MaloffProtect

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.

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

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.

• a high temperature (fever)
• headache
• tiredness
• sweats and chills
• vomiting

Tell your doctor that you have visited a malaria area.

• 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

• 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

• 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.

• 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.

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.

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.

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.

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.

Contact a doctor or pharmacist for advice. If possible, show them the Maloff Protect pack.

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.

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)

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.

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

Coating

Hypromellose, Titanium Dioxide (E171), Iron Oxide Red (E172), Macrogol 400, Macrogol 8000

Maloff Protect tablets are pinkish brown to brown coloured, circular, biconvex bevelled edge film-coated 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