APIXABAN ACCORD 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Apixaban Accord 5 mg film-coated tablets EFG

apixaban

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

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

Apixaban Accord 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 component of blood clotting.

Apixaban Accord 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, travel to the brain, and cause a stroke, or 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 Apixaban Accord

Do not take Apixaban Accord

• 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 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)

• 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 anticoagulant, while having an arterial or venous line and being treated with heparin to keep that line open, or when a tube is inserted into a blood vessel (catheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions

Tell your doctor, pharmacist, or nurse before taking 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
  • Your weight is 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 altered liver function

• 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

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 of time. If you are unsure whether a procedure may cause bleeding, consult your doctor.

Be careful with Apixaban Accord

• 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.

Children and adolescents

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

Using Apixaban Accord with other medicines

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 Accord and some medicines may decrease its effects. Your doctor will decide if you should be treated with Apixaban Accord if you are taking these medicines and if you should be kept under closer observation.

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

• 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). In particular, 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 Accord to prevent blood clot formation.

• 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 this medicine on pregnancy and the fetus are not known. You should not take Apixaban Accord if you are pregnant. Tell your doctor immediatelyif you become pregnant while taking this medicine.

It is not known whether Apixaban Accord 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 whether to stop or not start taking this medicine.

Driving and using machines

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

Apixaban Accord contains lactose (a type of sugar) and sodium.

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

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

3. How to take Apixaban Accord

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor, pharmacist, or nurse.

Dose

Take the tablet with water. Apixaban Accord 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 Apixaban Accord. 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, or in a plate with the convex side of a spoon.

• 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 liquids mentioned for making the mixture.
• Take the mixture.
• Rinse the mortar and pestle or the plate and spoon 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 Apixaban Accord tablet mixed in 60 ml of water or 5% glucose in water through a nasogastric tube.

Take Apixaban Accord according to the following recommendations:

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 Apixaban Accord is one Apixaban Accord 5 mgtablet twice a day.

The recommended dose is one Apixaban Accord 2.5 mgtablet 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, 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 tabletsof Apixaban Accord 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 Apixaban Accord 5 mgtwice 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 Apixaban Accord 2.5 mgtablet 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:

• Changing from Apixaban Accord to anticoagulant medicines

Stop taking Apixaban Accord. Start treatment with anticoagulant medicines (e.g., heparin) at the time you would have taken the next tablet.

• Changing from anticoagulant medicines to Apixaban Accord

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

• Changing from a treatment with anticoagulants that contain Vitamin K antagonists (e.g., warfarin) to Apixaban Accord

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 Apixaban Accord.

• Changing from Apixaban Accord to a treatment anticoagulant 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 Apixaban Accord 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 Apixaban Accord.

Patients undergoing cardioversion

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

If you take more Apixaban Accord than you should

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

If you take more Apixaban Accord 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.

If you forget to take Apixaban Accord

• Take the dose as soon as you remember and
• • Take the next dose of Apixaban Accord 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 Apixaban Accord

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. The most frequent adverse effect of this medicine is bleeding, which can put the patient's life at risk and requires immediate medical attention.

The following adverse effects have been reported when taking Apixaban Accord 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
• Bruising 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 bruising and swelling, discharge of blood or fluid from the wound/surgical incision (suppuration) or 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
• 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.

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).

Frequency Not Known (cannot be estimated from the 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 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.

Frequent 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 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 any surgery, with 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
• Increased liver enzymes
• Increased 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

• 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).

• Inflammation of the blood vessels (vasculitis) that can cause skin rash, appearance of red, round, and smooth 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 national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Apixaban Accord

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, 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. 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 Apixaban Accord

• The active ingredient is apixaban. Each tablet contains 5 mg of apixaban.
• The other ingredients are:
• • Tablet core: , microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
  • Coating: , hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172)

Appearance of the Product and Package Contents

The film-coated tablets are oval, biconvex, pink, and have "IU2" engraved on one side, and are smooth on the other.

They are available in aluminum-PVC/PVdC blisters of 10, 14, 20, 28, 56, 60, 100, 112, 168, and 200 film-coated tablets.

They are available in single-dose perforated aluminum-PVC/PVdC blisters of 10 x 1, 20 x 1, 28 x 1, 56 x 1, 60 x 1, 100 x 1, and 168 x 1 film-coated tablets.

HDPE bottle with a child-resistant polypropylene cap with 60, 100, 168, 180, 200, and 1,000 film-coated tablets.

Not all pack sizes may be marketed.

Patient Information Card: Handling of Information

Inside the Apixaban Accord 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 Apixaban Accord. 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 and Manufacturer

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est, 6a Planta,

08039 Barcelona,

Spain

Manufacturer

LABORATORI FUNDACIÓ DAU

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

08040 Barcelona, Spain

Accord Healthcare Polska Sp. z.o.o.

ul.Lutomierska 50,

95-200, Pabianice,

Poland

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Date of the Last Revision of this Leaflet:{MM/AAAA}.

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu/.