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

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

• You should 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 and Other Information

• 1. What Edoflusio is and what it is used for
• 2. Before you take 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. It helps to prevent the formation of blood clots. Edoflusio works by blocking the activity of Factor Xa, which is an important factor in the blood clotting process.

Edoflusio is used in adults to:

• prevent blood clots in the brain (stroke) and other blood vessels in the body, if you have a condition called non-valvular atrial fibrillation, and at least one additional risk factor, such as heart failure, a 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), and to prevent new blood clots from forming in the blood vessels of the legs and/or lungs.

2. Before You Take Edoflusio

When You Should Not Take Edoflusio

• if you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6);
• if you have active bleeding;
• if you have a condition or disease that increases the risk of major bleeding (e.g. stomach ulcer, injury or bleeding in the brain, or recent surgery of the brain or eyes);
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, rivaroxaban, apixaban or heparin), except when switching from one anticoagulant to another or when heparin is given to maintain catheter patency;
• if you have liver disease that increases the risk of bleeding;
• if you have uncontrolled high blood pressure;
• if you are pregnant or breastfeeding.

Warnings and Precautions

Before you start taking Edoflusio, tell your doctor or pharmacist:

• if you have any condition that increases the risk of bleeding, such as:
• severe kidney disease or if you are on dialysis;
• severe liver disease;
• bleeding disorders;
• retinopathy (disease of the blood vessels in the eyes);
• recent bleeding in the brain (intracranial or intraspinal bleeding);
• vascular diseases of the brain or spinal cord;
• if you have a mechanical heart valve.

Edoflusio 15 mg is only for use when switching from Edoflusio 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3).
When to Take Special Care with Edoflusio:

• if you have a condition called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), you should tell your doctor, who will decide whether to change your treatment.

If You Need to Have an Operation:

• it is very important that you take Edoflusio at the exact times specified by your doctor before and after the operation. If possible, you should stop taking Edoflusio at least 24 hours before the operation. Your doctor will decide when to restart Edoflusio. In emergency situations, your doctor will help you decide what to do with 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 the medicines you are taking, or have recently taken, and those you plan to take.

If you are taking any of the following medicines:

• certain medicines used to treat fungal infections (e.g. ketoconazole);
• medicines used to treat irregular heartbeat (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-relieving medicines (e.g. naproxen or acetylsalicylic acid);
• antidepressants called selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

If You Are Taking Any of These Medicines, Tell Your Doctor

before you start taking Edoflusio, because these medicines may increase the effect of Edoflusio and increase the risk of bleeding. Your doctor will decide whether to use Edoflusio and whether you need to be monitored.

If you are taking any of the following medicines:

• certain medicines used to treat epilepsy (e.g. phenytoin, carbamazepine, phenobarbital)
• St. John's Wort, a herbal medicine used to treat anxiety and mild depression
• rifampicin, an antibiotic

If You Are Taking Any of These Medicines, Tell Your Doctor

before you start taking Edoflusio, because the effect of Edoflusio may be reduced. Your doctor will decide whether to use Edoflusio and whether you need to be monitored.

Pregnancy and Breastfeeding

Do not take Edoflusio if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception during treatment with Edoflusio. If you become pregnant while taking Edoflusio, you should inform your 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 you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Edoflusio Contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially 'sodium-free'.

3. How to Take Edoflusio

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

How Much to Take

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

• If you have kidney problems, your doctor may reduce the dose to one 30 mg tablet once a day.
• If your body weight is 60 kg or less, the recommended dose is one 30 mg tablet once a day.
• If you are taking certain medicines called 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

Swallow the tablet with water.
Edoflusio can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Edoflusio. Just before taking, the tablet can be crushed and mixed with water or apple puree. If necessary, your doctor may also give you a crushed Edoflusio tablet through a tube inserted through the nose (nasogastric tube) or into the stomach (gastric tube).

Switching from One Anticoagulant to Another

Switching from a vitamin K antagonist (e.g. warfarin) to Edoflusio
Stop taking the vitamin K antagonist (e.g. warfarin). Your doctor will order a blood test and tell you 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 next scheduled dose.
Switching from an anticoagulant given by injection (e.g. heparin) to Edoflusio
Stop taking the anticoagulant (e.g. heparin) and start taking Edoflusio at the next scheduled dose.
Switching from Edoflusio to a vitamin K antagonist (e.g. warfarin)
If you are currently taking Edoflusio 60 mg:
Your doctor will instruct you to reduce the dose of Edoflusio to one 30 mg tablet once a day and to start taking a vitamin K antagonist (e.g. warfarin) at the same time. Your doctor will order a blood test and tell you when to stop taking Edoflusio.
If you are currently taking Edoflusio 30 mg (reduced dose):
Your doctor will instruct you to reduce the dose of Edoflusio to one 15 mg tablet once a day and to start taking a vitamin K antagonist (e.g. warfarin) at the same time. Your doctor will order a blood test and tell you 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 next scheduled dose of Edoflusio.
Switching from Edoflusio to an anticoagulant given by injection (e.g. heparin)
Stop taking Edoflusio and start taking an anticoagulant given by injection (e.g. heparin) at the next scheduled dose of Edoflusio.

Patients Undergoing Cardioversion:

If your irregular heartbeat needs to be restored to normal using a procedure called cardioversion, you should take Edoflusio at the time specified by your doctor to prevent blood clots in the brain and other blood vessels in the body.

Taking More Than the Recommended Dose of Edoflusio

If you have taken more Edoflusio tablets than you should, contact your doctor immediately. If you have taken more Edoflusio than recommended, you may be at increased risk of bleeding.

Forgetting to Take a Dose of Edoflusio

Take the tablet as soon as possible and continue taking one tablet once a day as directed. Do not take a double dose on the same day to make up for a forgotten dose.

Stopping Edoflusio

Do not stop taking Edoflusio without first talking to your doctor, because Edoflusio treats and prevents serious conditions.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Edoflusio can cause side effects, although not everybody gets them.
As with other medicines that reduce blood clotting, Edoflusio may cause bleeding, which can be life-threatening. In some cases, bleeding may not have obvious (visible) symptoms.
If you experience any bleeding that does not stop by itself or if you have symptoms of severe bleeding (unusual weakness, tiredness, paleness, dizziness, headache or swelling of unknown cause), you should contact your doctor immediately.
Your doctor may decide to monitor you closely or change your treatment.

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;
• anaemia (low number of red blood cells);
• nosebleeds;
• vaginal bleeding;
• rash;
• bleeding in the intestines;
• bleeding from the mouth and/or throat;
• blood in the urine;
• bleeding after injury (post-traumatic bleeding);
• bleeding in the stomach;
• 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 number of platelets (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 abdominal cavity;
• 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(frequency cannot be estimated from the available data)

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

Reporting of Side Effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the website. By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the carton after “EXP” and on each blister or bottle after “EXP”. The expiry date refers to the last day of that month.
Store in a cool, dry place, below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Edoflusio Contains

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

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

• The other ingredients are:

Edoflusio 15 mg film-coated tablets
Tablet 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 film-coated tablets
Tablet 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 film-coated tablets
Tablet 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” engraved on one side.
Edoflusio 30 mg is a light pink, round (8.6 mm in diameter), biconvex film-coated tablet (tablet), with “EX 30” engraved on one side.
Edoflusio 60 mg is a light yellow, round (10.6 mm in diameter), biconvex film-coated tablet (tablet), with “EX 60” engraved on one side.
Edoflusio is packaged in PVC/Aluminium blisters, single-dose perforated PVC/Aluminium blisters or HDPE bottles with a child-resistant polypropylene cap.

Marketing Authorisation Holder

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warszawa
tel. 22 209 70 00

Manufacturer

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

This Medicinal Product is Authorised 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 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

Date of Last Revision of the Leaflet: