MALARONE® Tablets (250/100)
MALARONE® Junior Tablets
(62.5/25)
MALARONE (Atovaquone and Proguanil Hydrochloride)
Consumer Medicine Information
from person to person by
What is in this Keep this leaflet with the bite of female
the medicine. mosquitos.
leaflet?
You may need to read it
Unless explained again.
differently, the Before you take
information for MALARONE
"MALARONE" in this
leaflet applies to both What MALARONE
MALARONE Tablets is used for When you must not
(250/100) and take MALARONE
MALARONE Junior
MALARONE Tablets and
Tablets (62.5/25) (refer to Do not take
the "Product description" MALARONE Junior
MALARONE if you
section near the end of tablets contain the active
have ever had an
the leaflet for a ingredients atovaquone
allergic reaction to
description of these two and proguanil
atovaquone or
products). hydrochloride.
proguanil or any of
the ingredients listed
Please read this leaflet This medicine belongs to
at the end of this
carefully before you take a group of drugs called
leaflet.
MALARONE. antimalarials.
It is used in the Do not take
This leaflet answers MALARONE if you
some common questions prevention and treatment
of malaria caused by a have severe kidney
about MALARONE. It problems.
does not contain all of the pathogen called
available information. Plasmodium falciparum.
Do not take
Malaria in humans is MALARONE if you
It does not take the place
caused by four species of are pregnant, trying to
of talking to your doctor
Plasmodium parasites. become pregnant or
or pharmacist.
Plasmodium falciparum is breastfeeding, unless
the most common your doctor says you
All medicines have risks
species in tropical areas should.
and benefits. Your doctor
has weighed the risks of and is transmitted
primarily during the rainy Your doctor will discuss
you taking MALARONE
season. the risks and benefits of
against the benefits this
using MALARONE if you
medicine is expected to
Malaria is a debilitating are pregnant or
have for you.
infectious disease breastfeeding.
If you have any characterised by chills,
shaking, and periodic Do not take
concerns about taking
bouts of intense fever. MALARONE after the
this medicine, ask your
Malaria is transmitted expiry date (EXP)
doctor or pharmacist.
printed on the pack.
1
rifabutin (a drug swallow, the tablet(s)
If you use the tablets used to treat may be crushed and
after the expiry date has bacterial mixed with food or a
passed, they may not infections) milky drink just before
work as well. indinavir, a being taken.
medicine used in
Do not take the treatment of If you vomit within 1 hour
MALARONE if the HIV infection. of taking MALARONE,
packaging is torn or warfarin or other take another dose as
shows signs of medicines that soon as you can. In the
tampering. prevent your event of diarrhoea,
blood from clotting normal dosing should be
If you're not sure (anticoagulants). continued. In addition,
whether you should be you are taking any personal protection from
taking MALARONE, talk other medicines, mosquitoes should be
to your doctor. including those you used (repellants,
buy from a bednets).
What you must do supermarket, How much to take
pharmacy or health
You must tell your food shop. Take MALARONE as
doctor if: you are directed by your doctor or
breastfeeding, pharmacist.
you are allergic to pregnant or trying to
foods, dyes, become pregnant. Prevention of Malaria
preservatives or any
other medicines. Some medicines may Adults: One
you have kidney affect the way others MALARONE Tablet
problems work. Your doctor or (250/100) daily.
you have been pharmacist will be able to
treated for malaria tell you what to do when Children (11-40kg):
caused by using MALARONE while Depending on the child’s
Plasmodium taking other medicines. weight, one, two or three
falciparum in the past MALARONE Junior
and it has occurred Tablets (62.5/25) daily.
again How to take For children over 40kg in
you have diarrhoea MALARONE weight, one MALARONE
(loose bowel Tablet (250/100) once a
motions). This may Take your medicine as day. Your doctor will
interfere with the your doctor has told you. choose the right dose for
absorption of the child.
MALARONE. The label on the pack will
you are an adult who tell you how many tablets In order to prevent
weighs less than 40kg to take and how often you malaria, it is important
you are taking any should take them. If you that you take your
medicines containing do not understand what MALARONE every day.
the following : you should do, ask your Start taking the tablets 1
tetracyclines (a doctor or pharmacist. or 2 days before
type of antibiotic) travelling to a country (or
countries) where you are
metoclopramide MALARONE tablets
should be taken with food at risk of getting malaria.
(a drug used for
or a milky drink at the Continue daily dosing
treatment of
same time each day. while you are there and
nausea)
for 7 days after leaving
rifampicin (a drug
For children who find the the country.
used to treat
tuberculosis) tablet(s) difficult to
2
Whilst in a malarious Use in children Things you must not
area, use of personal do
protection such as MALARONE is not
permethrin impregnated recommended for the Do not change the dose
bednets and topical treatment of malaria in of your MALARONE
insect repellents is also children less than 3 years without first checking with
strongly recommended. of age. your doctor.
Treatment of Malaria Do not give this medicine
If you take too much to anyone else, even if
Adults: Four (overdose) their symptoms seem
MALARONE Tablets similar to yours.
Immediately telephone
(250/100), once a day, for
your doctor or Poisons
three days. Things to be careful
Information Centre (0800
POISON O800 764 766) of
Children (11-40kg): for advice, if you think
Depending on the child’s you or anyone else may Be careful driving or
weight one, two or three have taken too many operating machinery until
MALARONE Tablets MALARONE tablets, you know how
(250/100) once a day, for even if there are no signs MALARONE affects you.
three days. of discomfort or
For children over 40 kg in poisoning. You may MALARONE generally
weight, four MALARONE need urgent medical does not cause any
tablets (250/100) once a attention. problems with your ability
day for three days. Your to drive a car or operate
doctor will choose the Keep telephone numbers machinery.
right dose for the child. for these places handy.
Side-Effects
If you are not sure what
How long to take it for to do, contact your doctor
Check with your doctor
or pharmacist.
Prevention of Malaria as soon as possible if
you have any problems
MALARONE should be While you are while taking
taken 1 or 2 days before taking MALARONE MALARONE, even if
travelling to a country (or you do not think the
countries) where you are problems are
at risk of getting malaria, Things you must do connected with the
and continued daily while medicine or are not
you are there and for 7 Tell your doctor or listed.
days after leaving the pharmacist that you are
country. taking MALARONE if you Like other medicines,
are about to be started on MALARONE can cause
Treatment of Malaria any new medicines. some side effects. If they
occur, they are most
Tell your doctor if you likely to be minor and
MALARONE should be become pregnant or are
taken for three days in a temporary. However,
trying to become some may be serious and
row. pregnant. need medical attention.
Do not stop taking Tell your doctor if, for any
MALARONE, or change The following side-effects
reason, you have not
the dose without first have been reported in
taken your medicine
checking with your persons taking
exactly as prescribed.
doctor. Otherwise, your doctor MALARONE or the active
may think it was not ingredients (atovaquone
effective and change your or proguanil). Most of
treatment unnecessarily.
3
these have been mild and Sometimes MALARONE This is not the complete
have not lasted very long: is associated with list of all possible side-
abnormal blood tests of effects. Others may
Loss of appetite, liver function. If this does occur in some people and
feeling sick (nausea) happen it is most likely a there may be some side-
and/or being sick effects not yet known.
temporary change, as
(vomiting), stomach blood tests of liver
pain, diarrhoea Tell your doctor if you
function become normal notice anything else
Mouth ulcers after completing the that is making you feel
Rash or itching treatment. unwell, even if it is not
Headache, difficulty on this list.
sleeping and Other abnormal blood
dizziness tests reported with Do not be alarmed by
Tiredness MALARONE include: this list of possible side
Inflammation of the effects. You may not
liver (hepatitis), yellow A reduction in the experience any of them.
discolouration of the number of red blood
skin or eyes cells (anaemia), white After taking
(jaundice) blood cells MALARONE
Inflammation of blood (neutropenia), or
vessels (vasculitis) platelets (cells
which may be visible necessary for blood Storage
as red or purple clotting).
raised spots on the Keep this medicine
skin, but can affect An increase in where young children
other parts of the cannot reach it.
amylase, which is an
body enzyme produced by
Cough the pancreas.
A locked cupboard at
Fever least one-and-a half
Hair loss metres above the ground
Low sodium is a good place to store
Skin rash, which may (hyponatraemia).
blister and looks like medicines.
small targets (central If you think you are
dark spots, Keep MALARONE in a
having an allergic cool, dry place where it
surrounded by paler reaction to MALARONE,
area with a dark ring stays below 30C.
tell your doctor
around the edge immediately or go to
(erythema Do not leave
the Accident and MALARONE in a car, on
multiforme). Emergency department
Widespread rash with a window sill or in the
at your nearest bathroom.
blisters and peeling hospital.
skin, particularly
occurring around the Heat, light and dampness
Symptoms of an can destroy some
mouth, nose, eyes allergic reaction usually
and genitals medicines.
include some or all of
(Stevens-Johnson the following:
syndrome). Keep MALARONE in its
pack until it is time to
Seeing or hearing wheezing. take the tablets.
things that are not swelling of the
there (hallucinations). lips/mouth.
difficulty in breathing.
If you notice any of these
hay fever. Disposal
symptoms contact a
doctor urgently. lumpy rash ("hives").
Fainting. If your doctor tells you
to stop taking
4
MALARONE, or the povidone K30, sodium
medicine has passed starch glycollate , This leaflet was prepared
the expiry date, ask magnesium stearate , on: 6 May 2013
your pharmacist what hypromellose, titanium
to do with any medicine dioxide, iron oxide red
left over. E172, macrogol 400, Version 4.0
macrogol 8000 .
Product
description Manufacturer
Your MALARONE is
What MALARONE supplied by:
looks like
GlaxoSmithKline NZ
MALARONE Tablets Private Bag 106600
(250/100) are round, bi- Downtown, Auckland
convex, pink, film-coated New Zealand
tablets, engraved on one
side with “GX CM3” Ph: (09) 367 2900
Fax: (09) 367 2910
MALARONE Junior
Tablets (62.5/25) are Further information
round, bi-convex, pink,
film-coated tablets, Pharmaceutical
engraved on one side companies are not in a
with “GX CG7”. position to give people
individual diagnosis or
MALARONE Tablets medical advice. Your
(250/100) and doctor or pharmacist is
MALARONE Junior the best person to give
Tablets (62.5/25) are you advice on the
supplied in blister packs treatment of your
of 12 tablets. condition. You may also
be able to find general
Ingredients information about your
disease and its treatment
Each MALARONE Tablet from books, for example
(250/100) contains the in public libraries.
active ingredients
atovaquone 250mg and Do not throw this leaflet
proguanil hydrochloride away. You may need to
100mg. read it again.
Each MALARONE Junior
Tablet (62.5/25) contains The information provided
the active ingredients applies only to
atovaquone 62.5mg and MALARONE® .
proguanil hydrochloride
25mg. MALARONE® is a
registered trade mark of
Each tablet also contains the GlaxoSmithKline
the inactive ingredients: group of companies.
Poloxamer 188, This leaflet is copyrighted
microcrystalline cellulose, to GlaxoSmithKline and
low-substituted may be reproduced but
hydroxypropyl cellulose, not altered in any way.
