Edoxaban Teva: detailed information

Package leaflet: Information for the user

Edoxaban Teva 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 because 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 you, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Edoxaban Teva is and what it is used for
What you need to know before taking Edoxaban Teva
How to take Edoxaban Teva
Possible side effects
How to store Edoxaban Teva
Contents of the pack and other information

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

Edoxaban Teva 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 Teva is used in adults:

to prevent the formation of blood clots in the brain (stroke) and in other blood vessels in the body when there is a type of irregular heartbeat 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 re-forming in the blood vessels of the legs and/or the lungs.

2. What you should know before taking Edoxaban Teva

Do not take Edoxaban Teva

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 ulcer, injury or bleeding in the brain, or recent surgery on the brain or eyes);
if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, rivaroxaban, apixaban or heparin), except when switching anticoagulant therapy or receiving heparin 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;
if you are pregnant or breastfeeding.

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

if you are at increased risk of bleeding, as may occur in the presence of any of the following conditions:
end-stage kidney disease or if you are on dialysis;
severe liver disease;
coagulation disorders;
blood vessel disorders in the back of the eyes (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 Teva 15 mg should only be used when switching from Edoxaban Teva 30 mg to a
vitamin K antagonist (e.g. warfarin) (see section 3 “How to take Edoxaban Teva”).
Exercise particular caution with Edoxaban Teva

if 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 treatment adjustment is necessary.

If you are scheduled for surgery,

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

Children and adolescents
Edoxaban Teva is not recommended for children and adolescents under 18 years of age.
Other medicines and Edoxaban Teva
Inform 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 medicines:

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);
antibiotic medicines (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-noradrenaline reuptake inhibitors.

If any of the above conditions apply to you, inform your doctor before taking Edoxaban Teva, as these medicines may increase the effects of Edoxaban Teva and the risk of unwanted bleeding. Your doctor will decide whether treatment with Edoxaban Teva is appropriate 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 remedy used for anxiety and mild depression;
rifampicin, an antibiotic medicine.

If any of the above conditions apply to you, inform your doctor before taking Edoxaban Teva, as the effects of Edoxaban Teva may be reduced. Your doctor will decide whether treatment with Edoxaban Teva is appropriate and whether you need to be monitored.
Pregnancy and breastfeeding
Do not take Edoxaban Teva if you are pregnant or breastfeeding. If there is a possibility that you could become pregnant, use a reliable method of contraception during treatment with Edoxaban Teva. If you become pregnant while taking Edoxaban Teva, inform your doctor immediately. Your doctor will decide how to manage your treatment.
Driving and using machines
Edoxaban Teva does not affect or has a negligible effect on the ability to drive or operate machinery.
Edoxaban Teva contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him 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 Edoxaban Teva

Take this medicine exactly as instructed 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 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 you 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 Teva can be taken with or without food.
If you have difficulty swallowing the tablet whole, ask your doctor for alternative ways to take Edoxaban Teva. The tablet may be crushed and mixed with water or freshly prepared apple puree immediately before administration. If necessary, your doctor may also administer crushed Edoxaban Teva tablets via a nasogastric tube (nasal tube) or gastric tube (gastric feeding tube).

Your doctor may adjust anticoagulant therapy as follows:
Switching from vitamin K antagonists (e.g. warfarin) to Edoxaban Teva
Stop treatment with the vitamin K antagonist (e.g. warfarin). Your doctor will perform blood tests and advise you when to start taking Edoxaban Teva.

Switching from oral anticoagulants other than vitamin K antagonists (dabigatran, rivaroxaban, or apixaban) to Edoxaban Teva
Stop treatment with the previous medicine (e.g. dabigatran, rivaroxaban or apixaban) and start taking Edoxaban Teva at the time the next dose would have been due.

Switching from parenteral anticoagulants (e.g. heparin) to Edoxaban Teva
Stop treatment with the parenteral anticoagulant (e.g. heparin) and start taking Edoxaban Teva at the time the next dose would have been due.

Switching from Edoxaban Teva to vitamin K antagonists (e.g. warfarin)
If you are currently taking Edoxaban Teva 60 mg:
Your doctor will instruct you to reduce the dose of Edoxaban Teva to one 30 mg tablet once daily, taken together with a vitamin K antagonist (e.g. warfarin). Your doctor will perform blood tests and advise you when to stop treatment with Edoxaban Teva.

If you are currently taking Edoxaban Teva 30 mg (reduced dose):
Your doctor will instruct you to reduce the dose of Edoxaban Teva to one 15 mg tablet once daily, taken together with a vitamin K antagonist (e.g. warfarin). Your doctor will perform blood tests and advise you when to stop treatment with Edoxaban Teva.

Switching from Edoxaban Teva to oral anticoagulants other than vitamin K antagonists (dabigatran, rivaroxaban or apixaban)
Stop treatment with Edoxaban Teva and start taking the alternative oral anticoagulant (e.g. dabigatran, rivaroxaban or apixaban) at the time the next dose of Edoxaban Teva would have been due.

Switching from Edoxaban Teva to parenteral anticoagulants (e.g. heparin)
Stop treatment with Edoxaban Teva and start taking the parenteral anticoagulant (e.g. heparin) at the time the next dose of Edoxaban Teva would have been due.

Patients undergoing cardioversion:
If an abnormal heart rhythm is to be corrected by a procedure called cardioversion, take Edoxaban Teva according to your doctor's instructions to prevent blood clots in the brain and other blood vessels of the body.

If you take more Edoxaban Teva than you should
Inform your doctor immediately if you have taken too many Edoxaban Teva tablets.
If you take more Edoxaban Teva than recommended, you may be at increased risk of bleeding.

If you forget to take Edoxaban Teva
Take the missed 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 the missed dose.

If you stop taking Edoxaban Teva
Do not stop treatment with Edoxaban Teva without first consulting your doctor. Edoxaban Teva 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 everyone gets them.
Like other similar medicines (medicines to reduce blood clotting), Edoxaban Teva may cause potentially life-threatening bleeding. 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 unexplained swelling), contact your doctor immediately.
Your doctor may decide to monitor you closely or 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;
rash;
bleeding in the intestine;
bleeding from the mouth and/or throat;
presence of blood in urine;
bleeding following injury (puncture);
bleeding in the stomach;
dizziness;
feeling unwell;
headache;
itching.

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;
decrease in the number of platelets in the blood (which may affect blood clotting);
allergic reaction;
hives.

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 after a surgical procedure;
anaphylactic shock;
swelling of 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 blood in the urine, leading to the kidneys being unable to function properly (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 may also report side effects directly via the national reporting system at 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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister or bottle after Exp.. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Teva contains

The active substance is edoxaban (as monohydrate tosylate):

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

The other components are:

Edoxaban Teva 15 mg film-coated tablets
Tablet core: monohydrate lactose, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate.
Film coating: hypromellose (E464), calcium carbonate (E170), macrogol (E1521), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172).
Edoxaban Teva 30 mg film-coated tablets
Tablet core: monohydrate lactose, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate.
Film coating: hypromellose (E464), calcium carbonate (E170), macrogol (E1521), talc (E553b) and red iron oxide (E172).
Edoxaban Teva 60 mg film-coated tablets
Tablet core: monohydrate lactose, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate.
Film coating: hypromellose (E464), calcium carbonate (E170), macrogol (E1521), talc (E553b) and yellow iron oxide (E172).

Description of the appearance of Edoxaban Teva and package contents
Edoxaban Teva 15 mg film-coated tablets are light orange, round-shaped tablets (approximately 6.4 mm in diameter), with "TV" engraved on one side and "15" on the other side.
Edoxaban Teva 30 mg film-coated tablets are pink, round-shaped tablets (approximately 8.5 mm in diameter), with "TV" engraved on one side and "30" on the other side.
Edoxaban Teva 60 mg film-coated tablets are yellow, round-shaped tablets (approximately 10.5 mm in diameter), with "TV" engraved on one side and "60" on the other side.

Edoxaban Teva is available in the following pack sizes:
Edoxaban Teva 15 mg film-coated tablets are available in blisters containing 10 film-coated tablets, in perforated, divisible unit-dose blisters containing 10 x 1 film-coated tablets, or in a bottle containing 100 film-coated tablets.
Edoxaban Teva 30 mg film-coated tablets are available in blisters containing 10, 28, 30, 100 and 105 film-coated tablets, in perforated, divisible unit-dose blisters containing 10 x 1, 28 x 1, 30 x 1 and 98 x 1 film-coated tablets, or in a bottle containing 100 and 120 film-coated tablets.
Edoxaban Teva 60 mg film-coated tablets are available in blisters containing 10, 28, 30, 100 and 105 film-coated tablets, in perforated, divisible unit-dose blisters containing 10 x 1, 28 x 1, 30 x 1 and 98 x 1 film-coated tablets, or in a bottle containing 100 and 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Titolare dell’autorizzazione all’immissione in commercio
TEVA ITALIA S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano
Italy

Manufacturer
Actavis Ltd.
BLB015, BLB016, Bulebel Industrial Estate,
ZTN3000 - Zeitun
Malta
TEVA Gyógyszergyár Zrt.
Debrecen, Pallagi út 13,
H-4042
Hungary