On.setron-Denk 4mg ODT tablets orodispersible

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

ondansetron

Disponible depuis:

Denk Pharma GmbH & Co. KG

Code ATC:

A04AA01

DCI (Dénomination commune internationale):

ondansetron

Dosage:

4mg

forme pharmaceutique:

tablets orodispersible

Unités en paquet:

(6/1x6/) in blister

Type d'ordonnance:

Prescription

Statut de autorisation:

Registered

Date de l'autorisation:

2020-08-04

Notice patient

_On. setron-Denk 4 mg ODT_
Orodispersible tablet – oral use
5-HT
3
receptor antagonist
Active substance: ondansetron
Package leaflet:
Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPOR-
TANT 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.
What is in this leaflet
1.
WHAT ON. SETRON-DENK 4 MG ODT
IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ON. SETRON-DENK 4 MG ODT
3.
HOW TO TAKE ON. SETRON-DENK 4 MG ODT
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ON. SETRON-DENK 4 MG ODT
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What On. setron-Denk 4 mg ODT is and
what it is used for
On. setron-Denk 4 mg ODT belongs to a group of medicines
called 5-HT
3
receptor antagonists. They are able to block
the effect of a chemical substance called serotonin which
can cause nausea and vomiting.
On. setron-Denk 4 mg ODT is used to:
•
treat nausea and vomiting caused by cytostatic agents
(medicines used in cancer treatment) or radiotherapy.
2.
What you need to know before you take
On. setron-Denk 4 mg ODT
Do not take On. setron-Denk 4 mg ODT
•
if you are allergic to ondansetron or any of the other
ingredients of this medicine (listed in section 6)
•
if you are taking apomorphine (used to treat Parkinson’s
disease)
•
in children with a body surface area less than 0.6 m2
or with a body weight up to 10 kg. For the correct oral
dosage of this patient group, more appropriate dosage
forms of ondansetron are available.
If you think any of these conditions are related to you, do
not take On. setron-Denk 4 mg ODT before you talked to
your docto

Résumé des caractéristiques du produit

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
On.setron-Denk 4 mg ODT
On.setron-Denk 8 mg ODT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: ondansetron
_ _
_On.setron-Denk 4 mg ODT _
Each orodispersible tablet contains 4 mg ondansetron.
Excipients with known effect: Each On.setron-Denk 4 mg orodispersible
tablet contains aspartame,
sorbitol and less than 1 mmol sodium (23 mg).
_On.setron-Denk 8 mg ODT _
Each orodispersible tablet contains 8 mg ondansetron.
Excipients with known effect: Each On.setron-Denk 8 mg orodispersible
tablet contains aspartame,
sorbitol and less than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet
_On.setron-Denk 4 mg ODT _
White, round, flat orodispersible tablets with bevelled edges and a
diameter of 7 mm.
_On.setron-Denk 8 mg ODT _
White, round, flat orodispersible tablets with bevelled edges and a
diameter of 10 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Adults
_On.setron-Denk 4 mg ODT _
-
Treatment of nausea and vomiting in therapy with cytotoxic agents and
radiation therapy.
_ _
_On.setron-Denk 8 mg ODT _
-
Treatment of nausea and vomiting in therapy with cytotoxic agents and
radiation therapy.
-
Prevention of nausea and vomiting after surgery.
_ _
Children and adolescents
-
Ondansetron is indicated in the treatment of nausea and vomiting in
therapy with cytotoxic agents
-
No studies have been conducted on the use of orally administered
ondansetron in the prevention and
therapy of nausea and vomiting after surgery. Administration by IV
injection is recommended for
this purpose.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
2
POSOLOGY
NAUSEA AND VOMITING INDUCED BY CYTOTOXIC AGENTS AND RADIATION
The emetogenic potential of cancer treatment varies according to the
doses and combinations of
chemotherapy and radiotherapy regimens used. The selection of dose
regimen should be determined by
the severity of the emetogenic challenge.
Adults
The recommended oral dose is 8