Ondansetron 4mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Ondansetron hydrochloride dihydrate

Dostupné z:

Sandoz Ltd

ATC kód:

A04AA01

INN (Medzinárodný Name):

Ondansetron hydrochloride dihydrate

Dávkovanie:

4mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 04060000

Príbalový leták

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

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ondansetron 4 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ondansetron 4mg (as ondansetron hydrochloride
dihydrate).
Excipients :Each tablet contains 74.25 mg lactose as lactose anhydrous
and lactose
monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film coated tablet.
Yellow, film coated oval shaped tablets, plain on both sides
4.1
THERAPEUTIC INDICATIONS
Adults:
Management of nausea and vomiting induced by cytotoxic chemotherapy
and
radiotherapy, Prevention and treatment of post-operative nausea and
vomiting
(PONV).
Paediatric Population:
Management of chemotherapy-induced nausea and vomiting in children
aged
≥
6
months.
Prevention and treatment of post-operative nausea and vomiting in
children aged
≥
1
month.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
_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 in the range
of 8-32 mg 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.
For oral administration: 8mg 1-2 hours before treatment, followed by
8mg 12 hours
later.
To protect against delayed or prolonged emesis after the first 24
hours, oral treatment
with ondansetron should be continued for up to 5 days after a course
of treatment.
The recommended dose for oral administration is 8mg twice daily.
Highly Emetogenic Chemotherapy: For patients receiving highly
emetogenic
chemotherapy, e.g. high-dose cisplatin, ondansetron can be given by
intravenous
administration.
To protect against delayed or prolonged emesis after the first 24
hours, oral treatment
with ondansetron should be continued for up to 5 days