Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Tabulated list of adverse reactions
The following adverse reactions reported during clinical trials in excess of placebo for 5 mg/120 mg prolonged-release tablets are listed in the following table by System Organ Class. Frequencies are defined as very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1000, < 1/100); rare (> 1/10,000, < 1/1000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).

System Organ Class               Frequency Category                Adverse Reactions 
Metabolism and nutrition
Common                            Thirst disorders

Nervousness, somnolence,
Common                            depression, agitation,
Psychiatric disorders                                              anorexia 
Very Common                       Insomnia

Confusion, tremor, increased
Uncommon                          sweating, hot flushes, taste
Nervous system disorders                                           perversion 
Common                            Dizziness

Eye disorders                    Uncommon                          Abnormal lacrimation 
Ear and labyrinth disorders      Uncommon                          Tinnitus 
Uncommon                          Palpitation
Cardiac disorders
Common                            Tachycardia

Uncommon                          Epistaxis
Respiratory, thoracic and mediastinal disorders
Common                            Pharyngitis, rhinitis
Constipation, nausea, dry
Gastrointestinal disorders       Common mouth
Skin and subcutaneous
Uncommon                         Pruritus tissue disorders

Micturition frequency and
Renal and urinary disorders      Uncommon                         disorder 

General disorders and administration site              Common                           Headache, fatigue conditions


Other adverse reactions reported during the post-marketing period are listed in the following table.

System Organ Class             Frequency Category                Adverse Reactions 
Hypersensitivity reactions (such
Immune system disorders          Very rare                    as anaphylaxis, rash, urticaria, and angioedema)
Very rare                    Vertigo, convulsions
Posterior reversible encephalopathy syndrome (PRES)
Nervous system disorders                                      (see section 4.4) Reversible Not known cerebral vasoconstriction syndrome (RCVS) (see section
4.4)
Cardiac disorders                Very rare                    Cardiac arrhythmias Vascular disorders               Very rare                    Hypertension Respiratory, thoracic and
Very rare                    Cough, bronchospasm mediastinal disorders
Hepatobiliary disorders          Very rare                    Abnormal hepatic function Very rare                    Alopecia
Skin and subcutaneous                                         Severe skin reactions, including tissue disorders                 Unknown                      acute generalised exanthematous pustulosis (AGEP)
Renal and urinary disorders      Very rare                    Urinary retention Gastrointestinal disorders       Unknown                      Ischaemic colitis Investigations                   Not known                    Weight increased Eye disorders                    Unknown                      Ischaemic optic neuropathy 

Other adverse reactions that were only reported for loratadine in clinical trials and during the post- marketing period include increased appetite, rash and gastritis.

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/