APICASSA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Apicassa 2.5 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Apicassa and what is it used for

This medicine 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.

Apixaban 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 forming blood clots in the veins of your legs. This can cause swelling in your legs, with or without pain. If a blood clot travels from your leg to your lungs, it can block the flow of blood, 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 you take Apicassa

Do not take Apicassa:

• if you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6).
• if you bleed excessively
• if you have an organ diseasein your body that increases the risk of severe bleeding (such as an active or recent stomach or intestinal ulcer, or recent brain hemorrhage)
• if you have a liver diseasethat increases the risk of bleeding (hepatic coagulopathy)
• if you are taking medicines to prevent blood coagulation(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching 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).

Warnings and precautions

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

• an 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 medicine will be used with caution in patients with signs of altered liver function

• you had a catheter or received an injection in your spine(for anesthesia or pain relief), your doctor will tell you to wait at least 5 hours after removing the catheter before taking this medicine
• 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 this medicine

• if you know you have a disease called antiphospholipid syndrome(an immune system disorder that increases the risk of forming 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, talk to your doctor.

Children and adolescents

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

Other medicines and Apicassa

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

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

The following medicines may increase the effects of apixaban and increase the possibility of an unwanted hemorrhage:

• some antifungal medicines(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)
• antidepressantscalled selective serotonin reuptake inhibitorsor serotonin-norepinephrine reuptake inhibitors

The following medicines may reduce the ability of apixaban to prevent the formation of 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 for the treatment of tuberculosisor other infections(e.g., rifampicin)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

It is not known if apixaban is excreted in human milk. Ask your doctor or pharmacist before taking this medicine during breastfeeding. They will tell you whether to stop breastfeeding or whether to stop or not start taking this medicine.

Driving and using machines

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

Apicassa contains lactose (a type of sugar) and sodium.

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

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

3. How to take Apicassa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor, pharmacist, or nurse again.

Dosage

Take the tablet with water. This medicine 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 Apicassa. The tablet can be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before taking it.

Instructions for crushing:

• Crush the tablets with a mortar.
• Transfer all the powder carefully into a suitable container, mixing the powder with a small amount, for example, 30 ml (2 tablespoons), of water or any of the other liquids mentioned to make the mixture.
• Take the mixture.
• Rinse 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 Apicassa tablet mixed in 60 ml of water or 5% glucose in water through a nasogastric tube.

Take Apicassa according to the following recommendations:

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

The recommended dose of Apicassa 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 had major hipsurgery, you will usually take the tablets for a period of 32 to 38 days.

If you have had 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 Apicassa is one 5 mg tablet twice a day.

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

• you have severely reduced 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 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 Apicassa to anticoagulant medicines

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

• Switching from anticoagulant medicines to Apicassa

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

• Switching from treatment with anticoagulants that contain Vitamin K antagonists (e.g., warfarin) to Apicassa

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 Apicassa.

• Switching from treatment with Apicassa to anticoagulant treatment that contains a Vitamin K antagonist (e.g., warfarin).

If your doctor tells you to start taking a medicine that contains a Vitamin K antagonist, continue taking Apicassa 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 Apicassa.

Patients undergoing cardioversion

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.

If you take more Apicassa than you should

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

If you take more apixaban 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Apicassa

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

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

If you stop taking Apicassa

Do not stop taking this medicine without talking to your doctor first, because the risk of developing a blood clot may be higher if you stop the treatment too soon.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Apixaban can be administered for three different diseases. The known adverse effects and the frequency with which they occur may be different and are therefore indicated separately below. For these conditions, the most frequent adverse effect of this medicine is bleeding, which can endanger the patient's life and requires immediate medical attention.

The following adverse effects have been reported when taking apixaban to prevent the formation of blood clots in hip or knee replacement surgeries.

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Anemia, which can cause fatigue or paleness
• Bleeding, including:
• • hematoma and swelling
• Nausea (feeling of discomfort)

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Decrease in the number of platelets in the blood (which can affect coagulation)
• Bleeding:
• • after surgery, including hematoma and swelling, blood or fluid secretion from the wound/surgical incision (suppuration), or at the injection site
  • in the stomach, intestine, or bright red blood in the stool
  • blood in the urine
  • from the nose
  • vaginal
• Low blood pressure that can cause fainting or a faster heart rate
• Blood tests may show:
• • abnormal liver function
  • increase in some liver enzymes
  • increase in bilirubin, a byproduct of red blood cells, which can cause yellowing of the skin and eyes.
• Itching

Rare Adverse Effects (may affect up to 1 in 1,000 people)

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

Unknown 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 the space behind the abdominal cavity
  • hemorrhoidal
  • tests showing 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 hematomas.

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

Frequent Adverse Effects (may affect up to 1 in 10 people)

• 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 heart rate
• Nausea (general discomfort)
• Blood tests may show:
• • an increase in gamma glutamyl transferase (GGT)

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• 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 hematoma and swelling, blood or fluid secretion from the wound/surgical incision (suppuration), or at the injection site
  • hemorrhoidal
  • tests showing 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
  • increase in some liver enzymes
  • increase in 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.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

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

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

• 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).

Unknown Frequency (cannot be estimated from available data)

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

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

Frequent Adverse Effects (may affect up to 1 in 10 people)

• 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 (feeling of discomfort)
• Skin rash
• Blood tests may show:
• • an increase in gamma glutamyl transferase (GGT) or alanine aminotransferase (GPT)

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Low blood pressure that can cause fainting or a faster heart rate
• Bleeding:
• • in the eyes
  • in the mouth or coughing up blood
  • bright red blood in the stool
  • tests showing 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
  • increase in some liver enzymes
  • increase in bilirubin, a byproduct of red blood cells, which can cause yellowing of the skin and eyes.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

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

Unknown Frequency (cannot be estimated from available data)

• 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 hematomas.

Reporting of Adverse Effects

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 leaflet. You can also report them 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 medicine.

5. Storage of Apicassa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton and on each blister after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE collection point in the pharmacy or in any other Medicinal Waste Collection System. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Apicassa

• The active ingredient is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other ingredients are:
• • Core of the tablet: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (E470b).
  • Coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172)

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

Appearance of the Product and Package Contents

Yellow, round, biconvex film-coated tablets with "IU1" engraved on one side and the other side smooth.

• They are presented in blisters within cartons containing 10, 20, 56, 60, 168, and 200 film-coated tablets.
• They are also available in single-dose blisters presented in clinical packaging containing 60 × 1 and 100 × 1 film-coated tablets.

Not all pack sizes may be marketed.

Patient Information Card: Information Management

Inside the Apicassa package, along with the leaflet, 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 Apicassa. You must keep this card with you at all times.

1. Take the card

1. Separate the language you need (this is facilitated through the perforated ends)

1. 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:

1. Fold the card and carry it with you at all times

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca. 1

Hungary

or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona, 08040, Spain

or

Pharmadox Healthcare Limited

KW20A Corradino Industrial, state,

Paola, PLA 3000, Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the Last Revision of this Leaflet:April 2022

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