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) and 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 50 micrograms twice daily. Frequencies at the higher dose of 100 micrograms 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 oedema and angioedema,                  Very Rare bronchospasm and anaphylactic shock
Metabolism & Nutrition    Hypokalaemia                            Rare 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 
Tachycardia                             Uncommon

Cardiac arrhythmias (including atrial   Very Rare fibrillation, supraventricular tachycardia and extrasystoles).
Respiratory, Thoracic &   Oropharyngeal irritation                Very Rare Mediastinal Disorders
Paradoxical bronchospasm (see section   Very Rare
4.4)
Gastrointestinal          Nausea                                  Very Rare Disorders
Musculoskeletal &         Muscle cramps                           Common Connective Tissue
Disorders                 Arthralgia                              Very Rare 

System Organ Class      Adverse Reaction                         Frequency General Disorders and   Non-specific chest pain                  Very Rare Administration Site
Conditions

The pharmacological side effects of beta2 agonist treatment, such as tremor, headache and palpitations 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 50 micrograms 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).