Maloff Protect 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

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 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: 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)

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

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