Lixiana 60 mg film-coated tablets

Package leaflet: Information for the user

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 the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Lixiana is and what it is used for
2. What you need to know before taking 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 the formation of blood clots. It works by blocking the activity of factor Xa, an important component in 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 body if they have a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor, such as heart failure, prior stroke, or hypertension;
• 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 recurring in the blood vessels of the legs and/or lungs.

2. What you need to know before taking Lixiana

Do not take Lixiana

• if you are allergic to edoxaban or to 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 serious bleeding (for example, stomach ulcer, injury or bleeding in the brain, or recent surgery on the brain or eyes);
• if you are taking other medicines to prevent blood clots (e.g., warfarin, dabigatran, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another or while heparin is being administered through a venous or arterial catheter to prevent blockage;
• 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 Lixiana,

• if you have an increased risk of bleeding, such as in the following conditions:
  • end-stage renal disease or if you are on dialysis;
  • severe liver disease;
  • bleeding disorders;
  • blood vessel problems in the back of the eyes (retinopathy);
  • recent bleeding in the brain (intracranial or intracerebral hemorrhage);
  • problems in blood vessels of the brain or spinal cord;
• 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).

Take special care with Lixiana,

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether your treatment needs to be adjusted.

If you need surgery,

• it is very important to take Lixiana before and after the operation exactly as scheduled by your doctor. If possible, Lixiana should be stopped at least 24 hours before surgery. 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 for 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 need to take any other medicines.

If you are taking any of the following:

• a medicine for fungal infection (e.g., ketoconazole);
• medicines to treat abnormal heart rhythm (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 transplant (e.g., cyclosporine);
• anti-inflammatory medicines and pain relievers (e.g., naproxen or acetylsalicylic acid);
• antidepressants known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.

If any of the above circumstances apply to you, inform your doctor before taking Lixiana, as 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 need to be monitored.

If you are taking any of the following:

• a medicine for 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 circumstances apply to you, inform your doctor before taking Lixiana, as the effect of Lixiana may be reduced. Your doctor will decide whether you should be treated with Lixiana and whether you need to be monitored.

Pregnancy and breastfeeding

Do not take Lixiana if you are pregnant or breastfeeding. If there is any possibility you could become pregnant, use an effective contraceptive method while taking Lixiana. If you become pregnant while taking Lixiana, inform your doctor immediately, who will decide on the appropriate course of treatment.

Driving and using machines

The effect of Lixiana on the ability to drive and use machines is none or negligible.

3. How to take Lixiana

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

What dose to take

The recommended dose is one 60 mg tablet once daily.

• if you have renal impairment, your doctor may reduce your dose to one 30 mg tablet once daily.
• if you weigh 60 kg or less, the recommended dose is one 30 mg tablet once daily.
• if your doctor has prescribed you medicines known as P-gp inhibitors: cyclosporine, dronedarone, erythromycin, or ketoconazole, the recommended dose is one 30 mg tablet once daily.

How to take the tablet

Swallow the tablet whole, preferably with water.

Lixiana may be taken with or without food.

If you have difficulty swallowing the tablet whole, speak with your doctor about other ways to take Lixiana. The tablet can be crushed and mixed with water or apple puree immediately before administration. If necessary, your doctor may also administer the crushed Lixiana tablet through a tube inserted through the nose (nasogastric tube) or into the stomach (gastric feeding tube).

Your doctor may switch 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 need to perform a blood test and will advise you when to start taking Lixiana.

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

Stop taking the previous medication (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 instruct you to reduce the dose of Lixiana to one 30 mg tablet once daily and to take it concomitantly with a vitamin K antagonist (e.g., warfarin). Your doctor will need to perform a blood test and will advise you when to stop taking Lixiana.

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

Your doctor will instruct you to reduce the dose of Lixiana to one 15 mg tablet once daily and to take it concomitantly with a vitamin K antagonist (e.g., warfarin). Your doctor will need to perform a blood test and will advise 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 oral 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 require restoration of your abnormal heartbeat to normal by 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

Inform your doctor immediately if you have taken too many Lixiana tablets. If you take more Lixiana than recommended, your risk of bleeding may increase.

If you forget to take Lixiana

Take the missed dose as soon as you remember, and then continue the next day with your usual once-daily dosing. Do not take a double dose on the same day to make up for a missed dose.

If you stop taking Lixiana

Do not stop treatment with Lixiana without first talking to your doctor, as Lixiana treats and prevents serious conditions.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

As with other similar medicines (medicines used to reduce blood clotting), Lixiana may cause bleeding, which could be life-threatening. In some cases, bleeding may not be obvious.

If you experience an episode of bleeding that does not stop on its own, or if you experience signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately.

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

General list of possible adverse effects:

Common (may affect up to 1 in 10 people)

• stomach pain;
• abnormal liver function test results in blood tests;
• bleeding of the skin or under the skin;
• anemia (low levels of red blood cells);
• nosebleeds;
• vaginal bleeding;
• skin rash;
• bleeding from the intestine;
• bleeding from the mouth and/or throat;
• blood in the urine;
• bleeding after an injury (puncture);
• bleeding from the stomach;
• 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 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 into muscles;
• bleeding into joints;
• bleeding in the abdomen;
• bleeding in the heart;
• bleeding inside the skull;
• bleeding after a surgical procedure;
• anaphylactic shock;
• swelling of any part of the body due to an allergic reaction.

Frequency not known (cannot be estimated from available data)

• bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys being unable to function properly (anticoagulation-related nephropathy).

Reporting of adverse effects

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

5. Storage of Lixiana

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or bottle after "EXP" and on each blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lixiana

• The active substance is edoxaban (as tosylate).

Lixiana 15 mg film-coated tablets

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

Lixiana 30 mg film-coated tablets

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

Lixiana 60 mg film-coated tablets

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

• The other components 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, iron oxide red (E 172), iron oxide yellow (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, iron oxide red (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, iron oxide yellow (E 172).

Nature and contents of the container

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

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

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

They are available in blister packs containing 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets; or in unit dose blisters in packs of 10 x 1, 50 x 1 or 100 x 1 film-coated tablets; or in bottles containing 90 film-coated tablets.

Lixiana 60 mg film-coated tablets are yellow-colored, round tablets (10.5 mm in diameter) with the imprint “DSC L60” on one side.

They are available in blister packs containing 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets; or in unit dose blisters in packs of 10 x 1, 50 x 1 or 100 x 1 film-coated tablets; or in bottles containing 90 film-coated tablets.

Only certain 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 the most recent review of this leaflet: {MM/YYYY}.

Other sources of information

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