Kimbek

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Kymbek, 15 mg, coated tablets

Kymbek, 30 mg, coated tablets

Kymbek, 60 mg, coated tablets

Edoxaban

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

• Keep this leaflet, you may need to read it again.
• 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Kymbek and what is it 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 is Kymbek and what is it used for

Kymbek contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. The medicine helps prevent blood clots from forming. It works by blocking the activity of Factor Xa, an important component of 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 irregular heart rhythm called non-valvular atrial fibrillation and at least one additional risk factor, such as heart failure, previous stroke, or high blood pressure;
• treat blood clots in the legs(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 legs and/or lungs.

2. Important information before taking Kymbek

When not to take Kymbek

• 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 major bleeding (e.g., stomach ulcer, injury, or bleeding in the brain, recent brain or eye surgery);
• if the patient is 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 used to maintain the patency of a venous or arterial catheter;
• 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 Kymbek, discuss with your doctor or pharmacist:

• if the patient has any condition that increases the risk of bleeding:
• end-stage kidney disease or if the patient is on dialysis;
• severe liver disease;
• bleeding disorders;
• problems with blood vessels in the back of the eye (retinopathy);
• recent bleeding in the brain (intracranial or intracerebral hemorrhage);
• blood vessel diseases in the brain or spinal cord;
• if the patient has a mechanical heart valve.

Kymbek 15 mg is only intended for use during the transition from Kymbek 30 mg to a vitamin K antagonist (e.g., warfarin) (see section 3. How to take Kymbek).
When to be particularly careful when taking Kymbek:

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

If the patient needs to undergo surgery,

• it is very important to take Kymbek at the exact times specified by the doctor before and after surgery. If possible, the patient should stop taking Kymbek at least 24 hours before surgery. The doctor will decide when to resume taking Kymbek after surgery. In emergency situations, the doctor will determine the appropriate course of action for Kymbek.

Children and adolescents

Kymbek is not recommended for use in children and adolescents under 18 years of age.

Kymbek and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
If you are taking any of the following medicines:

• •certain antifungal medicines (e.g., ketoconazole);
• •medicines for irregular heart rhythm (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 to prevent transplant rejection (e.g., cyclosporine);
• •anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid);
• •antidepressants, so-called selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors;

If you are taking any of these medicines, tell your doctor before taking Kymbek

as these medicines may increase the effect of Kymbek and increase the risk of unwanted bleeding. The doctor will decide whether you can take Kymbek 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 medicine used for anxiety and mild depression;
• rifampicin, an antibiotic.

If you are taking any of these medicines,tell your doctor before taking Kymbek, as these medicines may reduce the effect of Kymbek. The doctor will decide whether you can take Kymbek and whether you need to be monitored.

Pregnancy and breastfeeding

Kymbek must not be used if you are pregnant or breastfeeding. If there is a possibility that you may become pregnant, you should use effective contraception while taking Kymbek. If you become pregnant while taking Kymbek, you should inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Kymbek has no or negligible influence on the ability to drive and use machines.

Kymbek contains sodium

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

Kymbek contains glucose

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

3. How to take Kymbek

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

What dose 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 medicines called P-gp inhibitors: cyclosporine, dronedarone, erythromycin, or ketoconazole, the recommended dose is one 30 mg tablet once a day.

How to take the tablet

Swallow the tablet with water.
Kymbek can be taken with or without food.
If you have difficulty swallowing whole tablets, talk to your doctor about other ways to take Kymbek. The tablet can be crushed and mixed with water or apple sauce just before taking. If necessary, your doctor may also give you a crushed Kymbek tablet through 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 tell you when to start taking Kymbek.
Switching from another oral anticoagulant (dabigatran, rivaroxaban, or apixaban) to Kymbek
Stop taking the previous medicine (e.g., dabigatran, rivaroxaban, or apixaban) and start taking Kymbek at the next scheduled dose time.
Switching from an anticoagulant given by injection (e.g., heparin) to Kymbek
Stop taking the anticoagulant (e.g., heparin) and start taking Kymbek at the next scheduled dose time of the anticoagulant.
Switching from Kymbek to a vitamin K antagonist (e.g., warfarin)
If you are currently taking Kymbek 60 mg:
Your doctor will instruct you to reduce the dose of Kymbek to one 30 mg tablet once a day and start taking 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 Kymbek.
If you are currently taking Kymbek 30 mg (reduced dose):
Your doctor will instruct you to reduce the dose of Kymbek to one 15 mg tablet once a day and start taking 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 Kymbek.
Switching from Kymbek to another oral anticoagulant (dabigatran, rivaroxaban, or apixaban)
Stop taking Kymbek and start taking the other anticoagulant (e.g., dabigatran, rivaroxaban, or apixaban) at the next scheduled dose time of Kymbek.
Switching from Kymbek to an anticoagulant given by injection (e.g., heparin):
Stop taking Kymbek and start taking the anticoagulant given by injection (e.g., heparin) at the next scheduled dose time of Kymbek.

Patients undergoing cardioversion:

If you have irregular heart rhythm and need a procedure called cardioversion to restore a normal heart rhythm, you should take Kymbek at the exact times specified by your doctor to prevent blood clots in the brain and other blood vessels in the body.

Taking more Kymbek than prescribed

If you have taken more Kymbek than prescribed, tell your doctor immediately.
If you have taken more Kymbek than prescribed, you may be at increased risk of bleeding.

Missing a dose of Kymbek

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

Stopping Kymbek treatment

Do not stop taking Kymbek without first talking to your doctor, as Kymbek treats and prevents serious diseases.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Kymbek can cause side effects, although not everybody gets them.
As with other medicines of this type (medicines used to reduce blood clotting), Kymbek can cause bleeding, which can be life-threatening. In some cases, bleeding may not have obvious (visible) symptoms.
If you experience any bleeding that does not stop by itself or if you experience symptoms of severe bleeding (unusual weakness, tiredness, paleness, dizziness, headache, or swelling of unknown cause), you should contact your doctor immediately. Your doctor may decide to monitor you more closely or change your medicine.

List of possible side effects:

Common(may affect up to 1 in 10 people):

• stomach pain;
• abnormal liver function test results;
• bleeding from the skin or bleeding under the skin;
• anemia (low red blood cell count);
• nosebleeds;
• vaginal bleeding;
• rash;
• intestinal bleeding;
• bleeding from the mouth and/or throat;
• blood in the urine;
• bleeding after injury (after puncture);
• 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;
• reduced platelet count in the blood (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 the face, lips, tongue, or throat 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 kidney dysfunction (anticoagulant-related nephropathy).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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.

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 which is stated on the carton and on each blister or bottle after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Kymbek contains

The active substance is edoxaban (as edoxaban tosylate monohydrate).
Each Kymbek 15 mg coated tablet contains 15 mg of edoxaban (as edoxaban tosylate monohydrate).
Each Kymbek 30 mg coated tablet contains 30 mg of edoxaban (as edoxaban tosylate monohydrate).
Each Kymbek 60 mg coated tablet contains 60 mg of edoxaban (as edoxaban tosylate monohydrate).
The other ingredients are:
Core: mannitol (E421), hydroxypropylcellulose (E463), crospovidone (E1202), corn starch, colloidal anhydrous silica (E551), magnesium stearate (E470b).
Coating: sodium carmellose (E466), maltodextrin, glucose monohydrate, soybean lecithin (E322), calcium carbonate (E170)
Kymbek 15 mg, coated tablets also contain: yellow iron oxide (E172) and red iron oxide (E172)
Kymbek 30 mg, coated tablets also contain: red iron oxide (E172)
Kymbek 60 mg, coated tablets also contain: yellow iron oxide (E172)

What Kymbek looks like and contents of the pack

Kymbek 15 mg, coated tablets are orange, round, coated tablets with "15" engraved on one side and smooth on the other, with a diameter of 6.6 mm ± 5%.
Kymbek 30 mg, coated tablets are pink, round, coated tablets with "30" engraved on one side and smooth on the other, with a diameter of 8.4 mm ± 5%.
Kymbek 60 mg, coated tablets are yellow, round, coated tablets with "60" engraved on one side and smooth on the other, with a diameter of 10.4 mm ± 5%.

Blisters

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

Bottles

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

Marketing authorization holder

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

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

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

For more information about this medicine, contact your local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet: