • In the abdomen or the space behind the abdominal cavity
  • From haemorrhoids
  • Tests showing blood in stools or urine
• Skin rash which may form blisters and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).
• Inflammation of blood vessels (vasculitis), which may present as skin rashes or sharp, flat, red, round spots under the skin surface or bruising.
• 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 prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

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

• Bleeding, including:
  • In the eyes
  • In the stomach or intestines
  • From the rectum
  • In the urine
  • From the nose
  • From the gums
  • Bruising and swelling
• Anaemia, which may cause tiredness or pale skin
• Low blood pressure, which may cause dizziness or a rapid heartbeat
• Nausea (feeling unwell)
• Blood tests may show:
  • Increased gamma-glutamyltransferase (GGT) levels

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

• Bleeding:
  • Into 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, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or injection site
  • From haemorrhoids
  • Tests showing blood in stools or urine
• Reduction in the number of platelets in the blood (which may affect blood clotting)
• Blood tests may show:
  • 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 any of these symptoms occur.

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 form blisters and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).

Not known (frequency cannot be estimated from available data)

• Inflammation of blood vessels (vasculitis), which may present as skin rashes or sharp, flat, red, round spots under the skin surface or bruising.
• 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 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 the urine
  • Bruising and swelling
  • In the stomach, intestines, or from the rectum
  • In the mouth
  • From the vagina
• Anaemia, which may cause tiredness or pale skin
• Reduction in the number of platelets in the blood (which may affect blood clotting)
• Nausea (feeling unwell)
• Skin rash
• Blood tests may show:
  • Increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) levels

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

• Low blood pressure, which may cause weakness or a rapid heartbeat
• Bleeding:
  • Into the eyes
  • In the mouth or blood in sputum when coughing
  • Clear/red blood in stools
  • Tests showing blood in stools or urine
  • Occurring after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or 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 any of these symptoms occur.
• 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:
  • Into the brain or spinal cord
  • In the lungs

Not known (frequency cannot be estimated from available data)

• Bleeding:
  • In the abdomen or the space behind the abdominal cavity
• Skin rash which may form blisters and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• Inflammation of blood vessels (vasculitis), which may present as skin rashes or sharp, flat, red, round spots under the skin surface or bruising
• Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy)

Other side effects in children and adolescents
Contact the child’s doctor immediately if you notice any of the following symptoms:

• Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. The frequency of these side effects is common (may affect up to 1 in 10 people).

In general, side effects observed in children and adolescents treated with Apixaban Teva have been similar to those seen in adults and have mainly been mild to moderate in severity. The side effects observed more frequently in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

• Bleeding, including:
  • From the vagina
  • From the nose

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

• Bleeding, including:
  • From the gums
  • In the urine
  • Bruising and swelling
  • From the intestine or rectum
  • Clear/red blood in stools
  • Occurring after any surgery, including bruising and swelling, bleeding from the surgical wound/incision (wound discharge) or injection site
• Hair loss
• Anaemia, which may cause tiredness or pale skin
• Reduction in the number of platelets in the child’s blood (which may affect blood clotting)
• Nausea (feeling unwell)
• Skin rash
• Itching
• Low blood pressure, which may cause the child to feel weak or have a rapid heartbeat
• Blood tests may show:
  • Abnormal liver function
  • Increased levels of certain liver enzymes
  • Increased alanine aminotransferase (ALT)

Not known (frequency cannot be defined based on available data)

• Bleeding:
  • In the abdomen or the space behind the abdominal cavity
  • In the stomach
  • In the eyes
  • In the mouth
  • From haemorrhoids
  • In the mouth or blood in sputum when coughing
  • Into the brain or spinal cord
  • In the lungs
  • Into the muscle
• Skin rash which may form blisters and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• Inflammation of blood vessels (vasculitis), which may present as skin rashes or sharp, flat, red, round spots under the skin surface or bruising
• Blood tests may show:
  • Increased gamma-glutamyltransferase (GGT) levels
  • Tests showing blood in stools or urine
• Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy)

Reporting of side effects
If you get any side effects, including ones 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Apixaban Teva

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, bottle 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Apixaban Teva contains

• The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
• The excipients are:
  • Tablet core: lactose (see section 2), microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate.
  • Film coating: monohydrate lactose (see section 2), hypromellose (E464), titanium dioxide (E171), macrogol 3350, triacetin, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Apixaban Teva and contents of the pack
The film-coated tablets are round, light yellow in colour, with "TV" engraved on one side and "G1" on the other side of the tablet. Dimensions: diameter 5.9 – 6.5 mm, thickness 3.0 – 3.6 mm.
Apixaban Teva is available in:

• Unit-dose divisible blisters containing 10x1, 14x1, 20x1, 30x1, 56x1, 60x1, 100x1, 120x1, 168x1, 200x1 film-coated tablets
• Bottles containing 180, 200 and 500 film-coated tablets
• Bottles containing 180, 200 and 500 film-coated tablets with cotton

Not all pack sizes may be marketed.
Patient Alert Card: managing information
Inside the Apixaban Teva 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 contains important information that may be useful to you and alerts other doctors that you are taking Apixaban Teva. You must always carry this card with you.

1. Take the card.
2. 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:
3. Fold the card and always keep it with you.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa, 2600,
Bulgaria
This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following names:

Patient Information Leaflet: Information for the User

Apixaban Teva 5 mg film-coated tablets

apixaban
Generic medicine
Please read 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Apixaban Teva is and what it is used for
2. What you need to know before taking Apixaban Teva
3. How to take Apixaban Teva
4. Possible side effects
5. How to store Apixaban Teva
6. Contents of the pack and other information

2. What Apixaban Teva is and what it is used for

Apixaban Teva 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 the blood clotting process.
Apixaban Teva 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 break loose and travel to the brain causing a stroke, or may travel to other organs, blocking normal blood flow to these 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.

Apixaban Teva is used in children aged from 28 days up to less than 18 years to treat blood clots and to prevent blood clots from recurring in the veins or in the blood vessels of the lungs.
For the appropriate recommended dose according to body weight, see section 3.

4. What you need to know before taking Apixaban Teva

Do not take Apixaban Teva 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 leads to an increased risk of serious bleeding (such as an active or recent 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 clotting (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 this route 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 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 Teva

• 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 with body weight below 35 kg.
Other medicines and Apixaban Teva
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 Teva, while others can reduce them. Your doctor will decide whether you should be treated with Apixaban Teva when taking these medicines and how closely you should be monitored.
The following medicines may increase the effects of Apixaban Teva and increase the risk of unwanted bleeding:

• some medicines for fungal infections (e.g., ketoconazole, etc.),
• some antiviral medicines for HIV/AIDS (e.g., ritonavir),
• other medicines used to reduce blood clotting (e.g., enoxaparin, etc.),
• anti-inflammatory or painkillers (e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years old and are taking acetylsalicylic acid, you may have a higher risk of bleeding,
• medicines for high blood pressure or heart problems (e.g., diltiazem),
• antidepressants known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

The following medicines may reduce the effects of Apixaban Teva 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 to treat tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
The effects of apixaban during pregnancy and on the unborn child 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 Teva 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 Teva has not shown effects on the ability to drive or operate machinery.
Apixaban Teva contains lactose (a type of sugar) and sodium.
If your doctor has diagnosed you with 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”.

5. How to take Apixaban Teva

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor, pharmacist, or nurse.
Dose
Swallow the tablet with a little water. Apixaban Teva can be taken with or without food.
Try to take the tablets at the same time each day to achieve the best effect from
treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways you can take
Apixaban Teva. 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 of 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 Teva tablet mixed with 60 ml of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Teva as recommended:
To prevent 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 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 leg veins and blood vessels of the lungs
The recommended dose is two 5 mg tablets twice daily for the first 7 days, for example
two in the morning and two in the evening.
After 7 days, the recommended dose is one 5 mg tablet 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 2.5 mg tablet twice daily, for example, one in the morning
and one in the evening.
Your doctor will decide how long you should continue treatment.
Use in children and adolescents
To treat blood clots and to prevent recurrence of blood clots in veins or blood vessels of the lungs.
Take or administer this medicine exactly as instructed by your doctor, the child's doctor, or pharmacist. If you have any doubts, consult your doctor, the child's doctor, pharmacist, or nurse. Try to take or administer the dose at the same time each day to achieve the best effect from treatment.
The dose of Apixaban Teva depends on body weight and will be calculated by the doctor. The recommended dose for children and adolescents with body weight of at least 35 kg is two tablets of Apixaban Teva 5 mg twice daily for the first 7 days, for example four in the morning and four in the evening. After 7 days, the recommended dose is one tablet of Apixaban Teva 5 mg twice daily, for example, one in the morning and one in the evening.
For parents or caregivers: observe the child to ensure the full dose has been taken. It is important to keep scheduled medical appointments, as the dose may need to be adjusted as body weight changes.
Your doctor may modify your anticoagulant treatment as follows:

• Switching from Apixaban Teva to another anticoagulant medicine Stop taking Apixaban Teva. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you would have taken the next tablet.
• Switching from another anticoagulant medicine to Apixaban Teva Stop taking the anticoagulant medicine. Start treatment with Apixaban Teva at the time you would have taken the 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 Teva Stop taking the vitamin K antagonist anticoagulant medicine. Your doctor will need to perform blood tests and advise you when to start Apixaban Teva.
• Switching from Apixaban Teva 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 Teva 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 Apixaban Teva.

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 of the brain and other parts of your body.
If you take more Apixaban Teva than you should
Inform your doctor immediately if you have taken more than the prescribed dose of this medicine. Take the medicine pack with you, even if no tablets remain.
If you take more Apixaban Teva than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery, blood transfusion, or other treatments to reverse anti-factor Xa activity may be required.
If you forget to take Apixaban Teva

• If you forget a morning dose, take it as soon as you remember; you may take it together with your evening dose.
• A forgotten evening dose may only be taken the same evening. Do not take two doses the following morning; instead, continue with the recommended twice-daily dosing schedule the next day.

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 Teva
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 everybody will get 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 the formation of blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

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

• Bleeding, including:
  • in the eyes
  • in the stomach or 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, making you feel faint or experience a rapid heartbeat
• Nausea (feeling unwell)
• Blood tests may show:
  • an increase in gamma-glutamyltransferase (GGT)

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

• Bleeding:
  • in the brain or spinal cord
  • in the mouth or blood in coughed-up mucus when coughing
  • in the abdomen or from the vagina
  • clear/red blood in stools
  • bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site
  • from haemorrhoids
  • tests showing blood in stools or urine
• Decrease in the number of platelets in the blood (which may affect blood clotting)
• Blood tests may show:
  • abnormal liver function
  • increase in certain liver enzymes
  • increase in 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
  • in the space 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 appears 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 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 the 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 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 unwell)
• Rash
• Blood tests may show:
  • an increase in gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT)

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

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

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

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

Not known (frequency cannot be estimated from available data)

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

Other side effects in children and adolescents
Contact the child’s doctor immediately if you notice any of the following symptoms:

• Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. The frequency of these side effects is common (may affect up to 1 in 10 people).

In general, the side effects observed in children and adolescents treated with Apixaban Teva have been of a similar type to those observed in adults and have mainly been mild to moderate in severity. The side effects observed more frequently in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

• Bleeding, including:
  • from the vagina
  • from the nose

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

• Bleeding, including:
  • from the gums
  • blood in the urine
  • bruising and swelling
  • from the intestine or rectum
  • clear/red blood in stools
  • bleeding occurring after any surgery, including bruising and swelling, leakage of blood from the surgical wound/incision (wound discharge) or from the injection site
• Hair loss
• Anaemia, which may cause tiredness or pale skin
• Decrease in the number of platelets in the child’s blood (which may affect blood clotting)
• Nausea (feeling unwell)
• Rash
• Itching
• Low blood pressure, which may cause the child to feel weak or experience a rapid heartbeat
• Blood tests may show:
  • abnormalities in liver function
  • increase in certain liver enzymes
  • increase in alanine aminotransferase (ALT)

Not known (frequency cannot be estimated from available data)

• Bleeding:
  • in the abdomen or in the space behind the abdominal cavity
  • in the stomach
  • in the eyes
  • in the mouth
  • from haemorrhoids
  • in the mouth or blood in coughed-up mucus when coughing
  • in the brain or spinal cord
  • in the lungs
  • in the muscle
• Rash that may blister and appears as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• Inflammation of blood vessels (vasculitis), which may present as skin rashes or sharp, flat, red, round spots under the skin surface or bruising
• Blood tests may show:
  • an increase in gamma-glutamyltransferase (GGT)
  • tests showing blood in stools or urine
• Bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys being unable to function properly (anticoagulant-related nephropathy)

Reporting of side effects
If you get any side effects, 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 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 Teva

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, bottle 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Apixaban Teva contains

• The active substance is apixaban. Each tablet contains 5 mg of apixaban.
• The excipients are:
  • Tablet core: lactose (see section 2), microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate.
  • Film coating: monohydrate lactose (see section 2), hypromellose (E464), titanium dioxide (E171), macrogol 3350, triacetin, red iron oxide (E172).

Description of the appearance of Apixaban Teva and package contents
The film-coated tablets are modified oval-shaped, light pink in colour, with "TV" engraved on one side and "G2" on the other side of the tablet. Dimensions: length 9.9 – 10.5 mm, width 5.0 – 5.6 mm, thickness 4.2 – 4.8 mm.
Apixaban Teva is available in:

• Divisible blisters for single doses containing 10x1, 14x1, 20x1, 28x1, 30x1, 56x1, 60x1, 100x1, 120x1, 168x1, 200x1 film-coated tablets
• Bottles containing 180, 200 and 500 film-coated tablets
• Bottles containing 180, 200 and 500 film-coated tablets with cotton.

Not all pack sizes may be marketed.
Patient Alert Card: managing information
Inside the Apixaban Teva 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 contains important information that may be helpful to you and alerts other healthcare professionals that you are taking Apixaban Teva. You must always carry this card with you.

4. Take the card.
5. 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:
6. Fold the card and always keep it with you.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa, 2600,
Bulgaria
This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: