Edoflusio

Package leaflet: Information for the user

Edoflusio, 15 mg, film-coated tablets
Edoflusio, 30 mg, film-coated tablets
Edoflusio, 60 mg, film-coated tablets
Edoxaban
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Edoflusio is and what it is used for
2. Important information before taking Edoflusio
3. How to take Edoflusio
4. Possible side effects
5. How to store Edoflusio
6. Contents of the pack and other information

1. What Edoflusio is and what it is used for

Edoflusio contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent the formation of blood clots. It works by blocking the activity of factor Xa, which is an important component in the blood clotting process. Edoflusio is used in adults for:

• preventing blood clots in the brain (stroke) and in other blood vessels in the body when a patient has been diagnosed with a heart rhythm disorder called non-valvular atrial fibrillation and has at least one additional risk factor such as heart failure, previous stroke, or high blood pressure;
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as for preventing recurrence of blood clots in the blood vessels of the legs and (or) lungs.

2. Important information before taking Edoflusio

When not to take Edoflusio

• if the patient is allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6);
• if the patient has active bleeding;
• if the patient has a disease or condition leading to an increased risk of major bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, or recent surgery on the brain or eyes);
• if the patient is taking other anticoagulant medicines (e.g. warfarin, dabigatran, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery;
• if the patient has liver disease that increases the risk of bleeding;
• if the patient has uncontrolled high blood pressure;
• if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting Edoflusio, discuss with your doctor or pharmacist:

• if the patient has an increased risk of bleeding due to any of the conditions listed below:
  • end-stage renal disease or if the patient is on dialysis;
  • severe liver disease;
  • coagulation disorders;
  • vascular disease of the back of the eye (retinopathy);
  • recent intracranial or cerebral haemorrhage;
  • diseases involving blood vessels in the brain or spinal cord;
• if the patient has a mechanical heart valve.

Edoflusio 15 mg is intended for use only when switching treatment from Edoflusio 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3 How to take Edoflusio).
When to exercise particular caution when taking Edoflusio:

• if the patient has been diagnosed with antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether treatment should be changed.

If the patient needs to undergo surgery:

• it is very important to take Edoflusio at the exact times specified by the doctor, both before and after surgery. If possible, Edoflusio should be discontinued at least 24 hours before surgery. The doctor will decide when to restart Edoflusio. In emergency situations, the doctor will help determine appropriate actions regarding the use of Edoflusio.

Children and adolescents
Edoflusio is not recommended for use in children and adolescents under 18 years of age.
Edoflusio with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is taking any of the following medicines:

• certain antifungal medicines (e.g. ketoconazole);

• medicines used to treat heart rhythm disorders (e.g. dronedarone, quinidine, verapamil);

• other medicines used to reduce blood clotting (e.g. heparin, clopidogrel, or vitamin K antagonists including warfarin, acenocoumarol, phenprocoumon, or dabigatran, rivaroxaban, apixaban);

• antibiotics (e.g. erythromycin, clarithromycin);

• medicines used to prevent transplant rejection (e.g. cyclosporine);

• anti-inflammatory and pain medicines (e.g. naproxen or acetylsalicylic acid);

• antidepressants known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors. If the patient is taking any of the above medicines, they must inform their doctor before starting Edoflusio, as these medicines may enhance the effect of Edoflusio and increase the risk of bleeding. The doctor will decide whether to use Edoflusio and whether the patient needs to be monitored.
  If the patient is taking any of the following medicines:

• certain antiepileptic medicines (e.g. phenytoin, carbamazepine, phenobarbital);

• St John’s wort, a herbal medicine used to treat anxiety and mild depression;

• rifampicin, which belongs to the group of antibiotics.

If the patient is taking any of the above medicines, they must inform their doctor before starting Edoflusio, as the effect of Edoflusio may be reduced. The doctor will decide whether to use Edoflusio and whether the patient needs to be monitored.
Pregnancy and breastfeeding
Edoflusio must not be used if the patient is pregnant or breastfeeding. If there is a possibility that the patient could become pregnant, an effective method of contraception should be used during treatment with Edoflusio. If the patient becomes pregnant while taking Edoflusio, she must inform her doctor immediately, who will decide on further management.
Driving and operating machinery
Edoflusio has no effect or has a negligible effect on the ability to drive and operate machinery.
Edoflusio contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Edoflusio contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Edoflusio

This medicine should always be taken as instructed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
What dose should be taken
The recommended dose is one 60 mg tablet once daily:

• If the patient has impaired kidney function, the dose may be reduced by the doctor to one 30 mg tablet once daily.
• If the patient's body weight is 60 kg or less, the recommended dose is one 30 mg tablet once daily.
• If the patient is taking prescribed medicines known as P-gp (P-glycoprotein) inhibitors : cyclosporine, dronedarone, erythromycin, or ketoconazole, the recommended dose is one 30 mg tablet once daily.

How to take the tablet
The tablet should be swallowed whole, preferably with water.
Edoflusio may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should discuss alternative
methods of taking Edoflusio with their doctor. Immediately before administration, the tablet may be crushed
and mixed with water or apple puree. If necessary, the doctor may also administer crushed
Edoflusio tablets via a tube inserted through the nose (nasogastric tube) or into the stomach (gastric tube).
The doctor may change the patient's anticoagulant treatment as follows:
Switching from a vitamin K antagonist (e.g. warfarin) to Edoflusio
Stop taking the vitamin K antagonist (e.g. warfarin). The doctor will order a blood test and inform the
patient when to start taking Edoflusio.
Switching from another oral anticoagulant that is not a vitamin K antagonist (dabigatran,
rivaroxaban or apixaban) to Edoflusio
Stop taking the previous medicine (e.g. dabigatran, rivaroxaban or apixaban) and start taking Edoflusio
at the time of the next scheduled dose.
Switching from a parenterally administered anticoagulant (e.g. heparin) to Edoflusio
Stop taking the anticoagulant (e.g. heparin) and start taking Edoflusio at the time of the next scheduled
dose of the anticoagulant.
Switching from Edoflusio to a vitamin K antagonist (e.g. warfarin)
If the patient is currently taking Edoflusio 60 mg:
The doctor will instruct the patient to reduce the Edoflusio dose to one 30 mg tablet once daily
and to start taking a vitamin K antagonist (e.g. warfarin) at the same time. The doctor will order a
blood test and inform the patient when to stop taking Edoflusio.
If the patient is currently taking Edoflusio 30 mg (reduced dose):
The doctor will instruct the patient to reduce the Edoflusio dose to one 15 mg tablet once daily
and to start taking a vitamin K antagonist (e.g. warfarin) at the same time. The doctor will order a
blood test and inform the patient when to stop taking Edoflusio.
Switching from Edoflusio to another oral anticoagulant that is not a vitamin K antagonist
(dabigatran, rivaroxaban or apixaban)
Stop taking Edoflusio and start taking another oral anticoagulant that is not a vitamin K antagonist
(e.g. dabigatran, rivaroxaban or apixaban) at the time of the next scheduled Edoflusio dose.
Switching from Edoflusio to a parenterally administered anticoagulant (e.g. heparin)
Stop taking Edoflusio and start taking a parenterally administered anticoagulant (e.g. heparin)
at the time of the next scheduled Edoflusio dose.
Patients undergoing cardioversion:
If the patient's irregular heartbeat needs to be restored to normal using a procedure called
cardioversion, Edoflusio should be taken at the time recommended by the doctor to prevent
blood clots in the brain and other blood vessels in the body.
Taking more Edoflusio than recommended
If too many Edoflusio tablets are taken, contact a doctor immediately. If a patient takes more
Edoflusio than prescribed, the risk of bleeding may increase.
Missed dose of Edoflusio
Take the tablet as soon as possible, then continue taking it once daily the next day,
as directed. Do not take a double dose on the same day to make up for a missed dose.
Stopping Edoflusio
Do not stop taking Edoflusio without first consulting your doctor, as Edoflusio treats and prevents
serious conditions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
As with other medicines of similar action (medicines used to reduce blood clotting), Edoflusio may cause bleeding, which potentially could be life-threatening. In some cases, bleeding may not produce obvious (visible) symptoms.
If any bleeding occurs in the patient that does not stop spontaneously, or if symptoms of severe bleeding occur (unusual weakness, fatigue, paleness, dizziness, headache or swelling of unexplained cause), medical advice should be sought immediately.
The physician may decide that very close monitoring of the patient is necessary or that the treatment approach should be changed.

List of possible adverse reactions:
Common (may affect up to 1 in 10 people)

• abdominal pain;
• abnormal liver function test results;
• skin bleeding or subcutaneous bleeding;
• anaemia (low number of red blood cells);
• nosebleeds;
• vaginal bleeding;
• rash;
• gastrointestinal bleeding;
• bleeding from the mouth and/or throat;
• blood in urine;
• post-traumatic bleeding (after puncture);
• gastric bleeding;
• dizziness;
• nausea;
• headache;
• itching.

Uncommon (may affect up to 1 in 100 people)

• ocular bleeding;
• bleeding from surgical wound after surgery;
• presence of blood in sputum when coughing;
• intracranial haemorrhage;
• other types of bleeding;
• decreased platelet count (which may affect blood clotting);
• allergic reaction;
• urticaria.

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

• intramuscular bleeding;
• joint bleeding;
• intra-abdominal bleeding;
• cardiac bleeding;
• intracranial bleeding;
• bleeding after surgery;
• anaphylactic shock;
• swelling of any part of the body due to allergic reaction.

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

• kidney bleeding, sometimes with presence of blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Edoflusio

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after:
"Expiry date (EXP)" and on each blister or bottle after: "EXP". The expiry date refers to the last
day of the stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the
environment.

6. Contents of the pack and other information

What Edoflusio contains

• The active substance is edoxaban (as tosylate monohydrate).

Edoflusio 15 mg film-coated tablets
Each tablet contains 15 mg of edoxaban (as tosylate monohydrate).
Edoflusio 30 mg film-coated tablets
Each tablet contains 30 mg of edoxaban (as tosylate monohydrate).
Edoflusio 60 mg film-coated tablets
Each tablet contains 60 mg of edoxaban (as tosylate monohydrate).

• Other ingredients are:

Edoflusio 15 mg film-coated tablets
Tablet core: hydroxypropyl cellulose (E 463), lactose monohydrate, magnesium stearate (E 470b),
microcrystalline cellulose (E 460), sodium croscarmellose (E 468)
Coating: hypromellose, type 2910, 6.0 mPas (E 464), polyethylene glycol 8000, titanium dioxide (E 171),
talc (E 553b), yellow iron oxide (E 172) and red iron oxide (E 172)
Edoflusio 30 mg film-coated tablets
Tablet core: hydroxypropyl cellulose (E 463), lactose monohydrate, magnesium stearate (E 470b),
microcrystalline cellulose (E 460), sodium croscarmellose (E 468)
Coating: hypromellose, type 2910, 6.0 mPas (E 464), polyethylene glycol 8000, titanium dioxide (E 171),
talc (E 553b) and red iron oxide (E 172)
Edoflusio 60 mg film-coated tablets
Tablet core: hydroxypropyl cellulose (E 463), lactose monohydrate, magnesium stearate (E 470b),
microcrystalline cellulose (E 460), sodium croscarmellose (E 468)
Coating: hypromellose, type 2910, 6.0 mPas (E 464), polyethylene glycol 8000, titanium dioxide (E 171),
talc (E 553b) and yellow iron oxide (E 172)
What Edoflusio looks like and contents of the pack
Edoflusio 15 mg is a light orange, round (6.7 mm in diameter), biconvex film-coated tablet (tablet) with "EX 15" embossed on one side.
Edoflusio 30 mg is a light pink, round (8.6 mm in diameter), biconvex film-coated tablet (tablet) with "EX 30" embossed on one side.
Edoflusio 60 mg is a light yellow, round (10.6 mm in diameter), biconvex film-coated tablet (tablet) with "EX 60" embossed on one side.
Edoflusio medicinal product is packed in PVC/aluminum blisters, unit dose perforated PVC/aluminum blisters, or HDPE bottles with a child-resistant polypropylene cap, all contained in a cardboard carton.
Pack sizes (blisters):
15 mg:
10 and 14 film-coated tablets in blisters packed in a cardboard carton.
10 x 1, 28 x 1 and 98 x 1 film-coated tablets in unit dose blisters in a cardboard carton.
30 mg and 60 mg:
10, 14, 28, 30, 50, 84, 98 and 100 film-coated tablets in blisters in a cardboard carton.
10 x 1, 28 x 1 and 98 x 1 film-coated tablets in unit dose blisters in a cardboard carton.
Calendar printing may be present on the blisters, but is not mandatory.
Pack sizes (bottles):
100, 120 and 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
tel. 22 209 70 00
Manufacturer/Importer
Lek Pharmaceuticals d.d.
Trimlini 2d, Lendava, 9220
Slovenia
This medicinal product is authorised in the countries of the European Economic Area under the following names:
Sweden Edoflusio
Austria Edoflusio 15 mg - Filmtabletten
Edoflusio 30 mg - Filmtabletten
Edoflusio 60 mg - Filmtabletten
Bulgaria Edoflusio 15 mg film-coated tablets
Edoflusio 30 mg film-coated tablets
Edoflusio 60 mg film-coated tablets
Estonia Edoflusio
Croatia Edoflusio 15 mg filmom obložene tablete
Edoflusio 30 mg filmom obložene tablete
Edoflusio 60 mg filmom obložene tablete
Lithuania Edoflusio 30 mg plėvele dengtos tabletės
Edoflusio 60 mg plėvele dengtos tabletės
Latvia Edoflusio 30 mg apvalkotās tabletes
Edoflusio 60 mg apvalkotās tabletes
Poland Edoflusio
Slovenia Edoflusio 15 mg filmsko obložene tablete
Edoflusio 30 mg filmsko obložene tablete
Edoflusio 60 mg filmsko obložene tablete