APICASSA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Apicassa 5mg 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, 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 pack:

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 to prevent the formation of blood clots by blocking Factor Xa, an important element in blood clotting.

Apicassa 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 happening again 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 diseasethat 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 clotting(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 having a tube 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 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

• a 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 liver function alteration

• you have a heart valve replacement
• 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 blood clots), inform your doctor to decide if treatment modification may be necessary.

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 period. If you are unsure 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 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 clotting(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-noradrenaline reuptake inhibitors

The following medicines may reduce the ability of apixaban to prevent blood clot formation.

• medicines for the treatment of epilepsy or seizures(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)

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 for advice before taking this medicine during breastfeeding. They will tell you whether to stop breastfeeding or stop/avoid 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, talk to 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 unsure, talk to 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, 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 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 a blood clot in the heart of patients with an irregular heartbeat and at least one additional risk factor.

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

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

• you have severely reduced kidney function
• two or more of the following factors apply to you:
• • your blood test results suggest poor kidney function (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, e.g., 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 twoApicassa 5mgtablets twice a day for the first 7 days, e.g., two tablets in the morning and two tablets in the evening.

After 7 days, the recommended dose is oneApicassa 5mgtablet twice a day, e.g., one tablet in the morning and one in the evening.

To prevent blood clots from happening again after 6 months of treatment

The recommended dose is one Apicassa 2.5mgtablet twice a day, e.g., one tablet in the morning and one 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 Apicassa to other anticoagulant medicines

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

• Switching from other anticoagulant medicines to Apicassa

Stop taking other anticoagulant medicines. Start Apicassa treatment 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 Apicassa

Stop taking the Vitamin K antagonist medicine. Your doctor will need to perform blood tests and tell you when to start taking Apicassa.

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

If your doctor tells you to start taking a Vitamin K antagonist medicine, continue taking Apicassa for at least 2 days after your first dose of the Vitamin K antagonist medicine. 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 as your doctor instructs 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 higher dose of apixaban than prescribed. Take the medicine package 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 anti-factor Xa activity may be necessary.

In case of overdose or accidental ingestion, talk to 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 are unsure 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 treatment too soon.

If you have any further questions on 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 apixaban to prevent blood clot formation in the heart in patients with an 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
• blood in the urine
• from the nose
• from the gums
• bruising and swelling

• Anemia, which can cause tiredness 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)

Uncommon side 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 bruising and swelling, discharge of blood or fluid from the wound/surgical incision, or injection site
• hemorrhoidal
• tests showing blood in the stool or urine

• Decrease in the number of platelets in the blood (which can affect clotting)
• Blood tests may show:

• abnormal liver function
• increase in some liver enzymes
• increase in 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.

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 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).

Frequency not known (cannot be estimated from the available data)

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

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.

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

• 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 pallor
• Decreased platelet count in 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 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 an operation that includes bruising and swelling, discharge of blood or fluid from the wound/surgical incision (suppuration) 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. Inform 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

Frequency not known (cannot be estimated from the 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 round and smooth red spots under the skin surface or bruising.

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 that appears on the packaging and on each blister pack after "CAD". 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 any unused medicines in the SIGRE collection point at the pharmacy or in any other Medicines Waste Collection System. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Apicassa

• The active ingredient is apixaban. Each tablet contains 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, red iron oxide (E172) See section 2 "Apicassa contains lactose (a type of sugar) and sodium".

Appearance and package contents

C

• Blister packs are presented in cartons containing 14, 20, 28, 56, 60, 168, and 200 film-coated tablets.
• Unit dose blister packs are also available in clinical trial packs containing 100 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Patient Information Card: information management

Inside the Apicassa packaging, 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 should 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/)