Adverse reactions : תופעות לוואי

4.8      UNDESIRABLE EFFECTS
As Foster 100/6 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 100/6) 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, pneumonia* (in        Common Infestations            COPD patients)

Influenza, oral fungal infection, oropharyngeal      Uncommon candidiasis, oesophageal candidiasis,
vulvovaginal candidiasis, gastroenteritis,
sinusitis, rhinitis

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
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, blood pressure           Rare decreased

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 100/6.
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, erythema 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