APOBILEN 5 mg Film-Coated Tablets

Contents of the leaflet

1. Introduction
2. P
3. L
4. C
5. What is Apobilen and what is it used for
6. What you need to know before taking Apobilen
7. N
8. -bleed excessively;
9. A
10. -severe kidney disease or if you are on dialysis
11. N
12. O
13. -ntidepressantscalled selective serotonin reuptake inhibitorsor serotonin-norepinephrine reuptake inhibitors.
14. E
15. C
16. A
17. How to take Apobilen
18. D
19. I
20. T
21. -you have severely decreased kidney function;
22. P
23. S
24. S
25. S
26. Possible side effects
27. E
28. E
29. E
30. E
31. F
32. E
33. E
34. E
35. F
36. C
37. Storage of Apobilen
38. Package contents and additional information
39. A
40. T
41. T
42. F/2023

Introduction

P

Apobilen 5 mg film-coated tablets EFG

apixaban

L

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

C

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

1. What is Apobilen and what is it used for

Apobilen 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 element in blood coagulation.

Apobilen is used in adults:

• to prevent the formation of a blood clot in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose, move to the brain, and cause a stroke, or move to other organs, preventing proper irrigation (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 these blood clots from recurring in the blood vessels of the legs and/or lungs.

2. What you need to know before taking Apobilen

N

• are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6);

-bleed excessively;

• have a disease in an organof the body that increases the risk of severe bleeding (such as

an active or recent stomach or intestinal ulcer, or recent brain hemorrhage);

• suffer from a liver diseasethat increases the risk of bleeding (hepatic coagulopathy);
• are taking medicines to prevent blood coagulation(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching from one anticoagulant treatment to another, while having an arterial or venous line and being treated with heparin to keep the line open, or when having a tube inserted into a blood vessel (catheter ablation) to treat an irregular heartbeat (arrhythmia).

A

Tell your doctor, pharmacist, or nurse before starting to take Apobilen if you have any of these conditions:

• an increased risk of bleeding, such as:
• • bleeding disorders, including situations that result in decreased platelet activity;
  • very high blood pressure, not controlled by medical treatment;
  • you are over 75 years old;
  • you weigh 60 kg or less;

-severe kidney disease or if you are on dialysis

• a liver problem or history of liver problems;
• • This medicine will be used with caution in patients with signs of altered liver function
• have a heart valve prosthesis;
• if your doctor determines that your blood pressure is unstable or you are scheduled to receive another treatment or undergo surgery to remove the blood clot from your lungs.

Be careful with Apobilen

• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor to decide if it may be necessary to modify the treatment.

If you need to have surgery or a procedure that may cause bleeding, your doctor will tell you to temporarily stop taking this medicine for a while. If you are not sure if a procedure may cause bleeding, consult your doctor.

N

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

O

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines.

Some medicines may increase the effects of Apobilen, and some medicines may decrease its effects. Your doctor will decide if you should be treated with Apobilen if you are taking these medicines and if you should be kept under closer observation.

The following medicines may increase the effects of Apobilen and increase the possibility of unwanted bleeding:

• some medicines for fungal infections(e.g., ketoconazole, etc.);
• some antiviral medicines for HIV/AIDS(e.g., ritonavir);
• other medicines to reduce blood coagulation(e.g., enoxaparin, etc.);
• anti-inflammatoryor pain-relieving medicines(e.g., acetylsalicylic acid or naproxen). Especially if you are over 75 years old and taking acetylsalicylic acid, there is a higher likelihood of bleeding;
• medicines for high blood pressure or heart problems(e.g., diltiazem);

-ntidepressantscalled selective serotonin reuptake inhibitorsor serotonin-norepinephrine reuptake inhibitors.

The following medicines may reduce Apobilen's ability to prevent blood clots:

• medicines for the treatment of epilepsy or convulsions(e.g., phenytoin, etc.);
• St. John's Wort(a herbal medicine for the treatment of depression);
• medicines to treat tuberculosisor other infections(e.g., rifampicin).

E

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

The effects of Apobilen on pregnancy and the fetus are unknown. You should not take this medicine if you are pregnant. Tell your doctor immediatelyif you become pregnant while taking this medicine.

It is unknown whether Apobilen is excreted in human milk. Ask your doctor, pharmacist, or nurse before taking this medicine during breastfeeding. They will tell you whether to interrupt breastfeeding or whether to stop or not start taking this medicine.

C

Apobilen has no influence on the ability to drive or use machines.

A

If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

3. How to take Apobilen

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse.

D

Take the tablet with water. Apobilen can be taken with or without food.

Try to take the tablets at the same time each day to achieve a better effect of the treatment.

If you have difficulty swallowing the tablet whole, talk to your doctor about other possible ways to take Apobilen. The tablet can be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before taking it.

I

• Crush the tablets with a mortar.
• Transfer all the powder carefully into a suitable container, mixing the powder with a small amount, e.g., 30 ml (2 tablespoons), of water or any of the other liquids mentioned to make the mixture.
• Take the mixture.
• Rinse the mortar and pestle used to crush the tablet and the container with a small amount of water or one of the other liquids (e.g., 30 ml), and take that liquid.

If necessary, your doctor may also administer the crushed Apobilen tablet mixed in 60 ml of water or 5% glucose in water through a nasogastric tube. The tube should be flushed with 10 ml of water immediately after administering the dose of Apobilen.

T

To prevent the formation of a blood clot in the heart of patients with an irregular heartbeat and at least one additional risk factor.

The recommended dose of Apobilen is one Apobilen 5 mgtablet twice a day.

The recommended dose is one Apobilen 2.5 mgtablet twice a day if:

-you have severely decreased kidney function;

• you have two or more of the following factors:
• • your blood test results suggest poor kidney function (the serum creatinine value is 1.5 mg/dl (133 micromoles/l) or higher);
  • you are 80 years old or older;
  • your weight is 60 kg or less.

The recommended dose is one tablet twice a day, for example, take one tablet in the morning and one in the evening.

Your doctor will tell you how long to continue the treatment.

To treat blood clots in the veins of the legs and in the blood vessels of the lungs

The recommended dose is two tabletsof Apobilen 5 mgtwice a day for the first 7 days, for example, two tablets in the morning and two tablets in the evening.

After 7 days, the recommended dose is one tabletof Apobilen 5 mgtwice a day, for example, one tablet in the morning and one tablet in the evening.

To prevent blood clots from recurring after 6 months of treatment

The recommended dose is one Apobilen 2.5 mgtablet twice a day, for example, one tablet in the morning and one tablet in the evening.

Your doctor will tell you how long to continue the treatment.

Your doctor may change your anticoagulant treatment as follows:

• Switching from Apobilen to other anticoagulant medicines

Stop taking Apobilen. Start treatment with other anticoagulant medicines (e.g., heparin) at the time you would take the next Apobilen tablet.

• Switching from other anticoagulant medicines to Apobilen

Stop taking other anticoagulant medicines. Start treatment with Apobilen at the time you would take the next dose of an anticoagulant medicine, and then continue as usual.

• Switching from a treatment with anticoagulants that contain vitamin K antagonists (e.g., warfarin) to Apobilen

Stop taking the medicine that contains a vitamin K antagonist. Your doctor will need to perform blood tests and tell you when to start taking Apobilen.

• Switching from Apobilen to a treatment with anticoagulants that contain vitamin K antagonists (e.g., warfarin).

If your doctor tells you to start taking a medicine that contains a vitamin K antagonist, continue taking Apobilen for at least 2 days after your first dose of the medicine that contains a vitamin K antagonist. Your doctor will need to perform blood tests and tell you when to stop taking Apobilen.

P

If your heartbeat needs to be restored through a process called cardioversion, take this medicine at the times your doctor indicates to prevent blood clots in the blood vessels of the brain and other blood vessels in the body.

S

If you accidentally take more than the prescribed dose, contact your doctor, go to the nearest hospital immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount received.

Tell your doctor immediatelyif you have taken a dose greater than the prescribed dose of Apobilen. Take the medicine package to your doctor, even if there are no tablets left.

If you take more Apobilen than the recommended dose, you may increase the risk of bleeding. If bleeding occurs, surgery, blood transfusions, or other treatments that can reverse the anti-factor Xa activity may be necessary.

S

• Take the dose as soon as you remember and
• • take the next Apobilen dose at the usual time;
  • then continue taking the medicine as usual.

If you have doubts about what to do or if you have forgotten to take more than one dose,ask your doctor, pharmacist, or nurse.

Do not take a double dose to make up for forgotten doses.

S

Do not stop treatment with this medicine without talking to your doctor first, as the risk of developing a blood clot may be greater if treatment is stopped too soon.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

The following side effects have been reported when taking Apobilen to prevent the formation of blood clots in the heart in patients with an irregular heartbeat and at least one additional risk factor.

E

• Bleeding, including:

• in the eyes;
• in the stomach or intestine;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• bruising and swelling;

• Anemia, which can cause fatigue or paleness;
• Low blood pressure, which can cause fainting or a faster heartbeat;
• Nausea (general discomfort);
• Blood tests may show:

• an increase in gamma-glutamyl transferase (GGT).

E

• Bleeding:

• in the brain or spinal cord;
• in the mouth or coughing up blood;
• in the abdomen, or vagina;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, discharge of blood or fluid from the wound/surgical incision (purulent discharge), or injection site;
• hemorrhoidal;
• tests that show blood in the stool or urine;

• Decreased number of platelets in the blood (which can affect coagulation);
• Blood tests may show:

• abnormal liver function;
• increased liver enzymes;
• increased bilirubin, a product derived from red blood cells, which can cause yellowing of the skin and eyes.

• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Tell your doctor immediatelyif you experience any of these symptoms.

E

• Bleeding:

• in the lungs or throat;
• in the space behind the abdominal cavity;
• in a muscle.

E

• Skin rash that can form blisters and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around) (erythema multiforme).

F

• Inflammation of the blood vessels (vasculitis) that can cause skin rash, appearance of small, round, smooth red spots under the skin surface, or bruising.

The following side effects have been reported when taking Apobilen to treat or prevent blood clots from recurring in the veins of the legs and in the blood vessels of the lungs.

E

• Bleeding, including:

• from the nose;
• from the gums;
• blood in the urine;
• bruising and swelling;
• from the stomach, intestine, or rectum;
• in the mouth;
• vaginal;

• Anemia, which can cause fatigue or paleness;
• Decreased number of platelets in the blood (which can affect coagulation);
• Nausea (general discomfort);
• Skin rash;
• Blood tests may show:

• an increase in gamma-glutamyl transferase (GGT) or alanine aminotransferase (GPT).

E

• Low blood pressure, which can cause fainting or a faster heartbeat;
• Bleeding:

• in the eyes;
• in the mouth or coughing up blood;
• bright red blood in the stool;
• tests that show blood in the stool or urine;
• bleeding after surgery, including bruising and swelling, discharge of blood or fluid from the wound/surgical incision (purulent discharge), or injection site;
• hemorrhoidal;
• in a muscle;

• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Contact your doctor immediatelyif you experience any of these symptoms;
• Blood tests may show:

• abnormal liver function;
• increased liver enzymes;
• increased bilirubin, a product derived from red blood cells, which can cause yellowing of the skin and eyes.

E

• Bleeding:

• in the brain or spinal cord;
• in the lungs.

F

• Bleeding:

• in the abdomen or the space behind the abdominal cavity.
  • Skin rash that can form blisters and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around) (erythema multiforme);
  • Inflammation of the blood vessels (vasculitis) that can cause skin rash, appearance of red, round, and smooth spots under the skin surface or bruising.

C

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Apobilen

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on each blister, after CAD. The expiration date is the last day of the indicated month.

This medication does not require special storage conditions.

Medications should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Apobilen

• The active ingredient is apixaban. Each tablet contains 5 mg of apixaban.
• The other components are:
• • Tablet core: lactose, microcrystalline cellulose (PH 102) (E460), sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (E470b);
  • Film coating: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin, red iron oxide (E172), yellow iron oxide (E172).

See section 2 "Apobilen contains lactose (a type of sugar) and sodium".

A

Apobilen 5 mg film-coated tablets are pink, oval, film-coated tablets with dimensions of approximately 10.0 mm x 5.2 mm.

• They are presented in PCTFE/PVC/Aluminum blisters with 10, 14, 20, 28, 56, 60, and 100 film-coated tablets.

Only some package sizes may be marketed.

T

Inside the Apobilen packaging, along with the prospectus, you will find a Patient Information Card or your doctor may give you a similar card.

This Patient Information Card includes useful information for you and will alert other doctors that you are being treated with Apobilen. You must keep this card with you at all times.

1. Take the card.
2. Complete the following sections or ask your doctor to complete them:
   • Name:
   • Date of birth:
   • Indication:
   • Dose mg twice a day
   • Doctor's name:
   • Doctor's phone number:
3. Fold the card and carry it with you at all times.

T

Novalie Pharma S.L.

C/ Bélgica 64,

05004 – Ávila

Spain

Manufacturer:

PharmaPath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

This medication is authorized in the member states of theEconomic European Areawith the following names:

Denmark Apobilen

Spain Apobilen 5 mg film-coated tablets EFG

Portugal Apobilen

F/2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)