Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The safety of Daktarin Oral Gel was evaluated in 111 patients with oral candidiasis or oral mycoses who participated in 5 clinical trials. Of these 111 patients, 88 were adults with oral candidiasis or oral mycoses who participated in 1 randomised, active-controlled, double-blind clinical trial and 3 open-label clinical trials. The other 23 patients were paediatric patients with oral candidiasis who participated in 1 randomised, active-controlled, open-label clinical trial in paediatric patients (aged ≤1 month to 10.7 years). These patients took at least one dose of Daktarin Oral Gel and provided safety data.
Based on the pooled safety data from these 5 clinical trials (adult and paediatric), the most commonly reported (≥1% incidence) adverse reactions were nausea (6.3%), product taste abnormal (3.6%), vomiting (3.6%), oral discomfort (2.7%), regurgitation (1.8%), and dry mouth (1.8%). Dysgeusia was reported in 0.9% of patients.

Adult Patients
Based on the pooled safety data from the 4 clinical trials in adults, common adverse reactions reported included nausea (4.5%), product taste abnormal (4.5%), oral discomfort (3.4%), dry mouth (2.3%), dysgeusia (1.1%), and vomiting (1.1%).

Paediatric Patients
In the 1 paediatric clinical trial, the frequency of nausea (13.0%) and vomiting (13.0%) was very common, and regurgitation (8.7%) was common. As identified through post-marketing experience, choking may occur in infants and young children (See Section 4.3 Contraindications and Section 4.4 Special warnings and special precautions). The frequency, type, and severity of other adverse reactions in children are expected to be similar to that in adults.

Description of selected adverse reactions
Increases in INR and bleeding events such as epistaxis, contusion, haematuria, melaena, haematemesis, haematoma and haemorrhages have been reported in patients treated with oral anticoagulants such as warfarin in association with miconazole oral gel (see sections 4.4 and 4.5). Some events had fatal outcomes.
Table A includes all identified adverse reactions, including those that that have been reported from post-marketing experience.

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).

Table A: Adverse Drug Reactions in Patients Treated with DAKTARIN Oral Gel 
System Organ Class                              Adverse Drug Reactions Frequency Category
Common                   Uncommon                 Not Known
(≥1/100 to <1/10)        (≥1/1,000 to <1/100)

Immune System                                                              Anaphylactic reaction, Disorders                                                                  Hypersensitivity 

Nervous System                                    Dysgeusia
Disorders
Respiratory,                                                               Choking Thoracic and
Mediastinal
Disorders

Gastrointestinal         Dry mouth, Nausea,                                Diarrhoea, Stomatitis, Disorders                Oral discomfort,                                  Tongue discolouration Vomiting,
Regurgitation

Hepatobiliary                                                              Hepatitis Disorders
Skin and                                                                        Angioedema, Toxic Subcutaneous                                                                    epidermal necrolysis, Tissue Disorders                                                                Stevens-Johnson syndrome, Urticaria,
Rash, Acute generalised exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms

General Disorders         Product taste and Administration        abnormal
Site Conditions


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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