MALUSONE 250/100 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ATOVAQUONE, PROGUANIL HYDROCHLORIDE

Available from:

Clonmel Healthcare Ltd

ATC code:

P01BB51

INN (International Name):

ATOVAQUONE, PROGUANIL HYDROCHLORIDE

Dosage:

250/100 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Biguanides

Authorization status:

Authorised

Authorization date:

2012-10-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MALUSONE 250 MG/100 MG FILM-COATED TABLETS
ATOVAQUONE/PROGUANIL HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Malusone is and what it is used for
2. What you need to know before you take Malusone
3. How to take Malusone
4. Possible side effects
5.
How to store Malusone
6. Contents of the pack and other information
1. WHAT MALUSONE IS AND WHAT IT IS USED FOR
Malusone belongs to a group of medicines called
_antimalarials. _
They contain two active ingredients,
atovaquone and proguanil hydrochloride.
Malusone has two uses:

to prevent malaria in adults and children who weigh more than 40 kg

to treat malaria in adults and children who weigh more than 11 kg
Malaria is spread by the bite of an infected mosquito, which passes
the malaria parasite
_(Plasmodium _
_falciparum) _
into the bloodstream. Malusone prevents malaria by killing this
parasite. For people who
are already infected with malaria, Malusone also kills these
parasites.
PROTECT YOURSELF FROM CATCHING MALARIA
People of any age can get malaria. It is a serious disease, but is
preventable.
As well as taking Malusone, it is very important that you also take
steps to avoid being bitten by
mosquitoes.

USE INSECT REPELLENT ON EXPOSED AREAS OF THE SKIN

WEAR LIGHT COLOURED CLOTHING THAT COVERS MOST OF THE BODY,
especially after sunset as this is the
time when mosquitoes are most active

SLEEP IN A SCREENED ROOM
or under a mosquito net impregnated with insecticide

CLOSE W

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Malusone 250 mg/100 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Malusone tablet contains 250 mg atovaquone and 100 mg proguanil
hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pinkish brown to brown coloured, circular, biconvex beveled edge
film-coated tablets with’404’ debossed on one side
and ‘G’ debossed on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
It is indicated for:
Prophylaxis of_ Plasmodium falciparum_ malaria in adults and in
children weighing more than 40 kg.
Treatment of acute, uncomplicated_ Plasmodium falciparum_ malaria in
adults and in children weighing 11 kg or
more.
Official guidelines and local information on the prevalence of
resistance to antimalarial drugs should be taken into
consideration. Official guidelines will normally include World Health
Organisation (WHO) and public health
authorities'
guidelines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
The daily dose should be taken with food or a milky drink (to ensure
maximum absorption of atovaquone) at the same
time each day.
If patients are unable to tolerate food, Malusone should be
administered, but systemic exposure of atovaquone will be
reduced. In the event of vomiting within 1 hour of dosing a repeat
dose should be taken.
POSOLOGY
_Prophylaxis:_
Prophylaxis should:
commence 24 or 48 hours prior to entering a malaria-endemic area,
continue during the period of the stay,
continue for 7 days after leaving the area.
In residents (semi-immune subjects) of endemic areas, the safety and
effectiveness of atovaqone/proguanil has been
established in studies of up to 12 weeks.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__