LIXIANA 60 mg FILM-COATED TABLETS

Introduction

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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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.

Contents of the pack

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

1. What is Lixiana and what is it used for

Lixiana contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps to prevent the formation of blood clots. It works by blocking the activity of Factor Xa, an important component of blood clotting.

Lixiana is used in adults:

• to prevent the formation of a blood clot in the brain(stroke) and in other blood vessels of the bodyif they have a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor, such as heart failure, having previously had a stroke or high blood pressure;
• to treat blood clots in the veins of the legs(deep vein thrombosis) and in the blood vessels of the lungs(pulmonary embolism), and to prevent these blood clots from happening againin the blood vessels of the legs and/or lungs.

2. What you need to know before you take Lixiana

Do not take Lixiana

• if you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6);
• if you are actively bleeding;
• if you have a disease or condition that increases the risk of major bleeding (e.g. stomach ulcer, injury or bleeding in the brain or recent brain or eye surgery);
• if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, rivaroxaban, apixaban or heparin), except when switching treatment or while being administered heparin through a venous or arterial catheter, to prevent it from becoming blocked;
• if you have a liver disease that may increase the risk of bleeding;
• if you have uncontrolled high blood pressure;
• if you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Lixiana,

• if you have an increased risk of bleeding, such as if you have any of the following conditions:
• • end-stage kidney disease or if you are on dialysis;
  • severe liver disease;
  • bleeding disorders;
  • problems with the blood vessels in the back of the eyes (retinopathy);
  • recent bleeding in the brain (intracranial or intracerebral bleeding);
  • problems with the blood vessels in the brain or spine;
• if you have a mechanical heart valve.

Lixiana 15 mg is only indicated when switching from Lixiana 30 mg to a Vitamin K antagonist (e.g. warfarin) (see section 3. How to take Lixiana).

Be careful with Lixiana,

• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor to decide if it may be necessary to modify the treatment.

If you need to have surgery,

• it is very important to take Lixiana before and after the operation, exactly at the times indicated by your doctor. If possible, you should stop taking Lixiana at least 24 hours before an operation. Your doctor will determine when to restart Lixiana.

In emergency situations, your doctor will help determine the necessary actions regarding Lixiana.

Children and adolescents

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

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:

• any medicine for a fungal infection (e.g. ketoconazole);
• medicines for treating irregular heartbeat (e.g. dronedarone, quinidine, verapamil);
• other medicines to reduce blood clotting (e.g. heparin, clopidogrel or Vitamin K antagonists, such as warfarin, acenocoumarol, phenprocoumon or dabigatran, rivaroxaban, apixaban);
• antibiotics (e.g. erythromycin, clarithromycin);
• medicines to prevent organ rejection after a transplant (e.g. cyclosporin);
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
• antidepressants called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.

If any of the above applies to you, tell your doctorbefore taking Lixiana because these medicines may increase the effects of Lixiana and the risk of unwanted bleeding. Your doctor will decide whether you should be treated with Lixiana and whether you should be kept under closer observation.

If you are taking any of the following:

• any medicine for treating epilepsy (e.g. phenytoin, carbamazepine, phenobarbital);
• St. John's Wort, a herbal remedy used for anxiety and mild depression;
• rifampicin, an antibiotic.

If any of the above applies to you, tell your doctorbefore taking Lixiana, because the effect of Lixiana may be reduced. Your doctor will decide whether you should be treated with Lixiana and whether you should be kept under closer observation.

Pregnancy and breastfeeding

Do not take Lixiana if you are pregnant or breastfeeding. If there is a possibility that you may become pregnant, use an effective contraceptive while taking Lixiana. If you become pregnant while taking Lixiana, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines

Lixiana has no or negligible influence on the ability to drive and use machines.

3. How to take Lixiana

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

What dose to take

The recommended dose is one 60 mgtablet once a day.

• if you have kidney problems, your doctor may reduce your dose to one 30 mgtablet once a day.
• if you weigh 60 kg or less, the recommended dose is one 30 mgtablet once a day.
• if your doctor has prescribed you medicines known as P-gp inhibitors:cyclosporin, dronedarone, erythromycin or ketoconazole, the recommended dose is one 30 mgtablet once a day.

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 can be crushed and mixed with water or apple sauce immediately before taking it. If necessary, your doctor may also administer the crushed Lixiana tablet through a tube by the nose (nasogastric tube) or by the stomach (gastric feeding tube).

Your doctor may change your anticoagulant treatment as follows:

Switching from Vitamin K antagonists (e.g. warfarin) to Lixiana

Stop taking the Vitamin K antagonist (e.g. warfarin). Your doctor will have to do a blood test and tell you when to start taking Lixiana.

Switching from non-Vitamin K antagonist oral anticoagulants (dabigatran, rivaroxaban or apixaban) to Lixiana

Stop taking the previous medicines (e.g. dabigatran, rivaroxaban or apixaban) and start taking Lixiana at the time of the next scheduled dose of the anticoagulant.

Switching from parenteral anticoagulants (e.g. heparin) to Lixiana

Stop taking the anticoagulant (e.g. heparin) and start taking Lixiana at the time of the next scheduled dose of the anticoagulant.

Switching from Lixiana to Vitamin K antagonists (e.g. warfarin)

If you are currently taking 60 mg of Lixiana:

Your doctor will tell you to reduce the dose of Lixiana to one 30 mg tablet once a day and take it together with a Vitamin K antagonist (e.g. warfarin). Your doctor will have to do a blood test and tell you when to stop taking Lixiana.

If you are currently taking 30 mg (reduced dose) of Lixiana:

Your doctor will tell you to reduce the dose of Lixiana to one 15 mg tablet once a day and take it together with a Vitamin K antagonist (e.g. warfarin). Your doctor will have to do a blood test and tell you when to stop taking Lixiana.

Switching from Lixiana to non-Vitamin K antagonist oral anticoagulants (dabigatran, rivaroxaban or apixaban)

Stop taking Lixiana and start the non-Vitamin K antagonist anticoagulant (e.g. dabigatran, rivaroxaban or apixaban) at the time of the next scheduled dose of Lixiana.

Switching 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 you need your irregular heartbeat to be restored to normal through a procedure called cardioversion, take Lixiana at the times indicated by your doctor to prevent the formation of blood clots in the brain and in other blood vessels of 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 increase the risk of bleeding.

If you forget to take Lixiana

You should take the tablet as soon as you remember and then continue with your normal daily dose the next day. Do not take a double dose on the same day to make up for the forgotten dose.

If you stop taking Lixiana

Do not stop taking Lixiana without talking to your doctor first, as Lixiana treats and prevents serious diseases.

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 can cause bleeding, which can be life-threatening. In some cases, the bleeding may not be obvious.

If you experience a bleeding episode that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling), talk to your doctor immediately.

Your doctor will decide whether to keep you under closer observation or change your treatment.

General list of possible side effects:

Common(may affect up to 1 in 10 people)

• stomach pain;
• abnormal liver blood test results;
• bleeding from the skin or under the skin;
• anaemia (low red blood cell count);
• nosebleeds;
• vaginal bleeding;
• skin rash;
• bleeding from the intestines;
• bleeding from the mouth and/or throat;
• blood in the urine;
• bleeding after an injury (puncture);
• stomach bleeding;
• dizziness;
• nausea;
• headache;
• itching.

Uncommon(may affect up to 1 in 100 people)

• bleeding in the eyes;
• bleeding from a surgical wound after an operation;
• blood in the saliva when coughing;
• bleeding in the brain;
• other types of bleeding;
• decrease in the number of platelets in the blood (which may affect blood clotting);
• allergic reaction;
• hives.

Rare(may affect up to 1 in 1,000 people)

• bleeding in the muscles;
• bleeding in the joints;
• bleeding in the abdomen;
• bleeding in the heart;
• bleeding inside the skull;
• bleeding after surgery;
• anaphylactic shock;
• swelling of any part of the body due to an allergic reaction.

Frequency not known(cannot be estimated from the available data)

• bleeding in the kidneys, sometimes with blood in the urine, which can cause the kidneys to stop working properly (anticoagulant-related nephropathy).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 or blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Lixiana Composition

• The active ingredient is edoxaban (as tosilate).

Lixiana 15 mg film-coated tablets

Each tablet contains 15 mg of edoxaban (as tosilate).

Lixiana 30 mg film-coated tablets

Each tablet contains 30 mg of edoxaban (as tosilate).

Lixiana 60 mg film-coated tablets

Each tablet contains 60 mg of edoxaban (as tosilate).

• The other ingredients are:

Lixiana 15 mg film-coated tablets

Tablet core: mannitol (E 421), pregelatinized starch, crospovidone (E 1202), hydroxypropylcellulose (E 463), magnesium stearate (E 470b).

Film coating: hypromellose (E 464), macrogol (8000), titanium dioxide (E 171), talc (E 553b), carnauba wax, red iron oxide (E 172), yellow iron oxide (E 172).

Lixiana 30 mg film-coated tablets

Tablet core: mannitol (E 421), pregelatinized starch, crospovidone (E 1202), hydroxypropylcellulose (E 463), magnesium stearate (E 470b).

Film coating: hypromellose (E 464), macrogol (8000), titanium dioxide (E 171), talc (E 553b), carnauba wax, red iron oxide (E 172).

Lixiana 60 mg film-coated tablets

Tablet core: mannitol (E 421), pregelatinized starch, crospovidone (E 1202), hydroxypropylcellulose (E 463), magnesium stearate (E 470b).

Film coating: hypromellose (E 464), macrogol (8000), titanium dioxide (E 171), talc (E 553b), carnauba wax, yellow iron oxide (E 172).

Product Appearance and Packaging Contents

Lixiana 15 mg film-coated tablets are orange and round (6.7 mm in diameter) with “DSC L15” engraved on one side.

They are available in blister packs in containers of 10 film-coated tablets or in unit-dose blister packs in containers of 10 x 1 film-coated tablets.

Lixiana 30 mg film-coated tablets are pink and round (8.5 mm in diameter) with “DSC L30” engraved on one side.

They are available in blister packs in containers of 10, 14, 28, 30, 56, 60, 84, 90, 98, or 100 film-coated tablets or in unit-dose blister packs in containers 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 and round (10.5 mm in diameter) with “DSC L60” engraved on one side.

They are available in blister packs in containers of 10, 14, 28, 30, 56, 60, 84, 90, 98, or 100 film-coated tablets or in unit-dose blister packs in containers 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 Authorization Holder

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48

81379 Munich

Germany

Manufacturer

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:{MM/AAAA}.

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.