Delianda

Leaflet accompanying the packaging: patient information

Delianda, 15 mg, film-coated tablets

Delianda, 30 mg, film-coated tablets

Delianda, 60 mg, film-coated tablets

Edoxaban

You should carefully read the contents of this 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 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 any not listed in this leaflet, please inform your 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 irregular heart rhythm 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 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 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 significant bleeding (e.g., stomach ulcer, injury, or bleeding in the brain, or recent surgical procedure 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 changing anticoagulant treatment or when heparin is given to maintain the patency of a venous or arterial catheter;
• if you have liver disease that increases the risk of bleeding;
• if you have uncontrolled high blood pressure;
• if you are pregnant or breastfeeding.

Warnings and precautions

Before starting to take Delianda, you should discuss this with your doctor or pharmacist:

• if you have any of the following conditions that increase the risk of bleeding:
• severe kidney failure or if you are 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 you have a mechanical heart valve

Delianda 15 mg is intended for use only when changing treatment 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 you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

If you need to undergo surgery:

• You must carefully follow your doctor's instructions regarding the intake of Delianda at a specific time before or after surgery. If possible, you should stop taking Delianda at least 24 hours before surgery. Your doctor will decide when to resume taking Delianda. In emergency situations, your 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

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• certain medicines used to treat fungal infections (e.g., ketoconazole);
• medicines used to treat irregular heart rhythm (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 you are taking any of the above medicines, you should inform your doctor

before starting to take Delianda, as these medicines may enhance the effect of Delianda and increase the risk of unexpected bleeding. Your doctor will decide whether to use Delianda and whether you should be monitored.

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, which belongs to a group of antibiotics.

If you are taking any of the above medicines, you should inform your doctor

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

Pregnancy and breastfeeding

Delianda must not be taken if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception during treatment with Delianda. If you become pregnant while taking Delianda, you should immediately inform your 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 you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Delianda

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

How many tablets 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 P-gp inhibitors(e.g., cyclosporine, dronedarone, erythromycin, or ketoconazole), the recommended dose is one 30 mg tablet once a day.

How to take the tablet

Swallow the tablet whole, preferably with water.

Delianda can be taken with or without food.

If you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways of taking Delianda. Immediately before taking, the tablet can be crushed and mixed with water or apple sauce. If necessary, your doctor may also give you the crushed tablet through a tube inserted through the nose (nasogastric tube) or into the stomach (gastric tube).

Your doctor may change your anticoagulant treatment:

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

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

Changing 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 scheduled dose.

Changing 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 scheduled dose.

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

If you are currently taking Delianda 60 mg:

Your doctor will instruct you to reduce the dose of Delianda to one 30 mg tablet once a day and to 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 Delianda.

If you are currently taking Delianda 30 mg (reduced dose):

Your doctor will instruct you to reduce the dose of Delianda to one 15 mg tablet once a day and to 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 Delianda.

Changing 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 scheduled dose of Delianda.

Changing 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 scheduled dose of Delianda.

Patients undergoing cardioversion:

If your irregular heartbeat needs to be restored to normal using a procedure called cardioversion, you should take Delianda at the time instructed by your doctor to prevent the formation of blood clots in the brain and other blood vessels in the body.

Taking more Delianda than prescribed

If you have taken more Delianda than prescribed, you should immediately inform your doctor.

If you have taken more Delianda than prescribed, you may be at increased risk of bleeding.

Missing a dose of Delianda

You should take the missed dose as soon as possible, and then continue taking one dose per day as instructed.

Do not take a double dose on the same day to make up for the missed dose.

Stopping Delianda treatment

You should not stop taking Delianda without first discussing it with your doctor, as Delianda treats and prevents serious diseases.

If you have any further questions about the use of this medicine, ask your 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.

Not all bleeding will be obvious or visible.

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 unexplained swelling), you should immediately inform your doctor.

Your doctor may decide that you need to be closely monitored or that your treatment needs to be changed.

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;
• bleeding in the intestine;
• bleeding from the mouth and (or) throat;
• blood in the urine;
• bleeding after injury (post-traumatic bleeding);
• 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;
• reduced 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)

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should inform your 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, you can help provide more information on the safety of this medicine.

5. How to store Delianda

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after: Exp. Expiry date refers to the last day of the month stated.

Store in the original packaging to protect from moisture.

No special storage temperature instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging 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 are: dextrans (glucose), cornstarch, 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 film-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 film-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 film-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 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 unit 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 unit 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 tablet in perforated unit dose calendar blister packs, 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

For further information about this medicine, please 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: