Edoxaban Zentiva

Patient Information Leaflet

Edoxaban Zentiva 15 mg film-coated tablets, 30 mg film-coated tablets, 60 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Edoxaban Zentiva contains the active substance edoxaban and belongs to a group of medicines called
anticoagulants. This medicine helps to prevent the formation of blood clots. It works by
blocking the activity of factor Xa, which is an important component in blood clotting.
Edoxaban Zentiva is used in adults:

• to prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body when there is a heart rhythm disorder called 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) and to prevent blood clots from forming again in the blood vessels of the legs and/or lungs.

2. What you need to know before taking Edoxaban Zentiva

Do not take Edoxaban Zentiva

• if you are allergic to edoxaban or to 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 serious bleeding (e.g. stomach ulcers, injuries or bleeding in the brain, or recent brain or eye surgery);
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, rivaroxaban, apixaban or heparins), except when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open;
• if you have a liver disease that increases the risk of bleeding;
• if you have uncontrolled high blood pressure;
• during pregnancy or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Edoxaban Zentiva

• if you have an increased risk of bleeding, as may occur if you have any of the following conditions:
  • advanced kidney disease or if you are on dialysis;
  • severe liver disease;
  • coagulation disorders;
  • a blood vessel disorder in the back of the eye (retinopathy);
  • recent bleeding in the brain (intracranial or intracerebral haemorrhage);
  • problems with blood vessels in the brain or spinal cord;
• if you have a mechanical heart valve.

Edoxaban Zentiva 15 mg should only be used when switching from Edoxaban Zentiva 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3, How to take Edoxaban Zentiva).
Pay special attention with Edoxaban Zentiva,

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is necessary.

If you are scheduled for surgery,

• it is very important to take Edoxaban Zentiva exactly as directed by your doctor before and after the procedure. If possible, Edoxaban Zentiva should be stopped at least 24 hours before surgery. Your doctor will decide when to restart treatment with Edoxaban Zentiva. In emergency situations, your doctor will determine the appropriate actions regarding Edoxaban Zentiva.

Children and adolescents
Edoxaban Zentiva is not recommended for children and adolescents under 18 years of age.
Other medicines and Edoxaban Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking any of the following:

• certain antifungal medicines (e.g. ketoconazole);
• medicines for heart rhythm disorders (e.g. dronedarone, quinidine, verapamil);
• other medicines to reduce blood clotting (e.g. heparin, clopidogrel, or vitamin K antagonists such as warfarin, acenocoumarol, phenprocoumon, or dabigatran, rivaroxaban, apixaban);
• antibiotics (e.g. erythromycin, clarithromycin);
• medicines to prevent organ rejection after transplantation (e.g. cyclosporine);
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
• antidepressants known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

If any of the conditions described above apply to you, inform your doctor before taking Edoxaban Zentiva,
because these medicines may increase the effects of Edoxaban Zentiva and the risk of unwanted bleeding. Your doctor will decide whether you should be treated with Edoxaban Zentiva and whether you need to be monitored.
If you are taking any of the following:

• certain medicines for epilepsy (e.g. phenytoin, carbamazepine, phenobarbital);
• St. John’s wort, a herbal medicine used for the treatment of anxiety and mild depression;
• rifampicin, an antibiotic medicine.

If any of the conditions described above apply to you, inform your doctor before taking Edoxaban Zentiva,
because the effects of Edoxaban Zentiva may be reduced. Your doctor will decide whether you should be treated with Edoxaban Zentiva and whether you need to be monitored.
Pregnancy and breastfeeding
Do not take Edoxaban Zentiva if you are pregnant or breastfeeding. If you could become pregnant, use a reliable method of contraception during treatment with Edoxaban Zentiva. If you become pregnant during treatment with Edoxaban Zentiva, inform your doctor immediately, who will decide on the appropriate course of action.
Driving and using machines
Edoxaban Zentiva does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.

3. How to take Edoxaban Zentiva

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is one 60 mg tablet once daily.

• If kidney function is impaired, your doctor may decide to reduce the dose to one 30 mg tablet once daily;
• If body weight is 60 kg or less, the recommended dose is one 30 mg tablet once daily;
• If your doctor has prescribed medicines known as P-gp inhibitors: cyclosporine, dronedarone, erythromycin or ketoconazole, the recommended dose is one 30 mg tablet once daily.

How to take the tablet
Swallow the tablet, preferably with water. Edoxaban Zentiva can be taken with or without
food.
If you have difficulty swallowing the tablet whole, consult your doctor for alternative ways to
take Edoxaban Zentiva. The tablet may be crushed and mixed with water or apple puree
immediately before administration. If necessary, your doctor may administer the crushed
Edoxaban Zentiva tablet via a nasogastric tube or gastric tube.
Your doctor may adjust your anticoagulant treatment as follows:
Switching from vitamin K antagonists (e.g. warfarin) to Edoxaban Zentiva
Stop treatment with the vitamin K antagonist (e.g. warfarin). Your doctor will perform
blood tests and advise you when to start taking Edoxaban Zentiva.
Switching from oral anticoagulants other than VKAs (dabigatran, rivaroxaban or apixaban) to Edoxaban
Zentiva
Stop treatment with the previous medicine (e.g. dabigatran, rivaroxaban or apixaban) and start
taking Edoxaban Zentiva at the time the next dose would have been due.
Switching from parenteral anticoagulants (e.g. heparin) to Edoxaban Zentiva
Stop treatment with the anticoagulant (e.g. heparin) and start taking Edoxaban Zentiva at the
time the next dose of anticoagulant would have been due.
Switching from Edoxaban Zentiva to vitamin K antagonists (e.g. warfarin)
If you are taking Edoxaban Zentiva 60 mg:
Your doctor will ask you to reduce the dose of Edoxaban Zentiva to one 30 mg tablet once
daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will
perform blood tests and advise you when to stop taking Edoxaban Zentiva.
If you are taking Edoxaban Zentiva 30 mg (reduced dose):
Your doctor will ask you to reduce the dose of Edoxaban Zentiva to one 15 mg tablet once
daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will
perform blood tests and advise you when to stop taking Edoxaban Zentiva.
Switching from Edoxaban Zentiva to oral anticoagulants other than VKAs (dabigatran, rivaroxaban or
apixaban)
Stop treatment with Edoxaban Zentiva and start taking the non-VKA oral anticoagulant (e.g.
dabigatran, rivaroxaban or apixaban) at the time the next dose of Edoxaban Zentiva would have been due.
Switching from Edoxaban Zentiva to parenteral anticoagulants (e.g. heparin)
Stop treatment with Edoxaban Zentiva and start the parenteral anticoagulant (e.g.
heparin) at the time the next dose of Edoxaban Zentiva would have been due.
Patients undergoing cardioversion:
If an abnormal heart rhythm is to be corrected by a procedure called cardioversion, take Edoxaban Zentiva according to your doctor's instructions to prevent blood clots in the brain and other blood vessels in the body.
If you take more Edoxaban Zentiva than you should
Inform your doctor immediately if you have taken too many Edoxaban Zentiva tablets.
If you have taken a higher dose of Edoxaban Zentiva than recommended, you may have an
increased risk of bleeding.
If you forget to take Edoxaban Zentiva
Take the tablet as soon as you remember, then continue the next day with your usual once-daily dosing. Do not take a double dose on the same day to make up for a missed dose.
If you stop taking Edoxaban Zentiva
Do not stop treatment with Edoxaban Zentiva without first consulting your doctor, as Edoxaban Zentiva is used to treat and prevent serious conditions.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other similar medicines (medicines that reduce blood clotting), Edoxaban Zentiva can cause bleeding, which may be fatal. In some cases, bleeding may not be obvious.
If you experience any bleeding that does not stop on its own, or if you develop signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or swelling of unknown origin), consult your doctor immediately.
Your doctor may decide to monitor you closely or to adjust your treatment.

General list of possible side effects:

Common (may affect up to 1 in 10 people)

• stomach ache;
• abnormalities in blood tests assessing liver function;
• bleeding from or under the skin;
• anaemia (low levels of red blood cells);
• nosebleeds;
• vaginal bleeding;
• skin rash;
• bleeding in the intestine;
• bleeding from the mouth and/or throat;
• presence of blood in the urine;
• bleeding following injury (puncture);
• bleeding in the stomach;
• dizziness;
• feeling unwell;
• headache;
• itching sensation.

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1,000 people)

• bleeding into muscles;
• bleeding into joints;
• bleeding in the abdomen;
• bleeding in the heart;
• bleeding inside the skull;
• bleeding following a surgical procedure;
• anaphylactic shock (allergic shock);
• swelling in any part of the body due to an allergic reaction.

Not known (frequency cannot be estimated from the available data)

• bleeding in the kidney, sometimes with presence of blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Edoxaban Zentiva

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 blister and outer carton after
“EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Edoxaban Zentiva contains

• The active substance is edoxaban. Each film-coated tablet contains 15 mg of edoxaban (as monohydrate tosylate). Each film-coated tablet contains 30 mg of edoxaban (as monohydrate tosylate). Each film-coated tablet contains 60 mg of edoxaban (as monohydrate tosylate).
• The other components are:
  Tablet core: maize starch; pregelatinized maize starch; crospovidone; hydroxypropylcellulose (E463); magnesium stearate.
  Tablet film coating: hypromellose, macrogol, talc.
  Edoxaban Zentiva 15 mg also contains: yellow iron oxide (E172) and red iron oxide (E172).
  Edoxaban Zentiva 30 mg also contains: red iron oxide (E172).
  Edoxaban Zentiva 60 mg also contains: yellow iron oxide (E172).

Description of the appearance of Edoxaban Zentiva and contents of the pack
Edoxaban Zentiva 15 mg: round, biconvex film-coated tablet, red to brown in colour, approximately 6.5 mm in diameter.
Edoxaban Zentiva 30 mg: round, biconvex film-coated tablet, pink in colour, imprinted with "Z" on one side, approximately 8.0 mm in diameter.
Edoxaban Zentiva 60 mg: round, biconvex film-coated tablet, yellow in colour, approximately 10.5 mm in diameter.
Packaged in PVC/PVDC/Al blisters.
Pack sizes:
Edoxaban Zentiva 15 mg: available in blisters containing 10 film-coated tablets.
Edoxaban Zentiva 30 mg: available in blisters containing 10, 14, 28, 30, 98 and 100 film-coated tablets.
Edoxaban Zentiva 60 mg: available in blisters containing 10, 14, 28, 30, 60, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Italy

Manufacturer
Zentiva k.s.
U kabelovny 130
102 37, Praha 10
Dolní Měcholupy
Czech Republic
Labormed-Pharma S.A.
Bd. Theodor Pallady nr. 44B, sector 3
cod 032266 Bucharest
Romania

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Spain, Sweden: Edoxaban Zentiva