Adverse reactions : תופעות לוואי

4.8       Undesirable effects

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) including isolated reports.
Common and uncommon events were generally determined from clinical trial data. The incidence on placebo was not taken into account. Very rare events are generally determined from post-marketing spontaneous data.

The following frequencies are estimated at the standard dose of 50mcg twice daily.
Frequencies at the higher dose of 100mcg twice daily have also been taken to account where appropriate.

System Organ Class      Adverse Reaction                      Frequency Immune System           Hypersensitivity reactions with the
Disorders               following manifestations:

Rash (itching and redness)            Uncommon

Anaphylactic reactions including      Very Rare oedema and angioedema,bronchospasm and anaphylactic shock
Metabolism &            Hypokalaemia                          Rare
Nutrition Disorders     Hyperglycaemia                        Very Rare Psychiatric Disorders   Nervousness                           Uncommon Insomnia                              Rare
Nervous System          Headache (see section 4.4)            Common
Disorders               Tremor (see section 4.4)              Common
Dizziness                             Rare
Cardiac Disorders       Palpitations (see section 4.4)        Common
System Organ Class      Adverse Reaction                        Frequency Tachycardia                             Uncommon
Cardiac arrhythmias (including          Very Rare atrial fibrillation, supraventricular tachycardia and extrasystoles).
Respiratory, Thoracic   Oropharyngeal irritation                Very Rare & Mediastinal           Paradoxical bronchospasm (see           Very rare Disorders               section 4.4)
Gastrointestinal        Nausea                                  Very Rare Disorders
Musculoskeletal &       Muscle cramps                           Common Connective Tissue       Arthralgia                              Very Rare Disorders
General Disorders and   Non-specific chest pain                 Very Rare Administration Site
Conditions

The pharmacological side effects of β2-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and to reduce with regular therapy. Tremor and tachycardia occur more commonly when administered at doses higher than 50mcg twice daily.

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).