Apixaban 5 mg film-coated tablets

• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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).

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.

This medicine is not recommended in children and adolescents with a body weight of less than 35 kg.

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).

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 Apixaban.

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 Apixaban.

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

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 less than 1 mmol (23 mg) of sodium per film coated tablet, that is to say it is essentially ‘sodium-free.’

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.

• 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.

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.

Use in children and adolescents

For treating blood clots and to prevent re-occurrence of blood clots in the veins or in the blood vessels of your lungs.

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

Try to take or give the dose at the same time every day to have the best treatment effect.

The dose of Apixaban depends on the body weight, and will be calculated by the doctor.

The recommended dose for children and adolescents weighing at least 35 kg 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 parents or caregivers: please observe the child to ensure that the full dose is taken.

It is important to keep scheduled doctor’s visits because the dose may need to be adjusted as the weight changes.

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.

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.

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 miss a morning dose, take it as soon as you remember and it may be taken together with the evening dose.
• A missed evening dose can only be taken during the same evening. Do not take two doses the next morning, instead continue to follow the dosing schedule twice daily as recommended on the next day.

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

Do not stop taking Apixaban 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 get any side effects, talk to your doctor or pharmacist. 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. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is Apixaban. Each film-coated tablets contains 5 mg of apixaban

The other ingredients are:

Tablet core: Lactose, cellulose, microcrystalline (grade-101), sodium laurilsulfate, croscarmellose sodium, magnesium stearate.

Film coating:

Hypromellose 2910 (6 cps), triacetin, titanium dioxide, yellow iron oxide, red iron oxide.

Film-coated tablet.

Light pink to pink, oval, biconvex film-coated tablet, debossed with ‘N’ on one side and ‘5’ on the other side.

Apixaban film-coated tablets are available in blister packs.

Pack sizes:

Blister Packs: 10, 20, 28, 56 & 60 film-coated tablets.

Not all pack sizes may be marketed

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 the 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

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