Neo-Penotran Forte Adverse Reactions

The frequency of adverse events listed as follows is defined using 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), not known (cannot be estimated from the available data).
The frequency of systemic side/adverse 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%). In vaginitis, vaginal mucosa could be inflamed, therefore vaginal burning and itching may be seen after the first ovule is applied or toward to the third day of the treatment. These symptoms are fastly reduced while the treatment continues. If there is a severe irritation symptoms, the treatment should be stopped.
Undesirable effects regarding systemic use of active substances of NEO-PENOTRAN FORTE PESSARY are listed as follows: Blood and lymphatic system disorders: Not known: Leukopenia.
Immune system disorders: Not known: Hypersensitivity reactions, allergic reactions (anaphylaxis may occur in severe cases).
Psychiatric disorders: Uncommon: Depression.
Very rare: Mental alterations.
Nervous system disorders: Common: Dizziness, headache.
Not known: Tiredness or weakness, ataxia, convulsion, peripheral neuropathy due to intensive and/or prolonged metronidazole therapy.
Gastrointestinal disorders: Not known: Taste changes, metallic taste, nausea, vomiting, constipation, dry mouth, diarrhea, lack of appetite, abdominal pain or cramp.
General disorders and administration site conditions: Very common: Vaginal discharge.
Common: Vaginitis, vulvovaginal irritation, pelvic discomfort.
Uncommon: Feeling of thirst.
Rare: Vaginal burning, itching, irritation, stomachache, rash.
Not known: Local irritation and hypersensitivity, contact dermatitis.
These adverse effects are observed rarely since blood concentration of metronidazole is much lower when administered via intravaginal route.