Edoxaban tad

Patient Information Leaflet

Edoxaban TAD, 15 mg, film-coated tablets
Edoxaban TAD, 30 mg, film-coated tablets
Edoxaban TAD, 60 mg, film-coated tablets
Edoxabanum
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

• 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 personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Edoxaban TAD is and what it is used for
2. What you need to know before you take 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 Edoxaban TAD is and what it is 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 component in the blood clotting process.
Edoxaban TAD is used in adults:

• to prevent blood clots in the brain (stroke) and in other blood vessels in the body, when the patient has been diagnosed with a heart rhythm disorder called non-valvular atrial fibrillation and has at least one additional risk factor such as heart failure, previous stroke, or high blood pressure;
• to treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

2. Important information before using Edoxaban TAD

When not to use 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 leading to an increased risk of major bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, or recent surgery of the brain or eyes);
• 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 if heparin is administered to maintain catheter patency in a vein or artery;
• if the patient has a liver disease that leads to an increased 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 Edoxaban TAD, discuss this with your doctor or pharmacist.

• if the patient has an increased risk of bleeding due to any of the conditions listed below:
  • end-stage renal disease or if the patient is dialysed;
  • severe liver disease;
  • coagulation disorders;
  • vascular disease of the back of the eye (retinopathy);
  • recent intracranial or intracerebral haemorrhage;
  • vascular problems in the brain or spinal cord;
• if the patient has a mechanical heart valve.

Edoxaban TAD 15 mg is intended for use only when switching anticoagulant therapy from Edoxaban TAD 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3 “How to take Edoxaban TAD”).
When to be especially careful when taking Edoxaban TAD:

• If the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

If the patient needs to undergo surgery:

• It is essential to strictly follow the doctor's instructions regarding the timing of taking Edoxaban TAD before or after surgery. If possible, Edoxaban TAD should be discontinued at least 24 hours before surgery. The doctor will decide when to resume taking Edoxaban TAD. In emergency situations, the doctor will help determine 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
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
If the patient is taking any of the following medicines:

• certain antifungal medicines (e.g. ketoconazole);
• medicines used to treat heart rhythm disorders (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 medicines (e.g. naproxen or acetylsalicylic acid);
• antidepressants known as selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors.

If the patient is taking any of the above medicines, tell the doctor
before starting Edoxaban TAD, because 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 needs to 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 remedy used to treat anxiety and mild depression;
• rifampicin, which belongs to the group of antibiotics.

If the patient is taking any of the above medicines, tell the doctor
before starting Edoxaban TAD, because the effect of Edoxaban TAD may be reduced. The doctor will decide whether to use Edoxaban TAD and whether the patient needs to be monitored.
Pregnancy and breastfeeding
Do not use Edoxaban TAD if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Edoxaban TAD. If the patient becomes pregnant while taking Edoxaban TAD, inform the doctor immediately, who will decide on further treatment.
Driving and using machines
Edoxaban TAD has no effect or has a negligible effect on the ability to drive and use machines.
Edoxaban TAD contains dextrates (glucose)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to take Edoxaban TAD

This medicine should always be taken exactly as your doctor or pharmacist has told you.
If you are unsure, you should consult your doctor or pharmacist.
How many tablets to take
The recommended dose is one 60 mg tablet once daily:

• If the patient has impaired kidney function, 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 prescribed medicines known as P-gp inhibitors — such as 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 may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should speak to their doctor about other ways of taking Edoxaban TAD. Immediately before administration, the tablet may be crushed and mixed with water or apple puree. If necessary, the doctor may also administer the crushed tablet through a nasogastric tube or 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 arrange a blood test and advise 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 anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) and start taking Edoxaban TAD at the time of the next scheduled dose.

Switching from a parenterally administered anticoagulant (e.g. heparin) to Edoxaban TAD
Stop taking the anticoagulant (e.g. heparin) and start taking Edoxaban TAD at the time of 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 advise reducing the dose of Edoxaban TAD to one 30 mg tablet once daily, while simultaneously starting treatment with a vitamin K antagonist (e.g. warfarin). The doctor will arrange a blood test and advise when to stop taking Edoxaban TAD.

If the patient is currently taking Edoxaban TAD 30 mg (reduced dose):
The doctor will advise reducing the dose of Edoxaban TAD to one 15 mg tablet once daily, while simultaneously starting treatment with a vitamin K antagonist (e.g. warfarin). The doctor will arrange a blood test and advise 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 time of the next scheduled dose of Edoxaban TAD.

Switching from Edoxaban TAD to a parenterally administered anticoagulant (e.g. heparin)
Stop taking Edoxaban TAD and start taking the parenterally administered anticoagulant (e.g. heparin) at the time of the next scheduled dose of Edoxaban TAD.

Patients undergoing cardioversion:
If the patient's irregular heartbeat needs to be restored to normal rhythm by a procedure called cardioversion, Edoxaban TAD should be taken at the time advised by the doctor to prevent blood clots forming in the brain and other blood vessels in the body.

Taking more Edoxaban TAD than prescribed
Inform your doctor immediately if you have taken too many Edoxaban TAD tablets.
If you take more Edoxaban TAD than recommended, your risk of bleeding may increase.

If you miss a dose of Edoxaban TAD
Take the missed tablet as soon as possible, then continue taking one tablet daily the next day, as directed. Do not take a double dose on the same day to make up for a missed dose.

Stopping Edoxaban TAD
Do not stop taking Edoxaban TAD without first consulting your doctor, as this medicine treats and prevents serious medical conditions.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
As with other medicines of similar action (medicines used to reduce blood clotting), Edoxaban TAD may cause bleeding, which could potentially be life-threatening. The signs of bleeding are not always obvious or visible.
If any bleeding occurs in the patient that does not stop spontaneously, or if symptoms of severe bleeding occur (unusual weakness, fatigue, paleness, dizziness, headache or development of unexplained swelling), medical advice must be sought immediately.
The doctor may decide that very close monitoring of the patient is necessary or that the treatment should be changed.
List of possible adverse effects:
Common (may occur in less than 1 in 10 people)

• abdominal pain;
• abnormal liver function test results;
• bleeding from the skin or under the skin;
• anaemia (low number of red blood cells);
• nosebleeds;
• vaginal bleeding;
• rash;
• bleeding in the intestine;
• bleeding from the mouth and/or throat;
• blood in the urine;
• post-traumatic bleeding (after puncture);
• bleeding in the stomach;
• dizziness;
• nausea;
• headache;
• itching.

Uncommon (may occur in less than 1 in 100 people)

• bleeding in the eye;
• bleeding from the surgical wound after surgery;
• coughing up blood;
• bleeding in the brain;
• other types of bleeding;
• decreased number of platelets (which may affect blood clotting);
• allergic reaction;
• urticaria.

Rare (may occur in less than 1 in 1,000 people)

• bleeding in muscles;
• bleeding in joints;
• bleeding in the abdomen;
• bleeding in the heart;
• intracranial bleeding;
• 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 adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the 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 stated on the carton after: Exp. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
No special temperature storage requirements for this medicine.
Medicines must 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 of edoxaban. Each tablet contains edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each tablet contains edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban.
• The other ingredients (excipients) are: dextrates (glucose), corn starch gelatinized, 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 the imprint E1 on one side. Tablet dimensions: diameter approximately 6 mm.
Edoxaban TAD 30 mg, film-coated tablets are pink, round, biconvex film-coated tablets with the imprint E2 on one side. Tablet dimensions: diameter approximately 8 mm.
Edoxaban TAD 60 mg, film-coated tablets are brown-yellow, round, biconvex film-coated tablets with the imprint E3 on one side. Tablet dimensions: diameter 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 perforated single-dose blisters, 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 blisters, 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 single-dose blisters, 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 single-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/Importer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
tel. 22 57 37 500