Setiapo

Package leaflet: Information for the patient

Setiapo, 15 mg, film-coated tablets
Setiapo, 30 mg, film-coated tablets
Setiapo, 60 mg, film-coated tablets
Edoxaban
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This 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

1. What Setiapo is and what it is used for
2. Important information before taking Setiapo
3. How to take Setiapo
4. Possible side effects
5. How to store Setiapo
6. Contents of the pack and other information

1. What Setiapo is and what it is used for

Setiapo contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent the formation of blood clots. Setiapo works by blocking the activity of Factor Xa, an important component in the blood clotting process. Setiapo is used in adults:

• to prevent blood clots in the brain (stroke) and in other blood vessels in the body, if 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;
• for the treatment of blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as for preventing recurrence of blood clots in the blood vessels of the legs and (or) lungs.

2. Important information before taking Setiapo

When not to take Setiapo

• 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 involving 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 a venous or arterial catheter;
• if the patient has a 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 Setiapo, 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;
  • blood clotting disorders;
  • vascular disease of the back of the eye (retinopathy);
  • recent intracranial or intracerebral bleeding;
  • vascular diseases of the brain or spinal cord;
• if the patient has a mechanical heart valve.

Setiapo 15 mg is intended for use only when switching anticoagulant treatment
from Setiapo 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3, How to take Setiapo).
When to exercise special caution when taking Setiapo:

• If the patient has been diagnosed with a condition called antiphospholipid syndrome (an autoimmune disorder increasing the risk of blood clots), the patient should inform their 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 Setiapo before or after surgery. If possible, Setiapo should be discontinued at least 24 hours before surgery. The doctor will decide when to restart Setiapo. In emergency situations, the appropriate management regarding the use of Setiapo will be determined by the doctor.

Children and adolescents
Setiapo is not recommended for use in children and adolescents under 18 years of age.
Setiapo 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 medications (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);
• antidepressants known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.

If the patient is taking any of the above medicines, they must inform their doctor
before starting Setiapo, as these medicines may enhance the effect of Setiapo and increase the risk of bleeding. The doctor will decide whether to use Setiapo and whether the patient requires monitoring.
If the patient is taking any of the following medicines:

• certain antiepileptic drugs (e.g. phenytoin, carbamazepine, phenobarbital);
• St. John's wort, an herbal remedy used to treat anxiety and mild depression;
• rifampicin, an antibiotic.

If the patient is taking any of the above medicines, they must inform their doctor
before starting Setiapo, as the effect of Setiapo may be reduced. The doctor will decide whether to use Setiapo and whether the patient requires monitoring.
Pregnancy and breastfeeding
Setiapo 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 must be used during treatment with Setiapo. If the patient becomes pregnant while taking Setiapo, she must inform her doctor immediately, who will decide on further management.
Driving and using machines
Setiapo has no effect or a negligible effect on the ability to drive and operate machinery.

3. How to take Setiapo

This medicine should always be taken exactly as instructed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
What dose should be taken
The recommended dose is one tablet of 60 mg 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 prescription medicines known as P-gp (P-glycoprotein) inhibitors: cyclosporine, dronedarone, erythromycin, or ketoconazole, the recommended dose is one 30 mg tablet once daily.

How to take the tablet
The tablet should be swallowed whole, preferably with water. Setiapo may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should discuss alternative ways of taking Setiapo with their doctor. Immediately before administration, the tablet may be crushed and mixed with water or apple puree. If necessary, the doctor may also administer crushed Setiapo tablets via a tube inserted through the nose (nasogastric tube) or directly into the stomach (gastric tube).
The doctor may change the patient's anticoagulant treatment as follows:
Switching from a vitamin K antagonist (e.g. warfarin) to Setiapo
Stop taking the vitamin K antagonist (e.g. warfarin). The doctor will order a blood test and inform the patient when to start taking Setiapo.
Switching from another oral anticoagulant (other than a vitamin K antagonist) (dabigatran, rivaroxaban, or apixaban) to Setiapo
Stop taking the previous anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) and start taking Setiapo at the time of the next scheduled dose.
Switching from a parenterally administered anticoagulant (e.g. heparin) to Setiapo
Stop taking the anticoagulant (e.g. heparin) and start taking Setiapo at the time of the next scheduled anticoagulant dose.
Switching from Setiapo to a vitamin K antagonist (e.g. warfarin)
If the patient is currently taking Setiapo at a dose of 60 mg:
The doctor will instruct the patient to reduce the Setiapo dose to one 30 mg tablet once daily and simultaneously start taking a vitamin K antagonist (e.g. warfarin). The doctor will order a blood test and inform the patient when to stop taking Setiapo.
If the patient is currently taking Setiapo at a reduced dose of 30 mg:
The doctor will instruct the patient to reduce the Setiapo dose to one 15 mg tablet once daily and simultaneously start taking a vitamin K antagonist (e.g. warfarin). The doctor will order a blood test and inform the patient when to stop taking Setiapo.
Switching from Setiapo to another oral anticoagulant (other than a vitamin K antagonist) (dabigatran, rivaroxaban, or apixaban)
Stop taking Setiapo and start taking the other oral anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled Setiapo dose.
Switching from Setiapo to a parenterally administered anticoagulant (e.g. heparin)
Stop taking Setiapo and start taking the parenterally administered anticoagulant (e.g. heparin) at the time of the next scheduled Setiapo dose.
Patients undergoing cardioversion:
If the patient's irregular heartbeat needs to be restored to normal using a procedure called cardioversion, Setiapo should be taken at the time recommended by the doctor to prevent blood clots in the brain and other blood vessels in the body.
Taking more Setiapo than recommended
Contact your doctor immediately if you have taken too many Setiapo tablets.
If the patient has taken more Setiapo than prescribed, the risk of bleeding may increase.
Missing a dose of Setiapo
Take the missed tablet as soon as possible, then continue taking one tablet daily as directed. Do not take a double dose on the same day to make up for a missed dose.
Stopping Setiapo treatment
Do not stop taking Setiapo without first consulting your doctor, as Setiapo 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), Setiapo may cause bleeding, which could potentially be life-threatening. In some cases, bleeding may not produce obvious (visible) symptoms.
If any bleeding occurs in the patient that does not stop spontaneously, or if symptoms of increased bleeding occur (unusual weakness, fatigue, paleness, dizziness, headache or development of swelling of unknown cause), medical advice must be sought immediately.
The doctor may decide that the patient requires very close monitoring or that the treatment needs to be changed.

List of possible adverse reactions:

Common (may occur in less than 1 in 10 people)

• abdominal pain;
• abnormal liver function test results;
• skin bleeding or subcutaneous bleeding;
• anaemia (low number of red blood cells);
• nosebleeds;
• vaginal bleeding;
• rash;
• gastrointestinal bleeding;
• bleeding from the mouth and/or throat;
• blood in urine;
• bleeding after injury (post-traumatic bleeding);
• gastric bleeding;
• dizziness;
• nausea;
• headache;
• itching.

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

• ocular bleeding;
• bleeding from surgical wound after surgery;
• presence of blood in sputum during coughing;
• 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)

• bleeding into muscles;
• bleeding into joints;
• intra-abdominal bleeding;
• cardiac bleeding;
• intracranial bleeding;
• bleeding after surgery;
• anaphylactic shock;
• swelling of any part of the body due to allergic reaction.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 or to the representative of the marketing authorization holder in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Setiapo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer
carton after "EXP". The expiry date refers to the last day of the specified month.
No special temperature storage conditions apply for this medicine.
Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Setiapo contains

• The active substance is edoxaban. Each 15 mg coated tablet contains 15 mg of edoxaban (as monohydrate tosylate). Each 30 mg coated tablet contains 30 mg of edoxaban (as monohydrate tosylate). Each 60 mg coated tablet contains 60 mg of edoxaban (as monohydrate tosylate).
• Other ingredients are:
  Tablet core: maize starch, pregelatinised maize starch, crospovidone, hydroxypropylcellulose (E463), magnesium stearate
  Tablet coating: hypromellose, macrogol, talc
  Setiapo 15 mg also contains: iron oxide yellow (E172) and iron oxide red (E172).
  Setiapo 30 mg also contains: iron oxide red (E172).
  Setiapo 60 mg also contains: iron oxide yellow (E172).

What Setiapo looks like and contents of the pack
Setiapo 15 mg: Brownish-red, round, biconvex coated tablet with a diameter of approximately 6.5 mm.
Setiapo 30 mg: Pink, round, biconvex coated tablet with an embossed "Z" on one side, with a diameter of approximately 8.0 mm.
Setiapo 60 mg: Yellow, round, biconvex coated tablet with a diameter of approximately 10.5 mm.
Packaged in: PVC/PVDC/Aluminium blisters
Pack sizes:
Setiapo 15 mg: packed in blisters containing 10 coated tablets
Setiapo 30 mg: packed in blisters containing 10, 14, 28, 30, 98 or 100 coated tablets
Setiapo 60 mg: packed in blisters containing 10, 14, 28, 30, 60, 98 or 100 coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Zentiva, k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Labormed-Pharma S.A.
Bd. Theodor Pallady nr 44B, sector 3
032266 Bucharest
Romania

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00

This medicinal product is authorised in the Member States of the European Economic Area under the following names: