Edoxaban +pharma

Leaflet attached to the packaging: information for the user

Edoxaban +pharma, 15 mg, coated tablets

Edoxaban +pharma, 30 mg, coated tablets

Edoxaban +pharma, 60 mg, coated tablets

Edoxaban

Read the leaflet carefully before taking the medicine because it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Edoxaban +pharma and what is it used for
• 2. Important information before taking Edoxaban +pharma
• 3. How to take Edoxaban +pharma
• 4. Possible side effects
• 5. How to store Edoxaban +pharma
• 6. Contents of the packaging and other information

1. What is Edoxaban +pharma and what is it used for

Edoxaban +pharma contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent the formation of blood clots. The medicine works by blocking the activity of factor Xa, which is an important element in the blood clotting process.

Edoxaban +pharma is used in adults:

• to prevent the formation of blood clots in the brain(stroke) and in other blood vessels in the body, if the patient has been diagnosed with heart rhythm disorders called non-valvular atrial fibrillation and has 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 lower limbs(deep vein thrombosis) and in the blood vessels of the lungs(pulmonary embolism), as well as to prevent the recurrence of blood clotsin the blood vessels of the lower limbs and/or lungs

2. Important information before taking Edoxaban +pharma

When not to take Edoxaban +pharma

• 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 that increases the risk of significant bleeding (e.g., stomach ulcer, injury, or bleeding in the brain, or recent surgical procedure in the brain or eyes)
• if the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is administered through a venous catheter or arterial line to maintain their patency
• if the patient has 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 to take Edoxaban +pharma, the patient should discuss it with their doctor or pharmacist:

• if the patient has any of the following conditions that increase the risk of bleeding:
• end-stage renal disease or if the patient is on dialysis
• severe liver disease
• bleeding disorders
• vascular disease in the back of the eye (retinopathy)
• recent bleeding in the brain (intracranial or intraspinal bleeding)
• vascular problems in the brain or spinal cord
• if the patient has a mechanical heart valve.

Edoxaban +pharma 15 mg is intended for use only when switching from Edoxaban +pharma 30 mg to a vitamin K antagonist (e.g., warfarin) (see section 3 "How to take Edoxaban +pharma").

• if the patient has been diagnosed with a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether to change the treatment.

If the patient needs to undergo surgery

• the patient should carefully follow the doctor's instructions regarding the intake of Edoxaban +pharma at a specific time before or after surgery. If possible, the patient should stop taking Edoxaban +pharma at least 24 hours before surgery. The doctor will decide when to resume taking Edoxaban +pharma. In emergency situations, the doctor will determine the appropriate course of action regarding the use of Edoxaban +pharma.

Children and adolescents

Edoxaban +pharma is not recommended for use in children and adolescents under 18 years of age.

Edoxaban +pharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

• certain medicines used to treat fungal infections (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, dabigatran, rivaroxaban, apixaban)
• antibiotics (e.g., erythromycin, clarithromycin)
• medicines used to prevent transplant rejection (e.g., cyclosporine)
• anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid)
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors

If the patient is taking any of the above medicines, they should tell their doctor

before starting to take Edoxaban +pharma, as these medicines may increase the effect of Edoxaban +pharma and increase the risk of unexpected bleeding. The doctor will decide whether to use Edoxaban +pharma and whether the patient should be monitored.

• 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 should tell their doctor before starting to take Edoxaban +pharma, as the effect of Edoxaban +pharma may be reduced. The doctor will decide whether to use Edoxaban +pharma and whether the patient should be monitored.

Pregnancy and breastfeeding

Edoxaban +pharma should not be taken if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use effective contraception while taking Edoxaban +pharma. If the patient becomes pregnant while taking Edoxaban +pharma, they should immediately inform their doctor, who will decide on further treatment.

Driving and using machines

Edoxaban +pharma has no or negligible influence on the ability to drive and use machines.

Edoxaban +pharma contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is considered "sodium-free".

Edoxaban +pharma contains glucose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Edoxaban +pharma

The medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

What dose to take

The recommended dose is one 60 mg tablet once a day:

• if the patient has kidney problems, the dose may be reduced by the doctor to one 30 mg tablet once a day
• if the patient's body weight is 60 kg or less, the recommended dose is one 30 mg tablet once a day
• if the patient is 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

The tablet should be swallowed whole, preferably with water.

Edoxaban +pharma can be taken with or without food.

If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways to take Edoxaban +pharma. The tablet can be crushed and mixed with water or apple puree immediately before taking. If necessary, the doctor may also administer the crushed tablet through a tube inserted through the nose (nasogastric tube) or into the stomach (gastric tube).

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

Switching from a vitamin K antagonist (e.g., warfarin) to Edoxaban +pharma

The patient should stop taking the vitamin K antagonist (e.g., warfarin). The doctor will order a blood test and tell the patient when to start taking Edoxaban +pharma.

Switching from an oral anticoagulant other than a vitamin K antagonist (dabigatran, rivaroxaban, or apixaban) to Edoxaban +pharma

The patient should stop taking the previous medicine (e.g., dabigatran, rivaroxaban, or apixaban) and start taking Edoxaban +pharma at the time of the next scheduled dose.

Switching from an anticoagulant administered parenterally (e.g., heparin) to Edoxaban +pharma

The patient should stop taking the anticoagulant (e.g., heparin) and start taking Edoxaban +pharma at the time of the next scheduled dose of the anticoagulant.

Switching from Edoxaban +pharma to a vitamin K antagonist (e.g., warfarin)

If the patient is currently taking Edoxaban +pharma 60 mg

The doctor will instruct the patient to reduce the dose of Edoxaban +pharma to one 30 mg tablet once a day and start taking a vitamin K antagonist (e.g., warfarin) at the same time. The doctor will order a blood test and tell the patient when to stop taking Edoxaban +pharma.

If the patient is currently taking Edoxaban +pharma 30 mg (reduced dose):

The doctor will instruct the patient to reduce the dose of Edoxaban +pharma to one 15 mg tablet once a day and start taking a vitamin K antagonist (e.g., warfarin) at the same time. The doctor will order a blood test and tell the patient when to stop taking Edoxaban +pharma.

Switching from Edoxaban +pharma to an anticoagulant other than a vitamin K antagonist (dabigatran, rivaroxaban, or apixaban)

The patient should stop taking Edoxaban +pharma and start taking the other anticoagulant (e.g., dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Edoxaban +pharma.

Switching from Edoxaban +pharma to an anticoagulant administered parenterally (e.g., heparin)

The patient should stop taking Edoxaban +pharma and start taking the anticoagulant administered parenterally (e.g., heparin) at the time of the next scheduled dose of Edoxaban +pharma.

Patients undergoing cardioversion

If the patient's irregular heartbeat needs to be restored to normal using a procedure called cardioversion, Edoxaban +pharma should be taken as directed by the doctor to prevent the formation of blood clots in the brain and other blood vessels in the body.

Taking a higher dose of Edoxaban +pharma than recommended

The doctor should be informed immediately if the patient has taken too many Edoxaban +pharma tablets.

If the patient has taken more Edoxaban +pharma than recommended, the risk of bleeding may be increased.

Missing a dose of Edoxaban +pharma

The patient should take the tablet as soon as possible and continue taking it once a day as directed. The patient should not take a double dose on the same day to make up for the missed dose.

Stopping Edoxaban +pharma

The patient should not stop taking Edoxaban +pharma without first consulting their doctor, as Edoxaban +pharma treats and prevents serious diseases.

In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Edoxaban +pharma can cause side effects, although not everybody gets them.

As with other medicines of this type (medicines used to reduce blood clotting), Edoxaban +pharma may cause bleeding, which can be life-threatening. Not all bleeding will be obvious or visible.

If the patient experiences any bleeding that does not stop by itself or symptoms of severe bleeding (unusual weakness, tiredness, paleness, dizziness, headache, or unexplained swelling), they should immediately consult their doctor.

The doctor may decide to monitor the patient closely or change the treatment.

List of possible side effects

Common(may affect up to 1 in 10 people)

• abdominal pain
• abnormal liver function test results
• bleeding from the skin or subcutaneous bleeding
• anemia (low red blood cell count)
• nosebleeds
• vaginal bleeding
• rash
• intestinal bleeding
• bleeding from the mouth and/or throat
• blood in the urine
• traumatic bleeding (after puncture)
• stomach bleeding
• dizziness
• nausea
• headache
• itching

Uncommon(may affect up to 1 in 100 people)

• eye bleeding
• bleeding from a wound after surgery
• blood in the sputum when coughing
• brain bleeding
• other types of bleeding
• decreased platelet count (which may affect blood clotting)
• allergic reaction
• hives

Rare(may affect up to 1 in 1000 people)

• muscle bleeding
• joint bleeding
• abdominal bleeding
• heart bleeding
• intracranial bleeding
• postoperative bleeding
• 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 impaired kidney function (anticoagulant-related nephropathy)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder or its representative in Poland.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Edoxaban +pharma

The medicine should be stored out of sight and reach of children.

The medicine should not be taken after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated.

There are no special storage instructions for the medicine.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Edoxaban +pharma contains

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

Edoxaban +pharma, 15 mg, coated tablets

Each tablet contains 15 mg of edoxaban (in the form of edoxaban tosylate monohydrate).

Edoxaban +pharma, 30 mg, coated tablets

Each tablet contains 30 mg of edoxaban (in the form of edoxaban tosylate monohydrate).

Edoxaban +pharma, 60 mg, coated tablets

Each tablet contains 60 mg of edoxaban (in the form of edoxaban tosylate monohydrate).

Other ingredients are:

tablet core:mannitol, hydroxypropyl cellulose, crospovidone, corn starch, colloidal anhydrous silica, magnesium stearate

tablet coating:sodium carmellose, maltodextrin, glucose monohydrate, soybean lecithin, calcium carbonate, yellow iron oxide (E 172) and red iron oxide (E 172) (only Edoxaban +pharma, 15 mg, coated tablets), red iron oxide (E 172) (only Edoxaban +pharma, 30 mg, coated tablets), yellow iron oxide (E 172) (only Edoxaban +pharma, 60 mg, coated tablets)

What Edoxaban +pharma looks like and contents of the pack

Edoxaban +pharma, 15 mg, coated tablets

Orange, round, coated tablets with the inscription "15" on one side and smooth on the other side, with a diameter of 6.6 mm ± 5%.

Edoxaban +pharma, 30 mg, coated tablets

Pink, round, coated tablets with the inscription "30" on one side and smooth on the other side, with a diameter of 8.4 mm ± 5%.

Edoxaban +pharma, 60 mg, coated tablets

Yellow, round, coated tablets with the inscription "60" on one side and smooth on the other side, with a diameter of 10.4 mm ± 5%.

Blisters:

Edoxaban +pharma, 15 mg, coated tablets

Each pack contains 10 coated tablets in transparent, colorless blisters made of aluminum foil or 10 x 1 coated tablet in transparent, colorless perforated blisters made of aluminum foil, divided into single doses.

Edoxaban +pharma, 30 mg, coated tablets

Edoxaban +pharma, 60 mg, coated tablets

Each pack contains 10, 14, 28, 30, 56, 60, 84, 90, 98, or 100 coated tablets in transparent, colorless blisters made of aluminum foil or 10 x 1, 50 x 1, or 100 x 1 coated tablet in transparent, colorless perforated blisters made of aluminum foil, divided into single doses.

Bottles:

Edoxaban +pharma, 15 mg, coated tablets

White high-density polyethylene (HDPE) bottles with white polypropylene (PP) child-resistant caps containing 500 coated tablets.

Edoxaban +pharma, 30 mg, coated tablets

Edoxaban +pharma, 60 mg, coated tablets

White high-density polyethylene (HDPE) bottles with white polypropylene (PP) child-resistant caps containing 90 or 500 coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

+pharma arzneimittel gmbh

Hafnerstrasse 211

8054 Graz

Austria

Manufacturer

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

BBG3000 Birzebbuga

Malta

Genericon Pharma Ges.m.b.H.

Hafnerstrasse 211

8054 Graz

Austria

PharOS Pharmaceutical Oriented Services Ltd.

Lesvou Street End

Thesi Loggos Industrial Zone

14452 Metamorfossi

Greece

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

Austria

Edoxaban +pharma 15 mg/30 mg/60 mg Filmtabletten

Czech Republic

Edoxaban +pharma

Croatia

Edoksaban Genericon 15 mg/30 mg/60 mg film-coated tablets

Hungary

Enpar 15 mg/30 mg/60 mg film-coated tablets

Poland

Edoxaban +pharma

For more information about this medicine, the patient should contact the local representative of the marketing authorization holder:

+pharma Polska sp. z o.o.

ul. Podgórska 34

31-536 Kraków, Poland

tel.: +48 12 262 32 36

e-mail: [email protected]

Date of last revision of the leaflet: