Edoxaban +pharma

Package Leaflet: Information for the User

Edoxaban +pharma, 15 mg, Film-Coated Tablets

Edoxaban +pharma, 30 mg, Film-Coated Tablets

Edoxaban +pharma, 60 mg, Film-Coated Tablets

Edoxaban

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

• You should keep this leaflet so that you can read it again if you need to.
• 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 symptoms 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 Package 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 pack 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 blood clots from forming. It works by blocking the activity of Factor Xa, which is an important part of the blood clotting process.

Edoxaban +pharma is used in adults:

• to prevent blood clots in the brain (stroke) and other blood vessels in the body, if you have irregular heart rhythm (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), as well as to prevent new blood clots from forming in the veins of the legs and/or lungs

2. Important information before taking Edoxaban +pharma

When not to take Edoxaban +pharma

• 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 condition or disease that increases the risk of major bleeding (e.g., stomach ulcer, recent injury or bleeding in the brain, or recent surgery on 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 through a vein or artery to keep it open
• 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 Edoxaban +pharma, talk to your doctor or pharmacist:

• if you have an increased risk of bleeding due to any of the following conditions:
• severe kidney problems 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 (intracranial or intraspinal bleeding)
• vascular problems in the brain or spinal cord
• if you have a mechanical heart valve.

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

• if you have antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), you should inform 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 Edoxaban +pharma before or after surgery. If possible, you should stop taking Edoxaban +pharma at least 24 hours before surgery. Your doctor will decide when to restart Edoxaban +pharma. In emergency situations, your doctor will decide on the appropriate management 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

• certain medicines used to treat fungal infections (e.g., ketoconazole)
• medicines used to treat irregular heart rhythm (e.g., dronedarone, quinidine, verapamil)
• other medicines used to prevent 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)
• antidepressants called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors

If you are taking any of these medicines, tell your doctor before taking Edoxaban +pharma

because they may increase the effect of Edoxaban +pharma and increase the risk of unexpected bleeding. Your doctor will decide whether to use Edoxaban +pharma and whether you need to 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 you are taking any of these medicines, tell your doctor before taking Edoxaban +pharmabecause they may reduce the effect of Edoxaban +pharma. Your doctor will decide whether to use Edoxaban +pharma and whether you need to be monitored.

Pregnancy and breastfeeding

Do not take Edoxaban +pharma if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Edoxaban +pharma. If you become pregnant while taking Edoxaban +pharma, tell your doctor immediately, 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

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

Edoxaban +pharma contains glucose

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

3. How to take Edoxaban +pharma

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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 whole with water. Edoxaban +pharma can be taken with or without food.

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

Your doctor may change your anticoagulant treatment as follows:

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

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

Switching from another oral anticoagulant (dabigatran, rivaroxaban, or apixaban) to Edoxaban +pharma

Stop taking the previous medicine (e.g., dabigatran, rivaroxaban, or apixaban) and start taking Edoxaban +pharma at the next scheduled dose.

Switching from a parenteral anticoagulant (e.g., heparin) to Edoxaban +pharma

Stop taking the parenteral anticoagulant (e.g., heparin) and start taking Edoxaban +pharma at the next scheduled dose.

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

If you are currently taking Edoxaban +pharma 60 mg, your doctor will reduce the dose to one 30 mg tablet once a day and start you on 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 Edoxaban +pharma.

If you are currently taking Edoxaban +pharma 30 mg (reduced dose), your doctor will reduce the dose to one 15 mg tablet once a day and start you on 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 Edoxaban +pharma.

Switching from Edoxaban +pharma to another anticoagulant (dabigatran, rivaroxaban, or apixaban)

Stop taking Edoxaban +pharma and start taking the other anticoagulant (e.g., dabigatran, rivaroxaban, or apixaban) at the next scheduled dose.

Switching from Edoxaban +pharma to a parenteral anticoagulant (e.g., heparin)

Stop taking Edoxaban +pharma and start taking the parenteral anticoagulant (e.g., heparin) at the next scheduled dose.

Patients undergoing cardioversion

If your irregular heart rhythm needs to be restored to normal using a procedure called cardioversion, you should take Edoxaban +pharma as directed by your doctor to prevent blood clots from forming in the brain and other blood vessels in the body.

Taking more Edoxaban +pharma than prescribed

Tell your doctor immediately if you have taken more Edoxaban +pharma tablets than prescribed. If you have taken more Edoxaban +pharma than you should, you may be at risk of bleeding.

Missing a dose of Edoxaban +pharma

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

Stopping Edoxaban +pharma treatment

Do not stop taking Edoxaban +pharma without talking to your doctor first, as Edoxaban +pharma 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, Edoxaban +pharma can cause side effects, although not everybody gets them.

As with other medicines that work in a similar way (medicines that prevent blood clotting), Edoxaban +pharma may cause bleeding, which can be life-threatening. Not all bleeding may be obvious or external.

If you experience any bleeding that does not stop by itself or if you have symptoms of severe bleeding (unusual weakness, tiredness, paleness, dizziness, headache, or unexplained swelling), tell 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 bleeding under the skin
• anemia (low red blood cell count)
• 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)
• stomach bleeding
• 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 may affect blood clotting)
• allergic reaction
• hives

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

• bleeding into the muscles
• bleeding into the joints
• bleeding in the abdominal cavity
• bleeding into 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 damage due to bleeding, sometimes with blood in the urine, leading to kidney problems (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.

Side effects can be reported to the national reporting system listed in the contact information for your country.

5. How to store Edoxaban +pharma

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". The expiry date refers to the last day of that month.

No special storage precautions are required.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Edoxaban +pharma contains

The active substance is edoxaban (as tosylate monohydrate).

Edoxaban +pharma, 15 mg, film-coated tablets

Each tablet contains 15 mg of edoxaban (as tosylate monohydrate).

Edoxaban +pharma, 30 mg, film-coated tablets

Each tablet contains 30 mg of edoxaban (as tosylate monohydrate).

Edoxaban +pharma, 60 mg, film-coated tablets

Each tablet contains 60 mg of edoxaban (as tosylate monohydrate).

The other ingredients are:

tablet core:mannitol, hydroxypropylcellulose, crospovidone, maize starch, colloidal anhydrous silica, magnesium stearate

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

What Edoxaban +pharma looks like and contents of the pack

Edoxaban +pharma, 15 mg, film-coated tablets

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

Edoxaban +pharma, 30 mg, film-coated tablets

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

Edoxaban +pharma, 60 mg, film-coated tablets

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

Blisters:

Edoxaban +pharma, 15 mg, film-coated tablets

Each pack contains 10 film-coated tablets in transparent, colorless blisters or 10 x 1 film-coated tablet in transparent, colorless perforated blisters, divided into single doses.

Edoxaban +pharma, 30 mg, film-coated tablets

Edoxaban +pharma, 60 mg, film-coated tablets

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

Bottles:

Edoxaban +pharma, 15 mg, film-coated tablets

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

Edoxaban +pharma, 30 mg, film-coated tablets

Edoxaban +pharma, 60 mg, film-coated tablets

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

Poland

Edoxaban +pharma

For more information about this medicine, 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: krakow@pluspharma.eu

Date of last revision of the package leaflet: