Adverse reactions : תופעות לוואי

4.8      Undesirable effects
As Foster 200/6 contains beclometasone dipropionate and formoterol fumarate dihydrate, 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.
Undesirable effects which have been associated with beclometasone dipropionate and formoterol administered as a fixed combination (Foster) and as single agents are given below, listed by system organ class. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 < 1/1,000) and very rare (≤1/10,000).
Common and uncommon ADRs were derived from clinical trials in asthmatic and COPD patients.
System Organ Class      Adverse Reaction                                  Frequency 
Infections and          Pharyngitis, oral candidiasis                     Common Infestations
Influenza, oral fungal infection, oropharyngeal    Uncommon candidiasis, oesophageal candidiasis, vulvovaginal candidiasis, gastroenteritis, sinusitis, rhinitis,
pneumonia*

Blood and lymphatic     Granulocytopenia                                  Uncommon system disorders

Thrombocytopenia                                  Very rare

Immune system           Dermatitis allergic                               Uncommon disorders


Hypersensitivity reactions, including erythema,   Very rare lips, face, eye and pharyngeal oedema

Endocrine disorders     Adrenal suppression                               Very rare 

Metabolism and          Hypokalaemia, hyperglycaemia                      Uncommon nutrition disorders

Psychiatric disorders   Restlessness                                      Uncommon 
Psychomotor hyperactivity, sleep disorders,       Unknown anxiety, depression, aggression, behavioural changes (predominantly in children)

Nervous system          Headache                                          Common disorders
Tremor, dizziness                                 Uncommon

Eye disorders           Glaucoma, cataract                                Very rare Vision, blurred (see also section 4.4)               Unknown

Ear and labyrinth       Otosalpingitis                                       Uncommon disorders

Cardiac disorders       Palpitations, electrocardiogram QT corrected         Uncommon interval prolonged, electrocardiogram change,
tachycardia, tachyarrhythmia, atrial fibrillation*

Ventricular extrasystoles, angina pectoris           Rare

Vascular disorders      Hyperaemia, flushing                                 Uncommon 
Respiratory, thoracic   Dysphonia                                            Common and mediastinal disorders               Cough, productive cough, throat irritation,          Uncommon asthmatic crisis, pharyngeal erythema

Bronchospasm paradoxical                             Rare

Dyspnoea, exacerbation of asthma                     Very rare
Gastrointestinal        Diarrhoea, dry mouth, dyspepsia, dysphagia,          Uncommon disorders               burning sensation of the lips, nausea, dysgeusia 
Skin and                Pruritus, rash, hyperhidrosis, urticaria             Uncommon subcutaneous tissue disorders               Angioedema                                           Rare 
Musculoskeletal and     Muscle spasms, myalgia                               Uncommon connective tissue disorders
Growth retardation in children and adolescents       Very rare


Renal and urinary       Nephritis                                            Rare disorders

General disorders and Oedema peripheral                                      Very rare administration site conditions

Investigations          C-reactive protein increased, platelet count         Uncommon increased, free fatty acids increased, blood insulin increased, blood ketone body increased, blood cortisol decrease*

Blood pressure increased                               Uncommon


Blood pressure decreased                               Rare

Bone density decreased                                 Very rare

* One related non serious case of pneumonia was reported by one patient treated with Foster 100/6 in a pivotal clinical trial in COPD patients. Other adverse reactions observed with Foster 100/6 in COPD clinical trials were: reduction of blood cortisol and atrial fibrillation.

As with other inhalation therapy, paradoxical bronchospasm may occur (see 4.4 'Special Warnings and Precautions for Use').
Among the observed adverse reactions those typically associated with formoterol are: hypokalaemia, headache, tremor, palpitations, cough, muscle spasms and prolongation of QTc interval.
Adverse reactions typically associated with the administration of beclometasone dipropionate are: oral fungal infections, oral candidiasis, dysphonia, throat irritation.
Dysphonia and candidiasis may be relieved by gargling or rinsing the mouth with water or brushing the teeth after using the product. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst continuing the treatment with Foster 200/6.
Systemic effects of inhaled corticosteroids (e.g. beclometasone dipropionate) may occur particularly when administered at high doses prescribed for prolonged periods, these may include adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma (see also 4.4).
Hypersensitivity reactions including rash, urticaria pruritus, erhythema and oedema of the eyes, face, lips and throat may also occur.

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 Kamada LTD to email address: pharmacovigilance@kamada.com