Apixaban 5 mg film-coated tablets

Patient Leaflet Updated 31-Jan-2023 | axunio Pharma GmbH

Apixaban 5 mg film-coated tablets

Package leaflet: Information for the user

Apixaban 5 mg film-coated tablets

apixaban

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

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Apixaban is and what it is used for

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

Apixaban is used in adults:

  • to prevent a blood clot from forming in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break off and travel to the brain and lead to a stroke or to other organs and prevent normal blood flow to that organ (also known as a systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
  • to treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.

2. What you need to know before you take Apixaban

Do not take Apixaban if:

  • you are allergic to apixaban or any of the other ingredients of this medicine (listed in section 6);
  • you are bleeding excessively;
  • you have a disease in an organ of the body that increases the risk of serious bleeding (such as an active or a recent ulcer of your stomach or bowel, recent bleeding in your brain);
  • you have a liver disease which leads to increased risk of bleeding (hepatic coagulopathy);
  • you are taking medicines to prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran or heparin), except when changing anticoagulant treatment, while having a venous or arterial line and you get heparin through this line to keep it open, or if a tube is inserted into your blood vessel (catheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you take this medicine if you have any of the following:

  • an increased risk of bleeding, such as:
    • bleeding disorders, including conditions resulting in reduced platelet activity;
    • very high blood pressure, not controlled by medical treatment;
    • you are older than 75 years;
    • you weigh 60 kg or less;
  • a severe kidney disease or if you are on dialysis;
  • a liver problem or a history of liver problems;
    This medicine will be used with caution in patients with signs of altered liver function.
  • if you have a prosthetic heart valve;
  • if your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned.

Take special care with Apixaban

  • if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.

If you need to have surgery or a procedure which may cause bleeding, your doctor might ask you to temporarily stop taking this medicine for a short while. If you are not sure whether a procedure may cause bleeding, ask your doctor.

Children and adolescents

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

Other medicines and Apixaban

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

Some medicines may increase the effects of Apixaban and some may decrease its effects. Your doctor will decide, if you should be treated with Apixaban when taking these medicines and how closely you should be monitored.

The following medicines may increase the effects of Apixaban and increase the chance for unwanted bleeding:

  • some medicines for fungal infections (e.g., ketoconazole, etc.);
  • some antiviral medicines for HIV / AIDS (e.g., ritonavir);
  • other medicines that are used to reduce blood clotting (e.g., enoxaparin, etc.);
  • anti-inflammatory or pain medicines (e.g., acetylsalicylic acid or naproxen). Especially, if you are older than 75 years and are taking acetylsalicylic acid, you may have an increased chance of bleeding;
  • medicines for high blood pressure or heart problems (e.g., diltiazem);
  • antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin norepinephrine re-uptake inhibitors.

The following medicines may reduce the ability of Apixaban to help prevent blood clots from forming:

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

Pregnancy and breast-feeding

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

The effects of Apixaban on pregnancy and the unborn child are not known. You should not take this medicine if you are pregnant. Contact your doctor immediately if you become pregnant while taking this medicine.

It is not known if Apixaban passes into human breast milk. Ask your doctor, pharmacist or nurse for advice before taking this medicine while breast-feeding. They will advise you whether to stop breast-feeding or to stop/not start taking this medicine.

Driving and using machines

Apixaban has not been shown to impair your ability to drive or use machines.

Apixaban contains lactose (a type of sugar)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Apixaban contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Apixaban

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Dose

Swallow the tablet with a drink of water. Apixaban can be taken with or without food. Try to take the tablets at the same times every day to have the best treatment effect.

If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Apixaban. The tablet may be crushed and mixed with water, or 5% glucose in water, or apple juice or apple puree, immediately before you take it.

Instructions for crushing:

  • Crush the tablets with a pestle and mortar.
  • Transfer all the powder carefully into a suitable container, then mix the powder with a little e.g., 30 mL (2 tablespoons), water or one of the other liquids mentioned above to make a mixture.
  • Swallow the mixture.
  • Rinse the pestle and mortar you used for crushing the tablet and the container, with a little water or one of the other liquids (e.g., 30 mL), and swallow the rinse.

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

Take Apixaban as recommended for the following:

To prevent a blood clot from forming in the heart in patients with an irregular heart beat and at least one additional risk factor.

The recommended dose is one tablet of Apixaban 5 mg twice a day.

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

  • you have severely reduced kidney function;
  • two or more of the following apply to you:
    • your blood test results suggest poor kidney function (value of serum creatinine is 1.5 mg/dL (133 micromole/L) or greater);
    • you are 80 years old or older;
    • your weight is 60 kg or lower.

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 must continue treatment for.

To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs

The recommended dose is two tablets of Apixaban 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 tablet of Apixaban 5 mg twice a day, for example, one in the morning and one in the evening.

For preventing blood clots from re-occurring following completion of 6 months of treatment

The recommended dose is one tablet of Apixaban 2.5 mg twice a day for example, one in the morning and one in the evening.

Your doctor will decide how long you must continue treatment for.

Your doctor might change your anticoagulant treatment as follows:

  • Changing from Apixaban to anticoagulant medicines

Stop taking Apixaban. Start treatment with the anticoagulant medicines (for example heparin) at the time you would have taken the next tablet.

  • Changing from anticoagulant medicines to Apixaban

Stop taking the anticoagulant medicines. Start treatment with Apixaban at the time you would have had the next dose of anticoagulant medicine, then continue as normal.

  • Changing from treatment with anticoagulant containing vitamin K antagonist (e.g., warfarin) to Apixaban

Stop taking the medicine containing a vitamin K antagonist. Your doctor needs to do blood-measurements and instruct you when to start taking Apixaban.

  • Changing from Apixaban to anticoagulant treatment containing vitamin K antagonist (e.g., warfarin).

If your doctor tells you that you have to start taking the medicine containing a vitamin K antagonist, continue to take Apixaban for at least 2 days after your first dose of the medicine containing a vitamin K antagonist. Your doctor needs to do blood-measurements and instruct you when to stop taking Apixaban.

Patients undergoing cardioversion

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

If you take more Apixaban than you should

Tell your doctor immediately if you have taken more than the prescribed dose of Apixaban. Take the medicine pack with you, even if there are no tablets left.

If you take more Apixaban than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery, blood transfusions, or other treatments that may reverse anti-factor Xa activity may be required.

If you forget to take Apixaban

  • Take the dose as soon as you remember and:
    • take the next dose of Apixaban at the usual time;
    • then continue as normal.

If you are not sure what to do or have missed more than one dose, ask your doctor, pharmacist or nurse.

If you stop taking Apixaban

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

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

4. Possible side effects

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

The following side effects are known if you take apixaban to prevent a blood clot from forming in the heart in patients with an irregular heartbeat and at least one additional risk factor.

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

  • Bleeding including:
    • in your eyes;
    • in your stomach or bowel;
    • from your rectum;
    • blood in the urine;
    • from your nose;
    • from your gums;
    • bruising and swelling;
  • Anaemia which may cause tiredness or paleness;
  • Low blood pressure which may make you feel faint or have a quickened heartbeat;
  • Nausea (feeling sick);
  • Blood tests may show:
    • an increase in gamma-glutamyltransferase (GGT).

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

  • Bleeding:
    • in your brain or in your spinal column;
    • in your mouth or blood in your spit when coughing;
    • into your abdomen, or from the vagina;
    • bright/red blood in the stools;
    • bleeding occurring after your operation including bruising and swelling, blood or liquid leaking from the surgical wound/incision (wound secretion) or injection site;
    • from a haemorrhoid;
    • tests showing blood in the stools or in the urine;
  • Reduced number of platelets in your blood (which can affect clotting);
  • Blood tests may show:
    • abnormal liver function;
    • an increase in some liver enzymes;
    • an increase in 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 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 your lungs or your throat;
    • into the space behind your abdominal cavity;
    • into a muscle

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

  • Skin rash which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme).

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

  • Blood vessel inflammation (vasculitis) which may result in skin rash or pointed, flat, red, round spots under the skin's surface or bruising.

The following side effects are known if you take apixaban to treat or prevent re-occurrence of blood clots in the veins of your legs and blood clots in the blood vessels of your lungs.

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

  • Bleeding including:
    • from your nose;
    • from your gums;
    • blood in the urine;
    • bruising and swelling;
    • in your stomach, your bowel, from your rectum;
    • in your mouth;
    • from the vagina;
  • Anaemia which may cause tiredness or paleness;
  • Reduced number of platelets in your blood (which can affect clotting);
  • Nausea (feeling sick);
  • Skin rash;
  • Blood tests may show:
    • an increase in gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT).

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

  • Low blood pressure which may make you feel faint or have a quickened heartbeat;
  • Bleeding:
    • in your eyes;
    • in your mouth or blood in your spit when coughing;
    • bright/red blood in the stools;
    • tests showing blood in the stools or in the urine;
    • bleeding occurring after any operation including bruising and swelling, blood or liquid leaking from the surgical wound/incision (wound secretion) or injection site;
    • from a haemorrhoid;
    • into a 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;
    • an increase in some liver enzymes;
    • an increase in 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 your brain or in your spinal column;
  • in your lungs.

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

  • Bleeding:
    • into your abdomen or the space behind your abdominal cavity.
  • Skin rash which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme).
  • Blood vessel inflammation (vasculitis) which may result in skin rash or pointed, flat, red, round spots under the skin's surface or bruising.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store

5. How to store Apixaban

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 on the blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Apixaban contains

  • The active substance is apixaban. Each tablet contains 5 mg of apixaban.
  • The other ingredients are:
    • Tablet core: lactose monohydrate, cellulose, microcrystalline, croscarmellose sodium, povidone, magnesium stearate.
    • Film coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, red iron oxide (E172).

See section 2 “Apixaban contains lactose (a type of sugar) / sodium.”

What Apixaban looks like and contents of the pack

The film-coated tablets are pink, oval, biconvex and debossed with “AX” on one side and “5” on the other side.

They come in blisters in cartons of 14, 20, 28, 56, 60, 100, 168 and 200 film-coated tablets.

Unit dose blisters in cartons of 100x1 film-coated tablets for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Patient Alert Card: handling information

Inside the Apixaban pack together with the package leaflet, you will find a Patient Alert Card or your doctor might give you a similar card.

This Patient Alert Card includes information that will be helpful to you and alert other doctors that you are taking Apixaban. You should keep this card with you at all times.

1. Take the card

2. Separate your language as needed (this is facilitated by the perforated edges).

3. Complete the following sections or ask your doctor to do it:

  • Name:
  • Birth Date:
  • Indication:
  • Dose: ........mg twice daily
  • Doctor's Name:
  • Doctor's telephone:

4. Fold the card and keep it with you at all times.

Marketing Authorisation Holder

axunio Pharma GmbH
Van-der-Smissen-Strasse 1
22767 Hamburg
Germany

Manufacturer

Pharmadox Healthcare Ltd.
KWA20A Kordin Industrial Park
Paola
PLA 3000
Malta

Delorbis Pharmaceuticals Ltd.
17 Athinon Street
Ergates Industrial Area
2643 Ergates
Lefkosia
Cyprus

Glenmark Pharmaceuticals Europe Limited
Building 2
Croxley Green Business Park
Croxley Green
Hertfordshire
WD18 8YA
United Kingdom

This leaflet was last revised in 01/2023.

B-V02

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