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MALOFF 250 MG/100 MG FILM-COATED TABLETS

Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Maloff 250 mg/100 mg Film-coated tablets
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 symptoms 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.

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

1.

WHAT MALOFF IS AND WHAT IT IS USED FOR

Maloff belongs to a group of medicines called antimalarials. It contains two active ingredients,
atovaquone and proguanil hydrochloride.
Maloff is used for:
• to prevent malaria in adults and children who weigh more than 40 kg
• to treat malaria in adults and children who weigh more than 11 kg
Dosage instructions for each use are in Section 3, How to take Maloff MaloffMaloff
Malaria is spread by the bite of an infected mosquito, which passes the malaria parasite
(Plasmodium falciparum) into the bloodstream. Maloff prevents malaria by killing this
parasite. For people who are already infected with malaria, Maloff 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 Maloff,
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

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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 MALOFF

Do not take Maloff:
• if you are allergic ) to atovaquone and/or proguanil hydrochloride or any of the ingredients of this
medicine (listed in section 6).
• for preventing malaria, if you have severe kidney disease.
→ Tell your doctor if either of these apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Maloff :
• if the disease returns after treatment with Maloff, or if you get the disease even if you have taken
preventive treatment with Maloff. You will in these cases be treated with another drug.
• if the disease is caused by the parasite P. vivax or P. ovale. In these cases, treatment with Maloff
alone may not be enough and you need additional treatment with another drug.
• if you vomit within 1 hour after you take Maloff. You should then take another dose.
• if you have acute malaria with vomiting and diarrhea. You must then may need a different
medicine against malaria. Ask your doctor.
• if you are simultaneously being treated with tetracycline (anti-inflammatory) the amount of
parasites in your blood monitored.
• if you are also being treated for HIV.
• if you are being treated concomitantly with rifampicin or rifabutin (against inflammation).
• if you are concomitantly treated with metoclopramide (for nausea / vomiting).
• if you are taking warfarin or other means to prevent blood clots.
• if you are simultaneously being treated with etoposide (against cancer).
• if you have very poor kidney function and will require treatment for malaria.
If you have diarrhea, continue with the recommended dosage. By diarrhea and / or vomiting, you
should still protect yourself from mosquito bites (eg. By using mosquito nets and insect repellent).
For severe allergic reactions treatment should be discontinued immediately and appropriate treatment
is started. Contact your doctor.
The safety and efficacy of Maloff for the prevention of malaria in individuals weighing less than 40
kg and the treatment of malaria in children who weigh less than 11 kg has not been established.
Other medicines and Maloff
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines you’ve bought without a prescription.
Some medicines can affect the way Maloff works, or Maloff itself can strengthen or weaken
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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
• indinavir, used to treat HIV
• 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 Maloff isn’t suitable
for you, or that you need extra check ups while you’re taking it.
REMEMBER to tell your doctor if you start taking any other medicines while you’re taking Maloff.
Maloff with food and drink
Take Maloff with food or a milky drink, where possible. This will increase the amount of Maloff
your body can absorb, and make your treatment more effective.
The tablets should preferably not be crushed.
Pregnancy and breast-feeding
If you are pregnant or if you have the intention to get pregnant, do not take Maloff unless your doctor
recommends it.
Ask your doctor or pharmacist for advice before taking Maloff.
Do not breast-feed while taking Maloff, as the ingredients of Maloff may pass into breast milk and
may harm your baby.
Driving and using machines
Maloff 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 TAKE Maloff

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 Maloff with food or a milky drink, where possible.
It is best to take Maloff at the same time each day.
If you are sick (vomit)
For preventing malaria:
• if you are sick (vomit) within 1 hour of taking your Maloff tablet, take another dose straight
away
• it is important to take the full course of Maloff. 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. Maloff 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.
Maloff will not be as effective, as the amount absorbed will be reduced. The tests will
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check whether the malaria parasite is being cleared from your blood.
To prevent malaria:
The recommended usual dose for adults and adolescents weighing more than 40 kg is 1 tablet once a
day, taken as below.
Maloff is not recommended for preventing malaria in children, or in adults who weigh less than 40
kg.
There may be a different type of Maloff tablet available for children in your country.
To prevent malaria in adults:
• start taking Maloff 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 the dose depends on their bodyweight:
• 11 - 21 kg – 1 tablet once a day for 3 days
• 21 -31 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
Maloff tablet available in your country
If you take more Maloff than you should
Contact a doctor or pharmacist for advice. If possible show them the Maloff pack.
If you forget to take Maloff
It is very important that you take the full course of Maloff. If you forget to take a dose, don’t worry.
Just take your next dose as soon as you remember. Then continue your treatment as before.
Don’t take extra tablets to make up for a missed dose. Just take your next dose at the usual time.
Don’t stop taking Maloff without advice
Keep taking Maloff for 7 days after you return to a malaria-free area. Take the full course of
Maloff 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 product, ask your doctor or pharmacist.

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.

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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.
Contact a doctor immediately if you get any of these symptoms. Stop taking Maloff.
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: affects more than 1 in 10 people
• headache
• feeling sick and being sick (nausea and vomiting)
• stomach pain
• diarrhoea

Common: affects up to 1 in 10 people
• dizziness
• sleeping problems (insomnia)
• strange dreams
• depression
• loss of appetite
• fever
• rash which may be itchy
• cough
• allergic reactions

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: affects up to 1 in 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: affects up to 1 in 1000 people
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• 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 of the liver (hepatitis)
• blockage of the bile ducts (cholestatis)
• 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 (seizure)
• 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 sunlightEffects on your stomach (gastric intolerance)
Other side effects that may show up in your blood tests:
• A decrease in all types of blood cells (pancytopenia).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
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 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.

HOW TO STORE MALOFF

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 medicinal product 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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Maloff 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 , Low-substituted Hydroxypropyl Cellulose , Povidone
K30 , Sodium Starch Glycolate Type A, Silica Colloidal anhydrous, Magnesium Stearate
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Coating
Hypromellose, Titanium Dioxide ( E171) , Iron Oxide Red (E172 ), Macrogol 400, Macrogol 8000
What Maloff looks like and contents of the pack
Maloff tablets are Pinkish brown to brown coloured, circular, biconvex beveled edge film-coated
tablets with ‘404’ debossed on one side and ‘G’ debossed on the other side
Maloff are supplied in PVC/PVDC (clear) and hard tempered PVC/PVDC-Aluminium foil blister
packs containing 12 tablets
Pack size: 12, 24 and 36
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, WD 18 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 medicinal product is authorised in the Member States under the following names:
Denmark

Malomoz

United Kingdom

Maloff 250 mg /100 mg Film-coated tablets

This leaflet was last revised in.01/2016

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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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