The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 25258/0166.
Maloff Protect 250 mg/100 mg tablets
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
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
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.
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.
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.
Tell your doctor that you have visited a malaria area.
Talk to your doctor or pharmacist for advice.
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.
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.
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.
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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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:
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
Common: may affect up to 1 in 10 people
Common side effects, which may show up in your blood tests are:
Uncommon: may affect up to 1 to 100 people
Uncommon side effects that may show up in your blood tests:
Rare: may affect up to 1 in 1,000 people
Other side effects have occurred in a small number of people but their exact frequency is unknown.
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.
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.
The active substances are atovaquone and proguanil hydrochloride. Each tablet contains 250 mg atovaquone and 100 mg proguanil hydrochloride.
The other ingredients are:
Poloxamer 188, Microcrystalline Cellulose, Low-substituted Hydroxypropyl Cellulose, Povidone K30, Sodium Starch Glycolate Type A, Silica Colloidal anhydrous, Magnesium Stearate
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
This leaflet was last revised in May-2017