RIAMET 20 mg /120 mg artemether/lumefantrine 20 mg/120 mg dispersible tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

artemether, Quantity: 20 mg; lumefantrine, Quantity: 120 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

Artemether,Lumefantrine

Pharmaceutical form:

Tablet, dispersible

Composition:

Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; crospovidone; saccharin sodium; hypromellose; magnesium stearate; polysorbate 80; colloidal anhydrous silica; Flavour

Administration route:

Oral

Units in package:

180 tablets, 360 tablets, 12 tablets, 6 tablets, 540 tablets, 18 tablets, 24 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Riamet tablet is indicated for the treatment of acute, uncomplicated malaria due to Plasmodium falciparum in adults, children and infants of 5kg and above. Riamet Dispersible tablet is indicated for the treatment of acute, uncomplicated malaria due to Plasmodium falciparum in children and infants weighing between 5kg and less than 35kg.

Product summary:

Visual Identification: Yellow, round, flat tablets with a beveled edge, debossed with "CD" on one side and "NVR" on the reverse side; Container Type: Blister Pack; Container Material: PVC/PVDC/PE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2010-07-09

Patient Information leaflet

RIAMET
®
_20 MG/120 MG DISPERSIBLE TABLETS_
_artemether and lumefantrine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Riamet Dispersible
tablets. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. Some more recent
information on the medicine may be
available.
YOU SHOULD SPEAK TO YOUR
PHARMACIST OR DOCTOR TO OBTAIN THE
MOST UP TO DATE INFORMATION ON THE
MEDICINE. YOU CAN ALSO DOWNLOAD
THE MOST CURRENT LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of your child taking this
medicine against the benefits they
expect it will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT RIAMET
DISPERSIBLE IS USED FOR
Riamet Dispersible tablets contain
two antimalarial medicines,
artemether and lumefantrine. These
ingredients work together to kill the
Plasmodium falciparum parasite in
uncomplicated or mixed infections of
malaria.
Malaria commonly occurs in sub-
tropical and tropical areas. Riamet
Dispersible is used to treat malaria
infections acquired in areas where
malaria parasites may be resistant to
other anti-malarial medicines.
Malaria is an infectious mosquito-
borne disease, spread to humans by
the bite of the Anopheles mosquito.
The mosquito carries parasites and
injects them into the bloodstream
when it bites a person.
The parasites infect red blood cells,
causing fever, chills, a general
feeling of unwell (malaise), cough,
nausea, headaches, vomiting and
diarrhoea. Not all symptoms need to
be present to suggest that your child
has malaria.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOUR C

Summary of Product characteristics

1
AUSTRALIAN
PRODUCT
INFORMATION
–
RIAMET
®
TABLETS
AND
RIAMET
®
DISPERSIBLE TABLETS (ARTEMETHER/LUMEFANTRINE) 20MG/120MG
1
NAME OF THE MEDICINE
Artemether and lumefantrine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Riamet Tablets and Riamet Dispersible tablets contain the active
ingredient Artemether
and lumefantrine
Riamet Tablets: excipients with known effect: sugars and latex (in
trace amounts)
Riamet Dispersible tablets: excipients with known effect: sugars and
latex (in trace
amounts).
For the full list of excipients. Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
RIAMET TABLETS (20 MG/120MG)
Tablets
RIAMET DISPERSIBLE TABLETS (20 MG/120MG)
Dispersible tablets
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Riamet tablet is indicated for the treatment of acute, uncomplicated
malaria due to
_Plasmodium falciparum _in adults, children and infants of 5kg and
above.
Riamet Dispersible tablet is indicated for the treatment of acute,
uncomplicated malaria
due to _ Plasmodium falciparum_ in children and infants weighing
between 5kg and less
than 35kg.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE REGIMEN
RIAMET DISPERSIBLE TABLETS FOR INFANTS AND CHILDREN WEIGHING 5 KG TO <
35 KG, AND
AGED ≥ 3 MONTHS UP TO 12 YEARS:
Six doses of 1 to 3 dispersible tablets per dose, depending on
bodyweight (i.e. total course
of either 6, 12, or 18 tablets), given over a period of 60 hours.
5 to < 15 kg bodyweight, & ≥ 3 months: One dispersible tablet at the
time of initial
diagnosis, 1 tablet again after 8 hours and then 1 tablet twice daily
(morning and evening)
on each of the following two days (total course comprises 6 tablets).
2
15 to < 25 kg bodyweight: Two dispersible tablets as a single dose at
the time of initial
diagnosis, 2 tablets again after 8 hours and then 2 tablets twice
daily (morning and
evening) on each of the following two days (total course comprises 12
tablets).
25 to < 35 kg bodyweight & < 12 years: Three dispersible tablets as a
single dose at the
time of initial diagnosis, 3 tablets again