Gynomax 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).
Tioconazole + Tinidazole + Lidocaine (Gynomax) is well tolerated in the application site.
Adverse effects related to the systemic usage of the active ingredients in Tioconazole + Tinidazole + Lidocaine (Gynomax) are listed as follows, although they are not reported in the vaginal administration.
Since blood levels of tinidazole, tioconazole and lidocaine are lower in the intravaginal administration, these adverse effects are expected to be seen more rarely.
Inform the physician if the patient experiences any of the undesirable effect.
Blood and lymphatic system disorders: Not known: Leukopenia (temporary), neutropenia.
Immune system disorders: Not known: Allergic reactions (anaphylactic shock can be seen in severe cases).
Nervous system disorders: Common: Weakness, fatigue, malaise, headache, dizziness.
Not known: Ataxia, coma (rare), confusion (rare), depression (rare), loss of sensation, drowsiness, insomnia, sleep disturbances, anxiety, psychosis, seizure, speech impairment, agitation, apprehension, vertigo, peripheral neuropathy, convulsion, cramp, super excitation, disorientation, euphoria, hallucination, hyperesthesia, lethargy.
Cardiac and vascular disorders: Not known: Arrhythmia, bradycardia, arterial spasm, cardiovascular collapse, increase in the defibrillator threshold, edema, flushing, heart block, hypotension, sinus node suppression.
Gastrointestinal disorders: Common: Metallic/bitter taste, nausea, anorexia, loss of appetite, flatulence, dyspepsia, abdominal cramp, epigastric discomfort, vomiting, constipation.
Not known: Stomachache, diarrhea, furred tongue (rare), stomatitis, tongue discoloration, dry mouth, pseudomembranous colitis.
Skin and subcutaneous tissue disorders: Not known: Itching, urticaria, angioneurotic edema, cutaneous eruption.
Renal and urinary disorders: Common: Darkened urine.
General disorders and administration site conditions: Not known: Local burning, urinary burning, edema, local irritation, itching, vaginal discharge, dyspareunia, nocturia, vaginal pain.
If the patient experiences any of the following, stop using Tioconazole + Tinidazole + Lidocaine (Gynomax) and inform the physician or consult to the emergency service of the nearest hospital immediately: Serious skin rashes; Swelling in the face, lips, tongue and throat, shortness of breath.
Inform the physician whenever an unexpected effect is observed.