EDOXABAN 15 mg Фильм-Coated Таблетки

Содержание инструкции

1. Edoxaban Teva 15 mg film-coated tablets, 30 mg film-coated tablets, 60 mg film-coated tablets
   1. What is Edoxaban Teva and what is it used for
   2. What you need to know before taking Edoxaban Teva
   3. How to take Edoxaban Teva
   4. Possible side effects
   5. How to store Edoxaban Teva
   6. Package Contents and Other Information

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

Generic medicine

Read 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Edoxaban Teva and what is it 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 of blood coagulation.
Edoxaban Teva is used in adults:

• to prevent the formation of blood clots in the brain(stroke) and in other blood vesselsof the bodyin the presence of a form 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 leg veins(deep vein thrombosis) and in the bloodvessels of the lungs(pulmonary embolism) and to prevent blood clots fromreformingin the blood vessels of the legs and/or lungs.

2. What you need to know before taking Edoxaban Teva

Do not take Edoxaban Teva

• if you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6);
• if you have an ongoing 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 to the brain or eyes);
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, rivaroxaban, apixaban or heparin), unless you are changing your anticoagulant therapy or are receiving heparin through a venous or arterial catheter to keep it open;
• if you have a liver disease that involves an increased 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 happen in the presence of any of the following conditions:
• end-stage kidney disease or if you are undergoing dialysis;
• severe liver disease;
• blood clotting disorders;
• disorder of the blood vessels in the back of the eyes (retinopathy);
• recent bleeding in the brain (intracranial or intracerebral hemorrhage);
• problems with the 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”).
Take special care with Edoxaban Teva

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

If you are going to have surgery,

• it is very important to take Edoxaban Teva before and after surgery exactly according to the times indicated by your doctor. If possible, treatment with Edoxaban Teva should be stopped at least 24 hours before surgery. The doctor will decide when to resume taking Edoxaban Teva. In emergency situations, the doctor will help determine the appropriate actions to take regarding Edoxaban Teva.

Children and adolescents
Edoxaban Teva is not recommended in children and adolescents under 18 years of age.

Other medicines and Edoxaban Teva
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 medicines:

• some medicines for fungal infections (e.g. ketoconazole);
• medicines to treat heart rhythm abnormalities (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 a transplant (e.g. cyclosporine);
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

If any of the above conditions apply to you, tell your doctorbefore taking Edoxaban
Teva, as these medicines can increase the effects of Edoxaban Teva and the possibility that
an unwanted bleeding may occur. The doctor will decide whether you should be treated with Edoxaban
Teva and whether you should be monitored.

If you are taking any of the following medicines:

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

If any of the conditions described apply to you, tell your doctorbefore taking Edoxaban Teva,
as the effects of Edoxaban Teva may be reduced. The doctor will decide whether you should be
treated with Edoxaban Teva and whether you should be monitored.

Pregnancy and breastfeeding
Do not take Edoxaban Teva if you are pregnant or if you are breastfeeding. If
there is a possibility that you may become pregnant, use reliable contraception
during treatment with Edoxaban Teva. If you become pregnant during treatment with
Edoxaban Teva, tell your doctor immediately, who will decide how to treat you.

Driving and using machines
Edoxaban Teva does not alter or negligibly alters the ability to drive vehicles or use
machinery.

Edoxaban Teva contains lactose and sodium
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to take Edoxaban Teva

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.

Dosage to be taken
The recommended dose is one 60 mgtablet once a day .

• If renal function is impaired, your doctor may reduce the dose to one 30 mgtablet once a day.
• If body weight is equal to or less than 60 kg, the recommended dose is one 30 mgtablet once a day.
• If your doctor has prescribed you medicines known as P-gp inhibitors(cyclosporine, dronedarone, erythromycin or ketoconazole), the recommended dose is one 30 mgtablet once a day.

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 whole tablet, ask your doctor for other ways to take Edoxaban
Teva. The tablet can be crushed and mixed with water or applesauce just before
taking it. If necessary, your doctor may also administer the crushed tablet of
Edoxaban Teva to you via a tube into the nose (nasogastric tube) or into the stomach (gastric
tube for nutrition).

Your doctor may modify 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 need to
perform blood tests and will explain 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 medicines (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 anticoagulant (e.g. heparin) and start taking Edoxaban Teva at the
time the next dose of the anticoagulant 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 tell you to reduce the dose of Edoxaban Teva to one 30 mg tablet once a
day and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to
perform blood tests and will explain when to stop treatment with Edoxaban
Teva.
If you are currently taking Edoxaban Teva 30 mg (reduced dose):
Your doctor will tell you to reduce the dose of Edoxaban Teva to one 15 mg tablet once a
day and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to
perform blood tests and will explain 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 anticoagulant other than
vitamin K antagonists (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 heartbeat needs to be normalized with a procedure called cardioversion,
take Edoxaban Teva according to the times indicated by your doctor to prevent the formation of
blood clots in the brain and other blood vessels in the body.

If you take more Edoxaban Teva than you should
Tell your doctor immediately if you have taken too many tablets of Edoxaban Teva.
If you take an amount of Edoxaban Teva higher than that recommended, you may be exposed to a
greater risk of bleeding.

If you forget to take Edoxaban Teva
Take the tablet immediately and then continue the next day by taking the
tablet once a day, as usual. 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 in fact used to treat and prevent serious conditions.
If you have any doubts about the use of this medicine, ask 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 to reduce blood clotting), Edoxaban Teva can
cause potentially life-threatening bleeding. In some cases, the bleeding may not be
obvious.
If any bleeding event occurs that does not resolve on its own, or if you experience signs of
excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache or swelling of
unknown origin), consult your doctor immediately.
The doctor may decide to keep you under close observation or to change the medicine.

General list of possible side effects:
Common(may affect up to 1 in 10 people):

• stomach pain;
• abnormalities in blood tests that assess liver function;
• bleeding from the skin or under the skin;
• anemia (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.

Uncommon(may affect up to 1 in 100 people):

• bleeding in the eyes;
• bleeding from a wound following surgery;
• coughing up blood;
• bleeding in the brain;
• other types of bleeding;
• decreased number of platelets in the blood (which can affect 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 a surgical procedure;
• allergic shock;
• swelling of any part of the body due to an allergic reaction.

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

• bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys being unable to function properly (anticoagulant-associated nephropathy).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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 which is stated on the carton and on the blister or on the
bottle after Exp.. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 ingredient is edoxaban (as tosilate monohydrate):

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

• The other ingredients are:

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

Description of the appearance of Edoxaban Teva and contents of the pack
Edoxaban Teva 15 mg film-coated tablets are presented as light orange, round tablets (approximately 6.4 mm in diameter), with “TV” imprinted on one side and “15”
on the other side.
Edoxaban Teva 30 mg film-coated tablets are presented as pink, round tablets (approximately 8.5 mm in diameter), with “TV” imprinted on one side and “30” on the other
side.
Edoxaban Teva 60 mg film-coated tablets are presented as yellow, round tablets (approximately 10.5 mm in diameter), with “TV” imprinted 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 tablets
coated with film, in perforated blisters divisible for a single dose 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 blisters divisible for a single dose 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 blisters divisible for a single dose 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 Authorisation Holder

Marketing Authorisation Holder
TEVA ITALIA S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Italy

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