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

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 1. What Setiapo is and what it is used for
• 2. What you need to know before you take 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. It helps to prevent blood clots from forming. Setiapo works by blocking the activity of Factor Xa, which is an important part of the blood clotting process. Setiapo is used in adults to:

• prevent blood clots in the brain (stroke) and other blood vessels in the body, if you have a condition called non-valvular atrial fibrillation, and at least one additional risk factor, such as heart failure, a 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 new blood clots from forming in the legs and/or lungs.

2. What you need to know before you take Setiapo

Do not take Setiapo

• 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 condition or disease that increases the risk of major bleeding (e.g. stomach ulcer, injury or bleeding in the brain, or recent surgery in the brain or eyes);
• if you are 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 given to maintain catheter patency;
• 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 taking Setiapo, tell your doctor or pharmacist:

• if you have an increased risk of bleeding due to any of the following conditions:
• end-stage kidney disease or if you are on dialysis;
• severe liver disease;
• bleeding disorders;
• retinopathy (a disease of the blood vessels in the eye);
• recent bleeding in the brain (intracranial or intraspinal bleeding);
• blood vessel diseases in the brain or spinal cord;
• if you have a mechanical heart valve.

Setiapo 15 mg is only used when switching from Setiapo 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3, How to take Setiapo).

• 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 have surgery:

• Follow your doctor's instructions carefully about when to take Setiapo before or after surgery. If possible, stop taking Setiapo at least 24 hours before surgery. Your doctor will decide when to restart Setiapo. In emergency situations, your doctor will decide on the appropriate management of Setiapo.

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 the medicines you are taking, or have recently taken, and about any medicines you plan to take.

• certain medicines used to treat fungal infections (e.g. ketoconazole);
• medicines used to treat irregular heartbeat (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 called selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

If you are taking any of these medicines, tell your doctor before taking Setiapo

because they may increase the effect of Setiapo and increase the risk of bleeding. Your doctor will decide whether to use Setiapo and whether you need to be monitored.

• 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 is an antibiotic.

If you are taking any of these medicines, tell your doctor before taking Setiapo

because the effect of Setiapo may be reduced. Your doctor will decide whether to use Setiapo and whether you need to be monitored.

Pregnancy and breastfeeding

Do not take Setiapo if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception during treatment with Setiapo. If you become pregnant while taking Setiapo, tell your doctor immediately, who will decide on further treatment.

Driving and using machines

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

3. How to take Setiapo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

How much 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 certain medicines called 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 with water, preferably with food. Setiapo can be taken with or without food.

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

Switching from one anticoagulant to another

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

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

Switching from another oral anticoagulant (dabigatran, rivaroxaban or apixaban) to Setiapo

Stop taking the previous medicine (e.g. dabigatran, rivaroxaban or apixaban) and start taking Setiapo when the next dose of the previous medicine is due.

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

Stop taking the anticoagulant (e.g. heparin) and start taking Setiapo when the next dose of the anticoagulant is due.

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

If you are currently taking Setiapo 60 mg:

Your doctor will tell you to reduce the dose of Setiapo 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 Setiapo.

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

Your doctor will tell you to reduce the dose of Setiapo 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 Setiapo.

Switching from Setiapo to another oral anticoagulant (dabigatran, rivaroxaban or apixaban)

Stop taking Setiapo and start taking another oral anticoagulant (e.g. dabigatran, rivaroxaban or apixaban) when the next dose of Setiapo is due.

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

Stop taking Setiapo and start taking an anticoagulant given by injection (e.g. heparin) when the next dose of Setiapo is due.

Patients undergoing cardioversion:

If your irregular heartbeat needs to be restored to normal using a procedure called cardioversion, you should take Setiapo as directed by your doctor to prevent blood clots from forming in the brain and other blood vessels in the body.

If you take more Setiapo than you should

Contact your doctor immediately if you have taken more Setiapo tablets than you should. If you have taken more Setiapo than you should, you may be at risk of bleeding.

If you forget to take Setiapo

Take the tablet as soon as possible and continue taking one tablet once a day as directed by your doctor. Do not take a double dose on the same day to make up for a forgotten dose.

If you stop taking Setiapo

Do not stop taking Setiapo without talking to your doctor first, because Setiapo treats and prevents serious conditions.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Like other medicines that prevent blood clotting, Setiapo can cause bleeding, which can be life-threatening. In some cases, bleeding may not be obvious (visible).

If you experience any bleeding that does not stop by itself or if you experience signs of severe bleeding (unusual weakness, tiredness, paleness, dizziness, headache or unexplained swelling), contact your doctor immediately.

Your doctor may decide to monitor you closely or change your treatment.

List of possible side effects:

Common(may affect up to 1 in 10 people)

• stomach pain;
• abnormal liver function tests;
• bleeding from the skin or bleeding under the skin;
• anaemia (low number of red blood cells);
• nosebleeds;
• vaginal bleeding;
• rash;
• bleeding in the gut;
• bleeding from the mouth and/or throat;
• blood in the urine;
• bleeding after injury (post-traumatic bleeding);
• bleeding in the stomach;
• 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 number of platelets (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 abdomen;
• bleeding into 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 damage due to bleeding, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the national reporting system listed below.

By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the blister and carton after EXP.

The expiry date refers to the last day of that month.

There are no special storage instructions for this medicine.

Store in the original package to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Setiapo contains

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

What Setiapo looks like and contents of the pack

Setiapo 15 mg: Red to brownish, round, biconvex film-coated tablet, approximately 6.5 mm in diameter.

Setiapo 30 mg: Pink, round, biconvex film-coated tablet with "Z" engraved on one side, approximately 8.0 mm in diameter.

Setiapo 60 mg: Yellow, round, biconvex film-coated tablet, approximately 10.5 mm in diameter.

Packaged in: PVC/PVDC/Aluminium blisters

Pack sizes:

Setiapo 15 mg: packaged in blisters of 10 film-coated tablets

Setiapo 30 mg: packaged in blisters of 10, 14, 28, 30, 98 and 100 film-coated tablets

Setiapo 60 mg: packaged in blisters of 10, 14, 28, 30, 60, 98 and 100 film-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 on this medicine, 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:

Date of last revision of the leaflet: