Ondansetron 8mg orodispersible tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Ondansetron

Dostupné s:

DE Pharmaceuticals

ATC kód:

A04AA01

INN (Mezinárodní Name):

Ondansetron

Dávkování:

8mg

Léková forma:

Orodispersible tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 04060000

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
Ondansetron
4mg and 8mg Orodispersible Tablets
Ondansetron
Read all of this leaflet carefully before you start 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, nurse 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, nurse or
pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet
1. What Ondansetron Orodispersible Tablets are and what they
are used for
2. What you need to know before you take Ondansetron
Orodispersible Tablets
3. How to take Ondansetron Orodispersible Tablets
4. Possible side effects
5. How to store Ondansetron Orodispersible Tablets
6. Contents of the pack and other information
1. What Ondansetron Orodispersible Tablets are and what
they are used for
Ondansetron Orodispersible Tablets contain a medicine called
ondansetron. This belongs to a group of medicines called
anti-emetics. Ondansetron Orodispersible Tablets are a special
type of tablets that dissolves very quickly when put on top of the
tongue.
Ondansetron Orodispersible Tablets are used for:
•
preventing nausea and vomiting caused by chemotherapy (in
adults and children) or radiotherapy for cancer (adults only),
•
preventing nausea and vomiting after surgery (adults only).
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these uses.
2. What you need to know before you take Ondansetron
Orodispersible Tablets
Do not take Ondansetron Orodispersible Tablets if:
•
you are taking apomorphine (used to treat Parkinson’s disease),
•
you are allergic to ondansetron or any of the other ingredients of
this medicine (listed in Section 6).
Warnings and precautions
Talk to your doctor, nurse or pharmacist

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ondansetron 8 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains: 8 mg ondansetron.
Excipients with known effect:
Aspartame (E951) 1.76 mg per 8 mg tablet.
Sorbitol (E420) up to 16.884mg per 8 mg tablet.
Glucose 0.6336 mg per 8 mg tablet.
Maltodextrin 0.179 mg per 8 mg tablet.
Sulphur dioxide (E220) 0.000012 mg per 8 mg tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
White, flat, round, bevel-edged tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults:
The
management
of
nausea and
vomiting induced
by
cytotoxic
chemotherapy and
radiotherapy, and for the prevention of post-operative nausea and
vomiting in adults.
Paediatric Population:
Management of chemotherapy-induced nausea and vomiting in children
aged
≥
6 months.
Prevention and treatment of postoperative nausea and vomiting in
children aged
≥
1
month.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use. Place the orodispersible tablet on top of the tongue,
where it will disperse
within seconds.
For the different dosage regimens appropriate strengths and
formulations are available.
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING.
Adults:
The
emetogenic
potential
of
cancer
treatment
varies
according
to
the
doses
and
combinations
of
chemotherapy
and
radiotherapy
regimens
used.
The
route
of
administration and dose of Ondansetron should be flexible and selected
as shown below.
_Emetogenic chemotherapy and radiotherapy:_
For patients receiving emetogenic chemotherapy or radiotherapy
ondansetron can be
given either by oral or intravenous administration.
For most patients receiving emetogenic
chemotherapy or radiotherapy, ondansetron
should initially be administered intravenously immediately before
treatment, followed by
8 mg orally every twelve hours.
For oral administration: 8 mg 1-2 hours before treatment, followed by
8 mg 12 hours
later.
To protect against delay