APIXABAN 2.5 mg Tabletki powlekane

Treść ulotki

1. Apixaban Accord 2,5 mg film-coated tablets
   1. What is Apixaban Accord and what is it 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. Package Contents and Other Information
2. Apixaban Accord 5 mg film-coated tablets
   1. What is Apixaban Accord 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. Package contents and other information

Apixaban Accord 2,5 mg film-coated tablets

apixaban

Read this 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Apixaban Accord and what is it used for

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

• to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After a hip or knee operation, you may have a higher 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 moves from the leg to the lungs, it can block the 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 with at least one additional risk factor. Blood clots can detach and reach the brain and cause a stroke or reach other organs preventing the normal blood flow to those 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 reforming in the blood vessels of the legs and/or lungs.

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

2. What you need to know before taking 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);
• you have excessive bleeding;
• you have a disease in an organof the body that leads to a higher risk of serious bleeding (such as an ulcer,of the stomach or intestine, recent or active, a recentbrain bleed);
• you have a liver diseasethat leads to a higher risk of bleeding (hepatic coagulopathy);
• you are taking medicines to prevent blood clots from forming(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 suffer from
any of the following conditions:

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

Pay particular attention with Apixaban Accord

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

If you are going to have surgery or a procedure that may cause bleeding,
your doctor may ask you to temporarily stop taking this medicine. If
you are not sure if a procedure may cause bleeding, talk to your doctor.

Children and adolescents
This medicine is not recommended in children and adolescents weighing less than 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 and others can decrease it. Your
doctor will decide if you should be treated with Apixaban Accord while taking these
medicines and how you should be closely monitored.
The following medicines can increase the effect of Apixaban Accord and increase the possibility of
undesirable 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-inflammatoryor painkillers(e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years of age and are taking acetylsalicylic acid, you may have a greater chance of bleeding;
• medicines for high blood pressure or heart problems(e.g., diltiazem);
• antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin-norepinephrine reuptake inhibitors.

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor,
pharmacist or nurse for advice before taking this medicine.
The effect of this medicine on pregnancy and the fetus are not known. You should not take Apixaban
Accord if you are pregnant. Contact your doctor immediatelyif 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 stop/not start therapy with this medicine

Driving and using machines
Apixaban Accord has not been shown to affect the ability to drive vehicles 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 following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor, pharmacist or nurse.

Dosage
Swallow the tablet with a little water. Apixaban Accord can be taken with or without food.
Try to take the tablets at the same time each day, to get the best effect from the
therapy.
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 applesauce, immediately before taking it.

Instructions for crushing the tablet:

• crush the tablets with a pestle and mortar 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 with one of the other liquids mentioned above, to prepare a mixture;
• swallow the mixture;
• rinse the pestle and mortar 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 liquid.

If necessary, your doctor may also administer the crushed Apixaban Accord tablet and
mixed with 60 mL of water or 5% glucose in water, through a nasogastric tube.

Take Apixaban Accord as recommended
To prevent the formation of blood clots after hip or knee replacement surgeries.
The recommended dose is one Apixaban Accord 2.5 mg tablet, twice a day,
for example, one in the morning and one in the evening.
You should take the first tablet 12 to 24 hours after the operation.
If you have had a hipoperation, you will generally take the tablets for a period of 32-38 days.
If you have had a kneeoperation, you will generally take the tablets for a period of 10-
14 days.
To prevent the formation of blood clots in the heart of patients with irregular heartbeat and
with at least one additional risk factor.
The recommended dose 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;
• you fall into two or more of the following conditions:
• blood test results suggest poor kidney function (the serum creatinine value is 1.5 mg/dL (133 micromoles/L) or higher);
• you are 80 years of age or older;
• your weight is 60 kg or less.

The recommended dose is one tablet twice a day, for example, one in the morning and one in the
evening. Your doctor will decide how long you should continue 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 mg,twice a day for the first
7 days, for example, two in the morning and two in the evening.
After 7 days, the recommended dose is one tabletof Apixaban Accord 5 mg,twice a
day, for example, one in the morning and one in the evening.
To prevent blood clots from reforming after completing 6 months of treatment
The recommended dose is one Apixaban Accord 2.5 mgtablet, twice a day, 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 blood clots from reforming in the veins or in
the blood vessels of the lungs.
Take or administer this medicine following exactly the instructions of 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
Apixaban Accord 2.5 mg tablets twice a day for the first 7 days, for example four in the
morning and four in the evening. After 7 days, the recommended dose is two tabletsof Apixaban Accord
2.5 mg twice a day, for example, two in the morning and two in the evening.
For parents or caregivers: observe the child to make sure they have taken the entire dose.
It is important to keep scheduled medical visits because the dose may need to be
adjusted as body weight changes.

Your doctor may modify the anticoagulant treatment as follows:

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

Patients undergoing cardioversion
If you have an irregular heartbeat that needs to be restored to normal with a procedure
called cardioversion, take this medicine at the times your doctor tells you to
take it, 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 more than the prescribed dose of this medicine. Bring
the medicine packaging with you, even if there are no tablets left.
If you take more Apixaban Accord than recommended, you may have a higher risk of
bleeding. If bleeding occurs, surgical intervention, a transfusion or other treatments that can inactivate the activity against factor Xa may be necessary.

If you forget to take Apixaban Accord
If you forget to take Apixaban Accord

• If you forget to take a morning dose, take it as soon as you remember, you can take it with the evening dose.
• A forgotten evening dose can only be taken that same evening. Do not take two doses the next morning, and then continue instead to follow the dosing schedule twice a day, as recommended, the next day.

If you have any doubts about what to do or if you have forgotten more than one dose,consult your doctor, pharmacist or
nurse.

If you stop taking Apixaban Accord
Do not stop taking this medicine before talking to your doctor, as the risk of
developing a blood clot may be greater if you stop treatment too soon.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Apixaban Accord can be prescribed for three different medical conditions. The known side effects and the
frequency with which they occur may vary 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 the formation of blood clots
after hip or knee replacement surgery.

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

• Anemia, which can cause fatigue or paleness;
• Bleeding, which includes:
• bruising and swelling;
• Nausea (feeling sick).

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

• Reduced number of platelets in the blood (which may affect blood clotting);
• Bleeding:
• occurring after surgery, including bruising and swelling, leakage of blood or fluid; from the surgical
  wound/incision (wound secretion) or at the injection site;
• from the stomach, intestine, or fresh/red blood in the stool;
• blood in the urine;
• from the nose;
• from the vagina;
• Low blood pressure, which can cause dizziness or a fast heartbeat;
• Blood tests that may detect:
• abnormal liver function;
• some liver enzymes increased;
• increased bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and
  eyes;
• Itching.

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

• Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue and/or
  throat and difficulty breathing. Contact your doctor immediatelyif any of these symptoms occur.
• Bleeding:
• in the muscles;
• in the eyes;
• in the gums and blood in the sputum when coughing;
• from the rectum;
• Hair loss.

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

• Bleeding:
• in the brain or spinal cord;
• in the lungs or throat;
• in the mouth;
• in the abdomen or the space behind the abdominal cavity;
• from hemorrhoids;
• tests showing blood in the stool or urine;
• Skin rash that may blister and appears 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) that can cause skin rashes or pinpoint, flat, red, round spots
  under the skin surface or bruising;
• Bleeding in the kidney sometimes with blood in the urine resulting in the kidneys being unable to work
  properly (anticoagulant-related nephropathy).

The following side effects occur when Apixaban Accord is taken to prevent the formation of blood clots in
the heart of patients with irregular heartbeat and with 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;
• blood in the urine;
• from the nose;
• from the gums;
• bruising and swelling;
• Anemia, which can cause fatigue or paleness;
• Low blood pressure, which can cause dizziness or a fast heartbeat;
• Nausea (feeling sick);
• Blood tests that may show:
• increased gamma-glutamyl transferases (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 the sputum when coughing;
• in the abdomen or from the vagina;
• fresh/red blood in the stool;
• bleeding that occurs after surgery, including bruising and swelling, leakage of blood or fluid from the
  surgical wound/incision (wound secretion) or at the injection site.
• from hemorrhoids;
• tests showing blood in the stool or urine;
• Decreased number of platelets in the blood (which may affect blood clotting);
• Blood tests that may detect:
• abnormal liver function;
• increased liver enzymes;
• increased bilirubin, a breakdown product 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. Contact your doctor immediatelyif any of these symptoms occur.

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 muscle; Very rare side effects (may affect up to 1 in 10,000 people)
• Skin rash that may blister and appears 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) that can cause skin rashes or pinpoint, flat, red, round spots
  under the skin surface or bruising.
• Bleeding in the kidney sometimes with blood in the urine resulting in the kidneys being unable to work
  properly (anticoagulant-related nephropathy).

The following side effects occur when Apixaban Accord is used to treat or prevent blood clots from
reforming in the veins of the legs and blood vessels in 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, intestine, from the rectum;
• in the mouth;
• from the vagina;
• Anemia, which can cause fatigue or paleness;
• Decreased number of platelets in the blood (which may affect blood clotting);
• Nausea (feeling sick);
• Skin rash;
• Blood tests that may show:
• increased gamma-glutamyl transferases (GGT) or increased alanine aminotransferase (ALT);

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

• Low blood pressure, which can cause weakness or a fast heartbeat
• Bleeding:
• in the eyes;
• in the mouth or blood in the sputum when coughing;
• bright/red blood in the stool;
• tests showing blood in the stool or urine;
• bleeding that occurs after surgery, including bruising and swelling, leakage of blood or fluid from the
  surgical wound/incision (wound secretion) or from the injection site;
• from hemorrhoids;
• in the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue and/or
  throat and difficulty breathing. Contact your doctor immediatelyif any of these symptoms occur.
• Blood tests may show:
• abnormal liver function;
• increased liver enzymes;
• increased bilirubin, a breakdown product of red blood cells, which can 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 the available data)
Bleeding:

• in the abdomen or the space behind the abdominal cavity;
• Skin rash that may blister and appears 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) that can cause skin rashes or pinpoint, flat, red, round spots
  under the skin surface or bruising.
• Bleeding in the kidney sometimes with blood in the urine resulting in the kidneys being unable to work
  properly (anticoagulant-related nephropathy).

Other side effects in children and adolescents

Tell your child's doctor immediatelyif you notice any of these symptoms;

• Allergic reactions (hypersensitivity) that can 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 observed in adults and have been mainly of mild to moderate severity. The side effects that
have been observed more frequently in children and adolescents have been 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 intestine or rectum;
• bright/red blood in the stool;
• bleeding that occurs after any surgery, including bruising and swelling, leakage of blood or fluid from the
  surgical wound/incision (wound secretion) or from the injection site;
• Hair loss;
• Anemia, which can cause fatigue or paleness;
• Decreased number of platelets in the child's blood (which may affect blood clotting);
• Nausea (feeling unwell);
• Skin rash;
• Itching;
• Low blood pressure, which can cause the child to feel weak or have a fast 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 the space behind the abdominal cavity;
• in the stomach;
• in the eyes;
• in the mouth;
• from hemorrhoids;
• in the mouth or blood in the sputum when coughing;
• in the brain or spinal cord;
• in the lungs;
• in the muscle;
• Skin rash that may blister and appears 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) that can cause skin rashes or pinpoint, flat, red, round spots
  under the skin surface or bruising;
• Blood tests may show:
• increased gamma-glutamyl transferases (GGT);
• tests showing blood in the stool or urine.
• Bleeding in the kidney sometimes with blood in the urine resulting in the kidneys being unable to work
  properly (anticoagulant-related nephropathy).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse.
You can also report side effects directly through the national reporting system detailed 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 package and on the blister after
“Scad.” or “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 ingredient is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other ingredients are:
• tablet core: lactose (see paragraph 2), microcrystalline cellulose, croscarmellose sodium
• coating: lactose monohydrate (see paragraph 2), hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172).

Description of Apixaban Accord and package contents
The film-coated tablets are yellow, round, biconvex, with “IU1” imprinted on one side and smooth
on the other.
Aluminum-PVC/PVdC blisters. Packs of 10, 14, 20, 28, 56, 60, 100, 112, 168 and 200 film-coated
tablets.
Aluminum-PVC/PVdC divisible blisters for single doses of 10x1, 20x1, 28x1,
56x1, 60x1, 100x1 and 168x1 film-coated tablets.
High-density polyethylene (HDPE) bottle with a child-resistant screw cap containing 60, 100, 168,
180, 200, and 1000 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: information management
Alert for the Patient or your doctor may have a similar one.
This Patient Alert Card includes information that may be useful to you and warns other doctors that you are taking Apixaban Accord. You should always carry this
card with you.

• 1. Take the card
• 2. Detach the text in your language if necessary (you will be assisted 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 a day
• Doctor's name:
• Doctor's phone number:
• 4. Fold the card and always keep it with you Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6 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
Accord Healthcare single member S.A.
64th Km National Road Athens, Lamia,
Schimatari, 32009,
Greece
For further information on this medicinal product, 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.
Τel: +30 210 74 88 821

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

Apixaban Accord 5 mg film-coated tablets

apixaban

Read this 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Apixaban Accord 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 to prevent the formation of blood clots by blocking
Factor Xa, which is an important component of 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 can detach and reach the brain and cause a stroke or reach other organs preventing the normal blood flow to those 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 reforming in the blood vessels of the legs and/or lungs.

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

2. What you need to know before taking 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);
• you have excessive bleeding;
• you have a disease in an organof the body that leads to a higher risk of serious bleeding (such as an ulcer,of the stomach or intestine, recent or active, a recent bleedin the brain);
• you have a liver diseasethat leads to a higher 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 suffer from
any of the following conditions:

• increased risk of bleeding, such as: bleeding disorders, including conditions that lead to reduced platelet activity; very high blood pressure,not controlled by medical treatment; if you are over 75 years of age; if you weigh 60 kg or less;
• a serious kidney disease or if you are on dialysis;
• problems with the liver or a history of liver problems;This medicine will be used with caution in patients with signs of altered liver function,
• -you have a tube (catheter) or have had an injection into your spine(for anesthesia or pain relief). Your doctor will tell you to take this medicine 5 hours or more after the catheter is removed; you have a prosthetic heart valve;
• if your doctor finds that your blood pressure is unstable;
• if a different treatment or surgical procedure is planned to remove a blood clot from the lungs.

Pay particular attention with Apixaban Accord

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

If you are going to have surgery or a procedure that may cause bleeding,
your doctor may ask you to temporarily stop taking this medicine. If
you are not sure if a procedure may cause bleeding, talk to your doctor.

Children and adolescents
This medicine is not recommended in children and adolescents with a body weight of less than 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 and others can decrease it. The
doctor will decide if you need to be treated with Apixaban Accord while taking these
medicines and how you need to be closely monitored.
The following medicines can increase the effect of Apixaban Accord and increase the possibility of
undesirable 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-inflammatoryor painkillers(e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years of age and are taking acetylsalicylic acid, you may have a higher chance of bleeding;
• medicines for high blood pressure or heart problems(e.g., diltiazem);
• antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin-norepinephrine reuptake inhibitors.

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor, pharmacist or nurse for advice before taking this
medicine.
The effect of Apixaban Accord on pregnancy and the fetus is not known. You should not take this
medicine if you are pregnant. Contact your doctor immediatelyif 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 stop/not start therapy with Apixaban Accord.

Driving and using machines
Apixaban Accord has not shown to have effects on the ability to drive vehicles or use machines.

Apixaban Accord contains lactose (a type of sugar) and sodium.
If your doctor has diagnosed you as intolerant to some sugars, contact him 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 following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor, pharmacist or nurse.

Dosage
Swallow the tablet with a little water. Apixaban Accord can be taken with or without food.
Try to take the tablets at the same time each day, to get the best effect from the
therapy.
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 applesauce, immediately before taking it.

Instructions for crushing the tablet:

• crush the tablets with a pestle and mortar 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 with one of the other liquids mentioned above, to prepare a mixture,
• swallow the mixture,
• rinse the pestle and mortar (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 liquid.

If necessary, your doctor may also administer the crushed Apixaban Accord tablet and
mixed with 60 mL of water or 5% glucose in water, through a nasogastric tube.

Take Apixaban Accord as recommended
To prevent the formation of blood clots in the heart of patients with irregular heartbeat and
with at least one additional risk factor.
The recommended dose 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 a severely reduced kidney function
• you fall into two or more of the following conditions:
• blood test results suggest poor kidney function (the serum creatinine value is 1.5 mg/dL (133 micromoles/L) or higher);
• you are 80 years of age or older;
• your weight is 60 kg or less.

The recommended dose is one tablet twice a day, for example, one in the morning and one in the
evening.
Your doctor will decide 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 mg, twice a day for the first
7 days, for example, two in the morning and two in the evening.
After 7 days, the recommended dose is one tabletof Apixaban Accord 5 mg, twice a
day, for example, one in the morning and one in the evening.
To prevent blood clots from reforming after completing 6 months of treatment
The recommended dose is one Apixaban Accord 2.5 mgtablet, twice a day, for
example, one in the morning and one in the evening.
Your doctor will decide how long you should continue the treatment.
Use in children and adolescents
To treat blood clots and to prevent blood clots from reforming in the veins or in
the blood vessels of the lungs.
Take or administer this medicine following exactly the instructions of 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 the treatment.
The dose of Apixaban Accord depends on body weight and will be calculated by the doctor. The dose
recommended for children and adolescents with a body weight of at least 35 kg is four
Apixaban Accord 5 mg tablets twice a day for the first 7 days, for example four in the
morning and four in the evening. After 7 days, the recommended dose is two tabletsof Apixaban Accord
5 mg twice a day, for example, two in the morning and two in the evening.
For parents or caregivers: observe the child to make sure they have taken the entire dose.
It is important to keep scheduled medical visits because the dose may need to be
adjusted as body weight changes

The doctor may modify the anticoagulant treatment as follows:

• Switching from Apixaban Accord to an anticoagulant medicineStop taking Apixaban Accord. Start treatment with the anticoagulant medicine (e.g. heparin) at the time you would have taken the next tablet.
• Switching from an anticoagulant medicine to Apixaban AccordStop 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 normally.
• Switching from treatment with an anticoagulant containing a vitamin K antagonist (e.g.warfarin) to Apixaban AccordStop taking the medicine containing the vitamin K antagonist. The doctor will need to perform blood tests and instruct you on when to start treatment with Apixaban Accord.
• Switching from Apixaban Accord to treatment with an anticoagulant containing a vitamin Kantagonist (e.g. warfarin).If your doctor tells you to start taking a medicine containing a vitamin K antagonist, continue taking Apixaban Accord for at least 2 days after the first dose of the medicine containing a vitamin K antagonist. The doctor will need to perform blood tests and instruct you on 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 at the times your doctor tells you to
take it, 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
Tell your doctor immediatelyif you have taken more than the prescribed dose of Apixaban Accord. Bring the
medicine packaging with you, even if there are no tablets left.
If you take more Apixaban Accord than recommended, you may have a higher risk of
bleeding. If bleeding occurs, surgery or a transfusion or other treatments that can inactivate the activity against factor Xa may be necessary.

If you forget to take Apixaban Accord:

• If you forget to take a morning dose, take it as soon as you remember, you cantake it with the evening dose.
• -A forgotten evening dose can only be taken that same evening. Do not take twodoses the next morning, and then continue instead to follow the dosing scheduletwice a day, as recommended, the next day.

If you have any doubts about what to do or if you have forgotten more than one dose,consult your doctor, pharmacist or
nurse.

If you stop taking Apixaban Accord
Do not stop taking this medicine before talking to your doctor, as the risk of
developing a blood clot may be greater if you stop treatment too soon.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most common general side effect of 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 the
formation of blood clots in the heart in patients with irregular heartbeat and with 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;
• Anemia which can cause fatigue or paleness;
• Low blood pressure which can cause you to feel faint or your heartbeat to race;
• Nausea (feeling sick);
• Blood tests that 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 sputum when coughing;
• in the abdomen or from the vagina;
• bright/red blood in the stool;
• bleeding that occurs after surgery, including bruising and swelling, leakage of blood or fluid from the wound/surgical incision (wound secretion) or at the injection site;
• from hemorrhoids;
• tests showing blood in the stool or urine;
• Decreased number of platelets in the blood (which may affect blood clotting);
• Blood tests that may detect:
• abnormal liver function;
• increased liver enzymes;
• increased bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediatelyif any of these symptoms occur.

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)

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

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

• Inflammation of blood vessels (vasculitis) which can cause skin rashes or pinpoint, flat, red, round spots under the skin surface or bruising;
• Bleeding in the kidney sometimes with blood in the urine leading to the kidneys being unable to work properly (anticoagulant-related nephropathy).

The following side effects occur when Apixaban Accord is taken to treat or
prevent blood clots from reforming in the veins of the legs and blood vessels in 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, from the rectum;
• in the mouth;
• from the vagina;
• Anemia which can cause fatigue or paleness;
• Decreased number of platelets in the blood (which may affect blood clotting);
• Nausea (feeling sick);
• Skin rash;
• Blood tests that may show:
• increased gamma-glutamyl transferase (GGT) or increased alanine aminotransferase (ALT).

Uncommon side effects (may affect up to 1 in 100)
Low blood pressure which can cause you to feel faint or your heartbeat to race

• Bleeding:
• in the eyes;
• in the mouth or blood in sputum when coughing;
• bright/red blood in the stool;
• tests showing blood in the stool or urine;
• bleeding that occurs after surgery, including bruising and swelling, leakage of blood or fluid from the wound/surgical incision (wound secretion) or at the injection site;
• from hemorrhoids;
• in the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediatelyif any of these symptoms occur;
• Blood tests that may detect:
• abnormal liver function;
• some increased liver enzymes;
• increased bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes.

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

• in the brain or spinal cord;
• in 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 appears 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 can cause skin rashes or pinpoint, flat, red, round spots under the skin surface or bruising.
• Blood tests that may show:
• an increase in gamma-glutamyl transferase (GGT);
• tests showing blood in the stool or urine.
• Bleeding in the kidney sometimes with blood in the urine leading to the kidneys being unable to work properly (anticoagulant-related nephropathy

Other side effects in children and adolescents

Tell your child's doctor immediatelyif you notice any of these symptoms;

• Allergic reactions (hypersensitivity) which can 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 observed in adults and have been mostly mild to moderate in severity. The side effects that have been observed more frequently in children and
adolescents have been 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 intestine or rectum;
• bright/red blood in the stool;
• bleeding that occurs after any operation, including bruising and swelling, leakage of blood or
• fluid from the wound/surgical incision (wound secretion) or from the injection site;
• Hair loss;
• Anemia which can cause fatigue or paleness;
• Reduction in the number of platelets in the child's blood (which may affect blood clotting);
• Nausea (feeling unwell);
• Skin rash;
• Itching;
• Low blood pressure which can cause the child to feel weak or have a racing heartbeat;
• Blood tests may show:
• abnormal liver function;
• increased some 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;
• in the eyes;
• in the mouth;
• from hemorrhoids;
• in the mouth or blood in sputum when coughing;
• in the brain or spinal cord;
• in the lungs;
• in the muscle;
• Skin rash that may blister and appears 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 can cause skin rashes or pinpoint, flat, red, round spots under the skin surface or bruising;
• Blood tests may show:
• an increase in gamma-glutamyl transferase (GGT);
• tests showing blood in the stool or urine.
• Bleeding in the kidney sometimes with blood in the urine leading to the kidneys being unable to work properly (anticoagulant-related nephropathy

Reporting of side effects
If you get any side effect, talk to your doctor, pharmacist or nurse. This includes any side effect not listed in this leaflet. You can also report side effects directly
through 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 package and blister after
“Scad.” 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 in waste water 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 ingredient is apixaban. Each tablet contains 5 mg of apixaban.
• The other ingredients are: tablet core: anhydrous lactose (see paragraph 2), microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate; coating: monohydrate lactose (see paragraph 2), hypromellose, titanium dioxide (E171), triacetin, red iron oxide (E172).

Description of the appearance of Apixaban Accord and package contents
The film-coated tablets are pink, oval, biconvex, with “IU2” imprinted on one side and smooth
on the other.
Aluminum PVC/PVdC blister packs. Packs of 10, 14, 20, 28, 56, 60, 100, 112, 168 and 200 film-coated tablets
blister packs.
Aluminum-PVC/PVdC blister packs divisible for single dose of 10x1, 20x1, 28x1, 56x1, 60x1, 100x1 and
168x1 film-coated tablets.
HDPE bottle with a child-resistant 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
An alert card for the patient or your doctor may provide you with a similar one.
This Patient Alert Card includes information that may be useful to you and warns other doctors that you are taking Apixaban Accord. You should always carry this
card with you.

• 1. Take the card
• 2. Detach the text in your language where necessary (you will be assisted 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 a day
• Doctor's name:
• Doctor's phone 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, 6 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
Accord Healthcare single member S.A.
64th Km National Road Athens, Lamia,
Schimatari, 32009,
Greece
For further information on this medicinal product, 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.
Τel: +30 210 74 88 821

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