CanesPro

CanesPro

bifonazole

Manufacturer:

GP Grenzach

Distributor:

Bayer
Full Prescribing Info
Contents
Bifonazole.
Description
Each gram of cream contains: Bifonazole 10 mg.
Indications/Uses
Foot mycoses (alipunga), Ringworm (buni), Jock itch (hadhad), Pityriasis versicolor (an-an). Other skin fungal infection (Erythrasma, superficial candidiasis of the skin).
Dosage/Direction for Use
A small amount of cream is generally sufficient to treat an area of about the size of the palm of the hand. The cream is used once a day, preferably in the evening, before retiring. It should be applied thinly to the affected area and rubbed in.
To achieve a lasting cure, treatment with bifonazole must be carried out reliably and over an adequate period. The usual periods of treatment are summarized in the table as follows: See table.

Click on icon to see table/diagram/image

Missed dose: No available information.
Overdosage
Signs and Symptoms of Overdose: No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favorable to absorption) or inadvertent oral ingestion.
If an overdose is suspected contact a physician immediately.
When the patient has taken more than the recommended dosage: There is no specific antidote however patients should still consult a physician.
Contraindications
Hypersensitivity to the active substance(s) or to any of the ingredients of this product.
Special Precautions
Patients on warfarin therapy should be monitored when bifonazole is used concomitantly.
Some of the excipients in bifonazole cream may reduce the effectiveness of latex products such as condoms and diaphragms when applied to the genital area. The effect is temporary and occurs only during treatment.
When to consult a doctor: If symptoms of overdosage occur, the product should be stopped and a health care professional consulted.
Use in children: No in-depth studies have been performed in the pediatric population (0 to 18 years). From a survey of the clinical data reported there is no indication that harmful effects should be anticipated in pediatric population. However, in infants and toddlers, the medicinal product should only be used under medical supervision.
However, in neonates (0 to 27 days), infants and toddlers (28 days to 23 months) the medicinal product should only be used under medical supervision.
Use In Pregnancy & Lactation
Pregnancy: Preclinical safety data and pharmacokinetic data in humans give no indication that harmful effects on the mother and child should be anticipated when bifonazole is used during pregnancy. However, no clinical data are available. As a precautionary measure, it is preferable to avoid the use of bifonazole during the first trimester of pregnancy.
Lactation: It is unknown whether bifonazole is excreted in human breast milk. The excretion of bifonazole in milk has been studied in animals. Available pharmacodynamic/toxicological data in animals have shown excretion of bifonazole/metabolites in milk. Breastfeeding should be discontinued during treatment with bifonazole.
Adverse Reactions
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
General disorders and administration site conditions: Administration site pain, peripheral edema (at administration site).
Skin and subcutaneous tissue disorders: Contact dermatitis, allergic dermatitis, erythema, pruritus, rash, urticaria, blister, skin exfoliation, eczema, dry skin, skin irritation, skin maceration, skin burning sensation.
These side effects are reversible after discontinuation of the treatment. If symptoms continue/persist after treatment, seek medical advice.
Drug Interactions
Limited data suggest that an interaction between topical bifonazole and warfarin may be possible, leading to increases in the international normalized ratio (INR). If bifonazole is used in a patient on warfarin therapy, they should be appropriately monitored.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Topical Antifungals & Antiparasites
ATC Classification
D01AC10 - bifonazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Presentation/Packing
Form
CanesPro cream 10 mg/g (1% w/w)
Packing/Price
5 g x 1's (P220/tube)
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