Mafamoz 250mg/100mg Film-Coated Tablets
11TEVA UK Ref 231-30892040 LEAftTQVftQUQNE/PftQ
f you use more Mafamoz than you should
f you take more than you should, talk to a doctor or go to a pharmacist for advice.Take the medicine pack with you. f you forget to use Mafamoz
t is very important that you take the full course. If you forget to take a dose, take it as soon asyou remember - then continue as normal. Do nottake a double dose to make up for a missed dose.
f you have any further questions on the use of this product, ask your doctor or pharmacist.
f you stop using Mafamoz
Keep taking Mafamoz for 7 days after you return to a malaria-free area.Takethe full course of Mafamoz for maximum protection. Stopping early puts you at risk of getting malaria, as ittakes 7 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.
f 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 gets them.
Look out for the following severe reactions.They have occurred in a small
number of people, buttheir exactfrequency 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 ofthe body.
Contact a doctor immediately if you get 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).
f 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 pain
Common side effects (may affect uptol in 10 people):
* dizziness
* sleeping problems (insomnia)
* strange dreams
* depression
* lossof appetite
* rash which may be itchy ♦cough.
Common side effects, which may show up in your blood tests are:
* reduced numbers of red blood cells (anaemia) which can cause tiredness, headaches and shortness of breath
* reduced numbers ofwhite 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 your 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 notthere (hallucinations).
Other side effects:
Other side effects have occurred in a small number of people buttheir exact frequency is unknown.
* inflammation ofthe liver (hepatitis)
* blockage of the 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)
* panic attacks,crying
* severe mental health problem in which the person losescontactwith 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
f 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
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.
Do not usethis medicine afterthe expiry datewhich is stated on the label and parton after EXP (month, year).The expiry date refers to the last day 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.
6 Contents of the pack and other information
What Mafamoz contains:
The active substance is atovaquone and proguanil hydrochloride. Each tablet
pontains 250 mg of atovaquone and 100 mg 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 400and macrogol 8000.
What Mafamoz looks like and contents of the pack
Mafamoz 250 mg/100 mg Film-coated Tablets are pink, round, biconvex film-coated tablets debossed with "H" on one side and "175" 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-PVCBIister: 1,12, 21,24,28,36film-coatedtablets
HDPE containers with 38 mm PP child-resistantclosure: 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-StralSe3,89143 Blaubeuren, Germany.
This leaflet was last revised in 03/2014
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