Exablok

Patient Information Leaflet

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

• Keep this leaflet so that you can read it again if needed.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of Contents

1. What Exablok is and what it is used for
2. What you need to know before taking Exablok
3. How to take Exablok
4. Possible side effects
5. How to store Exablok
6. Contents of the pack and other information

1. What Exablok is and what it is used for

Exablok 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. Exablok is used in adults:

• to prevent blood clots in the brain (stroke) and in other blood vessels in the body, if 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;
• for the treatment of blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as for the prevention of recurrence of blood clots in the blood vessels of the legs and/or lungs.

2. Important information before taking Exablok

When not to take Exablok

• 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. peptic ulcer, trauma or intracranial haemorrhage, or recent surgery involving the brain or eyes);
• if the patient is taking other anticoagulant medicines (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 increases the risk of bleeding;
• if the patient has uncontrolled high blood pressure;
• if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting Exablok, discuss 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 failure or if the patient is on dialysis;
  • severe liver disease;
  • coagulation disorders;
  • vascular disease in the back of the eye (retinopathy);
  • recent intracranial haemorrhage (intracranial or intracerebral bleeding);
  • vascular diseases of the brain or spinal cord;
• if the patient has a mechanical heart valve.

The 15 mg dose of Exablok is intended only for use when switching treatment from Exablok 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3 How to take Exablok).
When to exercise special caution with Exablok:

• If the patient has been diagnosed with antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether a change in treatment is necessary.

If the patient needs to undergo surgery:

• The patient must strictly follow the doctor's instructions regarding the timing of Exablok administration before or after surgery. If possible, Exablok should be discontinued at least 24 hours before surgery. The doctor will decide when to restart Exablok. In emergency situations, the doctor will help determine the appropriate management regarding Exablok use.

Children and adolescents
Exablok is not recommended for use in children and adolescents under 18 years of age.
Exablok with 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-norepinephrine reuptake inhibitors.

If the patient is taking any of the above medicines, they must inform their doctor before starting Exablok, as these medicines may enhance the effect of Exablok and increase the risk of bleeding. The doctor will decide whether to use Exablok and whether the patient requires monitoring.
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, an antibiotic.

If the patient is taking any of the above medicines, they must inform their doctor before starting Exablok, as the effect of Exablok may be reduced. The doctor will decide whether to use Exablok and whether the patient requires monitoring.
Pregnancy and breastfeeding
Exablok must not be used 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 Exablok. If the patient becomes pregnant while taking Exablok, she must inform her doctor immediately, who will decide on further management.
Driving and using machines
Exablok has no effect or negligible effect on the ability to drive and use machines.
Exablok contains lactose and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to take Exablok

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.

What dose to take
The recommended dose is one 60 mg tablet once daily:

• If the patient has kidney function impairment, the doctor may reduce the dose 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 prescribed medicines known as P-gp (P-glycoprotein) inhibitors, such as cyclosporine, dronedarone, erythromycin, or ketoconazole, the recommended dose is one 30 mg tablet once daily.

How to take the tablet
Swallow the tablet whole, preferably with water.
Exablok may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should discuss alternative
administration methods with their doctor. Immediately before administration, the tablet may be crushed
and mixed with water or apple puree. If necessary, the doctor may also administer crushed Exablok tablets
through a tube inserted through the nose (nasogastric tube) or into the stomach (gastric tube).

The doctor may change the patient's anticoagulant treatment as follows:

Switching from a vitamin K antagonist (e.g. warfarin) to Exablok
Stop taking the vitamin K antagonist (e.g. warfarin). The doctor will order a blood test and inform the
patient when to start taking Exablok.

Switching from another oral anticoagulant (other than a vitamin K antagonist) (e.g. dabigatran,
apixaban, or rivaroxaban) to Exablok
Stop taking the previous anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) and start taking
Exablok at the time of the next scheduled dose.

Switching from a parenteral anticoagulant (e.g. heparin) to Exablok
Stop taking the parenteral anticoagulant (e.g. heparin) and start taking Exablok at the time of the
next scheduled dose of the anticoagulant.

Switching from Exablok to a vitamin K antagonist (e.g. warfarin)
If the patient is currently taking Exablok at a dose of 60 mg:
The doctor will instruct the patient to reduce the Exablok dose to one 30 mg tablet once daily and
simultaneously start taking a vitamin K antagonist (e.g. warfarin). The doctor will order a blood test
and inform the patient when to stop taking Exablok.

If the patient is currently taking Exablok at a reduced dose of 30 mg:
The doctor will instruct the patient to reduce the Exablok dose to one 15 mg tablet once daily and
simultaneously start taking a vitamin K antagonist (e.g. warfarin). The doctor will order a blood test
and inform the patient when to stop taking Exablok.

Switching from Exablok to another oral anticoagulant (other than a vitamin K antagonist)
(e.g. dabigatran, rivaroxaban, or apixaban)
Stop taking Exablok and start taking the other oral anticoagulant (e.g. dabigatran, rivaroxaban, or
apixaban) at the time of the next scheduled Exablok dose.

Switching from Exablok to a parenteral anticoagulant (e.g. heparin)
Stop taking Exablok and start taking the parenteral anticoagulant (e.g. heparin) at the time of the
next scheduled Exablok dose.

Patients undergoing cardioversion:
If the patient's abnormal heart rhythm needs to be restored to normal using a procedure called
cardioversion, Exablok should be taken at the time recommended by the doctor to prevent the
formation of blood clots in the brain and other blood vessels in the body.

Taking more Exablok than recommended
Contact your doctor immediately if you take too many Exablok tablets. If you take more Exablok than
prescribed, your risk of bleeding may increase.

Missing a dose of Exablok
Take the missed dose as soon as possible. On the following day, continue taking one tablet daily as
prescribed. Do not take a double dose on the same day to make up for a missed dose.

Stopping Exablok
Do not stop taking Exablok without first consulting your doctor, as Exablok 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 any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Like other medicines with a similar action (medicines used to reduce blood clotting), Exablok may cause bleeding, which potentially could be life-threatening. In some cases, bleeding may not produce obvious (visible) symptoms.
If any bleeding occurs in the patient that does not stop spontaneously, or symptoms of increased bleeding occur (unusual weakness, fatigue, paleness, dizziness, headache or development of swelling of unknown cause), medical advice should 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 subcutaneous bleeding;
• anaemia (low number of red blood cells);
• nosebleeds;
• vaginal bleeding;
• rash;
• gastrointestinal bleeding;
• bleeding from the mouth and/or throat;
• blood in urine;
• traumatic bleeding (after puncture);
• gastric bleeding;
• dizziness;
• nausea;
• headache;
• itching.

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

• ocular bleeding;
• bleeding from surgical wound after surgery;
• presence of blood in sputum when coughing;
• intracranial haemorrhage;
• 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 into muscles;
• bleeding into joints;
• intra-abdominal bleeding;
• bleeding into the heart;
• intracranial bleeding;
• bleeding after surgery;
• anaphylactic shock;
• swelling of any part of the body due to allergic reaction.

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

• renal bleeding, sometimes with blood in 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 your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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 . Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store the medicine Exablok

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
on the blister pack after: Expiry date (EXP), and on the blister and bottle after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What the medicinal product contains

• The active substance is edoxaban (in the form of monohydrate tosylate).

Exablok 15 mg film-coated tablets:
Each tablet contains edoxaban tosylate monohydrate equivalent to 15 mg
of edoxaban.
Exablok 30 mg film-coated tablets:
Each tablet contains edoxaban tosylate monohydrate equivalent to 30 mg
of edoxaban.
Exablok 60 mg film-coated tablets:
Each tablet contains edoxaban tosylate monohydrate equivalent to 60 mg
of edoxaban.

• Other ingredients are:

Exablok 15 mg film-coated tablets
Tablet core: lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate,
Coating: hypromellose (E464), calcium carbonate (E 170), macrogol (E 1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172)
Exablok 30 mg film-coated tablets
Tablet core: lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate,
Coating: hypromellose (E464), calcium carbonate (E 170), macrogol (E 1521), talc (E553b), red iron oxide (E172)
Exablok 60 mg film-coated tablets
Tablet core: lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate,
Coating: hypromellose (E464), calcium carbonate (E 170), macrogol (E 1521), talc (E553b), yellow iron oxide (E172)

What Exablok looks like and contents of the pack
Exablok 15 mg film-coated tablets are light orange, round (diameter approx. 6.4 mm), with "TV" embossed on one side and "15" on the other side of the tablet.
Exablok 30 mg film-coated tablets are pink, round (diameter approx. 8.5 mm), with "TV" embossed on one side and "30" on the other side of the tablet.
Exablok 60 mg film-coated tablets are yellow, round (diameter approx. 10.5 mm), with "TV" embossed on one side and "60" on the other side of the tablet.

The medicinal product is available in the following pack sizes:
Exablok 15 mg film-coated tablets are available in blister packs containing 10 film-coated tablets or in unit dose blisters containing 10 x 1 film-coated tablets or in bottles containing 100 film-coated tablets, in a cardboard box.
Exablok 30 mg film-coated tablets are available in blister packs containing 10, 28, 30, 100 and 105 film-coated tablets, in unit dose blisters containing 10 x 1, 28 x 1, 30 x 1, 98 x 1 film-coated tablets or in bottles containing 100 and 120 film-coated tablets, in a cardboard box.
Exablok 60 mg film-coated tablets are available in blister packs containing 10, 28, 30, 100 and 105 film-coated tablets, in unit dose blisters containing 10 x 1, 28 x 1, 30 x 1, 98 x 1 film-coated tablets or in bottles containing 100 and 120 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany

Manufacturer
Actavis Ltd. BLB015-016 Bulebel Industrial Estate, Zejtun ZTN 3000 Malta
TEVA Gyógyszergyár Zrt. Pallagi út 13, Debrecen 4042, Hungary
Teva Operations Poland Sp. z o.o, ul. Mogilska 80, 31-546 Kraków, Poland

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Bulgaria Exablok
Sweden Exablok
Poland Exablok