Ondansetron 8mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Ondansetron hydrochloride dihydrate

Dostupno od:

DE Pharmaceuticals

ATC koda:

A04AA01

INN (International ime):

Ondansetron hydrochloride dihydrate

Doziranje:

8mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 04060000

Uputa o lijeku

WHAT IS IN THIS LEAFLET:
1. What Ondansetron is and what it is used for
2. What you need to know before you take
Ondansetron
3. How to take Ondansetron
4. Possible side effects
5. How to store Ondansetron
6. Contents of the pack and other information
Ondansetron belongs to a group of medicines
called anti-emetics, drugs against feeling sick
(nausea) or being sick (vomiting).
This medicine is used for:
• preventing nausea (feeling sick) and vomiting
(being sick) caused by chemotherapy (in adults
and children) or radiotherapy for cancer
(adults only),
• preventing nausea and vomiting after surgery
(adults only).
DO NOT TAKE ONDANSETRON
• if you are taking apomorphine, a medicine
used to treat Parkinson's disease,
• if 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 or pharmacist before taking
Ondansetron:
• if you have ever had heart problems (e.g.
congestive heart failure which causes
shortness of breath and swollen ankles),
• if you have an uneven heart beat (arrhythmias),
• if you are allergic to medicines similar to
ondansetron, such as granisetron or
palonosetron,
• if you have liver problems,
• if you suffer from any blockage in your gut or
if you have severe constipation,
• if your blood levels of potassium or
magnesium are reduced,
• if you are having your tonsils out.
OTHER MEDICINES AND ONDANSETRON
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines that you buy
without a prescription and herbal medicines.
This is because Ondansetron 4 mg / 8 mg
Film-coated Tablets can affect the way some
medicines work. Also some other medicines can
affect the way Ondansetron 4 mg / 8 mg
Film-coated Tablets works.
In particular, tell your doctor or pharmacist:
• if you are taking phenytoin, carbamazepine
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
(used to treat epilepsy or other illnesses), or
rifampicin (used to treat c

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ondansetron 8 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ondansetron 8 mg (as the hydrochloride dihydrate)
Excipient(s) with known effect: Lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet (Tablet).
Ondansetron 8 mg Tablets are white, circular, biconvex film-coated
tablets with a breakline on one side, plain on the other. The
breakline
is only to facilitate breaking if necessary for ease of swallowing and
not to divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ADULTS: _
_ _
Ondansetron is indicated for the management of nausea and vomiting
induced by cytotoxic chemotherapy and radiotherapy.
Ondansetron is indicated for the prevention and treatment of post-
operative nausea and vomiting (PONV).
For
treatment
of
established
PONV,administration
by
injection
is
recommended.
_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,
administration by injection is recommended
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ 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
selection
of
dose
regimen
should
be
determined
by
the
severity of the emetogenic challenge. The route of administration and
dose of ondansetron should be flexible in the range of 8-32mg a day
and
selected as shown below.
_Emetogenic Chemotherapy and Radiotherapy_: Ondansetron can be given
either
by
rectal,
oral
(tablets
or
syrup),
intravenous
or
intramuscular
administration, using either Ondansetron 4 mg and 8 mg Tablets or
other
commercially-available ondansetron presentations.
For oral administration: 8mg 1-2 hours before chemotherapy or
r