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 the patient.

• Keep this package 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 experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. 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 the formation of blood clots. 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 the formation of blood clots in the brain(stroke) and in other blood vessels in the body, if the patient has irregular heart rhythm (non-valvular atrial fibrillation) and at least one additional risk factor, such as heart failure, 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 clotsin the blood vessels of the legs and/or lungs.

2. Important information before taking Edoxaban TAD

When not to take Edoxaban TAD

• 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 major bleeding (e.g., stomach ulcer, injury, 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 from one anticoagulant to another or when heparin is used to maintain catheter patency;
• 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 taking Edoxaban TAD, 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:
• severe kidney disease or if the patient is on dialysis;
• severe liver disease;
• bleeding disorders;
• vascular disease in the back of the eye (retinopathy);
• recent bleeding in the brain (intracranial or intraspinal bleeding);
• vascular problems in the brain or spinal cord;
• if the patient has a mechanical heart valve

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

When to exercise special caution when taking Edoxaban TAD:

• If the patient has a condition called 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 undergo surgery:

• The patient should carefully follow the doctor's instructions regarding the intake of Edoxaban TAD at a specific time before or after surgery. If possible, the patient should stop taking Edoxaban TAD at least 24 hours before surgery. The doctor will decide when to resume taking Edoxaban TAD. In emergency situations, the doctor will help determine the appropriate actions regarding the use of 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

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

• certain medicines used to treat fungal infections (e.g., ketoconazole);
• medicines used to treat irregular heart rhythm (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);
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors.

If the patient is taking any of the above medicines, they should inform their doctor

before starting to take Edoxaban TAD, as these medicines may enhance the effect of Edoxaban TAD and increase the risk of unexpected bleeding. The doctor will decide whether to use Edoxaban TAD and whether the patient should be monitored.

If the patient is 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 the patient is taking any of the above medicines, they should inform their doctor

before starting to take Edoxaban TAD, as the effect of Edoxaban TAD may be reduced. The doctor will decide whether to use Edoxaban TAD and whether the patient should be monitored.

Pregnancy and breastfeeding

Edoxaban TAD 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 during treatment with Edoxaban TAD. If the patient becomes pregnant during treatment with Edoxaban TAD, they should inform their 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 dextrans (glucose)

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Edoxaban TAD

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

How many tablets to take

The recommended dose is one 60 mg tablet once daily:

• If the patient has kidney problems, 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 P-gp inhibitors(e.g., 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.

Edoxaban TAD 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 Edoxaban TAD. 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 tablet of Edoxaban TAD through a nasogastric tube or a gastric tube.

The doctor may change the patient's anticoagulant treatment:

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

Stop taking the vitamin K antagonist (e.g., warfarin). The doctor will order a blood test and tell the patient 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 a parenteral anticoagulant (e.g., heparin) to Edoxaban TAD

Stop taking the parenteral 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 the patient is currently taking Edoxaban TAD 60 mg:

The doctor will instruct the patient to reduce the dose of Edoxaban TAD to one 30 mg tablet once daily 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 Edoxaban TAD.

If the patient is currently taking Edoxaban TAD 30 mg (reduced dose):

The doctor will instruct the patient to reduce the dose of Edoxaban TAD to one 15 mg tablet once daily 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 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 oral anticoagulant (e.g., dabigatran, rivaroxaban, or apixaban) at the next scheduled dose of Edoxaban TAD.

Switching from Edoxaban TAD to a parenteral anticoagulant (e.g., heparin)

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

Patients undergoing cardioversion:

If the patient's irregular heartbeat needs to be restored to normal using a procedure called cardioversion, Edoxaban TAD should be taken as instructed by the doctor to prevent the formation of blood clots in the brain and other blood vessels in the body.

Taking a higher dose of Edoxaban TAD than recommended

If the patient has taken more tablets than recommended, they should inform their doctor immediately.

If the patient has taken more Edoxaban TAD than recommended, there is a risk of increased bleeding.

Missing a dose of Edoxaban TAD

The patient should take the missed tablet as soon as possible and continue taking the medicine once daily as instructed.

The patient should not take a double dose on the same day to make up for the missed dose.

Stopping treatment with Edoxaban TAD

The patient should not stop taking Edoxaban TAD without consulting their doctor first, as Edoxaban TAD treats and prevents serious diseases.

If the patient has any further questions about the use of this medicine, they should ask their 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 of this type (medicines used to reduce blood clotting), Edoxaban TAD may cause bleeding, which can be life-threatening.

Not all bleeding is obvious or visible.

If the patient experiences any bleeding that does not stop by itself or signs of severe bleeding (unusual weakness, tiredness, paleness, dizziness, headache, or unexplained swelling), they should inform their doctor immediately.

The doctor may decide to monitor the patient closely or change the treatment.

List of possible side effects:

Common(may affect up to 1 in 10 people)

• stomach 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;
• traumatic bleeding (after puncture);
• 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 side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform 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, 02-222 Warsaw

tel.: +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, the patient can help provide more information on the safety of this medicine.

5. How to store Edoxaban TAD

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of the month.

Store in the original package to protect from moisture.

No special storage temperature instructions are required.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This 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: dextrans (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 dextrans (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 diameter is approximately 6 mm.

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 diameter is approximately 8 mm.

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 diameter is approximately 10 mm.

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 authorization holder

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

Manufacturer/Importer

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

For further information on this medicine, the patient should contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

tel. 22 57 37 500

Date of last revision of the package leaflet: