Each tube (5 g) cream contains: Active ingredient: Clotrimazole 50 mg.
Excipients/Inactive Ingredients: Cetyl Alcohol, Cetrimide, Glycerin, Isopropyl Myristate, Propylene Glycol, Stearyl Alcohol, Purified Water.
FUNGIDERM is indicated for dermatomycosis caused by dermatophytes, yeast, Candida species, molds, and other fungi such as: Tinea cruris (jock itch, occurs on the medial and upper parts of the thighs and the pubic area).
Tinea pedis (athlete's foot or ringworm of the feet).
Tinea capitis (on the scalp),
Tinea versicolor.
Tinea corporis.
Tinea unguium (onychomycosis).
Tinea barbae (barber's itch or ringworm of the beard).
Candidiasis of skin and nails.
FUNGIDERM has some action against gram positive bacteria, so it may be used in mycosis secondarily infected with such bacteria.
Fungiderm Cream should be applied to the affected area 2 or 3 times daily for 10 - 14 days. Tinea pedis (athlete's foot) needs 1 month regular and persistent medication. To prevent relapse, treatment should be continued for at least two weeks after the disappearance of all signs of infection. Patients should notify their physician if there is no improvement after 4 weeks of treatment.
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).
Hypersensitivity to the active substance or to any of the excipients.
All possibly infected areas should be treated at the same time.
Avoid contact with eyes and do not swallow.
Effects on ability to drive and use machine: The medication has no or negligible influence on the ability to drive or use machinery.
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.
Pregnancy: There are limited amount of data from the use of Clotrimazole in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Clotrimazole during the first trimester of pregnancy.
Lactation: Available pharmacodynamic/toxicological data in animals have shown excretion of Clotrimazole / metabolites in milk. Breast-feeding should be discontinued during treatment with Clotrimazole.
The following adverse reactions have been identified during post-approval use of Clotrimazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Immune system disorders: Allergic reaction (ME) (with symptoms such as urticaria (ME), dyspnoea (PT), hypotension (PT) and syncope (PT)).
Skin and subcutaneous tissue disorders: Pruritus (ME), rash (ME), blisters (PT), peeling/exfoliation (PT), discomfort/pain (PT), stinging/burning (PT), edema (PT), burning (PT), irritation, erythema (PT).
Laboratory tests have suggested that, 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.
Store below 30°C, in a tight container in a dry place.
Shelf life: 60 months.
D01AC01 - clotrimazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
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