Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticaria (CIU), at the recommended dose of 10 mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%).

Tabulated list of adverse reactions
The following adverse reactions reported during the post-marketing period are listed in the following table by System Organ Class. Frequencies are defined as 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), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

System Organ Class                                Frequency            Adverse Experience Term Hypersensitivity reactions
Immune system disorders                           Very rare            (including angioedema and anaphylaxis)
Nervous system disorders                          Very rare            Dizziness, convulsion Cardiac disorders                                 Very rare            Tachycardia, palpitation Gastrointestinal disorders                        Very rare            Nausea, dry mouth, gastritis Hepatobiliary disorders                           Very rare            Abnormal hepatic function Skin and subcutaneous tissue disorders            Very rare            Rash, alopecia General disorders and administration
Very rare            Fatigue site conditions
Investigations                                    Not Known            Weight increase 
Paediatric population
In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).

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. Healthcare professionals are asked to report any suspected adverse reactions to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il