Active ingredient
- edoxaban tosilate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/15/993/003, EU/1/15/993/017, EU/1/15/993/018, EU/1/15/993/019, EU/1/15/993/020, EU/1/15/993/021, EU/1/15/993/022, EU/1/15/993/023, EU/1/15/993/024, EU/1/15/993/025, EU/1/15/993/026, EU/1/15/993/027, EU/1/15/993/028.
Lixiana 15mg, 30mg, 60mg film-coated tablets
Package leaflet: Information for the user
Lixiana 15 mg film-coated tablets
Lixiana 30 mg film-coated tablets
Lixiana 60 mg film-coated tablets
edoxaban
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 Lixiana is and what it is used for
2. What you need to know before you take Lixiana
3. How to take Lixiana
4. Possible side effects
5. How to store Lixiana
6. Contents of the pack and other information
1. What Lixiana is and what it is used for
Lixiana contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps to prevent blood clots from forming. It works by blocking the activity of factor Xa, which is an important component of blood clotting.
Lixiana is used in adults to:
2. What you need to know before you take Lixiana
Do not take Lixiana
Warnings and precautions
Talk to your doctor or pharmacist before taking Lixiana,
Lixiana 15 mg is only to be used when changing from Lixiana 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3. How to take Lixiana).
Take special care with Lixiana,
If you need to have an operation,
Children and adolescents
Lixiana is not recommended in children and adolescents under 18 years of age. There is no information on its use in children and adolescents.
Other medicines and Lixiana
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking any of the following:
If any of the above apply to you, tell your doctor before taking Lixiana, because these medicines may increase the effects of Lixiana and the chance of unwanted bleeding. Your doctor will decide, if you should be treated with Lixiana and if you should be kept under observation.
If you are taking any of the following:
If any of the above apply to you, tell your doctor before taking Lixiana, because the effect of Lixiana may be reduced. Your doctor will decide if you should be treated with Lixiana and if you should be kept under observation.
Pregnancy and breast-feeding
Do not take Lixiana if you are pregnant or breast-feeding. If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Lixiana. If you become pregnant while you are taking Lixiana, immediately tell your doctor, who will decide how you should be treated.
Driving and using machines
Lixiana has no or negligible effects on your ability to drive or use machines.
3. How to take Lixiana
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
The recommended dose is one 60 mg tablet once daily.
How to take the tablet
Swallow the tablet, preferably with water.
Lixiana can be taken with or without food.
If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Lixiana. The tablet may be crushed and mixed with water or apple puree immediately before you take it. If necessary, your doctor may also give you the crushed Lixiana tablet through a stomach tube.
Your doctor may change your anticoagulant treatment as follows:
Changing from vitamin K antagonists (e.g. warfarin) to Lixiana
Stop taking the vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to start taking Lixiana.
Changing from non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) to Lixiana
Stop taking the previous medicines (e.g. dabigatran, rivaroxaban, or apixaban) and start Lixiana at the time of the next scheduled dose.
Changing from parenteral anticoagulants (e.g. heparin) to Lixiana
Stop taking the anticoagulant (e.g. heparin) and start Lixiana at the time of the next scheduled anticoagulant dose.
Changing from Lixiana to vitamin K antagonists (e.g. warfarin)
If you currently take 60 mg Lixiana:
Your doctor will tell you to reduce your dose of Lixiana to a 30 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to stop taking Lixiana.
If you currently take 30 mg (dose reduced) Lixiana:
Your doctor will tell you to reduce your dose of Lixiana to a 15 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to stop taking Lixiana.
Changing from Lixiana to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban)
Stop taking Lixiana and start the non-VKA anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Lixiana.
Changing from Lixiana to parenteral anticoagulants (e.g. heparin)
Stop taking Lixiana and start the parenteral anticoagulant (e.g. heparin) at the time of the next scheduled dose of Lixiana.
Patients undergoing cardioversion:
If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Lixiana at the times your doctor tells you to prevent blood clots in the brain and other blood vessels in your body.
If you take more Lixiana than you should
Tell your doctor immediately if you have taken too many Lixiana tablets.
If you take more Lixiana than recommended, you may have an increased risk of bleeding.
If you forget to take Lixiana
You should take the tablet immediately and then continue the following day with the once daily tablet as usual. Do not take a double dose on the same day to make up for a forgotten dose.
If you stop taking Lixiana
Do not stop taking Lixiana without talking to your doctor first, because Lixiana treats and prevents serious conditions.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other similar medicines (medicines to reduce blood clotting), Lixiana may cause bleeding which may potentially be life-threatening. In some cases the bleeding may not be obvious.
If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately.
Your doctor may decide to keep you under closer observation or change your medicine.
Overall list of possible side effects:
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Reporting of side effects
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 the 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.
5. How to store Lixiana
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 each blister or bottle 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 Lixiana contains
Lixiana 15 mg film-coated tablets
Each tablet contains 15 mg edoxaban (as tosilate).
Lixiana 30 mg film-coated tablets
Each tablet contains 30 mg edoxaban (as tosilate).
Lixiana 60 mg film-coated tablets
Each tablet contains 60 mg edoxaban (as tosilate).
Lixiana 15 mg film-coated tablets
Tablet core: mannitol (E421), pregelatinised starch, crospovidone (E1202), hydroxypropyl cellulose (E463), magnesium stearate (E470b).
Film coat: hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc (E553b), carnauba wax, iron oxide red (E172), iron oxide yellow (E172).
Lixiana 30 mg film-coated tablets
Tablet core: mannitol (E421), pregelatinised starch, crospovidone (E1202), hydroxypropyl cellulose (E463), magnesium stearate (E470b).
Film coat: hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc (E553b), carnauba wax, iron oxide red (E172).
Lixiana 60 mg film-coated tablets
Tablet core: mannitol (E421), pregelatinised starch, crospovidone (E1202), hydroxypropyl cellulose (E463), magnesium stearate (E470b).
Film coat: hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc (E553b), carnauba wax, iron oxide yellow (E172).
What Lixiana looks like and contents of the pack
Lixiana 15 mg film-coated tablets are orange, round-shaped (6.7 mm diameter) and debossed with “DSC L15” on one side.
They come in blisters in cartons of 10 film-coated tablets or unit dose blisters in cartons of 10 x 1 film-coated tablets.
Lixiana 30 mg film-coated tablets are pink, round-shaped (8.5 mm diameter) and debossed with “DSC L30” on one side.
They come in blisters in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets or unit dose blisters in cartons of 10 x 1, 50 x 1, or 100 x 1 film-coated tablets, or in bottles of 90 film-coated tablets.
Lixiana 60 mg film-coated tablets are yellow, round-shaped (10.5 mm diameter) and debossed with “DSC L60” on one side.
They come in blisters in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets or unit dose blisters in cartons of 10 x 1, 50 x 1, or 100 x 1 film-coated tablets, or in bottles of 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 11/2020.
Other sources of information
Detailed information on this medicine is available by scanning the QR Code below with a smartphone. The same information is also available on the following URL: www.dspatient.eu.
QR code to be included
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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+44 (0) 800 028 5122
+44 (0) 800 028 5122
+44 (0) 800 028 5122
+44 (0) 800 028 5122