Edoflusio

Leaflet accompanying the packaging: information for the user

Edoflusio, 15 mg, coated tablets

Edoflusio, 30 mg, coated tablets

Edoflusio, 60 mg, coated tablets

Edoxaban

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Edoflusio and what is it 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 packaging and other information

1. What is Edoflusio and what is it used for

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

• prevent blood clots in the brain(stroke) and in other blood vessels in the body, if the patient has irregular heart rhythm called non-valvular atrial fibrillation and at least one additional risk factor, such as heart failure, previous stroke, or high blood pressure;
• treat blood clots in the legs(deep vein thrombosis) and in the blood vessels of the lungs(pulmonary embolism), as well as to prevent the recurrence of blood clotsin 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 that increases the risk of significant bleeding (e.g., stomach ulcer, injury, or bleeding in the brain, or recent brain or eye surgery);
• if the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter;
• 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 to take Edoflusio, the patient should discuss it with their doctor or pharmacist:

• if the patient has any of the following conditions that increase the risk of bleeding:
• end-stage kidney disease or if the patient is on dialysis;
• severe liver disease;
• bleeding disorders;
• vascular disease of the retina;
• recent bleeding in the brain (intracranial or intraspinal hemorrhage);
• vascular diseases of the brain or spinal cord;
• if the patient has a mechanical heart valve.

Edoflusio 15 mg is only intended for use when switching from Edoflusio 30 mg to a vitamin K antagonist (e.g., warfarin) (see section 3 How to take Edoflusio).
When to be particularly careful when taking Edoflusio:

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

If the patient needs to have surgery:

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

Children and adolescents

Edoflusio is not recommended for use in children and adolescents under 18 years of age.

Edoflusio and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.
If the patient is taking any of the following medicines:

• certain antifungal medicines (e.g., ketoconazole);
• medicines for irregular heart rhythm (e.g., dronedarone, quinidine, verapamil);
• other medicines that 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 to prevent transplant rejection (e.g., cyclosporine);
• anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid);
• antidepressants called selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

If the patient is taking any of these medicines, they should tell their doctor

before starting to take Edoflusio, as these medicines may increase 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 medicines for epilepsy (e.g., phenytoin, carbamazepine, phenobarbital)
• St. John's Wort, a herbal medicine used to treat anxiety and mild depression
• rifampicin, which belongs to a group of antibiotics.

If the patient is taking any of these medicines, they should tell their doctor

before starting to take 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 taken if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use effective contraception while taking Edoflusio. If the patient becomes pregnant while taking Edoflusio, they should inform their doctor immediately, who will decide on further treatment.

Driving and using machines

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

Edoflusio contains lactose

If the patient has been told that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

Edoflusio contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially sodium-free.

3. How to take Edoflusio

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should ask their doctor or pharmacist.

What dose to take

The recommended dose is one 60 mg tablet once a day:

• If the patient has kidney problems, the dose may be reduced by the doctor to one 30 mg tablet once a day.
• If the patient's body weight is 60 kg or less, the recommended dose is one 30 mg tablet once a day.
• If the patient is taking P-gp inhibitors (e.g., cyclosporine, dronedarone, erythromycin, or ketoconazole), the recommended dose is one 30 mg tablet once a day.

How to take the tablet

The tablet should be swallowed, preferably with water.
Edoflusio can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways to take Edoflusio. The tablet can be crushed and mixed with water or apple puree just before taking. If necessary, the doctor may also give the patient a crushed Edoflusio tablet through 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 tell the patient when to start taking Edoflusio.
Switching from another oral anticoagulant (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 planned dose.
Switching from a parenteral anticoagulant (e.g., heparin) to Edoflusio
Stop taking the anticoagulant (e.g., heparin) and start taking Edoflusio at the time of the next planned 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 dose of Edoflusio to one 30 mg tablet once a day and start taking a vitamin K antagonist (e.g., warfarin) at the same time. The doctor will order a blood test and tell 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 dose of Edoflusio to one 15 mg tablet once a day and start taking a vitamin K antagonist (e.g., warfarin) at the same time. The doctor will order a blood test and tell the patient when to stop taking Edoflusio.
Switching from Edoflusio to another oral anticoagulant (dabigatran, rivaroxaban, or apixaban)
Stop taking Edoflusio and start taking another oral anticoagulant (e.g., dabigatran, rivaroxaban, or apixaban) at the time of the next planned dose of Edoflusio.
Switching from Edoflusio to a parenteral anticoagulant (e.g., heparin)
Stop taking Edoflusio and start taking a parenteral anticoagulant (e.g., heparin) at the time of the next planned dose of Edoflusio.

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 specified by the doctor to prevent blood clots in the brain and other blood vessels in the body.

Taking more Edoflusio than prescribed

If the patient takes more Edoflusio tablets than they should, they should contact their doctor immediately. If the patient takes more Edoflusio than prescribed, they may be at increased risk of bleeding.

Missing a dose of Edoflusio

The patient should take the missed tablet as soon as possible and continue taking one tablet once a day as prescribed. They should not take a double dose on the same day to make up for the missed dose.

Stopping Edoflusio

The patient should not stop taking Edoflusio without first talking to their doctor, as Edoflusio treats and prevents serious conditions.
If the patient has any further questions on the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Edoflusio can cause side effects, although not everybody gets them.
As with other medicines of this type (medicines that reduce blood clotting), Edoflusio may cause bleeding, which can be life-threatening. In some cases, bleeding may not show obvious symptoms.
If the patient experiences any bleeding that does not stop by itself or symptoms of severe bleeding (unusual weakness, tiredness, paleness, dizziness, headache, or swelling of unknown cause), they should contact their doctor immediately.
The doctor may decide that the patient needs to be closely monitored or that their treatment needs to be changed.

List of possible side effects:

Common(may affect up to 1 in 10 people)

• abdominal pain;
• abnormal liver function tests;
• bleeding from the skin or bleeding under the skin;
• anemia (low red blood cell count);
• nosebleeds;
• vaginal bleeding;
• rash;
• bleeding in the intestine;
• bleeding from the mouth and/or throat;
• blood in the urine;
• bleeding after injury (post-traumatic bleeding);
• stomach bleeding;
• dizziness;
• nausea;
• headache;
• itching.

Uncommon(may affect up to 1 in 100 people)

• bleeding in the eye;
• bleeding from a wound after surgery;
• blood in the sputum when coughing;
• bleeding in the brain;
• other types of bleeding;
• reduced platelet count (which may affect blood clotting);
• allergic reaction;
• hives.

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

• bleeding into the muscles;
• bleeding into the joints;
• bleeding in the abdominal cavity;
• bleeding into 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(frequency cannot be estimated from the available data)

• kidney bleeding, sometimes with blood in the urine, leading to kidney dysfunction (anticoagulant-related nephropathy).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Edoflusio

The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “EXP” and on each blister or bottle after “EXP”. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Edoflusio contains

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

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

• Other ingredients are:

Edoflusio 15 mg coated tablets
Core: hydroxypropylcellulose (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), macrogol 8000, titanium dioxide (E 171),
talc (E 553b), yellow iron oxide (E 172), and red iron oxide (E 172)
Edoflusio 30 mg coated tablets
Core: hydroxypropylcellulose (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), macrogol 8000, titanium dioxide (E 171),
talc (E 553b), and red iron oxide (E 172)
Edoflusio 60 mg coated tablets
Core: hydroxypropylcellulose (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), macrogol 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 is packaged in PVC/Aluminum blisters, single-dose perforated PVC/Aluminum blisters, or HDPE bottles with a child-resistant polypropylene cap, in a cardboard box.
Pack sizes (blisters):
15mg:
10 and 14 film-coated tablets in blisters packaged in a cardboard box.
10 x 1, 28 x 1, and 98 x 1 film-coated tablets in single-dose blisters in a cardboard box.
30 and 60 mg:
10, 14, 28, 30, 50, 84, 98, and 100 film-coated tablets in blisters in a cardboard box.
10 x 1, 28 x 1, and 98 x 1 film-coated tablets in single-dose blisters in a cardboard box.
The blisters may, but do not have to be, printed with calendar days.
Pack sizes (bottles):
100, 120, and 250 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
phone: 22 209 70 00

Manufacturer/importer

Lek Pharmaceuticals d.d.
Trimlini 2d, Lendava, 9220
Slovenia

This medicine is authorized in the Member States 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 film-coated tablets
Edoflusio 30 mg film-coated tablets
Edoflusio 60 mg film-coated tablets
Lithuania
Edoflusio 30 mg film-coated tablets
Edoflusio 60 mg film-coated tablets
Latvia
Edoflusio 30 mg film-coated tablets
Edoflusio 60 mg film-coated tablets
Poland
Edoflusio
Slovenia
Edoflusio 15 mg film-coated tablets
Edoflusio 30 mg film-coated tablets
Edoflusio 60 mg film-coated tablets

Date of last revision of the leaflet: