Each vaginal ovules contains :

• Miconazole nitrate   200 mg ,
• Miconazole nitrate    400 mg,
• Miconazole nitrate   1200 mg.

• Gyzol® ovules are indicated for the local treatment of vulvovaginal candidiasis and superinfections caused by Gram-Positive bacteria in pregnant (second and third trimesters only) and nonpregnant women .
• It may also be used for the treatment of mycotic balanitis.

• Hypersensitivity to Miconazole nitrate.

• Due to the limited systemic availability after vaginal application, clinically relevant interactions occur very rarely.
• In patients on oral anticoagulants, such as warfarin, caution should be considered and the anticoagulant effect should be monitored , because anticoagulants activity can be potentiated by miconazole administrated intravaginally .
• Contact should be avoided between latex products (such as contraceptive diaphragms and condoms) and Gyzol® vaginal ovules, since intravaginal preparations of miconazole may damage the latex .
• The effects and side effects of some other drugs (e.g., oral hypoglycemic and phenytoin), when co-administered with miconazole, can be increased and caution should be exercised .

Use during pregnancy :

• As systemic intravaginal absorption of miconazole nitrate is limited, no adverse effects have been reported with the use of Gyzol® vaginal ovules in pregnancy . However, it should only be used during the first trimester of pregnancy when considered essential to the welfare of the patient .

Use during lactation :

• It is not known whether intravaginal miconazole is excreted in breast milk . However, problems in humans have not been documented, caution should be considered . 

• Gyzol® vaginal ovules are usually well tolerated .
• some adverse reactions have rarely been reported including local irritation or sensitivity include mild burning sensation, erythema, and vaginal itching, vaginal discharge, abdominal cramps, headache, especially at the start of treatment .

• A single daily dose 200mg vaginal ovule for one week to be inserted deeply into the vagina before bedtime (the treatment can be shortened by beginning with one vaginal ovules on the first day and continuing with two vaginal ovules for the next three days, one in the morning, one before bedtime) .
• 400mg vaginal ovule for three days(in case of severe infections it may be advisable to prescribe a 6-day treatment course right from the start), to be inserted deeply into the vagina before bedtime .
• 1200mg vaginal ovule one ovule inserted deeply into the vagina for one day, preferably at bedtime.
• The entire course of treatment should be completed even the symptoms disappear or menstruation begins If needed,
• a further course of treatment can be given 
• If you miss a dose : Insert the missed ovules as soon as possible, if it is almost time for your next dose, wait until then to insert it, and skip the missed dose . 

• If local irritation and hypersensitivity reactions occur, treatment should be discontinued .
• General hygienic measures should be observed to control sources of infection or reinfection.
• Appropriate therapy is indicated when the sexual partner is also infected .

• Gyzol® 200mg ovules : Pack of 7 ovules.
• Gyzol® 400mg ovules : Pack of 3 ovules. 
• Gyzol® 1200mg ovules : Pack of 1 ovule.

• Store below 30ºC.
• protected from heat.