Clofan vaginal cream with applicator

INSTRUCTION
for medical use
CLOFAN^®

Composition:

active substance: Clotrimazole;

1 gram of cream contains: Clotrimazole 100 mg;
excipients: Tefose-63 (polyethylene glycol-6 stearate, ethylene glycol stearate, polyethylene glycol32 stearate); light mineral oil; cetostearyl alcohol; benzyl alcohol; buthylhydroxytoluene (E 321);
polysorbate 60; sodium dihydrogen phosphate dihydrate; purified water; triethanolamine.

Pharmaceutical form. Vaginal cream.

Main physicochemical properties: white, viscous, uniform cream.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents, used in gynecology. Clotrimazole.

ATC Code: G01A F02.

Pharmacological properties.

Pharmacodynamic.

Azoles (especially clotrimazole) are commonly recommended for the topical treatment of vulvovaginal
candidiasis, which is characterized by vulvovaginal symptoms such as itching, burning, discharge, redness, swelling, and tenderness.
Clotrimazole is an antifungal agent of local action of imidazole derivatives group.
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.
Clotrimazole has a broad spectrum of antifungal activity in vitro and in vivo, acting on dermatophytes,
yeast and molds.
Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than
0.062–8.0 μg/mL of substrate.
The mode of action of clotrimazole is primarily fungistatic or fungicidal depending on the
concentration of clotrimazole at the site of infection.
In vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive. Primarily resistant variants of sensitive fungal species are very rare. The development of secondary resistance by clotrimazole-sensitive fungi has so far only been observed in very isolated cases.

Pharmacokinetics.

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.

Clinical particulars.

Indications.

Clotrimazole vaginal cream is recommended for the treatment of candidal vaginitis.

Contraindications.

Hypersensitivity to clotrimazole or other ingredients of the drug.

Interaction with other medicinal products and other forms of interaction.

Latex contraceptives.
Concomitant use of the cream in genital area with latex contraceptives (such as condom or diaphragm)
may cause damage to the latter, therefore, the effectiveness of these contraceptives may decrease.
Patients should be advised to use alternative contraceptive methods for at least 5 days after using this preparation.
Tacrolimus/sirolimus.
Concomitant treatment with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant)
or sirolimus may lead to increased tacrolimus/sirolimus blood plasma level. Patients should therefore be closely monitored for signs and symptoms of tacrolimus/sirolimus overdosage, if necessary – by determination of the respective blood plasma levels.

Special warnings and precautions for use.

Before starting treatment with clotrimazole vaginal cream, you should consult your doctor.
You should consult your doctor if symptoms persist for longer than 7 days when using clotrimazole vaginal cream.
Clotrimazole vaginal cream can be reapplied if the symptoms of a candidiasis infection reappear 7
days after the end of therapy. However, you should consult your doctor if there have been more than two episodes of candidiasis during the last 6 months.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Butylhydroxytoluene can cause local skin reactions (such as contact dermatitis) or irritation of the eyes
and mucous membranes.

Fertility, pregnancy and lactation.

Pregnancy

There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies
with clotrimazole have shown reproductive toxicity at high oral doses. At the low systemic exposures
of clotrimazole, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole
can be used during pregnancy, but only under the supervision of a physician.

During pregnancy, another clotrimazole dosage form should be used that does not require the use of
an applicator

Breastfeeding.
There are no data on the excretion of clotrimazole in breast milk. However, systemic absorption is minimal after application and is unlikely to result in systemic effects. Clofan®, vaginal cream, can be used during breastfeeding.
Fertility.
No human studies of the effects of clotrimazole on fertility have been performed; however, animal
studies have not demonstrated any effects of the drug on fertility.
Effects on ability to drive and use machines.
Clofan®, vaginal cream has no or negligible influence on the ability to drive or use machines.

Posology and method of administration.

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. A second course of therapy may be
prescribed if necessary.
During menstruation, no treatment should be given. Treatment should be completed before menstruation begins. Do not use tampons, vaginal lavage, spermicides or other vaginal products when
using this medicine.
Sexual intercourse should be avoided during therapy as the infection can be transmitted to a partner.
Children.
There is no data on Clofan® safe use in children under 16 years of age, therefore, it should not be used
in this category of patients

Overdose.

No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal dose or application to the skin (application over a large area under conditions favorable to absorption) or inadvertent oral ingestion. There is no specific antidote.
However, 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). Gastric lavage should be carried out only if the airway can be protected adequately

Undesirable effects.

Since the data on the following undesirable effects are based on spontaneous reports, exact frequency of their occurrence is impossible to determine.
Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.
Vascular system disorders: syncope, arterial hypotension.
Respiratory system and mediastinal organs disorders: dyspnoea.
Reproductive system and mammary glands: peeling of the skin in the genital area, vaginal discharge, vaginal bleeding, vulvovaginal discomfort, vulvovaginal erythema, vulvovaginal burning,
vulvovaginal itching, vulvovaginal pain.
General disorders and administration site conditions: application site irritation, application site reaction, swelling, pain.

Reporting of suspected adverse reactions.
The reporting of adverse reactions after the registration of the medicinal product is of great importance.
This makes it possible to monitor the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical workers, as well as patients or their legal representatives should be notified of all cases of suspected adverse reactions and lack of efficacy of the medicinal product through the
Automated Pharmacovigilance Information System at the link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage.

Store in original packaging at a temperature below 25°С. Do not freeze.
Keep out of reach of children

Package.

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

Conditions of supply.

Without prescription.

Manufacturer.

KUSUM HEALTHCARE PVT LTD

Location of manufacturer and its address of its business activity.

SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.

Date of last revision.

09.07.2024