Neo-Penotran: There were no deaths or serious adverse events in clinical trials. Medical events judged to be common, uncommon and rare are listed as follows. Unless the percentages are otherwise stipulated, the occurrence of individual adverse reactions was <1%.
Vaginal Disorders: Vaginal irritation (burning, itching) 2-6%. Owing to the inflammation of the vaginal mucosa in vaginitis, vaginal irritation can be seen after the administration of the first ovule or towards the 3rd day of the treatment. These complaints disappear quickly when the treatment continues. If there is severe irritation, the physician should be informed because it may be necessary to stop the treatment.
Gastrointestinal Disorders: Abdominal pain or cramps (3%), metallic taste (1.7%), constipation, dry mouth, seldom diarrhea, lack of appetite, vomiting, nausea.
Nervous System Disorders: Headache, ataxia, dizziness, mental changes, peripheral neuropathy after overdose or long period of usage, cramps.
Skin Disorders: Rash.
Blood Disorders: Decreased white blood cells.
Neo-Penotran Forte/Neo-Penotran Forte L: Hypersensitivity reactions (skin rash) and side effects eg, abdominal pain, headache, vaginal itching, burning and irritation may be observed rarely. The incidence of systemic side effects is very rare since after intravaginal administration of metronidazole, very low plasma levels are observed (2-12% compared to oral route). Miconazole nitrate can cause vaginal irritation (burning, itching) as all other imidazole derivative antifungal drugs applied intravaginally (2-6%). These symptoms may be prevented with the local anesthetic action of lidocaine. If there is severe irritation, treatment should be discontinued. Side effects due to systemic use of metronidazole are hypersensitivity reactions (rare), leukopenia, ataxia, mental changes, peripheral neuropathy at overdose and after long period of usage, convulsion, seldom diarrhea, constipation, dizziness, headache, lack of appetite, vomiting, nausea, abdominal pain or cramps, seldom taste changes, dry mouth, metallic or bad taste, tiredness. These side effects occur very rarely because of low blood levels of metronidazole after intravaginal application.