Candid

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CANDID (CANDID)

Composition:

Active substance: clotrimazole;

1 g of cream contains 10 mg of clotrimazole;

Excipients: propylene glycol, white soft paraffin, mineral oil, non-ionic emulsifying wax, benzyl alcohol, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), butylhydroxytoluene (E 321), sodium dihydrogen phosphate, anhydrous sodium phosphate, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: semi-solid white cream.

Pharmacotherapeutic group.

Antifungal agents for topical use. Imidazole and triazole derivatives.

ATC code: D01AC01.

Pharmacological properties.

Pharmacodynamics.

Clotrimazole has a broad spectrum of antifungal activity in vitro and in vivo, which includes dermatophytes, blastomycetes, hyphomycetes, and dimorphic fungi.

In experimental studies, the minimum concentrations of clotrimazole that inhibit fungal growth range from 0.062 to 4 (-8) µg/mL in the substrate. Clotrimazole exerts primarily a fungistatic effect. In vitro effects are limited to action on proliferating fungal elements; fungal spores exhibit low susceptibility. The mechanism of action involves inhibition of ergosterol synthesis, leading to disruption and impaired function of the fungal cytoplasmic membrane.

In addition to its antifungal effect, clotrimazole inhibits in vitro the multiplication of corynebacteria and gram-positive cocci, except enterococci, at concentrations of 0.5–10 µg/mL in the substrate, and acts against trichomonads at a concentration of 100 µg/mL.

Resistance to clotrimazole is considered favorable in primarily resistant strains of otherwise sensitive fungal species. Secondary resistance develops in initially sensitive fungal species after treatment, although this is observed very rarely.

Pharmacokinetics.

Pharmacokinetic studies have shown that absorption of clotrimazole is negligible, with less than 2% and 3–10% of the applied dose being absorbed, resulting in a peak plasma concentration of the active substance of less than 10 ng/mL.

Clinical characteristics.

Indications.

Fungal infections of the skin and mucous membranes caused by dermatophytes, mould fungi, and yeasts, as well as other pathogens sensitive to clotrimazole.

Skin infections caused by Malassezia furfur (pityriasis versicolor) and Corynebacterium minutissimum (erythrasma).

Candidal vulvitis and candidal balanitis.

Contraindications.

Hypersensitivity to clotrimazole or to any of the excipients. Hypersensitivity to other imidazoles.

The cream should not be used for the treatment of nails or scalp skin infections.

Interaction with other medicinal products and other forms of interaction.

Clotrimazole may reduce the efficacy of other topical antifungal agents, particularly polyene antibiotics such as nystatin and natamycin.

Special precautions for use

The product is intended for dermatological use only.

The use of the product in ophthalmology is contraindicated. Avoid contact of the product with the eyes. Do not apply near the eye area. Do not swallow.

Do not scratch itchy affected areas of skin, as this may lead to the spread of infection.

Cases of cross-hypersensitivity reactions have been reported. Therefore, if a patient has experienced an allergic reaction to any imidazole-derived antifungal agent, cross-reactivity to other agents within this class should be considered. If an allergic reaction occurs, treatment with clotrimazole should be discontinued.

Sexual contact should be avoided during treatment with this product, as the infection may be transmitted to the partner.

The use of the cream in the genital area (external genital organs and perineum in women, or glans penis and foreskin in men) may reduce the effectiveness and safety of latex products such as condoms and diaphragms. This effect is temporary and may occur only during treatment.

Patients should consult a physician: if they have known hypersensitivity to any antifungal agents or imidazole derivatives; if there is a history of sexually transmitted infections in the patient or their sexual partner; or if the patient develops high fever (38 °C or higher), lower abdominal pain, dysuria, back pain, purulent vaginal discharge with unpleasant odor, vulvar or vaginal ulcers, redness, diarrhea, nausea, vomiting, vaginal bleeding accompanied by shoulder pain.

Warning regarding treatment of candidal vulvitis in women. Treatment should not be performed during menstruation. Treatment should be completed before the onset of menstruation.

Do not use tampons, intravaginal douches, spermicides, or other vaginal products during treatment with this medication.

The medicinal product contains benzyl alcohol and therefore should not be used in preterm infants and newborns.

The product contains propylene glycol, which may cause skin irritation.

The presence of methylparaben and propylparaben may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

Clinical studies on the effect of clotrimazole on female fertility have not been conducted; however, animal studies have shown no effect of clotrimazole on fertility. The number of studies on the use of clotrimazole during pregnancy is limited. Animal studies have not revealed any direct or indirect adverse effects with regard to reproductive toxicity. As a precautionary measure, it is advisable to avoid the use of clotrimazole during the first trimester of pregnancy.

Breastfeeding should be discontinued during treatment with clotrimazole.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage.

For adults, apply Candide cream thinly to affected skin areas 1–3 times daily, using approximately 0.5 cm of cream per palm-sized area. After application, gently rub in the cream.

For candidal vulvitis or candidal balanitis in adults, apply a thin layer of cream (0.5 cm strip) to affected areas 2–3 times daily (on external genital organs and perineum in women, or on glans penis and foreskin in men) and rub in.

Treatment of candidal vulvitis or candidal balanitis requires simultaneous treatment of both partners.

To ensure treatment efficacy, depending on the condition, continue using Candide cream for an additional 2 weeks after subjective symptoms have disappeared. Resolution of symptoms is expected after completing the treatment course with Candide:

• for dermatomycoses – 3–4 weeks;
• for erythrasma – 2–4 weeks;
• for pityriasis versicolor – 1–3 weeks;
• for candidal balanitis and candidal vulvitis – 1–2 weeks.

If no improvement occurs after 4 weeks of treatment, the patient must inform the physician.

Children.

Experience with the use of clotrimazole for treatment in children is lacking; therefore, it should not be used in this patient group.

Overdose.

There is no risk of acute intoxication, as overdose is unlikely following a single vaginal dose or topical application to the skin (even over large skin areas under conditions favoring increased absorption), as well as after accidental oral ingestion. No specific antidote exists.

After accidental oral ingestion, gastric lavage may rarely be necessary only if a life-threatening dose was ingested within the previous hour or if signs of overdose are present (e.g., dizziness, nausea, vomiting). Gastric lavage should be performed only if adequate airway protection is ensured.

Side effects.

The following adverse reactions may occur during the use of the medication:

• Immune system: allergic reactions, including fainting, arterial hypotension, dyspnea, urticaria;
• Skin and subcutaneous tissue: redness (erythema), blisters, malaise, discomfort/pain, swelling, irritation, peeling, itching, rash, prickling, burning/feeling of warmth.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging.

20 g of the medication in a tube; 1 tube per cardboard package.

Availability. Over-the-counter (without prescription).

Manufacturer.

Glenmark Pharmaceuticals Ltd./Glenmark Pharmaceuticals Ltd.

Manufacturer's address and location of business activity.

Plot No E-37/39, M.I.D.C., Industrial Estate, Satpur, Nasik – 422 007, India.