APOBILEN 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Apobilen 2.5 mg Film-Coated Tablets EFG

apixaban

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, ask your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

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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 further information

1. What is Apobilen and what is it used for

Apobilen contains the active substance apixaban and belongs to a group of medications called anticoagulants. This medication 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 blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After hip or knee replacement surgery, you may have a higher risk of developing blood clots in the veins of your legs. This can cause swelling in the legs, with or without pain. If a blood clot travels from your leg to your lungs, it can block blood flow, causing difficulty breathing, with or without chest pain. This medical condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.

• 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

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• is allergicto apixaban or any of the other components of this medication (listed in section 6);

-bleeds excessively;

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

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

• a increased risk of bleeding, such as:
• • bleeding disorders, including situations that result in a decrease in 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 medication will be used with caution in patients with signs of altered liver function
• you had a catheter or received an injection in the spine(for anesthesia or pain relief), your doctor will tell you to wait at least 5 hours after removing the catheter before taking this medication;
• you 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 undergo surgery or a procedure that may cause bleeding, your doctor will tell you to temporarily stop taking this medication for a while. If you are not sure if a procedure may cause bleeding, ask your doctor.

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

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

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

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

• some medications for fungal infections(e.g., ketoconazole, etc.);
• some antiviral medications for HIV/AIDS(e.g., ritonavir);
• other medications to reduce blood coagulation(e.g., enoxaparin, etc.);
• anti-inflammatoryor pain-relieving medications(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;
• medications for high blood pressure or heart problems(e.g., diltiazem);

-ntidepressantscalled selective serotonin reuptake inhibitorsor

serotonin-norepinephrine reuptake inhibitors.

The following medications may reduce the ability of Apobilen to prevent blood clot formation:

• medications for the treatment of epilepsy or convulsions(e.g., phenytoin, etc.);
• St. John's Wort(a plant-based medication for the treatment of depression);
• medications to treat tuberculosisor other infections(e.g., rifampicin).

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If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before using this medication.

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

It is unknown if Apobilen is excreted in human milk. Ask your doctor or pharmacist for advice before taking this medication during breastfeeding. They will tell you whether to stop breastfeeding or whether to stop or not start taking this medication.

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

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If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Apobilen

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, ask your doctor, pharmacist, or nurse.

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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 treatment effect.

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.

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• 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.
• Clear the mortar and the mortar's hand that have been 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 Apobilen dose.

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To prevent the formation of blood clots in hip or knee replacement surgeries.

The recommended dose of Apobilen is one 2.5 mg tablet twice a day. For example, take one tablet in the morning and one in the evening.

You should take the first tablet between 12 and 24 hours after surgery.

If you have undergone major hipsurgery, you will usually take the tablets for a period of 32 to 38 days.

If you have undergone major kneesurgery, you will usually take the tablets for a period of 10 to 14 days.

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

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

The recommended dose is one 2.5 mg tablet twice a day if:

-you have severely decreased kidney function;

• two or more of the following factors apply to you:
• • 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 you should 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 5 mg tabletstwice 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 5 mg tablettwice a day, for example, one tablet in the morning and one in the evening.

To prevent blood clots from recurring after 6 months of treatment

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

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

Your doctor may change your anticoagulant treatment as follows:

• Switching from Apobilen to anticoagulant medications

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

• Switching from anticoagulant medications to Apobilen

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

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

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

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

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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 medication and the amount taken.

Tell your doctor immediatelyif you have taken a higher dose than the prescribed dose of this medication. Take the medication packaging 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.

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Take the dose as soon as you remember and:

• take the next Apobilen dose at the usual time
• then continue taking the medication as usual.

If you are unsure 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.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. Apobilen can be administered in three different diseases. The known side effects and their frequency may be different, and therefore, they are indicated separately below. For these conditions, the most common side effect of this medication 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 hip or knee replacement surgeries.

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• Anemia, which can cause fatigue or paleness;
• Bleeding, including:
• hematoma and swelling;
• Nausea (general discomfort).

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• Decreased platelet count in the blood (which can affect coagulation);
• Bleeding:
• • after surgery, including hematoma and swelling, discharge of blood or fluid from the wound/surgical incision (suppuration), or at the injection site;
  • from the stomach, intestine, or bright red blood in the stool;
  • blood in the urine;
  • from the nose;
  • vaginal;
• Low blood pressure, which can cause fainting or a faster heartbeat;
• 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;
• Itching.

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• 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.
• Bleeding:
• • in a muscle;
  • in the eyes;
  • from the gums and coughing up blood;
  • from the rectum;
• Hair loss.

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• Bleeding:
• • in the brain or spinal cord;
  • in the lungs or throat;
  • in the mouth;
  • in the abdomen or the space behind the abdominal cavity;
  • hemorrhoidal;
  • tests that show blood in the stool or urine;
• 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.

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.

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• Bleeding, including:
• • in the eyes;
  • in the stomach or intestine;
  • from the rectum;
  • blood in the urine;
  • from the nose;
  • from the gums;
  • hematoma and swelling;
• Anemia, which can cause fatigue or paleness;
• Low blood pressure that can cause fainting or a faster heartbeat;
• Nausea (general discomfort);
• Blood tests may show:
• • an increase in gamma glutamyl transferase (GGT).

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• 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 that includes hematoma and swelling, blood or fluid secretion from the wound/surgical incision (suppuration) or at the injection site;
  • hemorrhoidal;
  • tests that show blood in the stool or urine;
• Decrease in the number of platelets in the blood (which can affect coagulation);
• Blood tests may show:
• • abnormal liver function;
  • increased liver enzymes;
  • increased bilirubin, a byproduct of 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. Inform your doctor immediatelyif you experience any of these symptoms.

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

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• 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).

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

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

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• Bleeding, including:
• • from the nose;
  • from the gums;
  • blood in the urine;
  • hematoma and swelling;
  • from the stomach, intestine, or rectum;
  • in the mouth;
  • vaginal;
• Anemia, which can cause fatigue or paleness;
• Decrease in the 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).

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• Low blood pressure that 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 hematoma and swelling, blood or fluid secretion from the wound/surgical incision (suppuration); or at the 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 byproduct of red blood cells, which can cause yellowing of the skin and eyes.

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

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• 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 round, smooth red spots under the skin surface, or hematomas.

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If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed 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 month indicated.

This medication does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE Point of 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

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• The active ingredient is apixaban. Each tablet contains 2.5 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, yellow iron oxide (E172).

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

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Apobilen 2.5 mg film-coated tablets are yellow, round film-coated tablets with an approximate diameter of 6 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.

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Inside the Apobilen package, 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

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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 2.5 mg film-coated tablets EFG

Portugal Apobilen

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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/)