Skip to Content

UK Edition. Click here for US version.

MAFAMOZ 250MG/100MG FILM-COATED TABLETS

Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
TEVA UK Ref:

231-30-89204-C LEA ATOVAQUONE/PROGUANIL HYDROCHLORIDE (MAFAMOZ) 250mg/100mg TUK
Version:

1

21 March 2014

MAFAMOZ 250 mg/100 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 you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
s 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.
7HATISINTHISLEAFLET

1. What Mafamoz 250 mg/100 mg Film-coated Tablets are and what they are
used for
2. What you need to know before you use Mafamoz 250 mg/100 mg Film-coated
Tablets
3. How to use Mafamoz 250 mg/100 mg Film-coated Tablets
4. Possible side effects
5. How to store Mafamoz 250 mg/100 mg Film-coated Tablets
6. Contents of the pack and other information

1 What Mafamoz 250 mg/100 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:
sTOPREVENTMALARIAINADULTSANDCHILDRENWHOWEIGHATLEASTKG
sTOTREATMALARIAINADULTSANDCHILDRENWHOWEIGHATLEASTKG
Malaria is spread by the bite of an infected mosquito, which passes the malaria
parasite (Plasmodium 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 yourself from catching malaria
People of any age can get malaria. It is a serious disease, but is preventable. As
well as taking Mafamoz, it is very important that you also take steps to avoid
being bitten by mosquitoes.
s5SEINSECTREPELLENTONEXPOSEDAREASOFTHESKIN
s7EARLIGHTCOLOUREDCLOTHINGTHATCOVERSMOSTOFTHEBODY ESPECIALLYAFTER
sunset as this is the time when mosquitoes are most active
s3LEEPINASCREENEDROOMORUNDERAMOSQUITONETIMPREGNATEDWITH
insecticide
s#LOSEWINDOWSANDDOORSATSUNSET IFTHEYARENOTSCREENED
s#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 you get symptoms such as high temperature,
headache, shivering and tiredness after returning home.

2 What you need to know before you use Mafamoz 250 mg/100 mg
Film-coated Tablets
Do not use Mafamoz:
sIFYOUAREALLERGICTOATOVAQUONEPROGUANILORANYOFTHEOTHERINGREDIENTSOF
this medicine (listed in section 6)
sFORPREVENTINGMALARIA IFYOUHAVESEVEREKIDNEYPROBLEMS
If any of the above applies to you, talk to your doctor before you start taking
this medicine.
Warnings and precautions
Talk to your doctor before taking Mafamoz.
If you are sick (vomit):
For preventing malaria:
sIFYOUARESICKVOMIT WITHINHOUROFTAKINGYOURTABLET TAKEANOTHERDOSE
straight away
sITISIMPORTANTTOTAKETHEFULLCOURSEOF-AFAMOZ)FYOUHAVETOTAKEEXTRA
tablets due to sickness, you may need another prescription.
sIFYOUHAVEBEENVOMITING ITISESPECIALLYIMPORTANTTOUSEEXTRAPROTECTION
such as repellents and bednets. Mafamoz may not be as effective, as the
amount absorbed will be reduced.
For treating malaria:
sIFYOUHAVEVOMITINGANDDIARRHOEATELLYOURDOCTOR YOUWILLNEEDREGULAR
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 your blood.
Other medicines and atovaquone/proguanil
4ELLYOURDOCTORORPHARMACISTIFYOUARETAKINGUSING HAVERECENTLYTAKENUSED
ORMIGHTTAKEUSEANYOTHERMEDICINE
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:
sMETOCLOPRAMIDE USEDTOTREATNAUSEAANDVOMITING
sTHEANTIBIOTICS TETRACYCLINE RIFAMPICINANDRIFABUTIN
sEFAVIRENZORCERTAINHIGHLYACTIVEPROTEASE INHIBITORSUSEDTOTREAT()6
sWARFARINANDOTHERMEDICINESTHATSTOPBLOODCLOTTING
sETOPOSIDEUSEDTOTREATCANCER
Tell your doctor if you are taking any of these. Your doctor may decide that
-AFAMOZISNOTSUITABLEFORYOU ORTHATYOUNEEDEXTRACHECKUPSWHILEYOURE
using it.
Remember to tell your doctor before you start taking any other medicines while
you are taking Mafamoz.
If any of the above apply to you (or you are not sure), talk to your doctor or
pharmacist before using Mafamoz.
Pregnancy, breast-feeding and fertility
)FYOUAREPREGNANTORBREAST FEEDING THINKYOUMAYBEPREGNANTORARE
planning to have a baby, ask your doctor or pharmacist for advice before using
this medicine.
Pregnancy
If you are pregnant, do not use this medicine unless your doctor recommends it.
Ask your doctor or pharmacist for advice before using this medicine.
Breast-feeding
$ONOTBREAST FEEDWHILEUSING-AFAMOZ ASTHEINGREDIENTSMAYPASSINTO
breast milk and may harm your baby.
Driving and using machines
If you feel dizzy, do not drive. This medicine makes some people feel dizzy. If this
happens to you, do not drive, use machines or take part in activities where you may
put yourself or others at risk.

3 How to use Mafamoz 250 mg/100 mg Film-coated Tablets
!LWAYSUSETHISMEDICINEEXACTLYASYOURDOCTORHASTOLDYOU#HECKWITHYOUR
doctor or pharmacist if you are not sure.
The recommended dose is:
To prevent malaria in adults and children weighing at least 40 kg.
4HEUSUALDOSEFORADULTSISTABLETONCEADAY TAKENASBELOW
Not recommended for preventing malaria in children, or in adults who weigh
LESSTHANKG4HEREMAYBEADIFFERENTTYPEOFATOVAQUONEPROGUANILTABLET
AVAILABLEFORCHILDRENWEIGHINGLESSTHANKG
To prevent malaria:
sSTARTTAKING-AFAMOZTODAYSBEFORETRAVELLINGTOANAREAWHICHHAS
malaria
sCONTINUETAKINGITEVERYDAYDURINGYOURSTAY
sCONTINUETAKINGITFORANOTHERDAYSAFTERYOURRETURNTOAMALARIA FREEAREA
To treat malaria in adults and children who weigh at least 11 kg
The usual dose for adults is 4 tablets once a day for 3 days.
For children the dose depends on their bodyweight:
s KGnTABLETONCEADAYFORDAYS
s KGnTABLETSONCEADAYFORDAYS
s KGnTABLETSONCEADAYFORDAYS
sOVERKGnDOSEASFORADULTS
.OTRECOMMENDEDFORTREATINGMALARIAINCHILDRENWHOWEIGHLESSTHANKG
&ORCHILDRENWHOWEIGHLESSTHANKGTALKTOYOURDOCTOR4HEREMAYBEA
DIFFERENTTYPEOFATOVAQUONEPROGUANILTABLETAVAILABLE
Method of administration
Take with food or a milky drink, where possible. It is best to take Mafamoz at
the same time each day. This will increase the amount of Mafamoz your body
can absorb, and make your treatment more effective.
)FYOUARESICKVOMIT WITHINHOUROFTAKINGYOURTABLET TAKEANOTHERDOSE
STRAIGHTAWAYSEEALSOSECTION 

TEVA UK Ref:

231-30-89204-C LEA ATOVAQUONE/PROGUANIL HYDROCHLORIDE (MAFAMOZ) 250mg/100mg TUK
Version:

1

21 March 2014

If you use more Mafamoz than you should
If you take more than you should, talk to a doctor or go to a pharmacist for
advice. Take the medicine pack with you.
If you forget to use Mafamoz
It is very important that you take the full course. If you forget to take a dose,
TAKEITASSOONASYOUREMEMBERnTHENCONTINUEASNORMAL$ONOTTAKEA
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
+EEPTAKING-AFAMOZFORDAYSAFTERYOURETURNTOAMALARIA FREEAREA4AKETHE
FULLCOURSEOF-AFAMOZFORMAXIMUMPROTECTION3TOPPINGEARLYPUTSYOUATRISK
OFGETTINGMALARIA ASITTAKESDAYSTOENSURETHATANYPARASITESTHATMAYBEIN
your blood following a bite from an infected mosquito are killed. Do not stop
taking Mafamoz just because you feel better.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Look out for the following severe reactions. They have occurred in a small
NUMBEROFPEOPLE BUTTHEIREXACTFREQUENCYISUNKNOWN
Severe allergic reactions SIGNSINCLUDE
sRASHANDITCHING
sSUDDENWHEEZING TIGHTNESSOFTHECHESTORTHROAT ORDIFFICULTYBREATHING
sSWOLLENEYELIDS FACE LIPS TONGUEOROTHERPARTOFTHEBODY
#ONTACTADOCTORIMMEDIATELYIFYOUGETANYOFTHESESYMPTOMS3TOPUSING
Mafamoz.
Severe skin reactions:
sSKINRASH WHICHMAYBLISTERANDLOOKSLIKESMALLTARGETSCENTRALDARKSPOTS
surrounded by paler area with a dark ring around the edge) (erythema
multiforme)
sSEVEREWIDESPREADRASHWITHBLISTERSANDPEELINGSKIN PARTICULARLYOCCURRING
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 
sHEADACHE
sFEELINGSICKANDBEINGSICKNAUSEAANDVOMITING
sSTOMACHPAIN
sDIARRHOEA
Common side effectsMAYAFFECTUPTOINPEOPLE 
sDIZZINESS
sSLEEPINGPROBLEMSINSOMNIA
sSTRANGEDREAMS
sDEPRESSION
sLOSSOFAPPETITE
sFEVER
sRASHWHICHMAYBEITCHY
sCOUGH
Common side effects, which may show up in your blood tests are:
sREDUCEDNUMBERSOFREDBLOODCELLSANAEMIA WHICHCANCAUSETIREDNESS
headaches and shortness of breath
sREDUCEDNUMBERSOFWHITEBLOODCELLSNEUTROPENIA WHICHMAYMAKEYOU
more likely to catch infections
sLOWLEVELSOFSODIUMINTHEBLOODHYPONATRAEMIA
sANINCREASEINLIVERENZYMES
Uncommon side effectsMAYAFFECTUPTOINPEOPLE 
sANXIETY
sANUNUSUALAWARENESSOFABNORMALBEATINGOFTHEHEARTPALPITATIONS
sSWELLINGANDREDNESSOFTHEMOUTH
sHAIRLOSS
Uncommon side effects that may show up in your blood tests:
sANINCREASEINAMYLASEANENZYMEPRODUCEDINTHEPANCREAS 
Rare side effects MAYAFFECTUPTOINPEOPLE 
sSEEINGORHEARINGTHINGSTHATARENOTTHEREHALLUCINATIONS 
Other side effects:
/THERSIDEEFFECTSHAVEOCCURREDINASMALLNUMBEROFPEOPLEBUTTHEIREXACT
frequency is unknown.
sINFLAMMATIONOFTHELIVERHEPATITIS
sBLOCKAGEOFTHEBILEDUCTSCHOLESTASIS
sINCREASEINHEARTRATETACHYCARDIA
sINFLAMMATIONOFTHEBLOODVESSELSVASCULITIS WHICHMAYBEVISIBLEASREDOR
purple raised spots on the skin but can affect other parts of the body
sFITSSEIZURES
sPANICATTACKS CRYING
sSEVEREMENTALHEALTHPROBLEMINWHICHTHEPERSONLOSESCONTACTWITHREALITY
and is unable to think and judge clearly
sNIGHTMARES
sMOUTHULCERS
sBLISTERS
sPEELINGSKIN
sINCREASEDSENSITIVITYOFTHESKINTOSUNLIGHT
Other side effects that may show up in blood tests:
sADECREASEINALLTYPESOFBLOODCELLSPANCYTOPENIA 
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
DIRECTLYVIATHE9ELLOW#ARD3CHEMEATWWWMHRAGOVUKYELLOWCARD
By reporting side effects you can help provide more information on the safety
of this medicine.

5 How to store Mafamoz 250 mg/100 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
CONTAINSMGOFATOVAQUONEANDMGPROGUANILHYDROCHLORIDE
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,
XXXXXXXXX

89204-C

860 X 170

Expand view ⇕

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.

Hide