Ondemet 8mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ondansetron hydrochloride dihydrate

Available from:

Alliance Pharmaceuticals Ltd

ATC code:

A04AA01

INN (International Name):

Ondansetron hydrochloride dihydrate

Dosage:

8mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5060061160216

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ONDEMET
® 4MG AND 8MG 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 or 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, or 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 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
1. WHAT ONDANSETRON IS AND WHAT IT IS USED FOR
Ondansetron belongs to a group of drugs called anti-emetics.
Ondansetron inhibits the effect of the neuro-transmitter serotonin
in the brain. Serotonin causes nausea and vomiting.
Ondansetron is used for:
Preventing and treating nausea and vomiting induced by cytotoxic
chemotherapy (CINV) and radiotherapy (adults and children aged

Preventing and treating nausea and vomiting in patients
following an
   
Your doctor may have prescribed Ondansetron for another use. Always
follow your doctor's advice.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONDANSETRON
•
if you are allergic to Ondansetron or any of the other ingredients of
this
medicine (listed in section 6)
•
if you have previously experienced allergy to other drugs belonging
to the group of serotonin antagonists (e.g. granisetron, dolasetron).
If
this is the case, it is possible that you are also allergic to
Ondansetron
•
if you are taking apomorphine (used to treat Parkinson's disease).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING

Summary of Product characteristics

OBJECT 1
ONDEMET 8 MG TABLETS
Summary of Product Characteristics Updated 02-Mar-2016 | Alliance
Pharmaceuticals
1. Name of the medicinal product
Ondemet 8mg Tablets
2. Qualitative and quantitative composition
Ondemet 8 mg
Each film-coated tablet contains 8 mg ondansetron (as hydrochloride
dihydrate).
Excipients:
Each film-coated tablet contains 169 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
8 mg: pale yellow, round biconvex, film-coated tablet embossed 42 on
one side, diameter 9.2 mm
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).
Paediatric Population:
- Ondansetron is indicated for the management of chemotherapy-induced
nausea and vomiting in children
aged ≥6 months and for the prevention and treatment of
post-operative nausea and vomiting in children
aged ≥1 month
4.2 Posology and method of administration
Oral use
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 twelve hourly.
For oral administration: 8 mg 1-2 hours before treatment, followed by
8 mg orally 12 hours later.
To protect against delayed or prolong