Package leaflet: Information for the user

Apixaban Liconsa 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.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

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

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

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

2. What you should know before taking Apixaban Liconsa

Do not take Apixaban Liconsa 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 a body organ that increases the risk of severe bleeding (such as a recent or active ulcer in the stomach or intestine, or a recent bleed in the brain);
you have a liver disease that increases the risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while you have a venous or arterial catheter and are receiving heparin through it to keep it open, or if a catheter is inserted into a blood vessel (transcatheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine if you have any of the following conditions:

an increased risk of bleeding, such as:
bleeding disorders, including conditions causing reduced platelet function;
very high blood pressure not controlled by medical treatment;
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 tube (catheter) or have had an injection into your spine (for anaesthesia or pain relief). Your doctor will tell 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.

Use special caution with Apixaban Liconsa

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.

Children and adolescents
This medicine is not recommended for children and adolescents with a body weight below 35 kg.

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

The following medicines may increase the effect of Apixaban Liconsa 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 (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).

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

medicines for epilepsy or seizures (e.g., phenytoin, etc.);
St. John’s wort (a herbal remedy used for depression);
medicines 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 Liconsa 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 Liconsa 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 Liconsa has not shown any effects on the ability to drive or use machinery.

Apixaban Liconsa 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 Liconsa

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 Liconsa 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 Liconsa. 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 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 Liconsa tablet mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Liconsa as recommended:
To prevent blood clots after hip or knee replacement surgery.
The recommended dose is one Apixaban Liconsa 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 blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.
The recommended dose is one Apixaban Liconsa 5 mg tablet twice daily.
The recommended dose is one Apixaban Liconsa 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 tablets of Apixaban Liconsa 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 Liconsa 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 Apixaban Liconsa 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 the veins or blood vessels of the lungs.
Take or administer this medicine exactly as directed by your doctor or the child's doctor or pharmacist. If you have any doubts, consult your doctor or 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 Liconsa 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 four tablets of Apixaban Liconsa 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 Liconsa 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 entire dose has been taken.
It is important to attend scheduled medical appointments because the dose may need to be adjusted as body weight changes.
Your doctor may modify your anticoagulant treatment as follows:

Switching from Apixaban Liconsa to another anticoagulant medicine Stop taking Apixaban Liconsa. Start treatment with the anticoagulant medicine (e.g., heparin) at the time when you would have taken the next tablet.
Switching from another anticoagulant medicine to Apixaban Liconsa Stop taking the anticoagulant medicine. Start treatment with Apixaban Liconsa at the time when you would have taken the next dose of the anticoagulant medicine, then continue taking it normally.
Switching from treatment with a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Liconsa Stop taking the medicine containing the vitamin K antagonist. Your doctor will need to perform blood tests and advise you on when to start treatment with Apixaban Liconsa.
Switching from Apixaban Liconsa to treatment with a vitamin K antagonist anticoagulant (e.g., warfarin) If your doctor tells you to start taking a medicine containing a vitamin K antagonist, continue taking Apixaban Liconsa 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 Liconsa.

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 take it, to prevent blood clots in the blood vessels of the brain and in other blood vessels of your body.
If you take more Apixaban Liconsa than you should
Inform your doctor immediately if you have taken more than the prescribed dose of this medicine. Bring the medicine carton with you, even if no tablets are left.
If you take more Apixaban Liconsa 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 Liconsa

If you forget to take a morning dose, take it as soon as you remember, and you may take it together with your evening dose.
A forgotten evening dose may be taken only on the same evening. Do not take two doses the following morning; instead, continue following the twice-daily dosing schedule as recommended 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 Liconsa
Do not stop taking this medicine without first talking to your doctor, because the risk of developing a blood clot may be higher if you stop treatment too early.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Apixaban Liconsa may be given for three different medical conditions. The known side effects and how frequently they occur may differ for each of these medical conditions and are listed separately below. For these conditions, the most common general side effect of this medicine is bleeding, which can potentially be life-threatening and requires immediate medical attention.

The following side effects are known to occur when Apixaban Liconsa 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 sick).

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 the stools;
- in the urine;
- from the nose;
- from the vagina;
Low blood pressure which may cause weakness or a rapid heartbeat;
Blood tests may show:
- abnormalities in 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 difficulty breathing. Contact your doctor immediately if any of these symptoms occur.
Bleeding:
- in the muscle;
- in the eyes;
- from the gums and blood in sputum when coughing;
- from the rectum;
Hair loss.

Not known (frequency cannot be estimated from available data)

Bleeding:
- in the brain or spinal cord;
- in the lungs or throat;
- in the mouth;
- in the abdomen or in the space behind the abdominal cavity;
- from haemorrhoids;
- tests showing blood in the stools or urine;
Skin rash which may blister 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 appear as skin rashes or sharp, flat, red, round spots under the skin surface or bruising.

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

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

Bleeding, including:
- in the eyes;
- in the stomach or intestine;
- from the rectum;
- in the urine;
- from the nose;
- from the gums;
- bruising and swelling;
Anaemia, which may cause tiredness or 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 sputum when coughing;
- in the abdomen or from the vagina;
- clear/red blood in the 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;
- tests showing blood in the stools or urine;
Reduction in the number of platelets in the blood (which may affect clotting);
Blood tests may show:
- abnormalities in 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 any of these symptoms occur.

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)

Skin rash which may blister 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 appear as skin rashes or sharp, flat, red, round spots under the skin surface or bruising.

The following side effects are known to occur when Apixaban Liconsa 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 the urine;
- bruising and swelling;
- in the stomach, intestine, or from the rectum;
- in the mouth;
- from the vagina;
Anaemia, which may cause tiredness or pale skin;
Reduction in the number of platelets in the blood (which may affect 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 weakness or a rapid heartbeat;
Bleeding:
- in the eyes;
- in the mouth or blood in sputum when coughing;
- clear/red blood in the stools;
- tests showing blood in the 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;
- 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 any of these symptoms occur;
Blood tests may show:
- abnormalities in 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 in the space behind the abdominal cavity.
Skin rash which may blister 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 appear as skin rashes or sharp, flat, red, round spots under the skin surface or bruising.

Other side effects in children and adolescents
Contact the child’s doctor immediately if you notice any of these 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 Liconsa 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 have been 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 the stools;
- 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;
Reduction in the number of platelets in the child’s blood (which may affect clotting);
Nausea (feeling sick);
Skin rash;
Itching;
Low blood pressure which may cause the child to feel weak or have a rapid heartbeat;
Blood tests may show:
- abnormalities in liver function;
increased levels of certain liver enzymes;
increased 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 sputum when coughing;
- in the brain or spinal cord;
- in the lungs;
- in the muscle;
Skin rash which may blister 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 appear as skin rashes or sharp, flat, red, round spots under the skin surface or bruising;
Blood tests may show:
- increased gamma-glutamyl transferase (GGT);
- tests showing blood in the stools or urine.

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 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 Liconsa

Keep this medicine out of 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 Liconsa contains

The active substance is apixaban. Each film-coated tablet contains 2.5 mg of apixaban.
The other components are: microcrystalline cellulose, anhydrous lactose (see section 2 "Apixaban Liconsa contains lactose (a type of sugar) and sodium"), sodium lauryl sulfate, sodium croscarmellose, magnesium stearate in the tablet core; hypromellose (E464), monohydrate lactose (see section 2 "Apixaban Liconsa contains lactose (a type of sugar) and sodium"), titanium dioxide (E171), triacetin, yellow iron oxide (E172) as the tablet coating.

Description of the appearance of Apixaban Liconsa and contents of the pack
Yellow, round, biconvex film-coated tablets with a diameter of approximately 6 mm.
Packed in PVC/PVDC//Al blisters.
Pack size: Pack of 60 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: managing information
Inside the Apixaban Liconsa package, together with the package leaflet, you will find a Patient Alert Card, or your doctor may provide you with one.
This Patient Alert Card includes information that may be useful to you and alerts other doctors that you are taking Apixaban Liconsa. You must always carry this card with you.

Take the card.
Separate the text in your language as needed (this will be facilitated by the pre-perforated edge).
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
Laboratorios Liconsa, S.A.
Calle Dulcinea S/N
28805, Alcalá de Henares, Madrid
Spain

Manufacturer
Laboratorios Liconsa, S.A.
Avenida Miralcampo, 7
Pol. Industrial Miralcampo
19200, Azuqueca de Henares, Guadalajara
Spain
Zentiva Romania S.A.
Theodor Pallady Bvd, no 50, 3 district,
032266 Bucharest
Romania

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark Apixaban Liconsa
Germany Apixaban Liconsa 2.5 mg Filmtabletten
Spain Apixaban ROVI 2.5 mg comprimidos recubiertos con película EFG
France Apixaban Liconsa 2.5 mg comprimé pelliculé
Italy Apixaban Liconsa
Greece Apixaban Liconsa 2.5 mg Film-coated tablets
Croatia Apiksaban Abela 2.5 mg filmom obložene tablete

Package leaflet: information for the user

Apixaban Liconsa 5 mg film-coated tablets

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

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

Contents of this leaflet

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

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

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

to prevent blood clots forming in the heart in patients with irregular heartbeats (atrial fibrillation) who have at least one additional risk factor. Blood clots can break loose and travel to the brain, causing stroke, or travel to 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.

Apixaban Liconsa 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 recommended dose according to body weight, see section 3.

2. What you should know before taking Apixaban Liconsa

Do not take Apixaban Liconsa 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 a body organ that leads to an increased risk of serious bleeding (such as a recent or active ulcer of the stomach or intestine, or recent bleeding in the

brain );

you have 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 a venous or arterial catheter and are receiving heparin through it to keep it open, or if a catheter is inserted into your 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 Liconsa

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

If you are scheduled for surgery or a procedure that may cause bleeding, your doctor may ask you to temporarily stop taking this medicine for a short time. 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 weighing less than 35 kg.
Other medicines and Apixaban Liconsa
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Some medicines can increase the effect of Apixaban Liconsa, while others can reduce it. Your doctor will decide whether you should be treated with Apixaban Liconsa when taking these medicines and how closely you should be monitored.
The following medicines may increase the effect of Apixaban Liconsa 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 Liconsa in helping to prevent blood clots:

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
The effect of Apixaban Liconsa 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 Liconsa passes into breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine during breastfeeding. They will advise you whether to stop breastfeeding or to stop or not start treatment with this medicine.
Driving and using machines
Apixaban Liconsa has not shown effects on the ability to drive or use machines.
Apixaban Liconsa contains lactose (a type of sugar) and sodium
If your doctor has told you that you have an intolerance to certain sugars, contact him 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 Liconsa

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 glass of water. Apixaban Liconsa 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 of taking Apixaban Liconsa. 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 mentioned 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 Liconsa tablet mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Liconsa 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 Liconsa 5 mg twice daily.
The recommended dose is one tablet of Apixaban Liconsa 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 Liconsa 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 Liconsa 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 Liconsa 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.
Use in children and adolescents
To treat blood clots and to prevent recurrence of blood clots in the veins or in the 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 Liconsa 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 Liconsa 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 Liconsa 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 Liconsa to another anticoagulant medicine

Stop taking Apixaban Liconsa. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you were due to take your next tablet.

Switching from another anticoagulant medicine to Apixaban Liconsa
Stop taking the anticoagulant medicine. Start treatment with Apixaban Liconsa at the time you were due to take your next dose of the anticoagulant medicine, then continue taking it as usual.
Switching from a vitamin K antagonist anticoagulant treatment (e.g., warfarin) to Apixaban Liconsa
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 Liconsa.
Switching from Apixaban Liconsa to a vitamin K antagonist anticoagulant treatment (e.g., warfarin)
If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban Liconsa 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 Liconsa.

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

If you forget to take a morning dose, take it as soon as you remember, and you may take it together with your evening dose.
A forgotten evening dose may be taken only on 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 Liconsa
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 the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them. The most common 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 Liconsa 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 fast 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;
- 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;
Decrease in the number of platelets in the blood (which may affect blood clotting);
Blood tests may show:
- abnormalities in liver function;
- increased levels of some liver enzymes;
- increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
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 which may blister 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 rashes or sharp, flat, red, round spots under the skin surface or bruising.

The following side effects are known to occur when Apixaban Liconsa 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 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 weakness or a fast heartbeat;
Bleeding:
- in the eyes;
- in the mouth or blood in coughed-up phlegm;
- bright red blood in the stools;
- 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:
- abnormalities in liver function;
- increased levels of some liver enzymes;
- increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.

Rare 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 which may blister 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 rashes or sharp, flat, red, round spots under the skin surface or bruising.

Other side effects in children and adolescents
Inform 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, side effects observed in children and adolescents treated with Apixaban Liconsa have been similar to those observed in adults and have mainly been mild to moderate in severity. The side effects observed more frequently in children and adolescents have been 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 intestines or rectum;
- bright red blood in the 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 have a fast heartbeat;
Blood tests may show:
- abnormalities in liver function;
- increased levels of some liver enzymes;
- increased 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 phlegm;
- in the brain or spinal cord;
- in the lungs;
- in the muscle;
Rash which may blister 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 rashes or sharp, flat, red, round spots under the skin surface or bruising;
Blood tests may show:
- increased gamma-glutamyl transferase (GGT);
- tests showing blood in the stools or urine.

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 Liconsa

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 no longer required. This will help protect the environment.

6. Package contents and other information

What Apixaban Liconsa contains

The active substance is apixaban. Each film-coated tablet contains 5 mg of apixaban.
The other components are: microcrystalline cellulose, anhydrous lactose (see section 2 "Apixaban Liconsa contains lactose (a type of sugar) and sodium"), sodium lauryl sulfate, sodium croscarmellose, magnesium stearate in the tablet core; hypromellose (E464), monohydrate lactose (see section 2 "Apixaban Liconsa contains lactose (a type of sugar) and sodium"), titanium dioxide (E171), triacetin, iron oxide red (E172) as the tablet coating.

Description of the appearance of Apixaban Liconsa and package contents
Pink, oblong, film-coated tablets, approximately 10 x 5 mm in size.
Packaged in PVC/PVDC//Al blisters.
Pack sizes: 56 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: information management
Inside the Apixaban Liconsa 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 Liconsa. You must always carry this card with you.

Take the card.
Separate the text in your language as needed (this will be facilitated by the pre-perforated edge).
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
Laboratorios Liconsa, S.A.
Calle Dulcinea S/N
28805, Alcalá de Henares, Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:
Denmark Apixaban Liconsa
Germany Apixaban Liconsa 5 mg Filmtabletten
Spain Apixaban ROVI 5 mg comprimidos recubiertos con película EFG
France Apixaban Liconsa 5 mg comprimé pelliculé
Republic of Ireland Apixaban Rowa 5 mg Film-coated tablets
Italy Apixaban Liconsa
Greece Apixaban Liconsa 5 mg Film-coated tablets
Croatia Apiksaban Abela 5 mg filmom obložene tablete