Adverse reactions : תופעות לוואי

4.8   Undesirable effects

As Seretide contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds.

Adverse events which have been associated with salmeterol/fluticasone propionate are given below, listed 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 not known (cannot be estimated from the available data). Frequencies were derived from clinical trial data. The incidence in placebo was not taken into account.

System Organ Class       Adverse Event                                             Frequency Infections &             Candidiasis of the mouth and throat                       Common Infestations
Pneumonia (in COPD patients)                              Common1,3,5 
Bronchitis                                                Common1,3

Oesophageal candidiasis                                   Rare
Immune System            Hypersensitivity reactions with the following Disorders                manifestations:

Cutaneous hypersensitivity reactions                     Uncommon

Angioedema (mainly facial and oropharyngeal              Rare oedema)
Respiratory symptoms (dyspnoea)                           Uncommon

Respiratory symptoms (bronchospasm)                       Rare

Anaphylactic reactions including anaphylactic shock       Rare

System Organ Class      Adverse Event                                        Frequency Endocrine Disorders     Cushing’s syndrome, Cushingoid features, Adrenal     Rare4 suppression, Growth retardation in children and adolescents, Decreased bone mineral density

Metabolism &            Hypokalaemia                                         Common3 Nutrition Disorders
Hyperglycaemia                                       Uncommon4

Psychiatric Disorders   Anxiety                                              Uncommon 
Sleep disorders                                      Uncommon

Behavioural changes, including psychomotor           Rare hyperactivity and irritability (predominantly in children)
Depression, aggression (predominantly in children)   Not known

Nervous System          Headache                                             Very Common1 Disorders
Tremor                                               Uncommon

Eye Disorders           Cataract                                             Uncommon 
Glaucoma                                             Rare4

Vision, blurred                                      Not known4
Cardiac Disorders       Palpitations                                         Uncommon 
Tachycardia                                          Uncommon

Cardiac arrhythmias (including supraventricular      Rare tachycardia and extrasystoles).
Atrial fibrillation                                  Uncommon

Angina pectoris                                      Uncommon

Respiratory, Thoracic   Nasopharyngitis                                      Very Common2,3 & Mediastinal
Disorders               Throat irritation                                    Common 
Hoarseness/dysphonia                                 Common

Sinusitis                                            Common1,3
Paradoxical bronchospasm                             Rare4

Skin and                Contusions                                           Common1,3 subcutaneous tissue disorders


System Organ Class       Adverse Event                                              Frequency Musculoskeletal &        Muscle cramps                                              Common Connective Tissue
Disorders                Traumatic fractures                                        Common1,3 
Arthralgia                                                 Common

Myalgia                                                    Common
1.    Reported commonly in placebo
2.    Reported very commonly in placebo
3.    Reported over 3 years in a COPD study
4.    See section 4.4
5.    See section 5.1.

Description of selected adverse reactions

The pharmacological side effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.

As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting bronchodilator and should be treated straightaway. Seretide Diskus should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat and, rarely, of the oesophagus can occur in some patients. Both hoarseness and incidence of mouth and throat candidiasis may be relieved by rinsing the mouth with water and/or brushing the teeth after using the product. Symptomatic mouth and throat candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the Seretide Diskus.

Paediatric population

Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression and growth retardation in children and adolescents (see section 4.4). Children may also experience anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability.

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)