COMPOSITION:

Active substance:

Clotrimazole;

1 gram of cream contains:

Clotrimazole 100 мг;

Excipients:

Tefose-63 (polyethylene glycol-6 stearate, ethylene glycol stearate, polyethylene glycol-32 stearate); mineral oil light; cetostearyl alcohol; benzyl alcohol; buthylhydroxytoluene (E 321); polysorbate 60; sodium dihydrogen phosphate dihydrate; purified water; triethanolamine.

INDICATIONS:

Clotrimazole is recommended for the treatment of infections in the genital area (vulvovaginitis), caused by fungi (usually Candida), or bacteria, sensitive to clotrimazole.

DOSAGE:

The cream should be administered intravaginally using the supplied applicator.

7 g of Clofan® cream (1 full applicator) is inserted as deeply as possible into the vagina, in the evening (before going to sleep) one time. The course of treatment is 1 day. The treatment should not be performed during the menstrual period and therefore should be finished before the onset of menstruation. The therapy of these diseases requires simultaneous treatment of both partners.

ADVERSE REACTIONS:

Skin and subcutaneous tissue:

Skin rash, pruritus, erythema, swelling, urticaria, irritation, peeling, fever sensation, burning sensation.

Reproductive system and breast disorders:

Allergic reaction from the vaginal mucosa,

genital peeling, pruritus, rash, oedema, discomfort, burning sensation, irritation, pelvic pain.

Gastrointestinal disorders:

abdominal pain.

General disorders and administration site conditions:

Syncope, arterial hypotension, dyspnea.

The symptoms persist during more than 7 days from the beginning of treatment.

.

Drug interactions:

Concomitant treatment with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) may lead to increased tacrolimus blood plasma level. Patients should thus be closely monitored for signs and symptoms of tacrolimus overdosage, if necessary – by determination of the respective blood plasma levels.

Concomitant use of clotrimazole with nystatin may decrease the activity of clotrimazole. When used vaginally, the drug reduces the activity of amphotericin B and other polyene antibiotics.

Concomitant use of the cream in genital area with latex contraceptives (such as preservative or diaphragm) may cause damage to the latter, therefore, the effectiveness of these contraceptives may decrease. This effect is temporary and may occur only during the treatment. Patients should be advised to use alternative contraceptive methods for at least 5 days after using this preparation.

Pregnancy and lactation:

The studies with the involvement of pregnant women have shown no epidemiological data on the expected adverse effects on both woman and fetus when administering clotrimazole during pregnancy. Clotrimazole may be used during pregnancy and lactation only if the physician considers that the benefit for the mother outweighs the risk to the foetus/child.

During pregnancy the treatment should be carried out using another form of the drug without applicator.

Children:

There is no data on safe use of the drug in children under 16 years of age, therefore, the drug Clofan® should not be used in individuals under 16 years of age.

Children over 16 years of age should consult a doctor prior to administering the drug.

PRECAUTIONS:

Before using clotrimazole, medical advice must be sought if any of the following is applicable:

• more than two infections of candidal vaginitis in the last 6 months;

• previous history of sexually transmitted diseases in patient or her intimate partner;

• pregnancy or suspected pregnancy;

• patient over 60 years of age;

• known hypersensitivity to imidazoles or other vaginal antifungal products;

• irregular vaginal bleeding;

• abnormal vaginal bleeding or a blood-stained discharge;

• vulval or vaginal ulcers, blisters or sores;

• lower abdominal pain;

• back pain;

• dysuria;

• any adverse events, associated with the use of clotrimazole;

• fever or chills;

• nausea or vomiting;

• diarrhea;

• pathological vaginal discharge.

Ability to influence reaction velocity while driving or operating any other mechanisms.

None applicable

Overdose:

Overdose by intravaginal application is practically not observed because of the very low absorbability of the drug.

In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting).

CONTRAINDICATIONS:

Hypersensitivity to clotrimazole or other ingredients of the drug

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents, used in gynecology. Clotrimazole.

ATC Code: G01A F02.

Pharmacodynamic.

Clotrimazole is an antifungal agent of local action of imidazole derivatives group. The drug has a wide spectrum of antimycotic activity against dermatophytes, yeasts and molds. It is also active against Trichomonas, staphylococci, streptococci and bacteroides. Has no effect on lactobacillus.

The mechanism of antimycotic action of clotrimazole is realized through inhibiting the synthesis of ergosterol, which leads to structural and functional impairment of cytoplasmic membrane. Depending on the concentration of clotrimazole in the site of infection, the drug has fungistatic or fungicidal effect. In vitro clotrimazole shows antimycotic activity mostly against proliferating fungal elements since fungal spores are only slightly sensitive to the drug action.

Primarily resistant variants of sensitive fungal species to clotrimazole are very rare. The development of secondary resistance in sensitive fungi to clotrimazole has so far only been observed in very isolated cases.

Pharmacokinetic.

Pharmacokinetic investigations after vaginal application have shown that only a small amount of clotrimazole (3 – 10%) is absorbed. The absorbed clotrimazole is metabolized in the liver into inactive metabolites. Therefore, the peak plasma concentrations of clotrimazole after vaginal application of a 500 mg dose were less than 10 ng/ml. This means that clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects.

PHARMACEUTICAL CHARACTERISTICS:

General physico-chemical properties:

White, viscous, uniform cream.

Shelf-life:

2 years.

Storage:

Store below 25°С. Do not freeze.

Keep out of reach of children.

Package:

7 g tube, 1 tube with applicator in carton..

Conditions of supply:

Without prescription.