Riamet tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Lumefantrine; Artemether

Prieinama:

Novartis Pharmaceuticals UK Ltd

ATC kodas:

P01BF01

INN (Tarptautinis Pavadinimas):

Lumefantrine; Artemether

Dozė:

120mg ; 20mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 05040100; GTIN: 5010678918021

Pakuotės lapelis

PACKAGE LEAFLET:
INFORMATION FOR THE USER
RIAMET
® 20 MG/120 MG TABLETS
artemether and lumefantrine
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.
– 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. This includes any possible side effects not
listed in this leaflet. (See section 4).
WHAT IS IN THIS LEAFLET
1. What Riamet is and what it is used for
2. What you need to know before you take Riamet
3. How to take Riamet
4. Possible side effects
5. How to store Riamet
6. Contents of the pack and other information
1. WHAT RIAMET IS AND WHAT IT IS USED FOR
Riamet contains two substances called artemether and
lumefantrine. They belong to a group of medicines called
anti-malarials.
Riamet is only used for the treatment of acute
uncomplicated malaria infections caused by a parasite
called “Plasmodium falciparum”. This parasite is a tiny
organism made up of one cell that is found inside red
blood cells.
Riamet is used to treat adults, children and infants of 5
kg body weight and above.
Riamet is not used to prevent malaria or to treat severe
malaria (where it has affected the brain, lungs or
kidneys).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RIAMET
DO NOT TAKE RIAMET
– if you are allergic (hypersensitive) to artemether,
lumefantrine, or any of the other ingredients of this
medicine (listed in section 6).
– if you have a severe type of malaria infection where it
has affected parts of your body such as the brain,
lungs or kidneys.
– if you have a heart condition, such as changes in the
rhythm or rate of the heart beat, a slow heart beat, or
severe heart disease.
– if any member of your family (parents, grandparents,
brothers or sisters) has died sudd

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Riamet 20mg/120mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 20mg artemether and 120mg lumefantrine
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Light yellow, round tablet with “NC” debossed on one side and
“CG” on the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Riamet is indicated for the treatment of acute uncomplicated
_Plasmodium falciparum_
malaria in adults, children and infants of 5 kg and above.
Consideration should be given to official guidance regarding the
appropriate use of
antimalarial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children weighing 35 kg and above
For patients 12 years of age and above and 35 kg body weight and
above, a course of
treatment comprises six doses of four tablets i.e. total of 24
tablets, given over a
period of 60 hours as follows: the first dose of four tablets, given
at the time of initial
diagnosis, should be followed by five further doses of four tablets
given at 8, 24, 36,
48 and 60 hours thereafter.
Children and infants weighing 5 kg to less than 35 kg
A six-dose regimen is recommended with 1 to 3 tablets per dose,
depending on
bodyweight:
5 to less than 15 kg bodyweight: the first dose of one tablet, given
at the time of initial
diagnosis, should be followed by five further doses of one tablet
given at 8, 24, 36, 48
and 60 hours thereafter.
15 to less than 25 kg bodyweight: the first dose of two tablets, given
at the time of
initial diagnosis, should be followed by five further doses of two
tablets given at 8,
24, 36, 48 and 60 hours thereafter.
25 to less than 35 kg bodyweight: the first dose of three tablets,
given at the time of
initial diagnosis, should be followed by five further doses of three
tablets given at 8,
24, 36, 48 and 60 hours thereafter.
Infants weighing less than 5 kg
The safety and efficacy of Riamet tablets have not been established in
infants
weighing less than 5 kg and no do