Apixaban Accord

Italy
Brand name Apixaban Accord
Form tablets, film-coated
Active substance / Dosage
APIXABAN
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
B01AF02
Registration number 048932
Manufacturer ACCORD HEALTHCARE, S.L.U.

Table of Contents

Package leaflet: Information for the user

Apixaban Accord 2.5 mg film-coated tablets

apixaban
Please 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 questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
  • If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Apixaban Accord contains the active substance apixaban and belongs to a group of medicines called
anticoagulants. This medicine helps prevent blood clots by blocking Factor Xa, an important component in blood clotting.
Apixaban Accord is used in adults:

  • to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After surgery on the hip or knee, you may have an increased risk of developing blood clots in the veins of the legs. This can cause swelling of the legs, with or without pain. If a blood clot travels from the leg to the lungs, it can block blood flow, causing shortness of breath, with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention;
  • to prevent the formation of blood clots in the heart of patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing a stroke, or reach other organs, blocking normal blood supply to these organs (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 blood clots from recurring in the blood vessels of the legs and/or lungs.

Apixaban Accord is used in children aged 28 days to less than 18 years to treat blood clots and to prevent blood clots from recurring in the veins or blood vessels of the lungs.
For the recommended dose according to body weight, see section 3.

2. What you should know before taking Apixaban Accord

Do not take Apixaban Accord if:

  • you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
  • you have excessive bleeding;
  • you have a disease in an organ of the body that leads to a higher risk of serious bleeding (such as an ulcer in the stomach or intestine, recent or active, recent bleeding in the brain);
  • you have a liver disease that increases the risk of bleeding (hepatic coagulopathy);
  • you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching to another anticoagulant treatment, while you have a venous or arterial catheter and are receiving heparin through it to keep it open, or if a catheter 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 taking this medicine if you have any of the following conditions:

  • increased risk of bleeding, such as: bleeding disorders, including conditions leading to reduced platelet function; very high blood pressure not controlled by medical treatment; if you are over 75 years old; if you weigh 60 kg or less;
  • severe kidney disease or if you are on dialysis;
  • liver problems or a history of liver problems; This medicine will be used with caution in patients showing signs of impaired liver function.
  • you have had a tube (catheter) or have received an injection into the spinal column (for anaesthesia or pain relief). Your doctor will advise you to take this medicine at least 5 hours after removal of the catheter;
  • you have a prosthetic heart valve;
  • if your doctor finds your blood pressure to be unstable, or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

Take special care with Apixaban Accord

  • if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is necessary.

If you are scheduled for surgery or a procedure that may cause bleeding,
your doctor may ask you to temporarily stop taking this medicine. If you are
unsure whether a procedure may cause bleeding, consult your doctor.
Children and adolescents
This medicine is not recommended for children and adolescents weighing less than 35 kg.
Other medicines and Apixaban Accord
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Some medicines can increase the effect of Apixaban Accord, while others can reduce it. Your doctor will decide whether you should be treated with Apixaban Accord while taking these medicines and how closely you need to be monitored.
The following medicines may increase the effect of Apixaban Accord and increase the risk of unwanted bleeding:

  • some medicines for fungal infections (e.g., ketoconazole, etc.);
  • some antiviral medicines for HIV/AIDS (e.g., ritonavir);
  • other medicines used to reduce blood clotting (e.g., enoxaparin, etc.);
  • anti-inflammatory medicines or painkillers (e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years old and taking acetylsalicylic acid, your risk of bleeding may be higher;
  • medicines for high blood pressure or heart problems (e.g., diltiazem);
  • antidepressants called selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).

The following medicines may reduce the effect of Apixaban Accord in preventing blood clot formation:

  • medicines for epilepsy or seizures (e.g., phenytoin, etc.);
  • St. John's wort (a herbal remedy used for depression);
  • medicines to treat tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
The effect of this medicine on pregnancy and the unborn baby is unknown. You must not take Apixaban Accord if you are pregnant. Contact your doctor immediately if you become pregnant while taking this medicine.
It is not known whether Apixaban Accord passes into breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine during breastfeeding. They will advise you whether to stop breastfeeding or to stop or not start treatment with this medicine.
Driving and using machines
Apixaban Accord has not been shown to affect the ability to drive or use machines.
Apixaban Accord contains lactose (a type of sugar) and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially “sodium-free”.

3. How to take Apixaban Accord

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with water. Apixaban Accord can be taken with or without food.
Try to take your tablets at the same time each day to get the best effect from your treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways you can take Apixaban Accord. The tablet can be crushed and mixed with water or 5% glucose in water, or apple juice or apple puree, immediately before taking.
Instructions for crushing the tablet:

  • Crush the tablets using a mortar and pestle, or on a plate using the convex side of a spoon;
  • Carefully transfer all the powder into a suitable container and then mix the powder with a small amount, e.g., 30 mL (2 tablespoons) of water or one of the other liquids mentioned above, to prepare a mixture;
  • Swallow the mixture;
  • Rinse the mortar and pestle or the spoon and plate used to crush the tablet and the container with a small amount of water (e.g., 30 mL) or one of the other liquids, and swallow the rinse liquid.

If necessary, your doctor may also administer the crushed Apixaban Accord tablet mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Accord as recommended
To prevent blood clots after hip or knee replacement surgery.
The recommended dose is one 2.5 mg Apixaban Accord tablet twice daily, for example, one in the morning and one in the evening.
You should take the first tablet 12 to 24 hours after surgery.
If you have had hip surgery, you will usually take the tablets for 32–38 days.
If you have had knee surgery, you will usually take the tablets for 10–14 days.
To prevent blood clots in the heart of patients with irregular heartbeat and at least one additional risk factor.
The recommended dose is one 5 mg Apixaban Accord tablet twice daily.
The recommended dose is one 2.5 mg Apixaban Accord tablet twice daily if:

  • you have severely reduced kidney function;
  • you meet two or more of the following criteria:
  • blood test results suggest poor kidney function (serum creatinine level is 1.5 mg/dL (133 micromoles/L) or higher);
  • you are 80 years of age or older;
  • your body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one in the morning and one in the evening. Your doctor will decide how long you should continue treatment.
For treating blood clots in the veins of the legs and in the blood vessels of the lungs
The recommended dose is two 5 mg Apixaban Accord tablets twice daily for the first 7 days, for example, two in the morning and two in the evening.
After 7 days, the recommended dose is one 5 mg Apixaban Accord tablet twice daily, for example, one in the morning and one in the evening.
To prevent recurrence of blood clots after completing 6 months of treatment
The recommended dose is one 2.5 mg Apixaban Accord tablet twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.
Use in children and adolescents
To treat blood clots and to prevent recurrence of blood clots in the veins or blood vessels of the lungs.
Take or administer this medicine exactly as instructed by your doctor or the child’s doctor or pharmacist. If you have any doubts, consult your doctor or the child’s doctor, pharmacist, or nurse.
Try to take or administer the dose at the same time each day to get the best effect from treatment. The dose of Apixaban Accord depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents with a body weight of at least 35 kg is four 2.5 mg Apixaban Accord tablets twice daily for the first 7 days, for example, four in the morning and four in the evening. After 7 days, the recommended dose is two 2.5 mg Apixaban Accord tablets twice daily, for example, two in the morning and two in the evening.
For parents or caregivers: Observe the child to ensure they have taken the full dose.
It is important to attend scheduled medical appointments, as the dose may need to be adjusted as body weight changes.
Your doctor may modify your anticoagulant treatment as follows:

  • Switching from Apixaban Accord to another anticoagulant medicine Stop taking Apixaban Accord. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you would have taken your next tablet.
  • Switching from another anticoagulant medicine to Apixaban Accord Stop taking the anticoagulant medicine. Start taking Apixaban Accord at the time you would have taken your next dose of the anticoagulant medicine, then continue taking it normally.
  • Switching from a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Accord Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to start taking Apixaban Accord.
  • Switching from Apixaban Accord to a vitamin K antagonist anticoagulant (e.g., warfarin) If your doctor tells you to start taking a vitamin K antagonist medicine, continue taking Apixaban Accord for at least 2 days after taking the first dose of the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to stop taking Apixaban Accord.

Patients undergoing cardioversion
If you have an abnormal heart rhythm that needs to be restored to normal by a procedure called cardioversion, take this medicine at the times your doctor tells you to, to prevent blood clots in the blood vessels of the brain and in other blood vessels of the body.
If you take more Apixaban Accord than you should
Contact your doctor immediately if you have taken more than the prescribed dose of this medicine. Take the medicine pack with you, even if no tablets are left.
If you take more Apixaban Accord than recommended, you may have an increased risk of bleeding. If bleeding occurs, you may need surgery, a blood transfusion, or other treatments to reverse the anticoagulant effect on factor Xa.
If you forget to take Apixaban Accord
If you forget to take Apixaban Accord

  • If you forget to take your morning dose, take it as soon as you remember, and you may take it together with your evening dose.
  • A forgotten evening dose may be taken only on the same evening. Do not take two doses the next morning; instead, continue with your usual twice-daily dosing schedule the next day.

If you are unsure what to do or if you have missed more than one dose, consult your doctor, pharmacist, or nurse.
If you stop taking Apixaban Accord
Do not stop taking this medicine without first talking to your doctor, as your risk of developing a blood clot may be higher if you stop treatment too early.
If you have any questions about how to use 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. Apixaban Accord may be prescribed for three different medical conditions. The known side effects and their frequency may differ and are listed separately below. For these conditions, the most common general side effect of Apixaban, this medicine, is bleeding, which can potentially be life-threatening and requires immediate medical attention.

The following side effects occur when Apixaban Accord is taken to prevent blood clots after hip or knee replacement surgery.

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

  • Anaemia, which can cause tiredness or pale skin;
  • Bleeding, including:
    • Bruising and swelling;
  • Nausea (feeling sick).

Uncommon side effects (may affect up to 1 in 100 people)

  • Reduction in the number of platelets in the blood (which may affect blood clotting);
  • Bleeding:
    • Occurring after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or at the injection site;
    • From the stomach, intestine, or bright/red blood in faeces;
    • In urine;
    • From the nose;
    • From the vagina;
  • Low blood pressure, which may cause fainting or a rapid heartbeat;
  • Blood tests that may show:
    • Abnormal liver function;
    • Increased liver enzymes;
    • Increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
  • Itching.

Rare side effects (may affect up to 1 in 1,000 people)

  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
  • Bleeding:
    • Into muscles;
    • Into the eyes;
    • From gums and blood in sputum when coughing;
    • From the rectum;
  • Hair loss.

Not known (frequency cannot be estimated from the available data)

  • Bleeding:
    • Into the brain or spinal cord;
    • Into the lungs or throat;
    • In the mouth;
    • In the abdomen or in the space behind the abdominal cavity;
    • From haemorrhoids;
    • Tests showing blood in faeces or urine;
  • Skin rash that may blister and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
  • Inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising;
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects occur when Apixaban Accord is taken to prevent blood clots forming in the heart of patients with irregular heartbeat and at least one additional risk factor.

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

  • Bleeding:
    • In the eyes;
    • In the stomach or intestine;
    • From the rectum;
    • In urine;
    • From the nose;
    • From the gums;
    • Bruising and swelling;
  • Anaemia, which may cause tiredness or pale skin;
  • Low blood pressure, which may cause fainting or rapid heartbeat;
  • Nausea (feeling sick);
  • Blood tests may show:
    • Increased gamma-glutamyl transferase (GGT).

Uncommon side effects (may affect up to 1 in 100 people)

  • Bleeding:
    • Into the brain or spinal cord;
    • In the mouth or blood in sputum when coughing;
    • In the abdomen or from the vagina;
    • Bright/red blood in faeces;
    • Occurring after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or at the injection site;
    • From haemorrhoids;
    • Tests showing blood in faeces or urine;
  • Decrease in the number of platelets in the blood (which may affect clotting);
  • Blood tests may show:
    • Abnormal liver function;
    • Increased liver enzymes;
    • Increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
  • Skin rash;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.

Rare side effects (may affect up to 1 in 1,000 people)

  • Bleeding:
    • Into the lungs or throat;
    • Into the space behind the abdominal cavity;
    • Into the muscle.

Very rare side effects (may affect up to 1 in 10,000 people)

  • Skin rash that may blister and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).

Not known (frequency cannot be estimated from the available data)

  • Inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising.
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects occur when Apixaban Accord is taken to treat or prevent recurrence of blood clots in the legs and blood vessels of the lungs.

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

  • Bleeding:
    • From the nose;
    • From the gums;
    • In urine;
    • Bruising and swelling;
    • In the stomach, intestine, or from the rectum;
    • In the mouth;
    • From the vagina;
  • Anaemia, which may cause tiredness or pale skin;
  • Decrease in the number of platelets in the blood (which may affect clotting);
  • Nausea (feeling sick);
  • Skin rash;
  • Blood tests may show:
    • Increased gamma-glutamyl transferase (GGT) or increased alanine aminotransferase (ALT);

Uncommon side effects (may affect up to 1 in 100 people)

  • Low blood pressure, which may cause weakness or rapid heartbeat;
  • Bleeding:
    • Into the eyes;
    • In the mouth or blood in sputum when coughing;
    • Bright/red blood in faeces;
    • Tests showing blood in faeces or urine;
    • Occurring after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or at the injection site;
    • From haemorrhoids;
    • Into the muscle;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
  • Blood tests may show:
    • Abnormal liver function;
    • Increased liver enzymes;
    • Increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1,000 people)
Bleeding:

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

Not known (frequency cannot be estimated from the available data)
Bleeding:

  • In the abdomen or in the space behind the abdominal cavity;
  • Skin rash that may blister and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
  • Inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising.
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Other side effects in children and adolescents
Contact the child’s doctor immediately if you notice any of these symptoms:

  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. The frequency of these side effects is common (may affect up to 1 in 10 people).

In general, the side effects observed in children and adolescents treated with Apixaban Accord have been of a similar type to those seen in adults and have mainly been mild to moderate in severity. The side effects observed more frequently in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

  • Bleeding, including:
    • From the vagina;
    • From the nose.

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

  • Bleeding, including:
    • From the gums;
    • In urine;
    • Bruising and swelling;
    • From the intestine or rectum;
    • Bright/red blood in faeces;
    • Occurring after any surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or at the injection site;
  • Hair loss;
  • Anaemia, which may cause tiredness or pale skin;
  • Reduction in the number of platelets in the child’s blood (which may affect clotting);
  • Nausea (feeling unwell);
  • Skin rash;
  • Itching;
  • Low blood pressure, which may cause the child to feel weak or have a rapid heartbeat;
  • Blood tests may show:
    • Abnormal liver function;
    • Increased liver enzymes;
    • Increased alanine aminotransferase (ALT).

Not known (frequency cannot be estimated from the available data)

  • Bleeding:
    • In the abdomen or in the space behind the abdominal cavity;
    • In the stomach;
    • Into the eyes;
    • In the mouth;
    • From haemorrhoids;
    • In the mouth or blood in sputum when coughing;
    • Into the brain or spinal cord;
    • Into the lungs;
    • Into the muscle;
  • Skin rash that may blister and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
  • Inflammation of blood vessels (vasculitis) which may present as skin rashes or small, flat, red, round spots under the skin surface or bruising;
  • Blood tests may show:
    • Increased gamma-glutamyl transferase (GGT);
    • Tests showing blood in faeces or urine.
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apixaban Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
“Exp.” or “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Apixaban Accord contains

  • The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
  • The other components are:
    • Tablet core: lactose (see section 2), microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate;
    • Coating: monohydrate lactose (see section 2), hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172).

Description of the appearance of Apixaban Accord and package contents
The film-coated tablets are yellow, round, biconvex, with "IU1" engraved on one side and smooth on the other.
Aluminum-PVC/PVdC blisters. Packs containing 10, 14, 20, 28, 56, 60, 100, 112, 168 and 200 film-coated tablets.
Single-dose divisible aluminum-PVC/PVdC blisters containing 10x1, 20x1, 28x1, 56x1, 60x1, 100x1 and 168x1 film-coated tablets.
HDPE bottle with child-resistant screw cap made of polypropylene containing 60, 100, 168, 180, 200 and 1000 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: managing information
Inside the Apixaban Accord package, together with the package leaflet, you will find a Patient Alert Card, or your doctor may have given you a similar one.
This Patient Alert Card includes information that may be useful to you and alerts other healthcare professionals that you are taking Apixaban Accord. You must always carry this card with you.

  1. Take the card
  2. Detach the text in your language when necessary (this will be facilitated by the pre-perforated edge)
  3. Complete the following sections or ask your doctor to do so:
    • Name:
    • Date of birth:
    • Indication:
    • Dose: ......mg twice daily
    • Doctor’s name:
    • Doctor’s telephone number:
  4. Fold the card and keep it with you at all times

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6th Floor,
08039 Barcelona,
Spain

Manufacturers
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
Accord Healthcare single member S.A.
64th Km National Road Athens, Lamia,
Schimatari, 32009,
Greece

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Tel: +30 210 74 88 821

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.

Package leaflet: information for the user

Apixaban Accord 5 mg film-coated tablets

apixaban
Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Apixaban Accord 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 component in blood coagulation.
Apixaban Accord is used in adults:

  • to prevent the formation of blood clots in the heart of patients with irregular heartbeat (atrial fibrillation) and with at least one additional risk factor. Blood clots may dislodge, travel to the brain and cause a stroke, or travel to other organs and block normal blood flow to these organs (known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
  • to treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

Apixaban Accord is used in children aged 28 days and up to 18 years to treat blood clots and to prevent recurrence of blood clots in the veins or blood vessels of the lungs.
For the recommended dose according to body weight, see section 3.

2. What you should know before taking Apixaban Accord

Do not take Apixaban Accord if:

  • you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
  • you have excessive bleeding;
  • you have a disease in a body organ that leads to an increased risk of serious bleeding (such as an ulcer in the stomach or intestine, recent or active, or a recent bleed in the brain);
  • you have a liver disease that increases the risk of bleeding (hepatic coagulopathy);
  • you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching to another anticoagulant treatment, while you have a venous or arterial catheter and are receiving heparin through it to keep it open, or if a catheter 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 taking this medicine if you have any of the following conditions:

  • increased risk of bleeding, such as: bleeding disorders, including conditions leading to reduced platelet function; very high blood pressure not controlled by medical treatment; if you are over 75 years old; if you weigh 60 kg or less;
  • severe kidney disease or if you are on dialysis;
  • liver problems or a history of liver problems; This medicine will be used with caution in patients showing signs of impaired liver function;
  • you have a tube (catheter) or have had an injection into the spinal column (for anaesthesia or pain relief). Your doctor will tell you when to start taking this medicine, at least 5 hours or more after catheter removal;
  • you have a prosthetic heart valve;
  • if your doctor finds that your blood pressure is unstable;
  • if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

Take special care with Apixaban Accord

  • if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether your therapy needs to be changed.

If you are scheduled for surgery or a procedure that may cause bleeding, your doctor may ask you to temporarily stop taking this medicine. If you are unsure whether a procedure could cause bleeding, consult your doctor.

Children and adolescents
This medicine is not recommended for children and adolescents with a body weight below 35 kg.

Other medicines and Apixaban Accord
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Some medicines can increase the effect of Apixaban Accord, while others can reduce it. Your doctor will decide whether you should take Apixaban Accord while using these medicines and how you should be closely monitored.

The following medicines may increase the effect of Apixaban Accord and increase the risk of unwanted bleeding:

  • some medicines for fungal infections (e.g., ketoconazole, etc.);
  • some antiviral medicines for HIV/AIDS (e.g., ritonavir);
  • other medicines used to reduce blood clotting (e.g., enoxaparin, etc.);
  • anti-inflammatory drugs or painkillers (e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years old and taking acetylsalicylic acid, your risk of bleeding may be higher;
  • medicines for high blood pressure or heart problems (e.g., diltiazem);
  • antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

The following medicines may reduce the effect of Apixaban Accord in preventing blood clots:

  • medicines for epilepsy or seizures (e.g., phenytoin, etc.);
  • St. John’s wort (a herbal product used for depression);
  • medicines to treat tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor, pharmacist, or nurse for advice before taking this medicine.

The effect of Apixaban Accord during pregnancy and on the unborn baby is unknown. You must not take this medicine during pregnancy. Contact your doctor immediately if you become pregnant while taking this medicine.

It is not known whether Apixaban Accord passes into breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine while breastfeeding. They will advise you whether to stop breastfeeding or to stop or not start treatment with Apixaban Accord.

Driving and using machines
Apixaban Accord has not shown to affect the ability to drive or use machines.

Apixaban Accord contains lactose (a type of sugar) and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Apixaban Accord

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor, pharmacist, or nurse.
Dose
Swallow the tablet with some water. Apixaban Accord may be taken with or without food.
Try to take the tablets at the same time each day to achieve the best effect from treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways in which you can take Apixaban Accord. The tablet may be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before administration.
Instructions for crushing the tablet:

  • Crush the tablets using a mortar and pestle or, on a plate, with the convex side of a spoon.
  • Carefully transfer all the powder into a suitable container and then mix the powder with a small amount, e.g., 30 mL (2 tablespoons), of water or one of the other liquids mentioned above, to prepare a mixture.
  • Swallow the mixture.
  • Rinse the mortar and pestle (or spoon and plate) used to crush the tablet and the container with a small amount of water (e.g., 30 mL) or one of the other liquids, and swallow the rinse liquid.

If necessary, your doctor may also administer the crushed Apixaban Accord tablet mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Accord as recommended
To prevent blood clots forming in the heart of patients with irregular heartbeat and at least one additional risk factor.
The recommended dose is one tablet of Apixaban Accord 5 mg twice daily.
The recommended dose is one tablet of Apixaban Accord 2.5 mg twice daily if:

  • you have severely reduced kidney function, or
  • you meet two or more of the following criteria:
  • blood test results suggest poor kidney function (serum creatinine level is 1.5 mg/dL (133 micromoles/L) or higher);
  • you are 80 years of age or older;
  • your body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.
For the treatment of blood clots in the veins of the legs and in the blood vessels of the lungs
The recommended dose is two tablets of Apixaban Accord 5 mg twice daily for the first 7 days, for example, two in the morning and two in the evening.
After 7 days, the recommended dose is one tablet of Apixaban Accord 5 mg twice daily, for example, one in the morning and one in the evening.
To prevent recurrence of blood clots after completion of 6 months of treatment
The recommended dose is one tablet of Apixaban Accord 2.5 mg twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.
Use in children and adolescents
To treat blood clots and to prevent recurrence of blood clots in the veins or in the blood vessels of the lungs.
Take or administer this medicine exactly as directed by your doctor, the child’s doctor, or pharmacist.
If you have any doubts, consult your doctor, the child’s doctor, pharmacist, or nurse.
Try to take or administer the dose at the same time each day to achieve the best effect from treatment.
The dose of Apixaban Accord depends on body weight and will be calculated by the doctor. The recommended dose for children and adolescents with body weight of at least 35 kg is four tablets of Apixaban Accord 5 mg twice daily for the first 7 days, for example, four in the morning and four in the evening. After 7 days, the recommended dose is two tablets of Apixaban Accord 5 mg twice daily, for example, two in the morning and two in the evening.
For parents or caregivers: observe the child to ensure that the full dose has been taken.
It is important to attend scheduled medical appointments, as the dose may need to be adjusted as body weight changes.
Your doctor may change your anticoagulant treatment as follows:

  • Switching from Apixaban Accord to another anticoagulant medicine Stop taking Apixaban Accord. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you would have taken the next tablet.
  • Switching from another anticoagulant medicine to Apixaban Accord Stop taking the anticoagulant medicine. Start treatment with Apixaban Accord at the time you would have taken the next dose of the anticoagulant medicine, then continue taking it as usual.
  • Switching from treatment with a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Accord Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to start treatment with Apixaban Accord.
  • Switching from Apixaban Accord to treatment with a vitamin K antagonist anticoagulant (e.g., warfarin) If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban Accord for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to stop treatment with Apixaban Accord.

Patients undergoing cardioversion
If you have an abnormal heartbeat that needs to be restored to normal by a procedure called cardioversion, take this medicine exactly as your doctor instructs, to prevent blood clots in the blood vessels of the brain and in other blood vessels of the body.
If you take more Apixaban Accord than you should
Inform your doctor immediately if you have taken more than the prescribed dose of Apixaban Accord. Take the medicine pack with you, even if no tablets are left.
If you take more Apixaban Accord than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgical intervention, blood transfusion, or other treatments that can reverse the factor Xa anticoagulant activity may be required.
If you forget to take Apixaban Accord:

  • If you forget a morning dose, take it as soon as you remember; you may take it together with your evening dose.
  • A forgotten evening dose may be taken only on the same evening. Do not take two doses the next morning; instead, continue with the twice-daily dosing schedule as recommended the following day.

If you are unsure what to do or if you have missed more than one dose, consult your doctor, pharmacist, or nurse.
If you stop taking Apixaban Accord
Do not stop taking this medicine without first discussing it with your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

The following side effects occur when Apixaban Accord is taken to prevent blood clots forming in the heart in patients with irregular heartbeat and at least one additional risk factor.

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

  • Bleeding:
    • in the eyes;
    • in the stomach or intestines;
    • from the rectum;
    • blood in the urine;
    • from the nose;
    • from the gums;
    • bruising and swelling;
  • Anaemia, which may cause tiredness or pale skin;
  • Low blood pressure, which may cause dizziness or rapid heartbeat;
  • Nausea (feeling sick);
  • Blood tests may show:
    • increased 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 blood in coughed-up phlegm;
    • in the abdomen or from the vagina;
    • bright red blood in the stools;
    • bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision (wound discharge) or at injection site;
    • from haemorrhoids;
    • tests showing blood in the stools or urine;
  • Decrease in the number of platelets in the blood (which may affect blood clotting);
  • Blood tests may show:
    • abnormal liver function;
    • increased liver enzymes;
    • increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
  • Rash;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if 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 the muscles.

Very rare side effects (may affect up to 1 in 10,000 people)

  • Rash which may form blisters and appear as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).

Not known (frequency cannot be estimated from available data)

  • Inflammation of blood vessels (vasculitis), which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising;
  • Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects occur when Apixaban Accord is taken to treat or prevent recurrence of blood clots in the veins of the legs and blood vessels of the lungs.

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

  • Bleeding:
    • from the nose;
    • from the gums;
    • blood in the urine;
    • bruising and swelling;
    • in the stomach, intestines, or from the rectum;
    • in the mouth;
    • from the vagina;
  • Anaemia, which may cause tiredness or pale skin;
  • Decrease in the number of platelets in the blood (which may affect blood clotting);
  • Nausea (feeling sick);
  • Rash;
  • Blood tests may show:
    • increased gamma-glutamyl transferase (GGT) or increased alanine aminotransferase (ALT).

Uncommon side effects (may affect up to 1 in 100 people)

  • Low blood pressure, which may cause dizziness or rapid heartbeat;
  • Bleeding:
    • in the eyes;
    • in the mouth or blood in coughed-up phlegm;
    • bright red blood in the stools;
    • tests showing blood in the stools or urine;
    • bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision (wound discharge) or at injection site;
    • from haemorrhoids;
    • in the muscle;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms;
  • Blood tests may show:
    • abnormal liver function;
    • increased liver enzymes;
    • increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1,000 people)

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

Not known (frequency cannot be estimated from available data)

  • Bleeding:
    • in the abdomen or in the space behind the abdominal cavity;
  • Rash which may form blisters and appear as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
  • Inflammation of blood vessels (vasculitis), which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising;
  • Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Other side effects in children and adolescents
Contact your child’s doctor immediately if you notice any of the following symptoms:

  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. The frequency of these side effects is common (may affect up to 1 in 10 people).

In general, the side effects observed in children and adolescents treated with Apixaban Accord have been similar to those seen in adults and have mainly been mild to moderate in severity. The side effects observed more frequently in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

  • Bleeding, including:
    • from the vagina;
    • from the nose.

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

  • Bleeding, including:
    • from the gums;
    • blood in the urine;
    • bruising and swelling;
    • from the intestines or rectum;
    • bright red blood in the stools;
    • bleeding occurring after any procedure, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision (wound discharge) or at injection site;
  • Hair loss;
  • Anaemia, which may cause tiredness or pale skin;
  • Decrease in the number of platelets in your child’s blood (which may affect blood clotting);
  • Nausea (feeling unwell);
  • Rash;
  • Itching;
  • Low blood pressure, which may cause your child to feel weak or have a rapid heartbeat;
  • Blood tests may show:
    • liver function abnormalities;
    • increased liver enzymes;
    • increased alanine aminotransferase (ALT).

Not known (frequency cannot be estimated from available data)

  • Bleeding:
    • in the abdomen or in the space behind the abdominal cavity;
    • in the stomach;
    • in the eyes;
    • in the mouth;
    • from haemorrhoids;
    • in the mouth or blood in coughed-up phlegm;
    • in the brain or spinal cord;
    • in the lungs;
    • in the muscle;
  • Rash which may form blisters and appear as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
  • Inflammation of blood vessels (vasculitis), which may present as skin rashes or small, flat, red, round spots under the skin surface or bruising;
  • Blood tests may show:
    • increased gamma-glutamyl transferase (GGT);
    • tests showing blood in the stools or urine;
  • Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apixaban Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "Exp." or "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Apixaban Accord Contains

  • The active substance is apixaban. Each tablet contains 5 mg of apixaban.
  • The other components are: tablet core: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate; coating: monohydrate lactose (see section 2), hypromellose, titanium dioxide (E171), triacetin, red iron oxide (E172).

Description of the Appearance of Apixaban Accord and Contents of the Pack

The film-coated tablets are pink, oval-shaped, biconvex, with "IU2" printed on one side and smooth on the other.
Aluminum PVC/PVdC blisters. Packs containing 10, 14, 20, 28, 56, 60, 100, 112, 168, and 200 film-coated tablets.
Single-dose divisible aluminum-PVC/PVdC blisters: 10x1, 20x1, 28x1, 56x1, 60x1, 100x1, and 168x1 film-coated tablets.
HDPE bottles with child-resistant polypropylene screw cap containing 60, 100, 168, 180, 200, and 1,000 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: Managing Information
Inside the Apixaban Accord package, together with the package leaflet, you will find a Patient Alert Card or your doctor may provide you with a similar one.
This Patient Alert Card includes information that may be helpful to you and alerts other physicians that you are taking Apixaban Accord. You must always carry this card with you.

  1. Take the card
  2. Tear off the text in your language as needed (a pre-perforated edge will assist you)
  3. Complete the following sections or ask your doctor to do so:
    • Name:
    • Date of birth:
    • Indication:
    • Dose: ......mg twice daily
    • Doctor’s name:
    • Doctor’s telephone number:
  4. Fold the card and keep 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, 6th Floor,
08039 Barcelona,
Spain

Manufacturers
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
Accord Healthcare single member S.A.
64th Km National Road Athens, Lamia,
Schimatari, 32009, Greece

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Tel: +30 210 74 88 821

Other Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/