Kymbek

Package leaflet: Information for the user

Kymbek, 15 mg, film-coated tablets
Kymbek, 30 mg, film-coated tablets
Kymbek, 60 mg, film-coated tablets
Edoxabanum
Please read carefully this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Kymbek is and what it is used for

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

• to prevent blood clots in the brain (stroke) and in other blood vessels in the body, if the patient has 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 recurrence of blood clots in the blood vessels of the legs and (or) lungs.

2. Important information before taking Kymbek
When not to take Kymbek

• 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 disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, 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 therapy to another or when heparin is administered to maintain patency of a venous or arterial catheter;
• if you have liver disease that leads to an increased risk of bleeding;
• if you have uncontrolled high blood pressure;
• if you are pregnant or breastfeeding.

Warnings and precautions
Before starting Kymbek, discuss with your doctor or pharmacist if:

• you have an increased risk of bleeding due to any of the following conditions:
  • end-stage renal failure or if you are on dialysis;
  • severe liver disease;
  • coagulation disorders;
  • problems with blood vessels at the back of the eyes (retinopathy);
  • recent intracranial or intracerebral haemorrhage;
  • vascular diseases of the brain or spinal cord;
• if you have a mechanical heart valve.

Kymbek 15 mg is intended for use only when switching anticoagulant therapy from Kymbek 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3. How to take Kymbek).
When to exercise particular caution when taking Kymbek:

• if you have been diagnosed with antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in treatment is necessary.

If you need to undergo surgery,

• it is very important to take Kymbek strictly at the times indicated by your doctor, both before and after surgery. If possible, you should stop taking Kymbek at least 24 hours before surgery. Your doctor will decide when to restart Kymbek after surgery. In emergency situations, your doctor will help determine the appropriate management of Kymbek.

Children and adolescents
Kymbek is not recommended for use in children and adolescents under 18 years of age.
Kymbek and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
If you are taking any of the following medicines:

• certain antifungal medicines (e.g. ketoconazole);
• medicines used to treat heart rhythm disorders (e.g. dronedarone, quinidine, verapamil);
• other medicines that reduce blood clotting (e.g. heparin, clopidogrel, vitamin K antagonists such as warfarin, acenocoumarol or phenprocoumon, as well as dabigatran, rivaroxaban or 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, such as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors;

If you are taking any of the above medicines, inform your doctor before taking Kymbek, as these medicines may enhance the effect of Kymbek and increase the risk of unwanted bleeding. Your doctor will decide whether you can take Kymbek and whether you require monitoring.
If you are taking any of the following medicines:

• 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 the above medicines, inform your doctor before taking Kymbek, as these medicines may reduce the effectiveness of Kymbek. Your doctor will decide whether you can take Kymbek and whether you require monitoring.
Pregnancy and breastfeeding
Kymbek must not be used if you are pregnant or breastfeeding. If you could become pregnant, you should use an effective method of contraception during treatment with Kymbek. If you become pregnant while taking Kymbek, inform your doctor immediately, who will decide on further management.
Driving and using machines
Kymbek has no effect or negligible effect on the ability to drive and use machines.
Kymbek contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".
Kymbek contains glucose
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Kymbek

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure,
please consult your doctor or pharmacist.

What dose should be taken

The recommended dose is one 60 mg tablet once daily.

• If the patient has kidney function impairment, the doctor may reduce the dose to one 30 mg tablet once daily;
• If the patient's body weight is 60 kg or less, the recommended dose is one 30 mg tablet once daily;
• If the patient is taking 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 whole, preferably with water.
Kymbek can be taken with food or independently of meals.
If you have difficulty swallowing whole tablets, discuss alternative ways of taking Kymbek with your doctor. Just before taking, the tablet may be crushed and mixed with water or apple puree. If necessary, your doctor may also administer crushed Kymbek tablets via a tube inserted through the nose (nasogastric tube) or directly into the stomach (gastric tube).

Your doctor may change your anticoagulant treatment:

Switching from a vitamin K antagonist (e.g. warfarin) to Kymbek
Stop taking the vitamin K antagonist (e.g. warfarin). Your doctor will order a blood test and inform you when to start taking Kymbek.

Switching from an oral anticoagulant other than a vitamin K antagonist (dabigatran, rivaroxaban, or apixaban) to Kymbek
Stop taking the previously used medicine (e.g. dabigatran, rivaroxaban, or apixaban) and start taking Kymbek at the time of the next scheduled dose.

Switching from a parenteral anticoagulant (e.g. heparin) to Kymbek
Stop taking the parenteral anticoagulant (e.g. heparin) and start taking Kymbek at the time of the next scheduled dose of the anticoagulant.

Switching from Kymbek to a vitamin K antagonist (e.g. warfarin)
If the patient is currently taking Kymbek 60 mg:
The doctor will advise reducing the Kymbek dose to one 30 mg tablet once daily and simultaneously starting a vitamin K antagonist (e.g. warfarin). The doctor will order a blood test and inform the patient when to stop taking Kymbek.

If the patient is currently taking Kymbek 30 mg (reduced dose):
The doctor will advise reducing the Kymbek dose to one 15 mg tablet once daily and simultaneously starting a vitamin K antagonist (e.g. warfarin). The doctor will order a blood test and inform the patient when to stop taking Kymbek.

Switching from Kymbek to an oral anticoagulant other than a vitamin K antagonist (dabigatran, rivaroxaban, or apixaban)
Stop taking Kymbek and start taking the other oral anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled Kymbek dose.

Switching from Kymbek to a parenteral anticoagulant (e.g. heparin):
Stop taking Kymbek and start taking the parenteral anticoagulant (e.g. heparin) at the time of the next scheduled Kymbek dose.

Patients undergoing cardioversion:

If a patient has an irregular heart rhythm and requires a procedure called cardioversion to restore normal heart rhythm, they should take Kymbek at strictly defined times as instructed by the doctor to prevent blood clots in the brain and other blood vessels in the body.

Taking more Kymbek than recommended

Inform your doctor immediately if you have taken too many Kymbek tablets.
If you have taken more Kymbek than recommended, your risk of bleeding may increase.

Missing a dose of Kymbek

Take the missed tablet as soon as possible, then continue taking the medicine once daily the next day, as directed. Do not take a double dose on the same day to make up for a missed dose.

Stopping Kymbek treatment

Do not stop taking Kymbek without first consulting your doctor, as Kymbek treats and prevents serious conditions.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Like other medicines with a similar action (medicines used to reduce blood clotting), the medicine
Kymbek can cause bleeding, which potentially may be life-threatening. In some
cases, bleeding may not produce obvious (visible) symptoms.
If any bleeding occurs in the patient that does not stop spontaneously, or if symptoms of severe bleeding occur (unusual weakness, fatigue, paleness, dizziness, headache
or swelling of unknown cause), seek immediate medical advice.
The doctor may decide that closer monitoring of the patient is necessary or that the medicine should be changed.
List of possible adverse reactions:
Common (may occur in up to 1 in 10 people):

• abdominal pain;
• abnormal liver function test results;
• bleeding from the skin or under the skin;
• anaemia (low number of red blood cells);
• nosebleeds;
• vaginal bleeding;
• rash;
• gastrointestinal bleeding;
• bleeding from the mouth and (or) throat;
• blood in the urine;
• bleeding after injury (after puncture);
• bleeding in the stomach;
• dizziness;
• nausea;
• headache;
• itching.

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

• bleeding in the eye;
• bleeding from the surgical wound after surgery;
• presence of blood in sputum when coughing;
• bleeding into the brain;
• other types of bleeding;
• decreased number of platelets in the blood (which may affect blood clotting);
• allergic reaction;
• urticaria.

Rare (may occur in up to 1 in 1000 people):

• bleeding into muscles;
• bleeding into joints;
• bleeding into the abdominal cavity;
• bleeding into the heart;
• intracranial bleeding;
• 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):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Kymbek

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on each blister or bottle after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Kymbek contains
The active substance is edoxaban (as monohydrate tosylate).
Each Kymbek 15 mg coated tablet contains 15 mg of edoxaban (as monohydrate tosylate).
Each Kymbek 30 mg coated tablet contains 30 mg of edoxaban (as monohydrate tosylate).
Each Kymbek 60 mg coated tablet contains 60 mg of edoxaban (as monohydrate tosylate).

Excipients:
Tablet core: mannitol (E421), hydroxypropylcellulose (E463), crospovidone (E1202), pregelatinized starch (corn), colloidal anhydrous silica (E551), magnesium stearate (E470b).
Tablet coating: sodium carboxymethylcellulose (E466), maltodextrin, monohydrate glucose, lecithin (soy) (E322), calcium carbonate (E170).
Kymbek 15 mg coated tablets also contain: iron oxide yellow (E172) and iron oxide red (E172).
Kymbek 30 mg coated tablets also contain: iron oxide red (E172).
Kymbek 60 mg coated tablets also contain: iron oxide yellow (E172).

What Kymbek looks like and contents of the pack
Kymbek 15 mg coated tablets are orange, round, film-coated tablets with "15" embossed on one side and smooth on the other, with a diameter of 6.6 mm ± 5%.
Kymbek 30 mg coated tablets are pink, round, film-coated tablets with "30" embossed on one side and smooth on the other, with a diameter of 8.4 mm ± 5%.
Kymbek 60 mg coated tablets are yellow, round, film-coated tablets with "60" embossed on one side and smooth on the other, with a diameter of 10.4 mm ± 5%.

Blister packs
Each Kymbek 15 mg, 30 mg and 60 mg package contains 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 tablets in transparent, colourless blisters made of aluminium foil.
Each Kymbek 15 mg, 30 mg and 60 mg package contains 10 x 1, 50 x 1 or 100 x 1 tablets in transparent, colourless blisters made of aluminium foil with perforations separating individual doses.

Bottles
Kymbek 15 mg, 30 mg and 60 mg is also available in white high-density polyethylene (HDPE) bottles closed with a white polypropylene (PP) child-resistant cap, containing 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer
Pharos MT Ltd.
HF62X, Hal Far Industrial Estate,
BBG3000 Birzebbugia
Malta

This medicinal product is authorised for sale in the European Economic Area Member States under the following names:

For more detailed information on this medicinal product, contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
45D Komitetu Obrony Robotników Street
02-146 Warsaw
Tel.: +48 22 417 92 00