Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Malarone Paediatric Tablets
In clinical trials of Malarone paediatric tablets for prophylaxis of malaria, 357 children or adolescents 11 to ≤40 kg body weight received Malarone paediatric tablets. Most of these were residents of endemic areas and took Malarone paediatric tablets for about 12 weeks. The rest were travelling to endemic areas, and most took Malarone paediatric tablets for 2-4 weeks.

Open label clinical studies investigating the treatment of children weighing between ≥5 kg and <11 kg have indicated that the safety profile is similar to that in children weighing between 11 kg and 40 kg, and adults.

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.

Malarone Tablets for Adults
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.

Malarone Tablets for Adults and Malarone Paediatric Tablets
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      Very         Common              Uncommon         Rare              Not known2 Class             Common
Blood and                      Anaemia                                                Pancytopenia lymphatic                      Neutropenia 1 disorders
Immune                         Allergic                                               Angioedema3 system                         reactions                                              Anaphylaxis disorders                                                                             (see section 4.4) Vasculitis3
Metabolism                     Hyponatraemia1      Elevated and nutrition                  Anorexia            amylase disorders                                          levels1
Psychiatric                    Abnormal            Anxiety          Hallucinations    Panic attack disorders                      dreams                                                 Crying Depression                                             Nightmares
Psychotic disorder

Nervous             Headache       Insomnia                                                    Seizure system                             Dizziness disorders
Cardiac                                                 Palpitations                           Tachycardia disorders
Gastrointestina     Nausea1                             Stomatitis                             Gastric l disorders         Vomiting                                                                   intolerance3 Diarrhoea                                                                  Oral ulceration3 Abdomina l pain
Hepatobiliary                      Elevated liver                                              Hepatitis disorders                          enzymes1                                                    Cholestasis3 Skin and                           Pruritus             Hair loss                              Stevens-Johnson subcutaneous                                            Urticaria                              Syndrome tissue                             Rash                                                        Erythema disorders                                                                                      multiforme Blister
Skin exfoliation
Photosensitivity reactions
General                            Fever disorders and administration site conditions
Respiratory,                       Cough thoracic and mediastinal disorders

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.
2.   Observed from post-marketing spontaneous reports and the frequency is therefore unknown
3.   Observed with proguanil.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/ Additionally, you should also report to GSK Israel (il.safety@gsk.com).