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MALOFF PROTECT 250MG/100MG TABLETS

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

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PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Maloff Protect 250 mg/100 mg tablets
atovaquone/proguanil hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.





Keep this leaflet. You may need to read it again.
Ask your pharmacist or doctor if you need more information or advice.
If you have any further questions, ask your doctor or pharmacist.
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.

In this leaflet:
1. What Maloff Protect is and what it is used for
2. What you need to know before you take Maloff
Protect
3. How to take Maloff Protect
4. Possible side effects
5. How to store Maloff Protect
6. Contents of the pack and other information

1. W
 HAT MALOFF PROTECT IS AND
WHAT IT IS USED FOR
Maloff Protect belongs to a group of medicines
called antimalarials. It contains two active
ingredients, atovaquone and proguanil
hydrochloride.
Maloff Protect is used to prevent malaria. It
is available from the pharmacy for adults. It is not
suitable for use in children or adolescents unless
it has been prescribed for them by a doctor. If you
are under 18 and you are visiting an area where
there is malaria, talk to your doctor, nurse or
pharmacist for advice.
Malaria is spread by the bite of an infected
mosquito, which passes the malaria parasite
(Plasmodium falciparum) into the bloodstream.
Maloff Protect prevents malaria by killing this
parasite.
IMPORTANT: You must get advice from a
healthcare professional about which antimalarial
medicine or medicines to take. You must ask your
doctor, nurse or pharmacist if Maloff Protect is
suitable for the part of the world that you are
visiting. Getting advice for malaria is only one
of the aspects to protect your health before
your travel. Remember to seek a full travel
consultation. If your travel plans change,
you must seek updated travel advice.
Protect yourself from malaria
People of any age can get malaria. It is a serious
disease, but it is preventable. As well as taking
Maloff Protect, it is very important that you also
take steps to avoid being bitten by mosquitoes.
The bite avoidance measures listed below
should be used in combination for maximum
effectiveness.
• Use insect repellent on exposed areas of
the skin.
• Wear clothing that covers most of the
body, especially after sunset as this is the time
when mosquitoes are most active.
• Sleep in a room with screened windows
and doors or under a mosquito net (it is
preferable to sleep under a mosquito net
treated with insecticide if possible).
• Close windows and doors at sunset, if they
are not screened.
• Sleep in a room with air-conditioning or
a fan, as mosquitoes are less active in cooler
temperatures.
• Consider using an insecticide (mats, spray,
plug-ins) to clear a room of insects or to stop
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 these
symptoms, particularly within three months
but even up to one year after returning
home:
• a high temperature (fever)
• headache
• tiredness
• sweats and chills
• vomiting
Tell your doctor that you have visited a malaria
area.

2. W
 HAT YOU NEED TO KNOW BEFORE
YOU TAKE MALOFF PROTECT
Do not take Maloff Protect if you:
• are allergic to atovaquone and/or proguanil
hydrochloride or any of the ingredients of this
medicine (listed in section 6)
• have kidney disease
• have liver disease

Do not take Maloff Protect unless it has
been prescribed for you by a doctor or other
qualified prescriber if you:
• are breastfeeding, pregnant or think you may
be pregnant (see section ‘Pregnancy and
Breastfeeding’)
• are under 18 years old or weigh less than
40 kg
• have ever had epilepsy, convulsions or fits
• suffer from depression
• have tuberculosis
Do not take Maloff Protect if you are already
taking any of the following medicines:
• etoposide, used to treat cancer
• metoclopramide, used to treat nausea and
vomiting
• the antibiotics tetracycline, rifampicin or
rifabutin
• indinavir, efavirenz, zidovudine or certain
medicines called protease inhibitors, used to
treat human immunodeficiency virus (HIV)
• warfarin, other coumarin based
anticoagulants, or new oral anticoagulants
(NOACs) such as dabigatran etexilate,
rivaroxaban, and apixaban
Talk to your doctor or pharmacist for advice.
Warnings and precautions:
• If you are sick (vomit) within one hour of
taking your Maloff Protect tablet, take another
dose straight away. If you don’t start vomiting
until more than one hour after taking Maloff
Protect, do not take another Maloff Protect
tablet until your next dose is due, as it is likely
that Maloff Protect will already be in your
system
• It is very important to take the full course of
Maloff Protect. If you have to take extra tablets
due to sickness, you may need to get some
more
• If you have been vomiting or have diarrhoea,
it is especially important to use extra bite
prevention, such as repellents and bed nets.
The Maloff Protect you have taken may not be
as effective because you may absorb less than
you need
Tell your doctor or pharmacist if you have taken
any medicines to prevent or treat malaria before
and they have not worked or if you have had an
allergic reaction to them. Maloff Protect may not
be suitable for you.
Other medicines and Maloff Protect
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines that you buy
without a prescription.
Do not take Maloff Protect if you are taking any of
the medicines listed in the above section “Do not
take Maloff Protect ”.
REMEMBER to tell your doctor or pharmacist if
you start taking any other medicines while you’re
taking Maloff Protect.
Maloff Protect with food and drink
Take Maloff Protect with food or a milky drink,
where possible. This will increase the amount of
Maloff Protect your body can absorb, and make
your treatment more effective.
It is best if you swallow the tablets whole and do
not crush them.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or
intend to get pregnant, or you are breastfeeding,
do not take Maloff Protect unless your doctor tells
you to.
Pregnant women have an increased risk
of developing severe malaria and a higher
risk of fatality compared to non-pregnant
women.
Seek advice from your doctor or pharmacist if you
are pregnant or breastfeeding and need to take
an antimalarial.
Driving and using machines
Maloff Protect makes some people feel dizzy. If
you feel dizzy, do not drive, use machines or take
part in activities where you may put yourself or
others at risk.
(Please turn over)

Always take this medicine exactly as described
in this leaflet or as your doctor, nurse or
pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Take Maloff Protect with food or a milky drink,
where possible as this helps your body absorb the
active ingredients.
It is best to take Maloff Protect at the same time
each day.
Adults: Take one tablet once a day, as described
below.
• Start taking Maloff Protect one to two days
before travelling to an area which has malaria.
• Continue taking it every day during your stay.
• Take Maloff Protect for another seven days
after your return to a malaria-free area.
• Take the full course of Maloff Protect for
maximum protection. Stopping early puts
you at risk of getting malaria, as it takes seven
days to ensure that any parasites that may
be in your blood after a bite from an infected
mosquito are killed.
Maloff Protect is only available without a
prescription for adults. It is not suitable for use
in children or adolescents unless it has been
prescribed for them by a doctor. If you are under
18 and you are visiting an area where there is
malaria, talk to your doctor, nurse or pharmacist
for advice.
If you take more Maloff Protect than you
should
Contact a doctor or pharmacist for advice. If
possible, show them the Maloff Protect pack.
If you forget to take Maloff Protect
It is important that you take the full course of
Maloff Protect. If you forget to take a dose, take
your next dose as soon as you remember. Then
continue your treatment as before.
Do not take a double dose (two doses at the same
time) to make up for a missed dose.
Only take an additional dose if you are sick (vomit)
within one hour of taking Maloff Protect. See
“Warnings and precautions” overleaf.
Don’t stop taking Maloff Protect unless your
doctor or pharmacist tells you to. The only
exception is if you experience one of the
serious side effects listed in section 4 below.
Talk to your doctor or pharmacist if you need any
advice.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. P
 OSSIBLE SIDE EFFECTS
Like all medicines, Maloff Protect can cause side
effects, although not everybody gets them.
IMPORTANT: If any side effect causes you to stop
taking Maloff Protect, or if you vomit or have
diarrhoea whilst taking Maloff Protect, you should
continue to protect yourself against malaria as
much as possible. Information on how to protect
yourself from malaria is provided in section one
of this leaflet. The bite avoidance measures listed
in section one should be used in combination for
maximum effectiveness.
Look out for the following severe reactions. They
have occurred in a small number of people, but
their exact frequency is unknown.
Stop taking Maloff Protect and contact a
doctor immediately if you notice any of the
following symptoms:
• Severe allergic reactions - signs include:
- rash and itching
- sudden wheezing, tightness of the chest or
throat, or difficulty breathing
- swollen eyelids, face, lips, tongue or other
part of the body
• 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)
Most of the following side effects reported have
been mild and have not lasted very long.
Very common: may affect more than 1 in 10
people
• headache
• feeling sick and being sick (nausea and
vomiting)
• stomach pain
• diarrhoea
Common: may affect up to 1 in 10 people
• dizziness
• sleeping problems (insomnia)
• strange dreams
• depression
• loss of appetite
• fever
• rash
• cough
• allergic reactions
• itching (pruritus)
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





r educed 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: may affect up to 1 to 100 people
• anxiety
• an unusual awareness of abnormal beating of
the heart (palpitations)
• swelling and redness of the mouth
• red swollen patches on the skin (hives)
• hair loss
Uncommon side effects that may show up in
your blood tests:
• an increase in amylase (an enzyme produced
in the pancreas)
Rare: may affect up to 1 in 1,000 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.
• pancytopenia (a decrease in all types of blood
cells)
• 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
• nightmares
• 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 of the skin to sunlight
• effects on your stomach (gastric intolerance)
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 the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By
reporting side effects, you can help provide more
information on the safety of this medicine.

5. H
 OW TO STORE MALOFF PROTECT
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 carton and the blister after
EXP. The expiry date refers to the last day of that
month.
This medicine does not require any special
storage conditions.
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. C
 ONTENTS OF THE PACK AND
OTHER INFORMATION
What Maloff Protect contains
The active substances are atovaquone and
proguanil hydrochloride. Each tablet contains
250 mg atovaquone and 100 mg proguanil
hydrochloride.
The other ingredients are:
Core
Poloxamer 188, Microcrystalline Cellulose, Lowsubstituted Hydroxypropyl Cellulose, Povidone
K30, Sodium Starch Glycolate Type A, Silica
Colloidal anhydrous, Magnesium Stearate
Coating
Hypromellose, Titanium Dioxide (E171), Iron Oxide
Red (E172), Macrogol 400, Macrogol 8000
What Maloff Protect looks like and contents
of the pack
Maloff Protect tablets are pinkish brown to brown
coloured, circular, biconvex bevelled edge filmcoated tablets with ‘404’ debossed on one side
and ‘G’ debossed on the other side.
Maloff Protect tablets are supplied in PVC/PVDC
(clear) and hard tempered PVC/PVDC-Aluminium
foil blisters containing 12 tablets.
Pack size: 24 or 36 tablets
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2 B Draycott Avenue,
Kenton, Middlesex, HA3 0BU,
United Kingdom
Manufacturer
Glenmark Pharmaceuticals Europe Limited.
Building 2, Croxley Green Business Park, Croxley
Green, Hertfordshire, WD18 8YA, United Kingdom
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b, 140 78 Prague 4,
Czech Republic
Tillomed Laboratories Limited
3 Howard Road, Eaton Socon,
St. Neots, Cambridgeshire, PE19 8ET,
United Kingdom
This leaflet was last revised in May-2017

PMUKP00004/A

3. H
 OW TO TAKE MALOFF PROTECT

Expand Transcript

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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