Candi Mazol 200- 500

(Vaginal Tablets)

Mechanism of Action:

Clotrimazole is a Gynaecological anti-infectives and antiseptics – imidazole derivatives acts against fungi by inhibiting ergosterol synthesis.

Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane.

Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection.

Indications

Candi Mazol Vaginal tablets are recommended for the treatment of candidal vaginitis.

Contraindications

Hypersensitivity to clotrimazole or any of the excipients

warnings and precautions for use

• Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.
• Before using Candi Mazol Vaginal tablets, medical advice must be sought if any of the following are applicable:

• more than two infections of candidal vaginitis in the last six months.
• previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease.
• pregnancy or suspected pregnancy.

• aged under 16 or over 60 years.

• known hypersensitivity to imidazoles or other vaginal anti-fungal products.

• Candi Mazol Vaginal tablets should not be used if the patient has any of the following symptoms whereupon medicaladvice should be sought:

• irregular vaginal bleeding.
• abnormal vaginal bleeding or a blood-stained discharge.
• vulval or vaginal ulcers, blisters or sores.
• lower abdominal pain or dysuria.
• any adverse events such as redness, irritation or swelling associated with the treatment.
• fever or chills.
• nausea or vomiting.
• diarrhoea.
• foul smelling vaginal discharge

• Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Candi Mazol Vaginal tablets.
• The pessaries can be used again if the candidal infection returns after 7 days.

Side Effects:

Local reactions including irritation and burning may occur. Contact allergic dermatitis has been reported. In the case of systemic absorption,

lower abdominal cramps, increase in urinary frequency or skin rash may occur. This vaginal tablet should not be administered to pregnant women

during the first trimester, since the safety in this regard has not been established. During pregnancy the vaginal tablet 500 mg should be inserted

without using an applicator. The vaginal tablet may only be used during pregnancy on the advice of a medical doctor. The possibility of absorption of clotrimazole when administered vaginally cannot be excluded.

In isolated cases there may be generalised hypersensitivity reactions of varying degrees of severity. These reactions may affect the skin (e.g. itching, redness), breathing (shortness of breath), the circulation (e.g. a drop in blood pressure requiring treatment or even impaired consciousness) or the gastrointestinal tract (e.g.nausea, diarrhoea).

Drug interaction:

•  When used together, this product may cause damage to latex contraceptives. Consequently, the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product.
• Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels and similarly with sirolimus. Patients should thus be closely monitored for signs and symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.

Pregnancy:

There are limited amount of data from the use of clotrimazole in pregnant women. Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.

During pregnancy Candi Mazol Vaginal tablets should be inserted without using an applicator

 Lactation:

There are no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after administration and is unlikely to lead to systemic effects. Clotrimazole may be used during lactation.

Dosage and administration

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

Adults:

200mg: One Tablet should be inserted daily (at night) for three consecutive days

500mg: OneTablet should be inserted at night

Candi Mazol Vaginal tablets need moisture in the vagina in order to dissolve completely, otherwise undissolved pieces of the pessary might crumble out of the vagina. Pieces of undissolved pessary may be noticed by women who experience vaginal dryness. To help prevent this it is important that the pessary is inserted as high as possible in to the vagina at bedtime.

Treatment during the menstrual period should not be performed due to the risk of the pessary being washed out by the menstrual flow. The treatment should be finished before the onset of menstruation.

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

Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected.

Children:

Not for use in children under 16.