Edoxaban
Setiapo contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. It helps to prevent blood clots from forming. It works by blocking the action of Factor Xa, which is involved in the process of blood clotting. Setiapo is used in adults to:
Before taking Setiapo, talk to your doctor or pharmacist if:
Setiapo 15 mg is only for use when switching from Setiapo 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3, How to take Setiapo).
If you need to have surgery:
Setiapo is not recommended for use in children and adolescents under 18 years of age.
Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
as 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.
as the effect of Setiapo may be reduced. Your doctor will decide whether to use Setiapo and whether you need to be monitored.
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.
Setiapo has no or negligible influence on the ability to drive and use machines.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.
The recommended dose is one 60 mg tablet once a day.
Swallow the tablet with water, with or without food. If you have difficulty swallowing the whole tablet, 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 the nose (nasogastric tube) or into the stomach (gastric tube).
Changing 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.
Changing 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.
Changing 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.
Changing from Setiapo to a vitamin K antagonist (e.g. warfarin)
If you are currently taking Setiapo 60 mg:
Your doctor will reduce the dose of Setiapo to one 30 mg tablet once a day and start you on 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 reduce the dose of Setiapo to one 15 mg tablet once a day and start you on 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.
Changing from Setiapo to another oral anticoagulant (dabigatran, rivaroxaban or apixaban)
Stop taking Setiapo and start taking the other oral anticoagulant (e.g. dabigatran, rivaroxaban or apixaban) when the next dose of Setiapo is due.
Changing from Setiapo to an anticoagulant given by injection (e.g. heparin)
Stop taking Setiapo and start taking the anticoagulant given by injection (e.g. heparin) when the next dose of Setiapo is due.
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 than you should, you may be at risk of bleeding.
Take the missed dose as soon as possible and continue taking one dose per day as directed. Do not take a double dose on the same day to make up for a missed dose.
Do not stop taking Setiapo without talking to your doctor first, as Setiapo treats and prevents serious conditions. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. As with other medicines that prevent blood clotting, Setiapo may cause bleeding, which can be life-threatening. In some cases, bleeding may not have obvious symptoms.
If you experience any bleeding that does not stop by itself or if you have symptoms 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.
Common(may affect up to 1 in 10 people)
Uncommon(may affect up to 1 in 100 people)
Rare(may affect up to 1 in 1,000 people)
Frequency not known(frequency cannot be estimated from the available data)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the https://smz.ezdrowie.gov.plwebsite. By reporting side effects, you can help provide more information on the safety of this medicine.
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 conditions. Keep the blister in the outer carton in order to protect from moisture. 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.
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.
Zentiva, k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
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
Zentiva Polska Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00
Czech Republic | Setiapo |
Slovakia | Setiapo 15 mg Setiapo 30 mg Setiapo 60 mg |
Romania | Setiapo 15mg film coated tablets Setiapo 30mg film coated tablets Setiapo 60mg film coated tablets |
Poland | Setiapo |
Bulgaria | СЕТИАПО 15 mg филмирани таблетки SETIAPO 15 mg film-coated tablets СЕТИАПО 30 mg филмирани таблетки SETIAPO 30 mg film-coated tablets СЕТИАПО 60 mg филмирани таблетки SETIAPO 60 mg film-coated tablets |
Croatia | Setiapo 15 mg filmom obložene tablete Setiapo 30 mg filmom obložene tablete Setiapo 60 mg filmom obložene tablete |
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