CLOTRIMAZOLE VAGINAL PESSARY

About CLOTRIMAZOLE VAGINAL PESSARY

Each pessary contains:

• Clotrimazole BP .. 500 mg
• Excipients q.s

Indications:

• Clotrimazole Pessaries are recommended for the treatment forCandidal Vaginitis.

Dosage andAdministration:

The pessaries should beinserted into the vagina, as high as possible, using the applicator provided.This is best achieved when lying back with legs bent up.

Adults:

One pessary should be inserteddaily (preferably at night) for three consecutive days. A second treatment maybe carried out if necessary.

There is no separate dosageschedule for the elderly.

Clotrimazole pessaries needmoisture in the vagina in order to dissolve completely. Undissolved pieces ofthe pessary might crumble out of the vagina in the women who experience vaginaldryness. To help prevent this, the pessary is inserted as high as possible intothe vagina at bedtime.

Treatment during the menstrualperiod should not be performed due to the risk of the pessary being washed outby the menstrual flow. The treatment should be finished before the onset ofmenstruation.

Do not use tampons,intravaginal douches, spermicides or other vaginal products while using thisproduct.

Vaginal intercourse should beavoided in case of vaginal infection and while using this product because thepartner could become infected.

Children:

Not for use in children under16.

Warnings and Precautions:

Medical advice should be sought if thisis the first time the patient has experienced symptoms of candidal vaginitis.

Medical advice is must before using ClotrimazolePessaries, if any of the following are applicable:

aged under 16 or over 60 years.

Clotrimazole Pessaries should not beused if the patient has

Irregular/abnormal vaginal bleeding or foul-smellingvaginal discharge or blood-stained discharge, vulval/vaginal ulcers, blisters/sores,lower abdominal pain, or dysuria; any adverse events such as redness, irritationor swelling associated with the treatment. Fever, chills, nausea, vomiting, diarrhoea.

Consult a physician if candidalinfection recurs more than twice within six months or symptoms have not beenrelieved within one week of using Clotrimazole Pessaries. The pessaries can beused again if the candidal infection returns after 7 days.