Kimbek

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: 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. Its action involves blocking the activity of factor Xa, an important element 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 heart rhythm disorders 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 serious 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, the patient should discuss with their 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 intended for use only when switching from Kymbek 30 mg to a vitamin K antagonist (e.g., warfarin) (see section 3. How to take Kymbek).
When to exercise special caution when taking Kymbek:

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

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

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If the patient is 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);
• •antidepressant medicines, known as selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors;

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

before taking Kymbek, as these medicines may enhance the effect of Kymbek and increase the risk of unwanted bleeding. The doctor will decide whether the patient can take Kymbek and whether the patient needs to be monitored.
If the patient is 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 the patient is taking any of the above medicines,they should inform their doctor before taking Kymbek, as these medicines may reduce the effect of Kymbek.
The doctor will decide whether the patient can take Kymbek and whether the patient needs to be monitored.

Pregnancy and breastfeeding

Kymbek must not be taken if the patient is pregnant or breastfeeding. If there is a possibility that the patient may become pregnant, she should use effective contraception while taking Kymbek. If the patient becomes pregnant while taking Kymbek, she should inform her 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 the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking Kymbek.

3. How to take Kymbek

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should ask their doctor or pharmacist.

What dose to take

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

• - If the patient has kidney problems,the doctor may reduce the dose 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 medicines known as P-gp inhibitors: 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, preferably with water.
Kymbek can be taken with or without food.
If the patient has difficulty swallowing whole tablets, they should talk to their doctor about other ways to take Kymbek. The tablet can be crushed and mixed with water or apple sauce just before taking. If necessary, the doctor may also give the patient a crushed Kymbek tablet through a tube inserted through the nose (nasogastric tube) or directly into the stomach (gastric tube).

The doctor may change the patient's anticoagulant treatment:

Switching from a vitamin K antagonist (e.g., warfarin) to Kymbek
Stop taking the vitamin K antagonist (e.g., warfarin). The doctor will order a blood test and tell the patient 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.
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 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 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. The doctor will order a blood test and tell the patient when to stop taking Kymbek.
If the patient is currently taking Kymbek 30 mg (reduced dose):
The doctor will 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. The doctor will order a blood test and tell the patient 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 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 of Kymbek.

Patients undergoing cardioversion:

If the patient has a heart rhythm disorder and needs a procedure called cardioversion to restore a normal heart rhythm, they should take Kymbek at the exact times specified by the doctor to prevent blood clots from forming in the brain and other blood vessels in the body.

Taking more Kymbek than prescribed

The patient should immediately inform their doctor if they have taken more Kymbek tablets than prescribed.
If the patient has taken more Kymbek than prescribed, there is a risk of increased bleeding.

Missing a dose of Kymbek

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

Stopping Kymbek treatment

The patient should not stop taking Kymbek without first consulting their doctor, as Kymbek treats and prevents serious diseases.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Kymbek can cause side effects, although not everybody gets them.
Like other medicines that work in a similar way (medicines used to reduce blood clotting), Kymbek can cause bleeding, which can be life-threatening. In some cases, bleeding may not show obvious symptoms.
If the patient experiences any bleeding that does not stop by itself or if they experience symptoms of severe bleeding (unusual weakness, tiredness, paleness, dizziness, headache, or swelling of unknown cause), they should immediately consult their doctor.
The doctor may decide to monitor the patient more closely or change the medicine.

List of possible side effects:

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

• abdominal pain;
• abnormal liver function tests;
• 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):

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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 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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Kymbek

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister or bottle after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for this 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 pack and other information

What Kymbek contains

The active substance is edoxaban (as edoxaban tosylate).
Each Kymbek 15 mg coated tablet contains 15 mg of edoxaban (as edoxaban tosylate).
Each Kymbek 30 mg coated tablet contains 30 mg of edoxaban (as edoxaban tosylate).
Each Kymbek 60 mg coated tablet contains 60 mg of edoxaban (as edoxaban tosylate).
The other ingredients are:
Tablet 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 with 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 with aluminum foil and perforations separating single 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 cap, 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, the patient should contact their local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet: