Delianda

Package leaflet: Information for the patient

Delianda, 15 mg, coated tablets
Delianda, 30 mg, coated tablets
Delianda, 60 mg, coated tablets
Edoxaban
Please read carefully the entire leaflet before using 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 share it with others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Delianda is and what it is 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 pack and other information

1. What Delianda is and what it is used for

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

Delianda is used in adults:

• to prevent blood clots in the brain (stroke) and in other blood vessels in the body, when the patient has been diagnosed with a heart rhythm disorder called non-valvular atrial fibrillation and has at least one additional risk factor such as heart failure, previous stroke, or high blood pressure;
• to treat blood clots in the deep 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 using Delianda

When not to use 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 leading to an increased risk of major bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, or recent surgery on the brain or eyes);
• 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 if heparin is administered to maintain patency of an intravenous or arterial catheter;
• if the patient has liver disease that leads to an increased risk of bleeding;
• if the patient has uncontrolled high blood pressure;
• if the patient is pregnant or breastfeeding.

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

• if the patient has an increased risk of bleeding due to any of the conditions listed below:
  • end-stage renal failure or if the patient is on dialysis;
  • severe liver disease;
  • bleeding disorders;
  • blood vessel disease in the back of the eye (retinopathy);
  • recent bleeding in the brain (intracranial or intracerebral haemorrhage);
  • problems with blood vessels in the brain or spinal cord;
• if the patient has a mechanical heart valve.

Delianda 15 mg is intended for use only during transition from Delianda 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3 "How to take Delianda").
When to exercise particular caution when using Delianda:

• If the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

If the patient needs to undergo surgery:

• The patient must strictly follow the doctor's instructions regarding when to take Delianda before or after surgery. If possible, Delianda should be discontinued at least 24 hours before surgery. The doctor will decide when to restart Delianda. In emergency situations, the doctor will help determine the appropriate actions regarding Delianda use.

Children and adolescents
Delianda is not recommended for use in children and adolescents under 18 years of age.
Delianda with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans 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 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 medicines (e.g. naproxen or acetylsalicylic acid);
• antidepressants known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

If the patient is taking any of the above medicines, they must inform the doctor
before starting Delianda, because 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 needs monitoring.
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 remedy used to treat anxiety and mild depression;
• rifampicin, which belongs to the group of antibiotics.

If the patient is taking any of the above medicines, they must inform the doctor
before starting Delianda, because the effect of Delianda may be reduced. The doctor will decide whether to use Delianda and whether the patient needs monitoring.
Pregnancy and breastfeeding
Delianda must not be used if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Delianda. If the patient becomes pregnant while taking Delianda, she must inform her doctor immediately, who will decide on further treatment.
Driving and using machines
Delianda has no effect or has a negligible effect on the ability to drive and operate machinery.
Delianda contains dextrates (glucose)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Delianda

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
How many tablets to take
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 — such as 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.
Delianda may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should speak with their doctor about
alternative ways of taking Delianda. Immediately before administration, the tablet may be crushed
and mixed with water or apple puree. If necessary, the doctor may also administer the crushed
tablet through a nasogastric tube (inserted through the nose) or a gastric tube (inserted into the stomach).

The doctor may change the patient's anticoagulant treatment:
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 inform 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 anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) and start taking
Delianda at the time of the next scheduled dose.
Switching from a parenteral anticoagulant (e.g. heparin) to Delianda
Stop taking the anticoagulant (e.g. heparin) and start taking Delianda at the time of the next scheduled 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 daily and
to start taking a vitamin K antagonist (e.g. warfarin) at the same time. The doctor will order a blood test and inform 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 daily and
to start taking a vitamin K antagonist (e.g. warfarin) at the same time. The doctor will order a blood test and inform 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 oral anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Delianda.
Switching from Delianda to a parenteral anticoagulant (e.g. heparin)
Stop taking Delianda and start taking the parenteral anticoagulant (e.g. heparin) at the time of the next scheduled dose of Delianda.

Patients undergoing cardioversion:
If the patient's abnormal heart rhythm needs to be restored to normal using a procedure called
cardioversion, Delianda should be taken at the time recommended by the doctor to prevent
the formation of blood clots in the brain and other blood vessels in the body.

Taking more Delianda than recommended
Inform your doctor immediately if you have taken more Delianda tablets than prescribed.
Taking more Delianda than recommended may increase the risk of bleeding.

If you miss a dose of Delianda
Take the missed tablet as soon as possible, then continue taking one tablet daily the next day,
as directed. Do not take a double dose on the same day to make up for a missed dose.

Stopping Delianda
Do not stop taking Delianda without first consulting your doctor, as Delianda treats and prevents serious medical 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
Delianda may cause bleeding, which potentially could be life-threatening. The signs of bleeding are not always obvious or visible.
If a patient experiences any bleeding that does not stop spontaneously, or symptoms of increased bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or development of swelling of unknown cause), medical advice should be sought immediately.
The doctor may decide that close monitoring of the patient is necessary or that the treatment should be changed.

List of possible adverse reactions:

Common (may occur in less than 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 at injury sites (after puncture);
• gastrointestinal haemorrhage;
• dizziness;
• nausea;
• headache;
• itching.

Uncommon (may occur in less than 1 in 100 people)

• eye bleeding;
• bleeding from surgical wound after surgery;
• coughing up blood;
• intracranial bleeding;
• other types of bleeding;
• decreased platelet count (which may affect blood clotting);
• allergic reaction;
• urticaria.

Rare (may occur in less than 1 in 1,000 people)

• muscle bleeding;
• joint bleeding;
• intra-abdominal bleeding;
• cardiac bleeding;
• intracranial haemorrhage;
• post-surgical bleeding;
• anaphylactic shock;
• swelling of any part of the body due to an allergic reaction.

Frequency not known (frequency cannot be estimated from available data)

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Delianda

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Exp. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
No special temperature storage requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Delianda contains

• The active substance 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: dextrates (glucose), pregelatinized starch (corn), crospovidone, hydroxypropylcellulose, and magnesium stearate (E470b) in the tablet core; hypromellose, talc, macrogol, titanium dioxide (E171), yellow iron oxide (E172) – only for 15 mg and 60 mg tablets, and red iron oxide (E172) – only for 15 mg and 30 mg tablets, in the tablet coating. See section 2 "Delianda contains dextrates (glucose)".

What Delianda looks like and contents of the pack
Delianda 15 mg film-coated tablets are light brown-orange, round, biconvex film-coated tablets with the imprint "E1" on one side. Tablet dimensions: approximately 6 mm in diameter.
Delianda 30 mg film-coated tablets are pink, round, biconvex film-coated tablets with the imprint "E2" on one side. Tablet dimensions: approximately 8 mm in diameter.
Delianda 60 mg film-coated tablets are brown-yellow, round, biconvex film-coated tablets with the imprint "E3" on one side. Tablet dimensions: approximately 10 mm in diameter.

Delianda 15 mg film-coated tablets are available in packs containing:

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

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

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

Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
tel. 22 57 37 500