Skip to Content

UK Edition. Click here for US version.

MAFAMOZ 62.5MG/25 MG FILM-COATED TABLETS

Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE / ATOVAQUONE / PROGUANIL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
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.
7HAT IS IN THIS LEAFLET

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:
s TO PREVENT MALARIA FOR CHILDREN WEIGHING BETWEEN  KG AND  KG
s TO TREAT MALARIA FOR CHILDREN WEIGHING BETWEEN  KG AND  KG 
Although this medicine is usually used for children and teenagers, it can be
PRESCRIBED FOR ADULTS WEIGHING LESS THAN  KG
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 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.
s 5SE INSECT REPELLENT ON EXPOSED AREAS OF THE SKIN
s 7EAR LIGHT COLOURED CLOTHING THAT COVERS MOST OF THE BODY ESPECIALLY AFTER
sunset as this is the time when mosquitoes are most active
s 3LEEP IN A SCREENED ROOM OR UNDER A MOSQUITO NET IMPREGNATED WITH
insecticide
s #LOSE WINDOWS AND DOORS AT SUNSET IF THEY ARE NOT SCREENED
s #ONSIDER USING AN INSECTICIDE MATS SPRAY PLUG INS TO CLEAR A ROOM OF INSECTS
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:
s IF YOUR CHILD IS ALLERGIC TO ATOVAQUONEPROGUANIL OR ANY OF THE OTHER INGREDIENTS
OF THIS MEDICINE LISTED IN SECTION 
s FOR PREVENTING MALARIA IF YOUR CHILD HAS SEVERE KIDNEY PROBLEMS
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:
s IF YOUR CHILD IS SICK VOMITS WITHIN  HOUR OF TAKING THE TABLET GIVE ANOTHER
dose straight away
s IT IS IMPORTANT TO TAKE THE FULL COURSE OF -AFAMOZ )F YOUR CHILD HAS TO TAKE
EXTRA TABLETS DUE TO SICKNESS THEY MAY NEED ANOTHER PRESCRIPTION
s IF YOUR CHILD HAS BEEN VOMITING IT IS ESPECIALLY IMPORTANT TO USE EXTRA
protection, such as repellents and bednets. Mafamoz may not be as effective,
as the amount absorbed will be reduced.
For treating malaria:
s IF YOUR CHILD HAS VOMITING AND DIARRHOEA TELL YOUR DOCTOR THEY WILL NEED
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
4ELL YOUR DOCTOR OR PHARMACIST IF YOUR CHILD IS TAKINGUSING HAS RECENTLY
TAKENUSED OR MIGHT TAKEUSE ANY OTHER MEDICINE
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:
s
s
s
s
s

METOCLOPRAMIDE USED TO TREAT NAUSEA AND VOMITING
THE ANTIBIOTICS TETRACYCLINE RIFAMPICIN AND RIFABUTIN
EFAVIRENZ OR CERTAIN HIGHLY ACTIVE PROTEASE INHIBITORS USED TO TREAT ()6
WARFARIN AND OTHER MEDICINES THAT STOP BLOOD CLOTTING
ETOPOSIDE USED TO TREAT CANCER

Tell your doctor if your child is taking any of these. Your doctor may decide that
-AFAMOZ IS NOT SUITABLE FOR THEM OR THAT THEY NEED EXTRA CHECK UPS WHILST
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
)F YOUR CHILD IS PREGNANT OR BREAST FEEDING THINK THEY MAY BE PREGNANT OR ARE
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
$O NOT BREAST FEED WHILE TAKING -AFAMOZ AS THE INGREDIENTS MAY PASS INTO
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
!LWAYS USE THIS MEDICINE EXACTLY AS YOUR DOCTOR HAS TOLD YOU #HECK WITH YOUR
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.
  KG n  TABLET ONCE A DAY
  KG n  TABLETS ONCE A DAY AS A SINGLE DOSE
  KG n  TABLETS ONCE A DAY AS A SINGLE DOSE
3TART GIVING THIS MEDICINE  n  DAYS BEFORE TRAVELLING TO AN AREA WHICH HAS
malaria.
#ONTINUE GIVING IT EVERY DAY DURING THE STAY
#ONTINUE GIVING IT FOR ANOTHER  DAYS AFTER YOUR RETURN TO A MALARIA FREE AREA
&OR MAXIMUM PROTECTION YOUR CHILD MUST TAKE THE FULL COURSE OF TREATMENT
To treat malaria
The usual dose to treat malaria depends on your child’s weight.
  KG n  TABLETS ONCE A DAY FOR  DAYS
  KG n  TABLETS ONCE A DAY FOR  DAYS
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
EFFECTIVE4HE TABLETS SHOULD BE SWALLOWED WHOLE (OWEVER FOR CHILDREN WHO
find them difficult to swallow, they may be crushed just before being taken and
MIXED WITH FOOD OR A MILKY DRINK
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 YOUR CHILD
HILD IS
I SICK
I K VOMITS
I WITHIN
I HI  H
HOUR OFF TAKING
KI
THE
H TABLET
BL GIVE
I ANOTHER
H D
DOSE
STRAIGHT AWAY SEE ALSO SECTION  
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 GIVE IT AS SOON AS YOU REMEMBER n THEN CONTINUE AS NORMAL $O NOT GIVE A
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
5SE FOR PREVENTING MALARIA +EEP GIVING -AFAMOZ FOR  DAYS AFTER YOU RETURN TO
A MALARIA FREE AREA 'IVE THE FULL COURSE OF TABLETS FOR MAXIMUM PROTECTION
3TOPPING EARLY PUTS YOUR CHILD AT RISK OF GETTING MALARIA AS IT TAKES  DAYS TO
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
NUMBER OF PEOPLE BUT THEIR EXACT FREQUENCY IS UNKNOWN
Severe allergic reactions - signs include:
s RASH AND ITCHING
s SUDDEN WHEEZING TIGHTNESS OF THE CHEST OR THROAT OR DIFFICULTY BREATHING
s SWOLLEN EYELIDS FACE LIPS TONGUE OR OTHER PART OF THE BODY
#ONTACT A DOCTOR IMMEDIATELY IF YOUR CHILD GETS ANY OF THESE SYMPTOMS 3TOP
using Mafamoz.
Severe skin reactions:
s SKIN RASH WHICH MAY BLISTER AND LOOKS LIKE SMALL TARGETS CENTRAL DARK SPOTS
SURROUNDED BY PALER AREA WITH A DARK RING AROUND THE EDGE erythema
multiforme
s SEVERE WIDESPREAD RASH WITH BLISTERS AND PEELING SKIN PARTICULARLY OCCURRING
AROUND THE MOUTH NOSE EYES AND GENITALS 3TEVENS *OHNSON SYNDROME 
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 effects MAY AFFECT MORE THAN  IN  PEOPLE 
s HEADACHE
s FEELING SICK AND BEING SICK NAUSEA AND VOMITING
s STOMACH PAINS
s DIARRHOEA
Common side effects MAY AFFECT UP TO  IN  PEOPLE 
s DIZZINESS
s SLEEPING PROBLEMS INSOMNIA
s STRANGE DREAMS
s DEPRESSION
s LOSS OF APPETITE
s FEVER
s RASH WHICH MAY BE ITCHY
s COUGH
Common side effects, which may show up in blood tests are:
s REDUCED NUMBERS OF RED BLOOD CELLS ANAEMIA WHICH CAN CAUSE TIREDNESS
headaches and shortness of breath
s REDUCED NUMBERS OF WHITE BLOOD CELLS NEUTROPENIA WHICH MAY MAKE YOU
more likely to catch infections
s LOW LEVELS OF SODIUM IN THE BLOOD HYPONATRAEMIA
s AN INCREASE IN LIVER ENZYMES
Uncommon side effects MAY AFFECT UP TO  IN  PEOPLE 
s ANXIETY
s AN UNUSUAL AWARENESS OF ABNORMAL BEATING OF THE HEART PALPITATIONS
s SWELLING AND REDNESS OF THE MOUTH
s HAIR LOSS
Uncommon side effects that may show up in blood tests:
s AN INCREASE IN AMYLASE AN ENZYME PRODUCED IN THE PANCREAS 
Rare side effects MAY AFFECT UP TO  IN  PEOPLE
s SEEING OR HEARING THINGS THAT ARE NOT THERE HALLUCINATIONS
Other side effects:
/THER SIDE EFFECTS HAVE OCCURRED IN A SMALL NUMBER OF PEOPLE BUT THEIR EXACT
frequency is unknown.
s INFLAMMATION OF THE LIVER HEPATITIS
s BLOCKAGE OF THE BILE DUCTS CHOLESTASIS
s INCREASE IN HEART RATE TACHYCARDIA
s INFLAMMATION OF THE BLOOD VESSELS VASCULITIS WHICH MAY BE VISIBLE AS RED OR
purple raised spots on the skin but can affect other parts of the body
s FITS SEIZURES
s PANIC ATTACKS CRYING
s SEVERE MENTAL HEALTH PROBLEM IN WHICH THE PERSON LOSES CONTACT WITH REALITY
and is unable to think and judge clearly
s NIGHTMARES
s MOUTH ULCERS
s BLISTERS
s PEELING SKIN
s INCREASED SENSITIVITY OF THE SKIN TO SUNLIGHT
Other side effects that may show up in blood tests:
s A DECREASE IN ALL TYPES OF BLOOD CELLS PANCYTOPENIA 
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
SIDE EFFECTS DIRECTLY VIA THE9ELLOW #ARD 3CHEME AT
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.
$O NOT USE THIS MEDICINE AFTER THE EXPIRY DATE WHICH IS STATED ON THE LABEL AND
CARTON AFTER %80 MONTH YEAR 4HE EXPIRY DATE REFERS TO THE LAST DAY OF THAT
month.
($0% BOTTLES ONLY
5SE WITHIN  DAYS OF FIRST OPENING
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
CONTAINS  MG OF ATOVAQUONE AND  MG OF PROGUANIL HYDROCHLORIDE
The other ingredients are:
0OLOXAMER  MICROCRYSTALLINE CELLULOSE % POVIDONE + % SODIUM
STARCH GLYCOLATE 4YPE ! MAGNESIUM STEARATE % HYPROMELLOSE %
LOW SUBSTITUTED HYDROXYPROPYL CELLULOSE % SILICA COLLOIDAL ANHYDROUS
% TITANIUM DIOXIDE % RED IRON OXIDE % MACROGOL  AND
MACROGOL 
What Mafamoz looks like and contents of the pack
-AFAMOZ  MG MG &ILM COATED4ABLETS ARE PINK ROUND BICONVEX
FILM COATED TABLETS DEBOSSED WITH h)v ON ONE SIDE AND hv ON THE OTHER SIDE
-AFAMOZ IS AVAILABLE IN BLISTER PACKS AND ($0% CONTAINERS
Pack sizes:
!LU !LU "LISTER       FILM COATED TABLETS
!LU 06# "LISTER       FILM COATED TABLETS
($0% CONTAINERS WITH  MM 00 CHILD RESISTANT CLOSURE  FILM COATED TABLETS
Not all pack sizes may be marketed.
Marketing Authorisation Holder
4EVA 5+ ,IMITED
%ASTBOURNE ". !' 5NITED +INGDOM
Manufacturer
-ERCKLE 'MB(
,UDWIG -ERCKLE 3TRA”E   "LAUBEUREN 'ERMANY
This leaflet was last revised in 03/2014
0, 
XXXXXXXXX

 #
 8 

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