Delianda

Leaflet attached to the packaging: patient information

Delianda, 15 mg, coated tablets

Delianda, 30 mg, coated tablets

Delianda, 60 mg, coated tablets

Edoxaban

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 Delianda and what is it used for
• 2. Important information before taking Delianda
• 3. How to take Delianda
• 4. Possible side effects
• 5. How to store Delianda
• 6. Contents of the packaging and other information

1. What is Delianda and what is it used for

Delianda contains the active substance edoxaban and belongs to a group of so-called anticoagulant medicines. This medicine helps prevent the formation of blood clots. The medicine works by blocking the activity of factor Xa, which is an important factor in blood clotting.

Delianda 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 atrial fibrillation not caused by a heart valve problem and has at least one additional risk factor, such as heart failure, a 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 the recurrence of blood clotsin the blood vessels of the legs and (or) lungs.

2. Important information before taking Delianda

When not to take Delianda

• 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, or 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 anticoagulant therapy or when heparin is given 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 Delianda, the patient should discuss this with their doctor or pharmacist:

• if the patient has a condition that increases the risk of bleeding:
• severe kidney 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 intracerebral hemorrhage);
• vascular problems in the brain or spinal cord;
• if the patient has a mechanical heart valve

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

When to exercise special caution when taking Delianda:

• If the patient has 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 Delianda at a specific time before or after surgery. If possible, the patient should stop taking Delianda at least 24 hours before surgery. The doctor will decide when to resume taking Delianda. In emergency situations, the doctor will help determine the appropriate actions regarding Delianda.

Children and adolescents

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

Delianda 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.

• if the patient is taking any of the following medicines:
• some antifungal medicines (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, or 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 Delianda, as these medicines may enhance the effect of Delianda and increase the risk of unexpected bleeding. The doctor will decide whether to use Delianda and whether the patient should be monitored.

• if the patient is taking any of the following medicines:
• some 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, which belongs to a group of antibiotics.

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

before starting to take Delianda, as the effect of Delianda may be reduced. The doctor will decide whether to use Delianda and whether the patient should be monitored.

Pregnancy and breastfeeding

Delianda 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 Delianda. If the patient becomes pregnant while taking Delianda, they should immediately inform their doctor, who will decide on further treatment.

Driving and using machines

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

Delianda contains dextrans (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 Delianda

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

How many tablets 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: 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.

Delianda 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 of taking Delianda. Immediately before taking, the tablet can be crushed and mixed with water or apple puree. If necessary, the doctor may also give the patient a crushed tablet of Delianda through a tube inserted through the nose (nasogastric tube) or into the stomach (gastric tube).

The doctor may change the patient's anticoagulant therapy:

Switching from a vitamin K antagonist (e.g., warfarin) to Delianda

Stop taking the vitamin K antagonist (e.g., warfarin). The doctor will order a blood test and tell the patient when to start taking Delianda.

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

Stop taking the previous medicine (e.g., dabigatran, rivaroxaban, or apixaban) and start taking Delianda at the time of the next planned dose.

Switching from an anticoagulant given by injection (e.g., heparin) to Delianda

Stop taking the anticoagulant (e.g., heparin) and start taking Delianda at the time of the next planned dose.

Switching from Delianda to a vitamin K antagonist (e.g., warfarin)

If the patient is currently taking Delianda 60 mg:

The doctor will instruct the patient to reduce the dose of Delianda to one 30 mg tablet once a day and to take 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 Delianda.

If the patient is currently taking Delianda 30 mg (reduced dose):

The doctor will instruct the patient to reduce the dose of Delianda to one 15 mg tablet once a day and to take 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 Delianda.

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

Stop taking Delianda and start taking the other anticoagulant (e.g., dabigatran, rivaroxaban, or apixaban) at the time of the next planned dose of Delianda.

Switching from Delianda to an anticoagulant given by injection (e.g., heparin)

Stop taking Delianda and start taking the anticoagulant given by injection (e.g., heparin) at the time of the next planned dose of Delianda.

Patients undergoing cardioversion:

If the patient's irregular heartbeat needs to be restored to normal using a procedure called cardioversion, Delianda 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 more Delianda than prescribed

The patient should immediately tell their doctor if they have taken more Delianda tablets than prescribed.

If the patient has taken more Delianda than prescribed, there is a risk of increased bleeding.

Missing a dose of Delianda

The patient should take the missed tablet as soon as possible and continue taking one tablet 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 Delianda

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

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Delianda can cause side effects, although not everybody gets them.

Like other medicines with similar effects (medicines used to reduce blood clotting), Delianda can cause bleeding, which can be life-threatening. The bleeding may not always be obvious or visible.

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 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 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;
• traumatic bleeding (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;
• coughing up blood;
• bleeding in the brain;
• other types of bleeding;
• decreased platelet count (which may affect blood clotting);
• allergic reaction;
• hives.

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

• bleeding in the muscles;
• bleeding in the joints;
• bleeding in the abdomen;
• bleeding in 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)

• bleeding in the kidneys, 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 Monitoring of Adverse Reactions to Medicinal Products 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

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 Delianda

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 after: Exp. Expiry date means the last day of the stated month.

Store in the original packaging to protect from moisture.

There are no special precautions for storage temperature.

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 Delianda contains

• The active substance of Delianda is edoxaban. Each tablet contains edoxaban tosylate monohydrate equivalent to 15 mg of edoxaban. Each tablet contains edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban. Each tablet contains edoxaban tosylate monohydrate equivalent to 60 mg of edoxaban.
• The other ingredients (excipients) are: dextrans (glucose), corn starch, crospovidone, hydroxypropylcellulose, and magnesium stearate (E470b), in the tablet core, and hypromellose, talc, macrogol, titanium dioxide (E171), yellow iron oxide (E172) - only for 15 mg and 60 mg, and red iron oxide (E172) - only for 15 mg and 30 mg, in the tablet coating. See section 2 "Delianda contains dextrans (glucose)".

What Delianda looks like and contents of the pack

Delianda 15 mg, coated tablets are light brown-orange, round, biconvex, film-coated tablets with the marking E1 on one side of the tablet. The tablet dimensions are: diameter approximately 6 mm.

Delianda 30 mg, coated tablets are pink, round, biconvex, film-coated tablets with the marking E2 on one side of the tablet. The tablet dimensions are: diameter approximately 8 mm.

Delianda 60 mg, coated tablets are brown-yellow, round, biconvex, film-coated tablets with the marking E3 on one side of the tablet. The tablet dimensions are: diameter approximately 10 mm.

Delianda 15 mg, coated tablets are available in packs containing:

• 10 film-coated tablets, in a blister, in a cardboard box.
• 10 x 1 film-coated tablet, in a perforated unit dose blister, in a cardboard box.

Delianda 30 mg and 60 mg, coated tablets are available in packs containing:

• 10, 28, 30, 56, 60, 84, 90, 98, and 100 film-coated tablets, in blisters, in a cardboard box.
• 10 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, and 100 x 1 film-coated tablet, in perforated unit dose blisters, in a cardboard box.
• 28, 56, 84, and 98 film-coated tablets, in calendar blisters, in a cardboard box.
• 28 x 1, 56 x 1, 84 x 1, and 98 x 1 film-coated tablet, in perforated unit dose calendar blisters, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer/Importer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

tel. 22 57 37 500

Date of last revision of the leaflet: