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MAFAMOZ 250MG/100MG FILM-COATED TABLETS
Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE
231-30-89204-C LEA ATOVAQUONE/PROGUANIL HYDROCHLORIDE (MAFAMOZ) 250mg/100mg TUK
21 March 2014
MAFAMOZ 250 mg/100 mg
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.
7HAT IS IN THIS LEAFLET
1. What Mafamoz 250 mg/100 mg Film-coated Tablets are and what they are
2. What you need to know before you use Mafamoz 250 mg/100 mg Film-coated
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:
s TO PREVENT MALARIA IN ADULTS AND CHILDREN WHO WEIGH AT LEAST KG
s TO TREAT MALARIA IN ADULTS AND CHILDREN WHO WEIGH AT LEAST 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 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.
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
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 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
Do not use Mafamoz:
s IF YOU ARE ALLERGIC TO ATOVAQUONEPROGUANIL OR ANY OF THE OTHER INGREDIENTS OF
this medicine (listed in section 6)
s FOR PREVENTING MALARIA IF YOU HAVE SEVERE KIDNEY PROBLEMS
If any of the above applies to you, talk to your doctor before you start taking
Warnings and precautions
Talk to your doctor before taking Mafamoz.
If you are sick (vomit):
For preventing malaria:
s IF YOU ARE SICK VOMIT WITHIN HOUR OF TAKING YOUR TABLET TAKE ANOTHER DOSE
s IT IS IMPORTANT TO TAKE THE FULL COURSE OF -AFAMOZ )F YOU HAVE TO TAKE EXTRA
tablets due to sickness, you may need another prescription.
s IF YOU HAVE 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 YOU HAVE VOMITING AND DIARRHOEA TELL YOUR DOCTOR YOU 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 your blood.
Other medicines and atovaquone/proguanil
4ELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKINGUSING HAVE 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:
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 you are taking any of these. Your doctor may decide that
-AFAMOZ IS NOT SUITABLE FOR YOU OR THAT YOU NEED EXTRA CHECK UPS WHILE YOURE
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
)F YOU ARE PREGNANT OR BREAST FEEDING THINK YOU MAY BE PREGNANT OR ARE
planning to have a baby, ask your doctor or pharmacist for advice before using
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.
$O NOT BREAST FEED WHILE USING -AFAMOZ AS THE INGREDIENTS MAY PASS INTO
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
!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 in adults and children weighing at least 40 kg.
4HE USUAL DOSE FOR ADULTS IS TABLET ONCE A DAY TAKEN AS BELOW
Not recommended for preventing malaria in children, or in adults who weigh
LESS THAN KG4HERE MAY BE A DIFFERENT TYPE OF ATOVAQUONEPROGUANIL TABLET
AVAILABLE FOR CHILDREN WEIGHING LESS THAN KG
To prevent malaria:
s START TAKING -AFAMOZ TO DAYS BEFORE TRAVELLING TO AN AREA WHICH HAS
s CONTINUE TAKING IT EVERY DAY DURING YOUR STAY
s CONTINUE TAKING IT FOR ANOTHER DAYS AFTER YOUR RETURN TO A MALARIA FREE AREA
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 KG n TABLET ONCE A DAY FOR DAYS
s KG n TABLETS ONCE A DAY FOR DAYS
s KG n TABLETS ONCE A DAY FOR DAYS
s OVER KG n DOSE AS FOR ADULTS
.OT RECOMMENDED FOR TREATING MALARIA IN CHILDREN WHO WEIGH LESS THAN KG
&OR CHILDREN WHO WEIGH LESS THAN KG TALK TO YOUR DOCTOR4HERE MAY BE A
DIFFERENT TYPE OF ATOVAQUONEPROGUANIL TABLET AVAILABLE
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.
)F YOU ARE SICK VOMIT WITHIN HOUR OF TAKING YOUR TABLET TAKE ANOTHER DOSE
STRAIGHT AWAY SEE ALSO SECTION
TEVA UK Ref:
231-30-89204-C LEA ATOVAQUONE/PROGUANIL HYDROCHLORIDE (MAFAMOZ) 250mg/100mg TUK
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,
TAKE IT AS SOON AS YOU REMEMBER n THEN CONTINUE AS NORMAL $O NOT TAKE 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
If you stop using Mafamoz
+EEP TAKING -AFAMOZ FOR DAYS AFTER YOU RETURN TO A MALARIA FREE AREA4AKE THE
FULL COURSE OF -AFAMOZ FOR MAXIMUM PROTECTION 3TOPPING EARLY PUTS YOU 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. 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
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
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 YOU GET ANY OF THESE SYMPTOMS 3TOP USING
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
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 FEELING SICK AND BEING SICK NAUSEA AND VOMITING
s STOMACH PAIN
Common side effects MAY AFFECT UP TO IN PEOPLE
s SLEEPING PROBLEMS INSOMNIA
s STRANGE DREAMS
s LOSS OF APPETITE
s RASH WHICH MAY BE ITCHY
Common side effects, which may show up in your 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 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 your 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 MOUTH ULCERS
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 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
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 250 mg/100 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
($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 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
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
!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
,UDWIG -ERCKLE 3TRAE "LAUBEUREN 'ERMANY
This leaflet was last revised in 03/2014
860 X 170
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.