LIXIANA 15 mg Tabletki Powlekane

Treść ulotki

1. Lixiana 15 mg film-coated tablets, 30 mg film-coated tablets, 60 mg film-coated tablets
   1. What is Lixiana and what is it 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

Lixiana 15 mg film-coated tablets, 30 mg film-coated tablets, 60 mg film-coated tablets

edoxaban

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 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, which is an important component of blood coagulation.
Lixiana is used in adults:

• to prevent the formation of blood clots in the brain(stroke) and in other blood vesselsof the bodyin the presence of an irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor, such as heart failure, previous stroke or high blood pressure;
• to treat blood clots in the leg veins(deep vein thrombosis) and in the bloodvessels of the lungs(pulmonary embolism) and to prevent blood clots from reformingin 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 any of the other ingredients of this medicine (listed in section 6);
• if you have ongoing bleeding;
• if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcers, injuries or bleeding in the brain, or recent surgery to the brain or eyes);
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, rivaroxaban, apixaban or heparins), except when changing anticoagulant therapy or when you are receiving heparins through a venous or arterial catheter to keep it open;
• if you have a liver disease that increases the risk of bleeding;
• if you have uncontrolled high blood pressure;
• during pregnancy or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lixiana

• if you have an increased risk of bleeding, such as may be the case if you have any of the following conditions:
• advanced kidney disease or if you are undergoing dialysis;
• severe liver disease;
• blood clotting disorders;
• a disorder of the blood vessels in the back of the eye (retinopathy);
• recent bleeding in the brain (intracranial or intracerebral haemorrhage);
• problems with the blood vessels in the brain or spinal cord;
• if you have a mechanical heart valve.

Lixiana 15 mg should only be used when switching from Lixiana 30 mg to a vitamin K antagonist
(e.g. warfarin) (see section 3, How to take Lixiana).
Take particular care with Lixiana,

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change your therapy.

If you are going to have surgery,

• it is very important to take Lixiana before and after surgery exactly as indicated by your doctor. If possible, taking Lixiana should be stopped at least 24 hours before surgery. Your doctor will decide when to restart treatment with Lixiana. In emergency situations, your doctor will determine the appropriate actions to take regarding Lixiana.

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

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:

• some medicines against fungal infections (e.g. ketoconazole);
• medicines for the treatment of irregular heartbeats (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. cyclosporine);
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

If any of the conditions described apply to you, tell your doctorbefore taking Lixiana, because
these medicines can increase the effects of Lixiana and the possibility of undesirable bleeding. Your doctor will decide if you should be treated with Lixiana and if you should be
closely monitored.

If you are taking any of the following:

• some medicines for the treatment of epilepsy (e.g. phenytoin, carbamazepine, phenobarbital);
• St. John's wort, a herbal medicine used to treat mild anxiety and depression;
• rifampicin, an antibiotic medicine.

If any of the conditions described apply to you, tell your doctorbefore taking Lixiana, because
the effects of Lixiana may be reduced. Your doctor will decide if you should be treated with Lixiana and if
you should be closely monitored.

Pregnancy and breastfeeding
Do not take Lixiana if you are pregnant or if you are breastfeeding. If there is a possibility that
you may become pregnant, use a reliable method of contraception during treatment
with Lixiana. If you become pregnant during treatment with Lixiana, tell your doctor immediately, who will decide how to proceed.

Driving and using machines
Lixiana does not alter or alters negligibly the ability to drive vehicles or use machines.

3. How to take Lixiana

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Dosage to be taken
The recommended dose is one 60 mgtablet once a day.

• If renal function is impaired, your doctor may decide to reduce the dose to one 30 mgtablet once a day;
• if body weight is equal to or less than 60 kg, the recommended dose is one 30 mgtablet once a day;
• if your doctor has prescribed medicines known as P-gp inhibitors:cyclosporine, 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, ask your doctor about other ways to
take Lixiana. The tablet can be crushed and mixed with water or applesauce
immediately before taking it. If necessary, your doctor can also administer the crushed tablet
of Lixiana through a tube into your nose (nasogastric tube) or into your stomach
(gastric tube).

Your doctor may modify the anticoagulant treatment as follows:

Switching from vitamin K antagonists (VKA) (e.g. warfarin) to Lixiana
Stop treatment with the vitamin K antagonist (e.g. warfarin). Your doctor will need to
perform blood tests and will explain when to start taking Lixiana.

Switching from oral anticoagulants other than VKA (dabigatran, rivaroxaban or apixaban) to Lixiana
Stop treatment with the previous medicines (e.g. dabigatran, rivaroxaban or apixaban) and
start taking Lixiana at the time the next dose would have been due.

Switching from parenteral anticoagulants (e.g. heparin) to Lixiana
Stop treatment with the anticoagulant (e.g. heparin) and start taking Lixiana at the time
the next dose of anticoagulant would have been due.

Switching from Lixiana to vitamin K antagonists (VKA) (e.g. warfarin)
If you are taking Lixiana 60 mg:
Your doctor will ask you to reduce the dose of Lixiana to a 30 mg tablet once a day and to
take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to perform
blood tests and will explain when to stop taking Lixiana.
If you are taking Lixiana 30 mg (reduced dose):
Your doctor will ask you to reduce the dose of Lixiana to a 15 mg tablet once a day and to
take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to perform
blood tests and will explain when to stop taking Lixiana.

Switching from Lixiana to oral anticoagulants other than VKA (dabigatran, rivaroxaban or apixaban)
Stop treatment with Lixiana and start taking the anticoagulant other than VKA (e.g.
dabigatran, rivaroxaban or apixaban) at the time the next dose of
Lixiana would have been due.

Switching from Lixiana to parenteral anticoagulants (e.g. heparin)
Stop treatment with Lixiana and start the parenteral anticoagulant (e.g. heparin) at the
time the next dose of Lixiana would have been due.

Patients undergoing cardioversion:
If an abnormal heartbeat needs to be normalized by a procedure called
cardioversion, take Lixiana according to the times indicated by your doctor to prevent the formation of
blood clots in the brain and other blood vessels in the body.

If you take more Lixiana than you should
Immediately inform your doctor if you have taken too many Lixiana tablets.
If you have taken a dose of Lixiana higher than the recommended one, you may have a greater risk of
bleeding.

If you forget to take Lixiana
Take the tablet immediately and then continue the next day with taking the
tablet once a day, as usual. Do not take a double dose on the same day to
make up for the missed dose.

If you stop taking Lixiana
Do not stop treatment with Lixiana without first consulting your doctor, because Lixiana
is used to treat and prevent serious illnesses.
If you have any questions about 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 medicines similar to it (medicines that reduce blood clotting), Lixiana can
cause bleeding which may be fatal. In some cases, the bleeding may not be obvious.
If any bleeding event occurs that does not resolve on its own, or if signs of
excessive bleeding appear (unusual weakness, fatigue, paleness, dizziness, headache or swelling of
unknown origin), consult your doctor immediately.
The doctor may decide to keep you under close observation or to change the medicine.

General list of possible side effects:
Common(may affect up to 1 in 10 people)

• stomach pain;
• abnormal liver function tests;
• bleeding from the skin or under the skin;
• anemia (low levels of red blood cells);
• nosebleeds;
• vaginal bleeding;
• skin rash;
• bleeding in the intestine;
• bleeding from the mouth and/or throat;
• presence of blood in the urine;
• bleeding following injury (puncture);
• bleeding in the stomach;
• dizziness;
• feeling unwell;
• headache;
• itching.

Uncommon(may affect up to 1 in 100 people)

• bleeding in the eyes;
• bleeding from a wound following surgery;
• coughing up blood;
• bleeding in the brain;
• other types of bleeding;
• reduced number of platelets in the blood (which may affect 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 following a surgical procedure;
• allergic shock;
• swelling in any part of the body due to an allergic reaction.

Not known(frequency cannot be estimated from the available data)

• bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys not working properly (anticoagulant-associated nephropathy).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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. 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 package or bottle after
Scad. and on each blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lixiana contains

• 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 ingredients are:

Lixiana 15 mg film-coated tablets
Tablet core: mannitol (E421), pregelatinized starch, crospovidone (E1202),
hydroxypropylcellulose (E463), magnesium stearate (E470b).
Film coating: hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc (E553b),
carnauba wax, red iron oxide (E172), yellow iron oxide (E172).
Lixiana 30 mg film-coated tablets
Tablet core: mannitol (E421), pregelatinized starch, crospovidone (E1202),
hydroxypropylcellulose (E463), magnesium stearate (E470b).
Film coating: hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc (E553b),
carnauba wax, red iron oxide (E172).
Lixiana 60 mg film-coated tablets
Tablet core: mannitol (E421), pregelatinized starch, crospovidone (E1202),
hydroxypropylcellulose (E463), magnesium stearate (E470b).
Film coating: hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc (E553b),
carnauba wax, yellow iron oxide (E172).

Description of the appearance of Lixiana and contents of the pack
Lixiana 15 mg film-coated tablets are orange-colored, round tablets
(6.7 mm in diameter), with “DSC L15” imprinted on one side.
They are supplied in blisters in cardboard packs of 10 film-coated tablets, or in divisible blisters
for unit dose in cardboard packs of 10 × 1 film-coated tablets.
Lixiana 30 mg film-coated tablets are pink-colored, round tablets (8.5 mm
in diameter), with “DSC L30” imprinted on one side.
They are supplied in blisters in cardboard packs of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated
tablets, or in divisible blisters for unit dose in cardboard packs of 10 × 1, 50 × 1 or
100 × 1 film-coated tablets, or in bottles of 90 film-coated tablets.
Lixiana 60 mg film-coated tablets are yellow-colored, round tablets
(10.5 mm in diameter), with “DSC L60” imprinted on one side.
They are supplied in blisters in cardboard packs of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated
tablets, or in divisible blisters for unit dose in cardboard packs of 10 × 1, 50 × 1 or
100 × 1 film-coated tablets, or in bottles of 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Daiichi Sankyo Europe GmbH
Zielstattstrasse 48
81379 Munich
Germany

Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen
Germany
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Daiichi Sankyo Belgium N.V.-S.A
Tél/Tel: +32-(0) 2 227 18 80

Lietuva
UAB “SERVIER PHARMA”
Tel: +370 (5) 2 63 86 28

България
Daiichi Sankyo Europe GmbH
Tel: +49-(0) 89 7808 0

Luxembourg/Luxemburg
Daiichi Sankyo Belgium N.V.-S.A
Tél/Tel: +32-(0) 2 227 18 80

Česká republika
Organon Czech Republic s.r.o.
Tel: +420 233 010 300

Magyarország
Organon Hungary Kft.
Tel.: +36 1 766 1963

Danmark
Organon Denmark ApS
Tlf: +45 4484 6800

Malta
Daiichi Sankyo Europe GmbH
Tel: +49-(0) 89 7808 0

Deutschland
Daiichi Sankyo Deutschland GmbH
Tel. +49-(0) 89 7808 0

Nederland
Daiichi Sankyo Nederland B.V.
Tel: +31-(0) 20 4 07 20 72

EestiNorge
Servier Laboratories OÜ
Tel: +372 664 5040
Organon Norway AS
Tlf: +47 24 14 56 60

Ελλάδα
Daiichi Sankyo Europe GmbH
Τηλ: +49-(0) 89 7808 0

Österreich
Daiichi Sankyo Austria GmbH
Tel: +43-(0) 1 485 86 42 0

España
Daiichi Sankyo España, S.A.
Tel: +34 91 539 99 11

Polska
Daiichi Sankyo Europe GmbH
Tel: +49-(0) 89 7808 0

France
Daiichi Sankyo France S.A.S.
Tél: +33-(0) 1 55 62 14 60

Portugal
Daiichi Sankyo Portugal, Unip. LDA
Tel: +351 21 4232010

Hrvatska
Daiichi Sankyo Europe GmbH
Tel: +49-(0) 89 7808 0

România
Daiichi Sankyo Europe GmbH
Tel: +49-(0) 89 7808 0

Ireland
Daiichi Sankyo Ireland Ltd
Tel: +353-(0) 1 489 3000

Slovenija
Daiichi Sankyo Europe GmbH
Tel: +49-(0) 89 7808 0

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Organon Slovakia s. r. o.
Tel: +421 2 44 88 98 88

Italia
Daiichi Sankyo Italia S.p.A.
Tel: +39-06 85 2551

Suomi/Finland
Organon Finland Oy
Puh/Tel: +358 (0) 29 170 3520

Κύπρος
Daiichi Sankyo Europe GmbH
Τηλ: +49-(0) 89 7808 0

Sverige
Organon Sweden AB
Tel: +46 8 502 597 00

United Kingdom (Northern Ireland)
Daiichi Sankyo Europe GmbH
Tel: +49-(0) 89 7808 0

Other sources of information
More detailed information on this medicine is available by scanning the QR
code with a smartphone.
The same information is also available at the following address: www.dspatient.eu.
QR code to be inserted
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/ .

Latvija
SIA Servier Latvia
Tel: +371 67502039