Docosanol

Docosanol should not be used in immuno compromised patients.

There are no data from the use of docosanol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Since systemic exposure to docosanol is negligible, docosanol can be used during pregnancy.

There are no data from the use of docosanol in breast feeding women. No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to docosanol is negligible. Docosanol can be used during breast-feeding.

Due to its negligible absorption docosanol has no influence on the ability to drive and use machines.

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data)

Results from clinical trials of the treatment of recurrent labial herpes simplex demonstrate no difference in the frequency or type of undesirable effects in patients treated with docosanol cream or placebo.

Nervous system disorders

Very common: Headache (10.4% of docosanol-treated patients and 10.7% of placebo-treated patients).

General disorders and administration site conditions

Common: Application site adverse reactions which include dry skin, rashes and skin disorders (2.9% of docosanol-treated patients and 2.3% of placebo-treated patients).

Facial oedema has also been reported but these application site adverse reactions are consistent with normal facial reactions experienced with cold sores.