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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

16 tablets, 400 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 is indicated for the treatment of acute, uncomplicated malaria due to Plasmodium falciparum in patients aged at least 12 years and weighing at least 35kg.

Product summary:

Visual Identification: YELLOW, ROUND, FLAT TABLET WITH BEVELLED EDGES AND SCORED ON ONE SIDE, IMPRINTED WITH "N/C" ON THE SCORED SIDE AND "CG" ON THE OTHER SIDE.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2002-07-24

Patient Information leaflet

RIAMET
®
_Artemether and lumefantrine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Riamet. 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.
SPEAK TO YOUR PHARMACIST OR
DOCTOR TO OBTAIN THE MOST UP TO
DATE INFORMATION ON THE MEDICINE.
YOU CAN ALSO DOWNLOAD THE MOST UP
TO DATE 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 you 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 IS USED
FOR
Riamet contains 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 is used to treat malaria
acquired in areas where the parasite
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 you have
malaria.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is only available with
a doctor's prescription.
It is not addicti

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