MALOFF PROTECT

Method of administration The daily dose should be taken with food or a milky drink (to ensure maximum absorption) at the same time each day. The tablets should preferably not be crushed. If patients are unable to tolerate food, Maloff Protect should be administered, but systemic exposure of atovaquone will be reduced.

In the event of vomiting within one hour of dosing a repeat dose should be taken. Posology Chemoprophylaxis Chemoprophylaxis should: • commence one to two days prior to entering a malaria-endemic area, continue during the period of the stay, • continue for seven days after leaving the area.

In residents (semi-immune subjects) of endemic areas, the safety and effectiveness of Maloff Protect has been established in studies of up to 12 weeks. In non-immune subjects, the average duration of exposure in clinical studies was 27 days.

Dosage in adults One Maloff Protect tablet daily. Maloff Protect tablets are not recommended for malaria chemoprophylaxis in persons under 40 kg bodyweight. 2).

In clinical trials of atovaquone-proguanil in the treatment of malaria the most commonly reported adverse reactions were abdominal pain, headache, anorexia, nausea, vomiting, diarrhoea and coughing. In clinical trials of atovaquone-proguanil for prophylaxis of malaria, the most commonly reported adverse reactions were headache, abdominal pain and diarrhoea.

The following table provides a summary of adverse reactions that have been reported to have a suspected (at least possible) causal relationship to treatment with atovaquone-proguanil, in clinical trials and spontaneous post-marketing reports.

The following convention is used for the classification of frequency: very common ( 1/10); common ( 1/100 to <1/10); uncommon ( 1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).

There are limited long term safety data in children. In particular, the long-term effects of Maloff on growth, puberty and general development have not been studied. 4) Vasculitis3 Metabolism and nutrition disorders Hyponatraemia1 Anorexia Elevated amylase levels1 Psychiatric disorders Abnormal dreams Depression Anxiety Hallucinations Panic attack Crying Nightmares Psychotic disorder Nervous system disorders Headache Insomnia Dizziness Seizure Cardiac disorders Palpitations Tachycardia Gastrointestinal disorders Nausea1 Vomiting Diarrhoea Abdominal pain Stomatitis Gastric intolerance3 Oral ulceration3 Hepatobiliary disorders Elevated liver enzymes1 Hepatitis Cholestasis3 Skin and subcutaneous tissue disorders Pruritus Rash Hair loss Urticaria Stevens- Johnson syndrome Erythema multiforme Blister Skin exfoliation Photosensitivity reactions General disorders and administration site conditions Fever Respiratory, thoracic and mediastinal disorders Cough 1.

Frequency taken from atovaquone label. Patients participating in clinical trials with atovaquone have received higher doses and have often had complications of advance Human Immunodeficiency Virus (HIV) disease. These events may have been seen at a lower frequency or not at all in clinical trials with atovaquone-proguanil.

Persons taking Maloff Protect for chemoprophylaxis of malaria should be advised to take a repeat dose if they vomit within one hour of dosing. In the event of diarrhoea, normal dosing should be continued. Absorption of atovaquone may be reduced in patients with diarrhoea or vomiting, but diarrhoea or vomiting was not associated with reduced efficacy in clinical trials of Maloff Protect for malaria chemoprophylaxis.

However, as with other antimalarial agents, subjects with diarrhoea or vomiting should be advised to continue with malaria prevention measures by complying with personal protection measures (repellents, bed nets). Occasionally, severe allergic reactions (including anaphylaxis) have been reported in patients taking Maloff Protect.

8) Maloff Protect should be discontinued promptly and appropriate treatment initiated. Maloff Protect should not be used unless advised by a doctor or other qualified prescriber: • In patients who are taking etoposide. 5) • In patients with a history of depression or seizures • In patients with tuberculosis • Patients who are pregnant, planning to become pregnant or breastfeeding.

Pregnant women have an increased risk of developing severe malaria and a higher risk of fatality compared to non-pregnant women. The safety and effectiveness of Maloff Protect has not been established for chemoprophylaxis of malaria in patients who weigh less than 40 kg.

Travellers should be reminded the need of receiving a full travel consultation if they have not already done so to undertake an overall risk assessment-based package of travel health advice. Malaria prophylaxis is only one of the aspects of pre-travel advice.

The maximum duration of travel for which Maloff Protect can be supplied without prescription is 12 weeks (93 tablets). For longer durations of travel, advice should be sought from a doctor or other qualified prescriber.

1 • Patients with diagnosed renal impairment of any severity • Patients with diagnosed hepatic impairment of any severity. • Maloff Protect is contraindicated for use in children and adolescents