Breast-feeding

The atovaquone concentrations in milk, in a rat study, were 30% of the concurrent atovaquone concentrations in maternal plasma. It is not known whether atovaquone is excreted in human milk.

Proguanil is excreted in human milk in small quantities.

Malarone should not be taken by breast-feeding women.

4.7 Effects on ability to drive and use machines
Dizziness has been reported. Patients should be warned that if affected they should not drive, operate machinery or take part in activities where this may put themselves or others at risk.

4.8 Undesirable effects
In clinical trials of Malarone 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 Malarone 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 Malarone on growth, puberty and general development have not been studied.

System Organ Class
 Very Common
 Common
 Uncommon
 Rare
 Not known2
 
Blood and lymphatic disorders
   Anaemia

Neutropenia 1
     Pancytopenia
 
Immune system disorders
   Allergic reactions
     Angioedema3

Anaphylaxis (see section 4.4)

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