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MAFAMOZ 62.5MG/25 MG FILM-COATED TABLETS

Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE

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TEVA UK Ref:

231-30-89207-C LEA ATOVAQUONE/PROGUANIL HYDROCHLORIDE (MAFAMOZ) 62.5mg/25mg TUK
Version:

1

24 March 2014

MAFAMOZ 62.5 mg/25
/ mg
FILM-COATED TABLETS
atovaquone/proguanil hydrochloride
Package leaflet: Information for the user

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
s Keep this leaflet. You may need to read it again.
s If you have any further questions, ask your doctor or pharmacist.
s This medicine has been prescribed for your child only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as your
child’s.
s If your child gets any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
7HATISINTHISLEAFLET

1. What Mafamoz 62.5 mg/25 mg Film-coated Tablets are and what they are
used for
2. What you need to know before you use Mafamoz 62.5 mg/25 mg
Film-coated Tablets
3. How to use Mafamoz 62.5 mg/25 mg Film-coated Tablets
4. Possible side effects
5. How to store Mafamoz 62.5 mg/25 mg Film-coated Tablets
6. Contents of the pack and other information

1 What Mafamoz 62.5 mg/25 mg Film-coated Tablets are and what
they are used for
Mafamoz belongs to a group of medicines called antimalarials. It contains two
active ingredients, atovaquone and proguanil hydrochloride.
Mafamoz has two uses:
ss TOPREVENTMALARIAFORCHILDRENWEIGHINGBETWEENKGANDKG
ss TOTREATMALARIAFORCHILDRENWEIGHINGBETWEENKGANDKG 
Although this medicine is usually used for children and teenagers, it can be
PRESCRIBEDFORADULTSWEIGHINGLESSTHANKG
Malaria is spread by the bite of an infected mosquito, which passes the malaria
PARASITEPlasmodium falciparum into the bloodstream. Mafamoz prevents
malaria by killing this parasite. For people who are already infected with
malaria, Mafamoz also kills these parasites.
Protect your child from catching malaria
People of any age can get malaria. It is a serious disease, but is preventable. As
well as giving Mafamoz, it is very important that you also take steps to avoid
being bitten by mosquitoes.
ss 5SEINSECTREPELLENTONEXPOSEDAREASOFTHESKIN
ss 7EARLIGHTCOLOUREDCLOTHINGTHATCOVERSMOSTOFTHEBODY ESPECIALLYAFTER
sunset as this is the time when mosquitoes are most active
ss 3LEEPINASCREENEDROOMORUNDERAMOSQUITONETIMPREGNATEDWITH

insecticide
ss #LOSEWINDOWSANDDOORSATSUNSET IFTHEYARENOTSCREENED
ss #ONSIDERUSINGANINSECTICIDEMATS SPRAY PLUG INS TOCLEARAROOMOFINSECTS
or to deter mosquitoes from entering the room.
If you need further advice, talk to your doctor or pharmacist.
It is still possible to get malaria after taking the necessary precautions. Some
types of malaria infection take a long time to cause symptoms, so the illness
may not start until several days, weeks or even months after returning from
abroad.
See a doctor immediately if your child gets symptoms such as high
temperature, headache, shivering and tiredness after returning home.

2 What you need to know before you use Mafamoz 62.5 mg/25 mg
Film-coated Tablets
Do not use Mafamoz:
ss IFYOURCHILDISALLERGICTOATOVAQUONEPROGUANILORANYOFTHEOTHERINGREDIENTS
OFTHISMEDICINELISTEDINSECTION
ss FORPREVENTINGMALARIA IFYOURCHILDHASSEVEREKIDNEYPROBLEMS
If any of the above applies to your child, talk to your doctor before your child
starts taking this medicine.
Warnings and precautions
Talk to your doctor before taking Mafamoz.
If your child is sick (vomits):
For preventing malaria:
ss IFYOURCHILDISSICKVOMITS WITHINHOUROFTAKINGTHETABLET GIVEANOTHER
dose straight away
ss ITISIMPORTANTTOTAKETHEFULLCOURSEOF-AFAMOZ)FYOURCHILDHASTOTAKE
EXTRATABLETSDUETOSICKNESS THEYMAYNEEDANOTHERPRESCRIPTION
ss IFYOURCHILDHASBEENVOMITING ITISESPECIALLYIMPORTANTTOUSEEXTRA
protection, such as repellents and bednets. Mafamoz may not be as effective,
as the amount absorbed will be reduced.
For treating malaria:
ss IFYOURCHILDHASVOMITINGANDDIARRHOEATELLYOURDOCTOR THEYWILLNEED
regular blood tests. Mafamoz will not be as effective, as the amount absorbed
will be reduced. The tests will check whether the malaria parasite is being
cleared from their blood.
Other medicines and Mafamoz
4ELLYOURDOCTORORPHARMACISTIFYOURCHILDISTAKINGUSING HASRECENTLY
TAKENUSEDORMIGHTTAKEUSEANYOTHERMEDICINE
Some medicines can affect the way Mafamoz works, or Mafamoz itself can
strengthen or weaken the effectiveness of other medicines taken at the same
time. These include:
ss METOCLOPRAMIDE USEDTOTREATNAUSEAANDVOMITING
ss THEANTIBIOTICS TETRACYCLINE RIFAMPICINANDRIFABUTIN
ss EFAVIRENZORCERTAINHIGHLYACTIVEPROTEASE INHIBITORSUSEDTOTREAT()6
ss WARFARINANDOTHERMEDICINESTHATSTOPBLOODCLOTTING
ss ETOPOSIDEUSEDTOTREATCANCER
Tell your doctor if your child is taking any of these. Your doctor may decide that
-AFAMOZISNOTSUITABLEFORTHEM ORTHATTHEYNEEDEXTRACHECKUPSWHILST
taking it.
Remember to tell your doctor if your child starts taking any other medicines
while they are taking Mafamoz.
Pregnancy, breast-feeding and fertility
)FYOURCHILDISPREGNANTORBREAST FEEDING THINKTHEYMAYBEPREGNANTORARE
planning to have a baby, ask your doctor or pharmacist for advice before using
this medicine.
Pregnancy
If your child is pregnant, do not give this medicine unless your doctor
recommends it.
Ask your doctor or pharmacist for advice before giving this medicine.
Breast-feeding
$ONOTBREAST FEEDWHILETAKING-AFAMOZ ASTHEINGREDIENTSMAYPASSINTO
breast milk and may harm the baby.
Driving and using machines
Mafamoz makes some people feel dizzy. If this happens to your child they
should not drive, use machines or take part in activities where they put
themselves or others at risk.

3 How to use Mafamoz 62.5 mg/25 mg Film-coated Tablets
!LWAYSUSETHISMEDICINEEXACTLYASYOURDOCTORHASTOLDYOU#HECKWITHYOUR
doctor or pharmacist if you are not sure.
The recommended dose is:
To prevent malaria
The usual dose to prevent malaria depends on your child’s weight.
 KGnTABLETONCEADAY
 KGnTABLETSONCEADAYASASINGLEDOSE
 KGnTABLETSONCEADAYASASINGLEDOSE
3TARTGIVINGTHISMEDICINEnDAYSBEFORETRAVELLINGTOANAREAWHICHHAS
malaria.
#ONTINUEGIVINGITEVERYDAYDURINGTHESTAY
#ONTINUEGIVINGITFORANOTHERDAYSAFTERYOURRETURNTOAMALARIA FREEAREA
&ORMAXIMUMPROTECTIONYOURCHILDMUSTTAKETHEFULLCOURSEOFTREATMENT
To treat malaria
The usual dose to treat malaria depends on your child’s weight.
 KGnTABLETSONCEADAYFORDAYS
 KGnTABLETSONCEADAYFORDAYS
Method of administration
Give Mafamoz with food or a milky drink, where possible. This will increase the
amount of Mafamoz your child’s body can absorb and make the treatment more
EFFECTIVE4HETABLETSSHOULDBESWALLOWEDWHOLE(OWEVER FORCHILDRENWHO
find them difficult to swallow, they may be crushed just before being taken and
MIXEDWITHFOODORAMILKYDRINK
It is best to give Mafamoz at the same time each day.

TEVA UK Ref:

231-30-89207-C LEA ATOVAQUONE/PROGUANIL HYDROCHLORIDE (MAFAMOZ) 62.5mg/25mg TUK
Version:

1

24 March 2014

)F
)FYOURCHILDISSICKVOMITS WITHINHOUROFTAKINGTHETABLET GIVEANOTHERDOSE
HILD I I K 
I I HI
H
F KI
H
BL
I
H D
STRAIGHTAWAYSEEALSOSECTION 
If your child takes too much Mafamoz
Talk to a doctor or go to a pharmacist for advice. Take the medicine pack with you.
If you forget to give Mafamoz
It is very important that your child takes the full course. If you forget to give a
DOSE GIVEITASSOONASYOUREMEMBERnTHENCONTINUEASNORMAL$ONOTGIVEA
double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
If you stop using Mafamoz
5SEFORPREVENTINGMALARIA+EEPGIVING-AFAMOZFORDAYSAFTERYOURETURNTO
AMALARIA FREEAREA'IVETHEFULLCOURSEOFTABLETSFORMAXIMUMPROTECTION
3TOPPINGEARLYPUTSYOURCHILDATRISKOFGETTINGMALARIA ASITTAKESDAYSTO
ensure that any parasites that may be in your blood following a bite from an
infected mosquito are killed.
If you have any further questions on the use of the medicine, ask your doctor or
pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them. The following side effects may occur:
Look out for the following severe reactions. They have occurred in a small
NUMBEROFPEOPLE BUTTHEIREXACTFREQUENCYISUNKNOWN
Severe allergic reactions - signs include:
s RASHANDITCHING
s
s SUDDENWHEEZING TIGHTNESSOFTHECHESTORTHROAT ORDIFFICULTYBREATHING
s
s
s SWOLLENEYELIDS FACE LIPS TONGUEOROTHERPARTOFTHEBODY
#ONTACTADOCTORIMMEDIATELYIFYOURCHILDGETSANYOFTHESESYMPTOMS3TOP
using Mafamoz.
Severe skin reactions:
s SKINRASH WHICHMAYBLISTERANDLOOKSLIKESMALLTARGETSCENTRALDARKSPOTS
s
SURROUNDEDBYPALERAREAWITHADARKRINGAROUNDTHEEDGE erythema
multiforme
s SEVEREWIDESPREADRASHWITHBLISTERSANDPEELINGSKIN PARTICULARLYOCCURRING
s
AROUNDTHEMOUTH NOSE EYESANDGENITALS3TEVENS *OHNSONSYNDROME 
If you notice any of these symptoms contact a doctor urgently. Most of the
other side effects reported have been mild and have not lasted very long.
Very common side effectsMAYAFFECTMORETHANINPEOPLE 
s HEADACHE
s
s FEELINGSICKANDBEINGSICKNAUSEAANDVOMITING
s
s STOMACHPAINS
s
s DIARRHOEA
s
Common side effectsMAYAFFECTUPTOINPEOPLE 
s DIZZINESS
s
s SLEEPINGPROBLEMSINSOMNIA
s
s STRANGEDREAMS
s
s DEPRESSION
s
s LOSSOFAPPETITE
s
s FEVER
s
s RASHWHICHMAYBEITCHY
s
s COUGH
s
Common side effects, which may show up in blood tests are:
s REDUCEDNUMBERSOFREDBLOODCELLSANAEMIA WHICHCANCAUSETIREDNESS
s
headaches and shortness of breath
s REDUCEDNUMBERSOFWHITEBLOODCELLSNEUTROPENIA WHICHMAYMAKEYOU
s
more likely to catch infections
s LOWLEVELSOFSODIUMINTHEBLOODHYPONATRAEMIA
s
s ANINCREASEINLIVERENZYMES
s
Uncommon side effectsMAYAFFECTUPTOINPEOPLE 
s ANXIETY
s
s ANUNUSUALAWARENESSOFABNORMALBEATINGOFTHEHEARTPALPITATIONS
s
s SWELLINGANDREDNESSOFTHEMOUTH
s
s HAIRLOSS
s
Uncommon side effects that may show up in blood tests:
s ANINCREASEINAMYLASEANENZYMEPRODUCEDINTHEPANCREAS 
s
Rare side effectsMAYAFFECTUPTOINPEOPLE
s SEEINGORHEARINGTHINGSTHATARENOTTHEREHALLUCINATIONS
s
Other side effects:
/THERSIDEEFFECTSHAVEOCCURREDINASMALLNUMBEROFPEOPLEBUTTHEIREXACT
frequency is unknown.
s INFLAMMATIONOFTHELIVERHEPATITIS
s
s BLOCKAGEOFTHEBILEDUCTSCHOLESTASIS
s
s INCREASEINHEARTRATETACHYCARDIA
s
s INFLAMMATIONOFTHEBLOODVESSELSVASCULITIS WHICHMAYBEVISIBLEASREDOR
s
purple raised spots on the skin but can affect other parts of the body
s FITSSEIZURES
s
s PANICATTACKS CRYING
s
s SEVEREMENTALHEALTHPROBLEMINWHICHTHEPERSONLOSESCONTACTWITHREALITY
s
and is unable to think and judge clearly
s NIGHTMARES
s
s MOUTHULCERS
s
s BLISTERS
s
s PEELINGSKIN
s
s INCREASEDSENSITIVITYOFTHESKINTOSUNLIGHT
s
Other side effects that may show up in blood tests:
s ADECREASEINALLTYPESOFBLOODCELLSPANCYTOPENIA 
s
Reporting of side effects
If your child gets any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also report
SIDEEFFECTSDIRECTLYVIATHE9ELLOW#ARD3CHEMEAT
WWWMHRAGOVUKYELLOWCARD
By reporting side effects you can help provide more information on the safety
of this medicine.

5 How to store Mafamoz 62.5 mg/25 mg Film-coated Tablets
Keep this medicine out of the sight and reach of children.
$ONOTUSETHISMEDICINEAFTERTHEEXPIRYDATEWHICHISSTATEDONTHELABELAND
CARTONAFTER%80MONTH YEAR 4HEEXPIRYDATEREFERSTOTHELASTDAYOFTHAT
month.
($0%BOTTLESONLY
5SEWITHINDAYSOFFIRSTOPENING
Do not use if you notice any visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help protect the environment.

6 Contents of the pack and other information
What Mafamoz contains:
The active substance is atovaquone and proguanil hydrochloride. Each tablet
CONTAINSMGOFATOVAQUONEANDMGOFPROGUANILHYDROCHLORIDE
The other ingredients are:
0OLOXAMER MICROCRYSTALLINECELLULOSE% POVIDONE+% SODIUM
STARCHGLYCOLATE4YPE! MAGNESIUMSTEARATE% HYPROMELLOSE%
LOW SUBSTITUTEDHYDROXYPROPYLCELLULOSE% SILICACOLLOIDALANHYDROUS
% TITANIUMDIOXIDE% REDIRONOXIDE% MACROGOLAND
MACROGOL
What Mafamoz looks like and contents of the pack
-AFAMOZMGMG&ILM COATED4ABLETSAREPINK ROUND BICONVEX
FILM COATEDTABLETSDEBOSSEDWITHh)vONONESIDEANDhvONTHEOTHERSIDE
-AFAMOZISAVAILABLEINBLISTERPACKSAND($0%CONTAINERS
Pack sizes:
!LU !LU"LISTER     FILM COATEDTABLETS
!LU 06#"LISTER     FILM COATEDTABLETS
($0%CONTAINERSWITHMM00CHILD RESISTANTCLOSUREFILM COATEDTABLETS
Not all pack sizes may be marketed.
Marketing Authorisation Holder
4EVA5+,IMITED
%ASTBOURNE ".!' 5NITED+INGDOM
Manufacturer
-ERCKLE'MB(
,UDWIG -ERCKLE 3TRA”E "LAUBEUREN 'ERMANY
This leaflet was last revised in 03/2014
0,
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8

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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