Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Adverse drug reactions (ADRs) are summarized below for Duac Gel as a combination including any additional ADRs that have been reported for the single topical active ingredients, benzoyl peroxide or clindamycin. Adverse drug reactions are listed by MedDRA system organ class and by frequency. 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 and <1/1,000) and not known (cannot be estimated from the available data).

MedDRA SOC             Very Common        Common         Uncommon               Not known** Immune system                                                              Allergic reactions disorders                                                                  including hypersensitivity and anaphylaxis
Nervous system                                           Paraesthesia disorders*
Gastrointestinal                                                           Colitis (including disorders                                                                  pseudomembranous colitis), hemorrhagic diarrhea, diarrhea,
abdominal pain
Skin and                Erythema,           Burning      Dermatitis,       Urticaria subcutaneous tissue     peeling, dryness    sensation    pruritus,
disorders*              (Generally                       erythematous reported as                      rash,
‘mild’ in                        worsening of severity)                        acne
General disorders                                                           Application site reactions and Administration                                                          including skin site conditions                                                             discoloration *At site of application. **Based on post-marketing reports. Since these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency however, systemic reactions are rarely seen.

In addition to the ADRs reported in the table above, in the pivotal trial conducted with topical clindamycin 1%/benzoyl peroxide 3% gel, application site photosensitivity reaction was also reported commonly.
Also in addition to the ADRs reported above, in studies conducted with topical clindamycin alone, headache and application site pain were reported commonly.

Local Tolerability
During the five clinical trials with Duac Gel, all patients were graded for facial erythema, peeling, burning, and dryness on the following scale: 0 = absent, 1 = mild, 2 = moderate and 3 = severe. The percentage of patients that had symptoms present before treatment (at baseline) and during treatment were as follows:

Local Tolerability Assessments for Subjects (N=397) in the Duac Gel Group during the Phase 3 Studies
Before Treatment (Baseline)              During Treatment
Mild         Moderate         Severe         Mild         Moderate         Severe 
Erythema        28%          3%               0              26%          5%               0 Peeling        6%            <1%             0              17%          2%               0 
Burning        3%            <1%             0              5%           <1%              0 
Dryness        6%            <1%             0              15%          <1%              0 

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 can also report to Padagis.co.il.