Инструкция по применению SETOFILM
Содержание инструкции
Setofilm 4 mg, orodispersible film, 8 mg, orodispersible film
Ondansetron
Generic medicine
Read this leaflet carefully before you start to use this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Setofilm is and what it is used for
- 2. What you need to know before you use Setofilm
- 3. How to use Setofilm
- 4. Possible side effects
- 5. How to store Setofilm
- 6. Contents of the pack and other information
1. What is Setofilm and what is it used for
Setofilm contains a medicine called ondansetron, which belongs to the group of
medicines called antiemetics.
Setofilm is used to treat and prevent nausea and vomiting caused by
chemotherapy or radiotherapy. It can also be used after surgery to prevent and treat
nausea and vomiting.
2. What you need to know before you use Setofilm
Do not use Setofilm
- if you are allergic to ondansetron or any of the other ingredients of this medicine listed in section 6.
- if you are allergic to other medicines belonging to the group of selective serotonin (5-HT) receptor antagonists (e.g. granisetron or dolasetron).
- if you are taking apomorphine (used in the treatment of Parkinson's disease). See section “Other medicines and Setofilm” for further information.
Warnings and precautions:
Talk to your doctor, nurse or pharmacist before using Setofilm if:
- you have ever suffered from heart problems
- you suffer from irregular or erratic heartbeats (arrhythmia)
- you suffer from liver problems
- you suffer from bowel obstruction or severe constipation
- you suffer from problems with salt levels in the blood, such as potassium, sodium and magnesium
- your tonsils or adenoids have been or are to be removed, as treatment with Setofilm may mask the symptoms of internal bleeding
- this medicine is prescribed to a child under 2 years of age or with a body surface area less than 0.6 m and/or a weight of up to 10 kg
- you suffer from depression or other conditions that are treated with antidepressants. The use of these medicines together with Setofilm may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and Setofilm”).
If you need to have blood or urine tests, tell the person performing the test that you are
taking Setofilm.
If you are not sure if any of the above applies to you, talk to your doctor,
nurse or pharmacist before taking Setofilm.
Other medicines and Setofilm
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or
may take any other medicines, including those available without a prescription and
herbal remedies. This is because Setofilm can affect the activity of some medicines and also
other medicines can affect the activity of Setofilm.
In particular, tell your doctor, nurse or pharmacist if you are taking any of
the following medicines:
Apomorphine (a medicine used to treat Parkinson's disease), as a severe drop in blood
pressure and loss of consciousness have been reported when Setofilm (ondansetron) is
administered with apomorphine.
phenytoin, carbamazepine (medicines used to treat epilepsy)
rifampicin (for the treatment of serious bacterial infections, such as tuberculosis (TB))
antibiotics such as erythromycin
antifungal agents such as ketoconazole
tramadol (for pain relief)
antiarrhythmics (used to treat a fast or irregular heartbeat)
beta-blockers (used to treat heart or eye problems, anxiety or to prevent
migraine)
medicines that can have effects on the heart (such as haloperidol or methadone)
anticancer medicines (especially anthracyclines and trastuzumab)
antidepressants such as SSRIs (selective serotonin reuptake inhibitors) used for the
treatment of depression and/or anxiety including fluoxetine, paroxetine, sertraline,
fluvoxamine, citalopram, escitalopram; or
SNRIs (serotonin/noradrenaline reuptake inhibitors) used for the treatment
of depression and/or anxiety including venlafaxine, duloxetine
Buprenorphine/opioids (medicines used to treat pain or narcotic dependence).
If you are not sure if any of these conditions apply to you, talk to your doctor,
nurse or pharmacist before taking Setofilm.
Setofilm with food and drink
You can take Setofilm with food and drink.
Pregnancy, breastfeeding and fertility
Pregnancy:
Setofilm should not be used during the first trimester of pregnancy, as Setofilm
may slightly increase the risk of the baby being born with cleft lip and/or palate
(fissures or splits in the upper lip and/or palate).
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask
your doctor or pharmacist for advice before taking this medicine. If you are a woman
of childbearing potential, you may be advised to use effective contraceptive measures.
Breastfeeding:
You should not breastfeed while taking Setofilm, as it may pass into breast milk.
Fertility
There is no information on the effects of ondansetron on human fertility.
Driving and using machines
Setofilm has no or negligible effects on the ability to drive and operate machines.
3. How to use Setofilm
Use this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Setofilm is only for oral use. It may be recommended to patients who may have problems
taking or swallowing tablets; for example children or the elderly.
Remove the Setofilm orodispersible film from the single sachet carefully
without damaging the film, as follows: open the sachet only at the indicated point and
tear slowly. Do not cut the sachet.
Before use, check that the film is not damaged as only undamaged films should be used.
Make sure your mouth is empty (and your fingers are dry) before placing the Setofilm orodispersible film
on your tongue.
In a few seconds, the film will dissolve without water on the tongue (in the saliva, which
will then need to be swallowed).
Treatment and prevention of discomfort (nausea and vomiting) in patients undergoing
chemotherapy or radiotherapy.
Elderly:
Setofilm is well tolerated in elderly patients, who may take the same dosage as
adults (see below).
Adults:
8 mg 1-2 hours before the chemotherapy or radiotherapy session, followed by 8 mg every 12 hours
for a maximum of 5 days. The doctor may recommend that the first dose be administered
by injection.
Children (from 6 months of age) and adolescents (<18 years):< strong>
The doctor will advise on which dosage of ondansetron should be administered. The
individual dose will depend on the child's weight or body surface area.
Prevention and treatment of discomfort (nausea and vomiting) post-operatively.
Elderly:
Ondansetron is well tolerated in elderly patients, who may take the same dosage
as adults, see below.
Adults:
Take 16 mg of Setofilm 1 hour before surgery or 8 mg administered one hour before
surgery, followed by two further doses of 8 mg at intervals of 8 hours as directed by
the doctor.
Children over 4 years of age and adolescents:
In children weighing 40 kg or more, take 4mg of Setofilm one hour before
surgery, followed by a further dose of 4 mg after 12 hours.
Hepatic dysfunction:
Do not take more than 8 mg of ondansetron daily in case of hepatic dysfunction (moderate to severe liver problems).
If you use more Setofilm than you should
Contact your doctor or go to hospital immediately if you or your child have
or as prescribed by your doctor. Bring the medicine packaging with you.
If you forget to take Setofilm
If you forget to take Setofilm and feel nauseous or vomit
Take a dose of Setofilm as soon as possible
Take the next dose of Setofilm at the scheduled time
Do not take a double dose to make up for a missed dose.
If you forget to take a dose but do not feel nauseous or vomit
Take the next dose
Do not take a double dose to make up for a missed dose.
If you stop taking Setofilm
If you feel unwell and stop taking Setofilm, consult your doctor or
nurse as soon as possible.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious:
Stop taking Setofilm and contact your doctor immediately or go to the nearest
hospital if you or your child develop any of the following conditions:
Allergic reactions:
Symptoms of an allergic reaction can include:
sudden shortness of breath and chest pain or chest tightness
severe itching of the skin
skin rash – red spots or swelling of the skin (hives) anywhere on the
body
swelling of the eyelids, throat, face, lips, tongue or mouth
difficulty breathing or swallowing
collapse
Myocardial ischemia:
Signs include:
- sudden chest pain or
- chest tightness
Other side effects include:
Very common side effects (may affect more than 1 in 10 people):
headache
Common side effects (may affect up to 1 in 10 people):
feeling of warmth or flushing
constipation: if you experience abdominal pain or difficulty with bowel movements, contact your doctor
who may consider it necessary to monitor you closely to assess the
consequences of the treatment
Uncommon side effects (may affect up to 1 in 100 people):
hiccups
low blood pressure, which may cause you to feel weak or dizzy
palpitations (feeling your heartbeat) or irregular or slow heartbeat
chest pain
seizures
unusual and involuntary movements of the eye or body or tremor
changes in liver function test results (changes are more common
if you take ondansetron in combination with a medicine called Cisplatin)
Rare side effects (may affect up to 1 in 1,000 people):
allergic reactions, sometimes severe, including anaphylactic reactions
feeling dizzy or lightheaded [when ondansetron is given intravenously (e.g. through a tube into a vein)]
.
temporary vision disturbances, for example blurred vision (mainly
when ondansetron is given intravenously) heart rhythm disturbances and
changes in the ECG, including a particular type of heart rhythm disturbance
called Torsades de Pointes (which sometimes causes sudden loss of consciousness)
Very rare side effects (may affect up to 1 in 10,000 people):
blurred or temporary loss of vision (mainly during
intravenous administration of ondansetron) which usually resolves within 20
minutes.
toxic skin rash including widespread rash with blisters and peeling
of the skin over large areas of the body (toxic epidermal necrolysis)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Setofilm
Keep this medicine out of sight and reach of children.
Keep the sachets tightly closed to protect the medicine from moisture.
Do not use this medicine after the expiry date (Exp.) that is stated on the pack. The
expiry date refers to the last day of that month.
Do not use Setofilm if you notice signs of damage.
Do not dispose of any medicine in 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 Setofilm contains
The active ingredient is ondansetron. Each film contains 4 mg or 8 mg of ondansetron.
The other ingredients are: polyvinyl alcohol, Macrogol 1000, acesulfame potassium E950,
glycerol E422, titanium dioxide E171, rice starch, levomenthol and polysorbate 80 E433.
Description of the appearance of Setofilm and contents of the pack
Setofilm 4 mg is in the form of white and rectangular orodispersible films (dimensions 3 cm).
Setofilm 8 mg is in the form of white and rectangular orodispersible films (dimensions 6 cm).
Each orodispersible film of Setofilm 4 mg is contained within a sachet. Each
pack contains 6, 10 or 50 sachets.
Each orodispersible film of Setofilm 8 mg is contained within a sachet. Each
pack contains 6, 10 or 50 sachets.
Some pack sizes may not be marketed.
Marketing Authorisation Holder:
Norgine Italia S.r.l.
Via Fabio Filzi 25
20124 Milano
Manufacturer:
LTS Lohmann Therapie-Systeme AG
Lohmannstrasse 2
D-56626 Andernach
GERMANY
This medicinal product is authorised in the Member States of the European Economic Area and
in the United Kingdom (Northern Ireland) with the following denominations:
Setofilm: France, United Kingdom (Northern Ireland), Belgium, Spain, Italy
Sales concessionaire:
GENTILI (logo)
ISTITUTO GENTILI S.r.l.
[email protected]
- Страна регистрации
- Форма выпускаOrodispersible tablet, 4 MG
- Код АТХA04AA01
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги SETOFILMФорма выпуска: Injectable or infusion solution, 4 MGДействующее вещество: ОндансетронПроизводитель: ACCORD HEALTHCARE, S.L.U.Отпускается по рецептуФорма выпуска: Injectable solution, 2 MG/MLДействующее вещество: ОндансетронПроизводитель: B. BRAUN MELSUNGEN AGОтпускается по рецептуФорма выпуска: Orodispersible tablet, 4 MGДействующее вещество: ОндансетронПроизводитель: DOC GENERICI SRLОтпускается по рецепту
Аналоги SETOFILM в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог SETOFILM в Испания
Аналог SETOFILM в Польша
Аналог SETOFILM в Украина
Врачи онлайн по SETOFILM
Обсудите применение SETOFILM и возможные следующие шаги — по оценке врача.
Получите рецепт на SETOFILM онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
SETOFILM требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество SETOFILM — Ондансетрон. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
SETOFILM производится компанией NORGINE ITALIA S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения SETOFILM с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить SETOFILM в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Ондансетрон) включают ONDANSETRON AKKORD, ONDANSETRON B. BRAUN, ONDANSETRON DOK. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















