Package leaflet: Information for the user
Eliquis 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.
What is in this leaflet
1. What Eliquis is and what it is used for
2. What you need to know before you take Eliquis
3. How to take Eliquis
4. Possible side effects
5. How to store Eliquis
6. Contents of the pack and other information
1. What Eliquis is and what it is used for
Eliquis 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.
Eliquis is used in adults:
2. What you need to know before you take Eliquis
Do not take Eliquis if:
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you take this medicine if you have any of the following:
Take special care with Eliquis
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 Eliquis
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 Eliquis and some may decrease its effects. Your doctor will decide, if you should be treated with Eliquis when taking these medicines and how closely you should be monitored.
The following medicines may increase the effects of Eliquis and increase the chance for unwanted bleeding:
The following medicines may reduce the ability of Eliquis to help prevent blood clots from forming:
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 Eliquis 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 Eliquis 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
Eliquis has not been shown to impair your ability to drive or use machines.
Eliquis contains lactose (a type of sugar) and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodium-free".
3. How to take Eliquis
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. Eliquis 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 Eliquis. 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:
If necessary, your doctor may also give you the crushed Eliquis tablet mixed in 60 mL of water or 5% glucose in water, through a nasogastric tube.
Take Eliquis 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 Eliquis 5 mg twice a day.
The recommended dose is one tablet of Eliquis 2.5 mg twice a day if:
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 Eliquis 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 Eliquis 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 Eliquis 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:
Stop taking Eliquis. Start treatment with the anticoagulant medicines (for example heparin) at the time you would have taken the next tablet.
Stop taking the anticoagulant medicines. Start treatment with Eliquis at the time you would have had the next dose of anticoagulant medicine, then continue as normal.
Stop taking the medicine containing a vitamin K antagonist. Your doctor needs to do blood‑measurements and instruct you when to start taking Eliquis.
If your doctor tells you that you have to start taking the medicine containing a vitamin K antagonist, continue to take Eliquis 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 Eliquis.
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 Eliquis than you should
Tell your doctor immediately if you have taken more than the prescribed dose of Eliquis. Take the medicine pack with you, even if there are no tablets left.
If you take more Eliquis 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 Eliquis
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 Eliquis
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 Eliquis to prevent a blood clot from forming in the heart in patients with an irregular heart beat and at least one additional risk factor.
Common side effects (may affect up to 1 in 10 people)
- Bleeding including:
Uncommon side effects (may affect up to 1 in 100 people)
- Bleeding:
Rare side effects (may affect up to 1 in 1,000 people)
- Bleeding:
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)
The following side effects are known if you take Eliquis 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:
- 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:
Rare side effects (may affect up to 1 in 1,000 people)
Bleeding:
Not known (frequency cannot be estimated from the available data)
- Bleeding:
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Ireland
HPRA Pharmacovigilance
Website: www.hpra.ie
5. How to store Eliquis
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 Eliquis contains
What Eliquis looks like and contents of the pack
The film coated tablets are pink, oval (9.73 mm x 5.16 mm) and marked with “894” on one side and “5” on the other side.
Not all pack sizes may be marketed.
Patient Alert Card: handling information
Inside the Eliquis 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 Eliquis. 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:
4. Fold the card and keep it with you at all times.
Marketing Authorisation Holder
Bristol-Myers Squibb/Pfizer EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
CATALENT ANAGNI S.R.L.
Loc. Fontana del Ceraso snc
Strada Provinciale Casilina, 41
03012 Anagni (FR)
Italy
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
Swords Laboratories Unlimited Company T/A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Pfizer Ireland Pharmaceuticals
Little Connell Newbridge
Co. Kildare
Ireland
This leaflet was last revised in August 2022.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.