Apixaban 1 mg/ml Oral Suspension

• 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.

1. What Apixaban 1 mg/ml Oral Suspension is and what it is used for
2. What you need to know before you take Apixaban 1 mg/ml Oral Suspension
3. How to take Apixaban 1 mg/ml Oral Suspension
4. Possible side effects
5. How to store Apixaban 1 mg/ml Oral Suspension
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 Apixaban will be used with caution in patients with signs of altered liver function.
• had a tube (catheter) or an injection into your spinal column (for anaesthesia or pain reduction), your doctor will tell you to take Apixaban 5 hours or more after catheter removal
• 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 under 18 years of age.

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 Apixaban 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 to either stop breast-feeding or to stop/not start taking Apixaban.

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

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

Apixaban contains 1 mg sodium benzoate in each ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

Apixaban contains 0.39 mg propylene glycol in each ml.

Apixaban can be taken with or without food. Try to take the suspension at the same times every day to have the best treatment effect.

Instructions for dosing:

Apixaban is for oral use only.

A 5 ml graduated oral syringe with intermediate graduations of 0.1 ml and a “press-in” oral syringe/bottle adaptor are provided with the product.

The oral suspension requires redispersing by shaking the bottle prior to dosing.

1. Shake well before use.
2. Open the bottle and at first use insert the “Press-In” Bottle Adaptor (PIBA) (see pictures A-B).
3. Insert the oral syringe into the PIBA and draw out the required volume from the inverted bottle (see pictures C-D).
4. Remove the filled oral syringe from the bottle in the upright position (see picture E).
5. Discharge the oral syringe contents into the mouth. Repeat steps 3 to 4 as needed to achieve the required dose.
6. Rinse the oral syringe and replace the cap on the bottle (PIBA remains in place).

Take Apixaban as recommended for the following:

To prevent blood clots from forming after hip or knee replacement operations

The recommended dose is 2.5 ml of Apixaban twice a day. For example, once in the morning and once in the evening.

You should take the first dose 12 to 24 hours after your operation.

If you have had a major hip operation, you will usually take the suspension for 32 to 38 days. If you have had a major knee operation, you will usually take the suspension for 10 to 14 days.

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

The recommended dose is 5 ml of Apixaban twice a day.

The recommended dose is 2.5 ml of Apixaban 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 2.5 ml twice a day, for example, once in the morning and once 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 10 ml of Apixaban twice a day for the first 7 days, for example, 10 ml in the morning and 10 ml in the evening.

After 7 days the recommended dose is 5 ml of Apixaban twice a day, for example, 5 ml in the morning and 5 ml in the evening.

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

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

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

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 dose of the oral suspension.

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 Apixaban 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 is no suspension left.

If you take more Apixaban than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery or blood transfusions may be required.

Take the dose as soon as you remember and:

• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 1 ml of suspension contains 1 mg of apixaban.
• The other ingredients are: citric acid, sodium citrate, glycerol (E 422), cherry flavour (containing propylene glycol), polysorbate 80, simeticone emulsion, sodium benzoate (E211), sucralose, xanthan gum, citric acid (as solution 30% w/w), purified water.

Apixaban is an off white to white, slightly viscous suspension with characteristic cherry odour.

The product is available in an amber glass bottle with a child resistant cap and a 5 ml oral syringe with a "press-in" oral syringe/bottle adaptor. Each bottle contains 150 ml of the product.

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

Manufacturer

For information in large print, tape, CD or Braille, telephone 01283 890091