Edoxaban Tad

Package Leaflet: Information for the Patient

Edoxaban TAD, 15 mg, Film-Coated Tablets

Edoxaban TAD, 30 mg, Film-Coated Tablets

Edoxaban TAD, 60 mg, Film-Coated Tablets

Edoxaban

Read the package leaflet carefully before taking the medicine, as 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 symptoms 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 Package Leaflet

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

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

Edoxaban TAD contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots from forming. It works by blocking the activity of Factor Xa, which is an important factor in blood clotting.

Edoxaban TAD 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;
• to treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the legs and/or lungs.

2. Important information before taking Edoxaban TAD

When not to take Edoxaban TAD

• 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 brain or eye surgery);
• 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 taking Edoxaban TAD, discuss with your doctor or pharmacist.

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

Edoxaban TAD 15 mg is only intended for use when switching from Edoxaban TAD 30 mg to a vitamin K antagonist (e.g., warfarin) (see section 3 "How to take Edoxaban TAD").

When to exercise extra caution when taking Edoxaban TAD:

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

If you need to have surgery:

• You must follow your doctor's instructions exactly regarding when to take Edoxaban TAD before or after surgery. If possible, you should stop taking Edoxaban TAD at least 24 hours before surgery. Your doctor will decide when to restart Edoxaban TAD. In emergency situations, your doctor will help you decide what to do with Edoxaban TAD.

Children and adolescents

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

Edoxaban TAD and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

• certain medicines used to treat fungal infections (e.g., ketoconazole);
• medicines used to treat irregular heart rhythms (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 norepinephrine reuptake inhibitors.

If you are taking any of these medicines, tell your doctor

before starting Edoxaban TAD, as they may increase the effect of Edoxaban TAD and increase the risk of unexpected bleeding. Your doctor will decide whether to use Edoxaban TAD 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, which belongs to a group of antibiotics.

If you are taking any of these medicines, tell your doctor

before starting Edoxaban TAD, as the effect of Edoxaban TAD may be reduced. Your doctor will decide whether to use Edoxaban TAD and whether you need to be monitored.

Pregnancy and breastfeeding

Do not take Edoxaban TAD if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception during treatment with Edoxaban TAD. If you become pregnant while taking Edoxaban TAD, you should inform your doctor immediately, who will decide on further treatment.

Driving and using machines

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

Edoxaban TAD contains dextrates (glucose)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Edoxaban TAD

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

How many tablets 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 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 whole, with water if possible.

Edoxaban TAD can be taken with or without food.

If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Edoxaban TAD. Just before taking, the tablet can be crushed and mixed with water or apple puree. If necessary, your doctor may also give you the crushed tablet through a tube inserted through the nose (nasogastric tube) or into the stomach (gastric tube).

Your doctor may change your anticoagulant treatment:

Switching from a vitamin K antagonist (e.g., warfarin) to Edoxaban TAD

Stop taking the vitamin K antagonist (e.g., warfarin). Your doctor will order a blood test and tell you when to start taking Edoxaban TAD.

Switching from an oral anticoagulant other than a vitamin K antagonist (dabigatran, rivaroxaban, or apixaban) to Edoxaban TAD

Stop taking the previous medicine (e.g., dabigatran, rivaroxaban, or apixaban) and start taking Edoxaban TAD at the next scheduled dose.

Switching from an anticoagulant given by injection (e.g., heparin) to Edoxaban TAD

Stop taking the anticoagulant (e.g., heparin) and start taking Edoxaban TAD at the next scheduled dose.

Switching from Edoxaban TAD to a vitamin K antagonist (e.g., warfarin)

If you are currently taking Edoxaban TAD 60 mg:

Your doctor will instruct you to reduce the dose of Edoxaban TAD to one 30 mg tablet once a day and 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 Edoxaban TAD.

If you are currently taking Edoxaban TAD 30 mg (reduced dose):

Your doctor will instruct you to reduce the dose of Edoxaban TAD to one 15 mg tablet once a day and 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 Edoxaban TAD.

Switching from Edoxaban TAD to an oral anticoagulant other than a vitamin K antagonist (dabigatran, rivaroxaban, or apixaban)

Stop taking Edoxaban TAD and start taking the other anticoagulant (e.g., dabigatran, rivaroxaban, or apixaban) at the next scheduled dose of Edoxaban TAD.

Switching from Edoxaban TAD to an anticoagulant given by injection (e.g., heparin)

Stop taking Edoxaban TAD and start taking the anticoagulant given by injection (e.g., heparin) at the next scheduled dose of Edoxaban TAD.

Patients undergoing cardioversion:

If your irregular heartbeat needs to be restored to normal using a procedure called cardioversion, you should take Edoxaban TAD as instructed by your doctor to prevent blood clots from forming in the brain and other blood vessels in the body.

Taking more Edoxaban TAD than prescribed

If you take more Edoxaban TAD than you should, tell your doctor immediately.

If you take more Edoxaban TAD than prescribed, you may be at increased risk of bleeding.

Missing a dose of Edoxaban TAD

Take the missed dose as soon as possible, and continue taking one dose per day as instructed.

Do not take a double dose on the same day to make up for a missed dose.

Stopping Edoxaban TAD treatment

Do not stop taking Edoxaban TAD without first talking to your doctor, as Edoxaban TAD treats and prevents serious conditions.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Edoxaban TAD can cause side effects, although not everybody gets them.

As with other medicines that reduce blood clotting, Edoxaban TAD may cause bleeding, which can be life-threatening. Not all bleeding may be obvious or external.

If you experience any bleeding that does not stop by itself or symptoms of severe bleeding (unusual weakness, tiredness, paleness, dizziness, headache, or unexplained swelling), you should contact your doctor immediately.

Your doctor may decide that you need to be closely monitored or that your 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 bruising;
• anaemia (low number of red blood cells);
• nosebleeds;
• vaginal bleeding;
• rash;
• bleeding in the gut;
• bleeding from the mouth and/or throat;
• blood in the urine;
• traumatic bleeding (after injection);
• 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;
• coughing up blood;
• 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 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(frequency cannot be estimated from the available data)

• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney damage (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.

Side effects can be reported to the national reporting system listed below.

You can also report side effects directly via the national reporting system.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Edoxaban TAD

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". The expiry date refers to the last day of that month.

Store in the original package to protect from moisture.

No special storage instructions.

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 protect the environment.

6. Contents of the pack and other information

What Edoxaban TAD contains

• The active substance is edoxaban. Each tablet contains edoxaban tosylate monohydrate equivalent to 15 mg edoxaban. Each tablet contains edoxaban tosylate monohydrate equivalent to 30 mg edoxaban. Each tablet contains edoxaban tosylate monohydrate equivalent to 60 mg edoxaban.
• The other ingredients are: dextrates (glucose), maize starch, crospovidone, hydroxypropylcellulose, and magnesium stearate (E470b), in the tablet core, and hypromellose, talc, macrogol, titanium dioxide (E171), yellow iron oxide (E172) - only for 15 mg and 60 mg, and red iron oxide (E172) - only for 15 mg and 30 mg, in the tablet coating. See section 2 "Edoxaban TAD contains dextrates (glucose)".

What Edoxaban TAD looks like and contents of the pack

Edoxaban TAD 15 mg film-coated tablets are light brown-orange, round, biconvex film-coated tablets with "E1" engraved on one side of the tablet. The tablet size is approximately 6 mm in diameter.

Edoxaban TAD 30 mg film-coated tablets are pink, round, biconvex film-coated tablets with "E2" engraved on one side of the tablet. The tablet size is approximately 8 mm in diameter.

Edoxaban TAD 60 mg film-coated tablets are brown-yellow, round, biconvex film-coated tablets with "E3" engraved on one side of the tablet. The tablet size is approximately 10 mm in diameter.

Edoxaban TAD 15 mg film-coated tablets are available in packs containing:

• 10 film-coated tablets in a blister pack, in a cardboard box.
• 10 x 1 film-coated tablet in a perforated unit dose blister pack, in a cardboard box.

Edoxaban TAD 30 mg and 60 mg film-coated tablets are available in packs containing:

• 10, 28, 30, 56, 60, 84, 90, 98, and 100 film-coated tablets in blister packs, in a cardboard box.
• 10 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, and 100 x 1 film-coated tablet in perforated unit dose blister packs, in a cardboard box.
• 28, 56, 84, and 98 film-coated tablets in calendar blister packs, in a cardboard box.
• 28 x 1, 56 x 1, 84 x 1, and 98 x 1 film-coated tablet in perforated unit dose calendar blister packs, in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information on this medicine, please contact:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warszawa

tel. 22 57 37 500

Date of last revision of the package leaflet: