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%). These symptoms are greatly reduced while the treatment continues. If there is severe irritation, the treatment should be stopped.
Undesirable effects regarding systemic use of active substances of Metronidazole + Miconazole (Metromic) 500 mg/ 100 mg Vaginal Suppositories are listed as follows: Blood and lymphatic system disorders:
Not known: Leucopenia.
Immune system disorders:
Not known: Hypersensitivity reactions, allergic reactions, anaphylaxis may occur in severe cases.
Very rare: Mental alterations.
Nervous system disorders:
Common: Dizziness, headache.
Not known: Tiredness or weakness, ataia, convulsion, peripheral neuropathy due to intensive and/or prolonged metronidazole therapy.
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, rash.
Not known: Local irritation and hypersensitivity, contact dermatitis.
These adverse effects are observed rarely since blood concentration of metronidazole and miconazole is much lower when administered via intravaginal route.
For suspected adverse drug reaction, report to FDA: www.fda.gov.ph and contact Kusum Healthcare Private Limited Branch Office at (02) 245-9048 and/or e-mail: firstname.lastname@example.org.
Please seek medical attention immediately at the first sign of any adverse drug reaction shall appear.