EDOXABAN SANDOZ 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for thepatient

Edoxaban Sandoz 15 mg film-coated tablets EFG

Edoxaban Sandoz 30 mg film-coated tablets EFG

Edoxaban Sandoz 60 mg film-coated tablets EFG

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

• Keep this package leaflet, as 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, and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What Edoxaban Sandoz is and what it is used for
2. What you need to know before you take Edoxaban Sandoz
3. How to take Edoxaban Sandoz
4. Possible side effects

5 Storage of Edoxaban Sandoz

1. Contents of the pack and further information

1. What Edoxaban Sandoz is and what it is used for

Edoxaban Sandoz 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 element in the blood clotting process.

Edoxaban is used in adults:

• to prevent the formation of a blood clot in the brain(stroke) and in other blood vessels of the bodyif they have a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor, such as heart failure, having previously had a stroke or high blood pressure,
• 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 happening againin the blood vessels of the legs and/or lungs.

2. What you need to know before you take Edoxaban Sandoz

Do not take Edoxaban Sandoz

• if you are allergic to edoxaban or 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 major bleeding (e.g. stomach ulcer, injury or bleeding in the brain or recent surgery in 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 being administered heparin through a venous or arterial catheter to prevent it from becoming blocked,
• 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 taking edoxaban:

• if you have an increased risk of bleeding, such as if you have any of the following conditions:

• end-stage kidney disease or if you are on dialysis,
• severe liver disease,
• bleeding disorders,
• problems with the blood vessels in the back of the eyes (retinopathy),
• recent bleeding in the brain (intracranial or intracerebral bleeding),
• problems with the blood vessels in the brain or spine,

• if you have a mechanical heart valve.

Edoxaban 15 mg is only indicated when switching from edoxaban 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3. How to take Edoxaban Sandoz).

Be careful with edoxaban,

• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so that they can decide whether it is necessary to modify the treatment.

If you need to have surgery,

• it is very important to take edoxaban before and after the operation, exactly at the times indicated by your doctor. If possible, you should stop taking edoxaban at least 24 hours before an operation. Your doctor will decide when to restart edoxaban.

In emergency situations, your doctor will help determine the necessary actions regarding edoxaban.

Children and adolescents

Edoxaban is not recommended for children and adolescents under 18 years of age.

Other medicines and Edoxaban Sandoz

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:

• any medicine for a fungal infection (e.g. ketoconazole),
• medicines to treat irregular heartbeat (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),
• antidepressants called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.

If any of the above applies to you, tell your doctorbefore taking edoxaban, because these medicines may increase the effects of edoxaban and the risk of unwanted bleeding. Your doctor will decide whether you should be treated with this medicine and whether you should be kept under observation.

If you are taking any of the following:

• any medicine for the treatment of 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 applies to you, tell your doctorbefore taking edoxaban, because the effect of edoxaban may be reduced. Your doctor will decide whether you should be treated with edoxaban and whether you should be kept under observation.

Pregnancy and breastfeeding

Do not take edoxaban if you are pregnant or breastfeeding. If there is a possibility that you may become pregnant, use an effective contraceptive while taking edoxaban. If you become pregnant while taking edoxaban, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines

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

Edoxaban Sandoz contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Edoxaban Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Edoxaban Sandoz

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

What dose to take

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

• if you have kidney problems, your doctor may reduce your dose to one 30 mg tablet once a day.
• if you weigh 60 kg or less, the recommended dose is one 30 mg tablet once a day.
• 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 a day.

How to take the tablet

Swallow the tablet, preferably with water.

Edoxaban can be taken with or without food.

If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take edoxaban. The tablet can be crushed and mixed with water or apple sauce immediately before taking it. If necessary, your doctor can also administer the crushed edoxaban tablet through a tube in the nose (nasogastric tube) or stomach (gastric feeding tube).

Your doctor may switch your anticoagulant treatment as follows:

Switching from vitamin K antagonists (e.g. warfarin) to edoxaban

Stop taking the vitamin K antagonist (e.g. warfarin). Your doctor will have to do a blood test and tell you when to start taking edoxaban.

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

Stop taking the previous medicines (e.g. dabigatran, rivaroxaban or apixaban) and start taking edoxaban at the time of the next scheduled dose of the anticoagulant.

Switching from parenteral anticoagulants (e.g. heparin) to edoxaban

Stop taking the anticoagulant (e.g. heparin) and start taking edoxaban at the time of the next scheduled dose of the anticoagulant.

Switching from edoxaban to vitamin K antagonists (e.g. warfarin)

If you are currently taking 60 mg of edoxaban:

Your doctor will tell you to reduce the dose of edoxaban to one 30 mg tablet once a day and take it in combination with a vitamin K antagonist (e.g. warfarin). Your doctor will have to do a blood test and tell you when to stop taking edoxaban.

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

Your doctor will tell you to reduce the dose of edoxaban to one 15 mg tablet once a day and take it in combination with a vitamin K antagonist (e.g. warfarin). Your doctor will have to do a blood test and tell you when to stop taking edoxaban.

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

Stop taking edoxaban and start the non-vitamin K antagonist anticoagulant (e.g. dabigatran, rivaroxaban or apixaban) at the time of the next scheduled dose of edoxaban.

Switching from edoxaban to parenteral anticoagulants (e.g. heparin)

Stop taking edoxaban and start the parenteral anticoagulant (e.g. heparin) at the time of the next scheduled dose of edoxaban.

Patients undergoing cardioversion:

If you need your irregular heartbeat to be restored to normal through a procedure called cardioversion, take edoxaban 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 Edoxaban Sandoz than you should

Tell your doctor immediately if you have taken too many edoxaban tablets.

If you take more edoxaban than recommended, you may increase the risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Edoxaban Sandoz

Take the tablet as soon as you remember and continue the next day with the usual once-daily tablet intake. Do not take a double dose on the same day to make up for the forgotten dose.

If you stop taking Edoxaban Sandoz

Do not stop taking edoxaban without talking to your doctor first, as edoxaban treats and prevents serious diseases.

If you have any further questions on 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 similar medicines (medicines to reduce blood clotting), edoxaban can cause bleeding, which can be life-threatening. In some cases, the bleeding may not be apparent.

If you experience a bleeding episode that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling), talk to your doctor immediately.

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

General list of possible side effects:

Common(may affect up to 1 in 10 people):

• stomach pain,
• abnormal liver values in blood tests,
• bleeding from the skin or under the skin,
• anaemia (low red blood cell count),
• nosebleeds,
• vaginal bleeding,
• skin rash,
• intestinal bleeding,
• bleeding from the mouth and/or throat,
• blood in the urine,
• bleeding after an injury (puncture),
• stomach bleeding,
• 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 the saliva when coughing,
• bleeding in the brain,
• other types of bleeding,
• decrease in the number of platelets in the blood (which can affect blood 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 after surgery,
• anaphylactic shock,
• swelling of any part of the body due to an allergic reaction.

Frequency not known(cannot be estimated from the available data):

• bleeding in the kidneys, sometimes with blood in the urine, which can cause the kidneys to stop working properly (anticoagulant-related nephropathy).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Edoxaban Sandoz

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, on each blister or on the bottle after EXP. The expiry date is the last day of the month stated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Container contents and additional information

Composition of Edoxabán Sandoz

• The active ingredient is edoxaban (as tosilate monohydrate)

Edoxabán Sandoz 15 mg film-coated tablets EFG:

Each tablet contains 15 mg of edoxaban (as tosilate monohydrate).

Edoxabán Sandoz 30 mg film-coated tablets EFG:

Each tablet contains 30 mg of edoxaban (as tosilate monohydrate).

Edoxabán Sandoz 60 mg film-coated tablets EFG:

Each tablet contains 60 mg of edoxaban (as tosilate monohydrate).

• The other components are

Edoxabán Sandoz 15 mg film-coated tablets EFG:

Tablet core: hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate (E470b), microcrystalline cellulose (E460), sodium croscarmellose (E468).

Film coating: hypromellose type 2910, 6.0 mPas (E464), macrogol, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), and red iron oxide (E172).

Edoxabán Sandoz 30 mg film-coated tablets EFG:

Tablet core: hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate (E470b), microcrystalline cellulose (E460), sodium croscarmellose (E468).

Film coating: hypromellose type 2910, 6.0 mPas (E464), macrogol, titanium dioxide (E171), talc (E553b), and red iron oxide (E172).

Edoxabán Sandoz 60 mg film-coated tablets EFG:

Tablet core: hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate (E470b), microcrystalline cellulose (E460), sodium croscarmellose (E468).

Film coating: hypromellose type 2910, 6.0 mPas (E464), macrogol, titanium dioxide (E171), talc (E553b), and yellow iron oxide (E172).

Appearance and packaging of the product

Edoxabán Sandoz 15 mg are light orange, round (diameter 6.7 mm), biconvex, film-coated tablets, engraved with “EX 15” on one side.

Edoxabán Sandoz 30 mg are light pink, round (diameter 8.6 mm), biconvex, film-coated tablets, engraved with “EX 30” on one side.

Edoxabán Sandoz 60 mg are light yellow, round (diameter 10.6 mm), biconvex, film-coated tablets, engraved with “EX 60” on one side.

Edoxabán Sandoz is packaged in PVC/Aluminum blisters, single-dose PVC/Aluminum blisters, or HDPE bottles with a child-resistant polypropylene screw cap.

Blister pack sizes:

15 mg:

10 and 14 film-coated tablets in blisters in cardboard boxes.

10x1, 28x1, and 98x1 film-coated tablets in single-dose blisters in cardboard boxes.

30 and 60 mg:

10, 14, 28, 30, 50, 84, 98, and 100 film-coated tablets in blisters in cardboard boxes.

10x1, 28x1, and 98x1 film-coated tablets in single-dose blisters in cardboard boxes.

The blisters may or may not have the calendar days printed on them.

Bottle pack sizes:

100, 120, and 250 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals, d.d.

Trimlini 2D,

9220 Lendava

Slovenia

Date of the last revision of this prospectus:November 2024

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/