Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The safety of Daktacort ceam Cream was evaluated in 480 patients who participated in 13 clinical trials (six double-blind and seven open-label trials) of Daktacort ceam Cream. These studies examined patients from 1 month to 95 years of age with infections of the skin caused by dermatophytes or Candida species in which inflammatory symptoms were prominent.

All Patients
No adverse reactions were reported by ≥1% of the 480 Daktacort ceam Cream-treated patients (adult and paediatric patients combined).
The frequency categories use the following convention: very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data).

Of the three adverse reactions identified from the 13 clinical trials of Daktacort ceam Cream, skin irritation was reported in one clinical trial that included patients aged 17 to 84 years, skin burning sensation in two clinical trials that included patients aged 13 to 84 years, and irritability in one clinical trial of infants aged 1 to 34 months.

Paediatric Population
The safety of Daktacort ceam Cream was evaluated in 63 paediatric patients (1 month to 14 years of age) who were treated with Daktacort ceam Cream in 3 of the 13 clinical trials noted above. One adverse reaction term (irritability) was reported in these 3 trials. The frequency of irritability in Daktacort ceam Cream-treated paediatric patients was common (3.2%).
All events of irritability occurred in one clinical trial of infants (aged 1 to 34 months) with napkin (diaper) dermatitis. The frequency, type, and severity of other adverse reactions in paediatric patients are expected to be similar to those in adults. Adverse reactions were reported by ≥1% of the 480 Daktacort ceam Cream-treated patients (adult and paediatric patients combined).


Adverse Reactions in Adult and Paediatric Patients Treated With Daktacort ceam Cream
System      Organ Adverse Reactions
Class
Frequency Category

Uncommon                         Not Known
(≥1/1,000 to <1/100)

Immune System                                              Anaphylactic reaction, Disorders                                                  Hypersensitivity 

Skin and                  Skin irritation, Skin burning    Angioedema, Rash, Contact Subcutaneous              sensation, Urticaria, Pruritus   dermatitis, Erythema, Skin Tissue Disorders                                           inflammation, Skin hypopigmentation, Application site reaction

General Disorders         Irritability and Administration
Site Conditions

Eye disorders                                              Vision, blurred (see also section 4.4) 

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/