Exablok

Package Leaflet: Information for the User

Exablok, 15 mg, film-coated tablets

Exablok, 30 mg, film-coated tablets

Exablok, 60 mg, film-coated tablets

Edoxaban

Read all of this leaflet carefully before taking this medicine because 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 signs of illness 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 pack and other information

• 1. What Exablok is and what it is used for
• 2. What you need to know before you take 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. It helps to prevent blood clots from forming. Exablok works by blocking the activity of Factor Xa, which is an important part of the blood clotting process. Exablok 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;
• treat blood clots in the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent new blood clots from forming in the legs and/or lungs.

2. What you need to know before you take Exablok

Do not take Exablok

• 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 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 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 a venous or arterial line;
• 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 Exablok, tell your doctor or pharmacist:

• if you have an increased risk of bleeding due to any of the following conditions:
• severe kidney disease or if you are on dialysis;
• severe liver disease;
• bleeding disorders;
• retinopathy (a disease of the blood vessels in the eyes);
• recent bleeding in the brain (cerebral or intracranial bleeding);
• vascular diseases in the brain or spinal cord;
• if you have a mechanical heart valve.

Exablok 15 mg is only for use when switching from Exablok 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3). When to be extra careful when taking Exablok:

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

If you need to have surgery:

• You should carefully follow your doctor's instructions about when to take Exablok before or after surgery. If possible, you should stop taking Exablok at least 24 hours before surgery. Your doctor will decide when to restart Exablok. In emergency situations, your doctor will decide on the appropriate management of Exablok.

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 the medicines you are taking, or have recently taken, and about any medicines you plan to take.

• if you are taking any of the following medicines:
• certain medicines for fungal infections (e.g. ketoconazole);
• medicines for heart rhythm disorders (e.g. dronedarone, quinidine, verapamil);
• other medicines that 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 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 noradrenaline reuptake inhibitors

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

because they may increase the effect of Exablok and increase the risk of bleeding. Your doctor will decide whether to use Exablok and whether you need to be monitored.

• if you are taking any of the following medicines:
• certain medicines for epilepsy (e.g. phenytoin, carbamazepine, phenobarbital)
• St. John's Wort, a herbal medicine used for anxiety and mild depression
• rifampicin, which belongs to a group of antibiotics.

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

because the effect of Exablok may be reduced. Your doctor will decide whether to use Exablok and whether you need to be monitored.

Pregnancy and breastfeeding

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

Driving and using machines

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

Exablok contains lactose and sodium

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

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially sodium-free.

3. How to take Exablok

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

How much 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 with water. Exablok can be taken with or without food.

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

Your doctor may switch your anticoagulant treatment as follows:

Switching from a vitamin K antagonist (e.g. warfarin) to Exablok

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

Switching from another oral anticoagulant (dabigatran, rivaroxaban, or apixaban) to Exablok

Stop taking the previous medicine (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 parenteral anticoagulant.

Switching from Exablok to a vitamin K antagonist (e.g. warfarin)

If you are currently taking Exablok 60 mg:

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

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

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

Switching from Exablok to another oral anticoagulant (dabigatran, rivaroxaban, or apixaban)

Stop taking Exablok and start taking another oral anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Exablok.

Switching from Exablok to a parenteral anticoagulant (e.g. heparin)

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

Patients undergoing cardioversion:

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

Take more Exablok than prescribed

Contact your doctor immediately if you have taken more Exablok tablets than prescribed. If you have taken more Exablok than prescribed, you may be at increased risk of bleeding.

Miss a dose of Exablok

Take the tablet as soon as possible and continue taking one tablet once a day as instructed. Do not take a double dose on the same day to make up for a missed dose.

Stop taking Exablok

Do not stop taking Exablok without first talking to your doctor, as Exablok 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, Exablok can cause side effects, although not everybody gets them. As with other medicines of this type (medicines that reduce blood clotting), Exablok may cause bleeding, which can be life-threatening. In some cases, bleeding may not be obvious (visible).

If you experience any bleeding that does not stop by itself or signs of severe bleeding (unusual weakness, tiredness, paleness, dizziness, headache, or unexplained swelling), you should contact your doctor immediately. Your doctor may decide to monitor you closely or change your 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 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;
• bleeding after injury (post-traumatic bleeding);
• 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;
• blood in the sputum when coughing;
• bleeding in the brain;
• other types of bleeding;
• low platelet count (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(frequency cannot be estimated from the available data)

• kidney bleeding, 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. You can also report side effects directly via the national reporting system listed in the https://smz.ezdrowie.gov.plwebsite. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Exablok

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 and blister after EXP. and on the blister and bottle after EXP. The expiry date refers to the last day of that month.

No special storage precautions are required.

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 Exablok contains

• The active substance is edoxaban (as tosylate monohydrate).

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.

• The other ingredients are:

Exablok 15 mg film-coated tablets

Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, magnesium stearate, purified water

Coating: hypromellose (E464), calcium carbonate (E 170), macrogol (E 1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E 172)

Exablok 30 mg film-coated tablets

Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, magnesium stearate, purified water

Coating: hypromellose (E464), calcium carbonate (E 170), macrogol (E 1521), talc (E553b), red iron oxide (E 172)

Exablok 60 mg film-coated tablets

Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, magnesium stearate, purified water

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 (about 6.4 mm in diameter), with "TV" embossed on one side and "15" on the other side.

Exablok 30 mg film-coated tablets are pink, round (about 8.5 mm in diameter), with "TV" embossed on one side and "30" on the other side.

Exablok 60 mg film-coated tablets are yellow, round (about 10.5 mm in diameter), with "TV" embossed on one side and "60" on the other side.

The product is available in the following pack sizes:

Exablok 15 mg film-coated tablets are available in blisters containing 10 tablets or blister packs containing 10 x 1 tablet, or a bottle containing 100 tablets, in a cardboard box.

Exablok 30 mg film-coated tablets are available in blisters containing 10, 28, 30, 100, and 105 tablets, or blister packs containing 10 x 1, 28 x 1, 30 x 1, 98 x 1 tablets, or a bottle containing 100 and 120 tablets, in a cardboard box.

Exablok 60 mg film-coated tablets are available in blisters containing 10, 28, 30, 100, and 105 tablets, or blister packs containing 10 x 1, 28 x 1, 30 x 1, 98 x 1 tablets, or a bottle containing 100 and 120 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

For further information on this medicine, contact the Marketing Authorisation Holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel. (22) 345 93 00.

This medicine is authorised in the Member States of the European Economic Area under the following names:

Bulgaria

Exablok

Sweden

Exablok

Poland

Exablok

Date of last revision of the leaflet: