Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The following frequency categories are used for the evaluation of undesirable effects: 
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)
Not known (frequency cannot be estimated from the available data)
Skin and subcutaneous tissue disorders
Very rare: drying, reddening, burning and itching of the skin. In these cases it is appropriate to continue treatment with the Aknemycin preparations Aknemycin Ointment or Aknemycin Emulsion, as these dry out the skin to a lesser extent. Aknemycin Solution can also be applied alternately with these preparations.

In individual cases the above symptoms may also be signs of a hypersensitivity reaction to the active substance or any of the excipients (allergic contact eczema).

Not known: acute generalised exanthematous pustulosis (AGEP)

After prolonged treatment the symptoms may become worse through the development of resistance and gram-negative folliculitis.

Reporting 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/ and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com