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ATOVAQUONE/PROGUANIL HYDROCHLORIDE 250MG/ 100MG FILM-COATED TABLETS

Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE

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(atovaquone/proguanil hydrochloride)

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• 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.
• 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.
What is in this leaflet:
1. What Atovaquone/Proguanil Hydrochloride is and
what it is used for.
2. What you need to know before you take Atovaquone/
Proguanil Hydrochloride.
3. How to take Atovaquone/Proguanil Hydrochloride
4. Possible side effects.
5. How to store Atovaquone/Proguanil Hydrochloride.
6. Contents of the pack and other information.
1. WHAT ATOVAQUONE/PROGUANIL HYDROCHLORIDE
IS AND WHAT IT IS USED FOR
Atovaquone/Proguanil Hydrochloride belongs
to a group of medicines called antimalarials.
It contains two active ingredients, atovaquone and
proguanil hydrochloride.
Atovaquone/Proguanil Hydrochloride is used to:
• Prevent malaria.
• Treat malaria.
Malaria is spread by the bite of an infected
mosquito, which passes the malaria parasite
(Plasmodium falciparum) into the bloodstream.
Atovaquone/Proguanil Hydrochloride prevents
malaria by killing this parasite. For people who are
already infected with malaria, Atovaquone/Proguanil
Hydrochloride also kills these parasites.
Protecting yourself from catching malaria
People of any age can get malaria. It is a serious disease,
but is preventable.
As well as taking Atovaquone/Proguanil Hydrochloride,
it is very important that you also take steps to avoid
being bitten by mosquitoes:
• 
Use insect repellent on exposed areas of the skin.
• 
Wear light coloured clothing that covers most of the
body, especially after sunset as this is the time when
mosquitoes are most active.
• 
Sleep in a screened room or under a mosquito net
impregnated with insecticide.
• 
Close windows and doors at sunset, if they are
not screened.
• 
Consider 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 TAKE
ATOVAQUONE/PROGUANIL HYDROCHLORIDE

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Do not take Atovaquone/Proguanil Hydrochloride:
• if you are allergic to atovaquone, proguanil
hydrochloride or any of the other ingredients of this
medicine (listed in section 6)
• For preventing malaria, if you have severe kidney
disease
• Tell your doctor if either of these applies to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Atovaquone/Proguanil Hydrochloride:
Children
Atovaquone/Proguanil Hydrochloride 250 mg/ 100 mg
film-coated tablets should not be used in children
or in adults who weigh less than 40 kg. There may
be a different type of tablets available in your
country for children, containing less atovaquone and
proguanil hydrochloride.
Other medicines and
Atovaquone/Proguanil Hydrochloride
Tell your doctor or pharmacist if you are taking or have
recently taken or might take any other medicines.
Some medicines can affect the way
Atovaquone/Proguanil Hydrochloride works, or
Atovaquone/Proguanil Hydrochloride 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 HIV

Tell your doctor if you are taking any of these.

Your doctor may decide that Atovaquone/Proguanil
Hydrochloride is not suitable for you, or that you need
extra check ups while you are taking it.
Remember to tell your doctor if you start

taking any other medicines while you are taking
Atovaquone/Proguanil Hydrochloride.
Atovaquone/Proguanil Hydrochloride with food and
drink
Take Atovaquone/Proguanil Hydrochloride with food or a
milky drink, where possible. This will increase the amount
of Atovaquone/Proguanil Hydrochloride your body can
absorb, and make your treatment more effective.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant
or are planning to have a baby, do not take
Atovaquone/Proguanil Hydrochloride unless your
doctor recommends it.
Ask your doctor or pharmacist for advice before taking
this medicine.
Do not breast-feed while taking
Atovaquone/Proguanil Hydrochloride, as the ingredients
of Atovaquone/Proguanil Hydrochloride may pass into
breast milk and may harm your baby.
Driving and using machines
If you feel dizzy, do not drive.
Atovaquone/Proguanil Hydrochloride 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.
Atovaquone/Proguanil Hydrochloride contains lactose. If you
have been told by your doctor that you have an intolerance to
some sugars, such as lactose, contact your doctor before taking
this medicine.

3. HOW TO TAKE ATOVAQUONE/PROGUANIL
HYDROCHLORIDE
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or pharmacist
if you are not sure.

Take Atovaquone/Proguanil Hydrochloride with food or a
milky drink, where possible.
It is best to take Atovaquone/Proguanil Hydrochloride at
the same time each day.
To prevent malaria:
The recommended dose for adults and children
weighing at least 40 kg is 1 tablet once a day, taken
as below. Atovaquone/Proguanil Hydrochloride is not
recommended for preventing malaria in children, or in
adults or adolescents who weigh less than 40 kg:
• start taking Atovaquone/Proguanil Hydrochloride 1 to
2 days before travelling to an area which has malaria
• continue taking it every day during your stay
• continue taking it for another 7 days after your return
to a malaria-free area.
To treat malaria:
The recommended dose for adults is 4 tablets once a

day for 3 days.

For children weighing 11 kg or more the dose depends
on their bodyweight:
11-20 kg – 1 tablet once a day for 3 days
21-30 kg – 2 tablets once a day for 3 days
31-40 kg – 3 tablets once a day for 3 days
over 40 kg – dose as for adults.
Not recommended for treating malaria in children who
weigh less than 11 kg.
For children who weigh less than 11 kg talk to your
doctor. There may be a different type of tablets available
in your country for children, containing less atovaquone
and proguanil hydrochloride.
If you take more Atovaquone/Proguanil Hydrochloride
than you should
Contact a doctor or pharmacist for advice.
If possible show them the Atovaquone/Proguanil
Hydrochloride pack.
If you forget to take Atovaquone/Proguanil
Hydrochloride
It is very important that you take the full course of
Atovaquone/Proguanil Hydrochloride.
If you forget to take a dose, do not worry. Just take your
next dose as soon as you remember. Then continue your
treatment as before. Do not take a double dose to make
up for a forgotten dose.
If you stop taking Atovaquone/Proguanil
Hydrochloride
Do not stop taking Atovaquone/Proguanil Hydrochloride
without advice.
Keep taking Atovaquone/Proguanil Hydrochloride for
7 days after you return to a malaria-free area. Take the
full course of Atovaquone/Proguanil Hydrochloride for
maximum protection. Stopping early puts you 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 this
medicine, ask your doctor or pharmacist.
If you are sick (vomit):
For preventing malaria:

• If you are sick (vomit) within 1 hour of taking your

Date: 22 Apr 2014
Description Atovaquone Proguanil Hydrochloride 250/100mg 12/24
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 407316

SAP No. N/A

Superceded Affiliate Item Code 10005258

Vendor Job No. 228174

TrackWise PR No. 407316

Proof No. 2

MA No. 04569/1271

Client Market UK/IE

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

TBC

ATOVAQUONE/PROGUANIL
HYDROCHLORIDE 250 mg/100 mg
FILM-COATED TABLETS

• warfarin and other medicines that stop blood clotting
• etoposide used to treat cancer.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Time: 16:13
Page Count

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Non-Print
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with
Main Font Myriad Pro
Dimensions 170 x 360mm

Body Text Size 9pt

Atovaquone/Proguanil Hydrochloride film-coated
tablet, take another dose straight away.
• It is important to take the full course of Atovaquone/
Proguanil Hydrochloride. If you have to take extra
tablets due to sickness, you may need another
prescription.
• If you have been vomiting, it is especially important to
use extra protection, such as repellents and bednets.
Atovaquone/Proguanil Hydrochloride may not be as
effective, as the amount absorbed will be reduced.
For treating malaria:
• If you have vomiting and diarrhoea tell your
doctor, you will need regular blood tests.
Atovaquone/Proguanil Hydrochloride 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.
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, but their exact
frequency is unknown.
Severe allergic reactions – signs include:
• rash and itching
• sudden wheezing, tightness of the chest or throat, or
difficulty breathing or low blood pressure
• swollen eyelids, face, lips, tongue or other part of
the body.
Contact a doctor immediately if you get
any of these symptoms and stop taking
Atovaquone/Proguanil Hydrochloride.
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 pain
• diarrhoea.
Common side effects (may affect up to 1 in
10 people):
• dizziness
• sleeping problems (insomnia)
• strange dreams
• depression
• loss of appetite
• fever
• 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 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 of the mouth
• hair loss.
Uncommon side effects that may show up in your
blood tests:
• An increase in amylase (an enzyme produced in
the pancreas).
Not known (frequency cannot be estimated from the
available data)
Other side effects have occurred in a small number of
people but their exact frequency is unknown:
• inflammation of the liver (hepatitis)
• blockage of the bile ducts (cholestasis)
• increase in heart rate (tachycardia)
• 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
• fits (seizures)
• panic attacks, crying
• seeing or hearing things that are not there
(hallucinations)
• nightmares
• mouth ulcers
• blisters
• peeling skin
• increased sensitivity of the skin to sunlight.
Other side effects that may show up in your blood tests:
• in people with severe kidney disease, 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:
UK
Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard
Ireland
Pharmacovigilance Section
Irish Medicines Board
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE ATOVAQUONE/PROGUANIL
HYDROCHLORIDE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which
is stated on the blister and the carton after 'EXP'.
The expiry date refers to the last day of that month.
Store in the original package in order to protect
from moisture.
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 Atovaquone/Proguanil Hydrochloride contains:
• The active substances are atovaquone and proguanil
hydrochloride. Each film-coated tablet contains 250
mg atovaquone and 100 mg proguanil hydrochloride.
• The other ingredients are:
Tablet core: Cellulose, microcrystalline, Povidone
(K-30), Crospovidone (Type A), Poloxamer 188,
Magnesium stearate.
Film-coat: Titanium dioxide (E171), Lactose
monohydrate, Macrogol 4000, Hypromellose 15cP
(E464), Hypromellose 50cP (E464), Hypromellose 3cP
(E464), Iron oxide red (E172), Iron oxide black (E172),
Iron oxide yellow (E172).
What Atovaquone/Proguanil Hydrochloride looks like
and contents of the pack
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg
film-coated tablets are buff coloured, round, biconvex,
film-coated tablets debossed with 'A-P' over '2' on
one side and 'M' on the other side. They are supplied
in PVC-Aluminium, OPA/Aluminium/PVC-Aluminium,
PVC/PVdC-Aluminium blister packs containing
12, 24 tablets or 12 x 1, 24 x 1 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Generics [UK] Ltd., Potters Bar, Herts., EN6 1TL,
United Kingdom.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd., Potters Bar, Herts., EN6 1TL,
United Kingdom.
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1,
Hungary.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany Malarex
250 mg/100 mg Filmtabletten
Austria Atovaquon/Proguanil
Arcana 250 mg/100 mg Filmtabletten
Belgium Atovaquone/Proguanil Mylan
250 mg/100 mg Filmomhulde
tabletten
Denmark Provaqomyl
Finland Provaqomyl
France Atovaquone/Proguanil
MYLAN, 250 mg/100 mg,
comprimé pelliculé
Italy Atovaquone e Proguanile Mylan
Generics
Ireland Atovaquone/Proguanil Hydrochloride
250 mg/100 mg film-coated tablets
Norway Provaqomyl
Sweden Provaqomyl
Spain Atovacuona/Hidrocloruro
de proguanil
MYLAN 250 mg/100 mg comprimidos
recubiertos con película EFG
The Netherlands Atovaquon/Proguanil HCl Mylan
250/100 mg, filmomhulde tabletten
United Kingdom Atovaquone/Proguanil
Hydrochloride
250 mg/100 mg film-coated tablets
This leaflet was last revised in January 2014.

Date: 22 Apr 2014
Description Atovaquone Proguanil Hydrochloride 250/100mg 12/24
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 407316

SAP No. N/A

Superceded Affiliate Item Code 10005258

Vendor Job No. 228174

TrackWise PR No. 407316

Proof No. 2

MA No. 04569/1271

Client Market UK/IE

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

407316
00000000

Time: 16:13
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 360mm

Body Text Size 9pt

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.

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