I TEVA UK Pel: 231-30-89207-C LEA ATOVAQUONE/PROGUf

170 mm

If yourchild is sick (vomits) within 1 hour of taking the tablet, give another dose straight away (see also section 2).

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-then continue as normal. Do 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

Use for preventing malaria: Keep giving Mafamoz for 7 days afteryou return to a malaria-free area. Give the full course of tablets for maximum protection. Stopping early puts yourchild at risk of getting malaria, as it takes 7 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.

^ 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, buttheir exact frequency is unknown.

Severe allergic reactions - signs include:

♦    rash and itching

♦    sudden wheezing, tightness of the chest orthroat, or difficulty breathing

♦    swollen eyelids,face, lips,tongue or other part of the body.

Contact a doctor immediately ifyour child gets any ofthese symptoms. Stop using Mafamoz.

Severe skin reactions:

♦    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)

♦    severe widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson 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 1 in 10 people):

♦    headache

♦    feeling sick and being sick (nausea and vomiting)

♦    stomach pains

Common side effects (may affect up to 1 in 10 people):

♦    dizziness

♦    sleeping problems (insomnia)

♦    strange dreams

♦    loss of appetite

♦    rash which may be itchy

♦    cough.

Common side effects, which may show up in blood tests are:

♦    reduced numbers of red blood cells (anaemia) which can cause tiredness, headaches and shortness of breath

♦    reduced numbers of white blood cells (neutropenia) which may make you more likely to catch infections

♦    low levels of sodium in the blood (hyponatraemia)

♦    an increase in liver enzymes.

Uncommon side effects (may affect up to 1 in 100 people):

♦    anxiety

♦    an unusual awareness of abnormal beating of the heart (palpitations)

♦    swelling and redness ofthe mouth

♦    hair loss.

Uncommon side effects that may show up in blood tests:

♦    an increase in amylase (an enzyme produced in the pancreas).

Rare side effects (may affect up to 1 in 1000 people)

♦    seeing or hearing things that are not there (hallucinations)

Other side effects:

Other side effects have occurred in a small number of people but their exact frequency is unknown.

♦    inflammation ofthe liver (hepatitis)

♦    blockage ofthe bile ducts (cholestasis)

♦    increase in heart rate (tachycardia)

♦    inflammation ofthe blood vessels (vasculitis) which may bevisible as red or purple raised spots on the skin but can affect other parts of the body

♦    fits (seizures)

♦    panicattacks,crying

♦    severe mental health problem in which the person loses contact with reality and is unable to think and judge clearly

♦    mouth ulcers

♦    blisters

♦    peeling skin

♦    increased sensitivity ofthe skin to sunlight.

Other side effects that may show up in blood tests:

♦    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 theYellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

3 How to store Mafamoz 62.5 mg/25 mg Film-coated Tablets Keep this medicine out of the sight and reach of children.

Do not use this medicine afterthe expiry date which is stated on the label and carton after EXP (month,year).The expiry date refers to thelastday ofthat month.

HDPE bottles only:

Use within 90 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.

^ Contents of the pack and other information

What Mafamoz contains:

The active substance is atovaquone and proguanil hydrochloride. Each tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride.

The other ingredients are:

Poloxamer 188, microcrystalline cellulose (E460), povidone K30 (E2101), sodium starch glycolate (Type A),magnesium stearate (E572), hypromellose (E464), low-substituted hydroxypropyl cellulose (E463), silica colloidal anhydrous (E551),titanium dioxide (E171), red iron oxide (E172), macrogol 400 and macrogol 8000.

What Mafamoz looks like and contents of the pack

Mafamoz 62.5 mg/25 mg Film-coatedTablets are pink, round, biconvex film-coated tablets debossed with "I" on one side and "11" on the other side.

Mafamoz is available in blister packs and HDPE containers.

Pack sizes:

Alu-Alu Blister: 1, 12,21,24, 28,36 film-coated tablets Alu-PVC Blister: 1, 12,21,24, 28,36 film-coated tablets

HDPE containers with 33 mm PP child-resistant closure: 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva UK Limited,

Eastbourne, BN22 9AG, United Kingdom.

Manufacturer

Merckle GmbH,

Ludwig-Merckle-StraBe 3,89143 Blaubeuren, Germany.

This leaflet was last revised in 03/2014

PL 00289/1762 XXXXXXXXX

170 mm