Ondansetron 8mg orodispersible tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Ondansetron

Dostopno od:

Healthcare Pharma Ltd

Koda artikla:

A04AA01

INN (mednarodno ime):

Ondansetron

Odmerek:

8mg

Farmacevtska oblika:

Orodispersible tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04060000; GTIN: 5060013779985

Navodilo za uporabo

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, pharmacist or nurse.
!
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, pharmacist or nurse. 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 use 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 works by blocking signals in
the brain that cause nausea and vomiting.
Ondansetron Orodispersible Tablets are a
special type of tablet 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, pharmacist or nurse 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 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).
If you are not sure, talk to your doctor,
pharmacist or nurse before taking
Ondansetron Orodispersible

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ondansetron 4 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
One orodispersible tablet contains 8 mg ondansetron.
Excipients with known effect:
Each orodispersible tablet contains 19 mg lactose (as lactose
monohydrate) and 6 mg
aspartame (E951).
This medicine contains up to 100 microgram benzyl alcohol in each
orodispersible tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
_ _
White to off-white, round tablets debossed with ‘5’ on one side
and ‘E’ on the other
side with an embossed circular edge
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Ondansetron is indicated for the management of nausea and vomiting
induced by cytotoxic
chemotherapy and radiotherapy, and for the prevention and treatment of
post-operative nausea
and vomiting (PONV).
Paediatric population
Ondansetron is indicated for the management of chemotherapy-induced
nausea and vomiting
(CINV) in children aged
≥
6 months, and for the prevention and treatment of PONV in
children aged
≥
1 month.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Chemotherapy and radiotherapy induced nausea and vomiting
The emetogenic potential of cancer treatment varies according to the
doses and combinations
of chemotherapy and radiotherapy regimens used. Selection of the dose
and dosing regimen
must therefore be guided by the emetogenic potential.
_ _
_Adults_
The recommended oral dose is 8 mg, taken 1-2 hours prior to
chemotherapy or radiation,
followed by 8 mg orally every 12 hours over a maximum of 5 days.
In highly emetogenic chemotherapy, a single oral dose up to a maximum
of 24 mg
ondansetron can be given orally together with 12 mg
dexamethasone-21-dihydrogen
phosphate disodium salt or equivalent 1 to 2 hours prior to
chemotherapy. After the first
24 hours, ondansetron treatment can be continued orally for up to 5
days after a course of
treatment. The recommended dose is 8 mg twice daily.
For t