Rolifin Xl

Uses

Rolifin Xl Hydrochloride is used for Dermatomycoses caused by dermatophytes: tinea pedis (athlete's foot), tinea cruris, tinea inguinalis, tinea corporis, tinea manuum. Pityriasis versicolor.

Rolifin Xl is also used to associated treatment for these conditions: Dermatomycoses, Fungus, Nail, Pityriasis versicolor, Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea inguinalis, Tinea manuum, Cutaneous candidiasis

Dosage

Rolifin Xl dosage

Adult: To be applied to affected skin areas once daily following cleansing (in the evening). The treatment should be continued without interruption until clinical cure, and for 3-5 days thereafter. The required duration of treatment depends on the species of fungi and on the localisation of the infection. In general, treatment should be continued for at least two to three weeks. With foot mycoses, up to six weeks of therapy may be necessary.

Elderly: There are no specific dosage recommendations for use in elderly patients.

Children: There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.

Side Effects

Side effects are Skin Irritation, erythema, pruritus, skin burning sensation, Hypersensitivity (systemic allergic reaction).

Precaution

Avoid contact of Rolifin Xl cream with eyes, ears and mucous membranes. This medicinal product contains stearyl alcohol which may cause local skin reaction (e.g. contact dermatitis) Owing to the lack of clinical experience available to date, the use of Rolifin Xl 0.25% cream in children is not recommended. A systemic or local allergic reaction could possibly occur after use of this product. If this happens, the product should be stopped immediately and medical advice should be sought. Remove the product carefully by cleaning the skin. The product should not be reapplied.

Interaction

There are no specific studies involving concomitant treatment with other topical medicines. Use of nail varnish or artificial nails should be avoided during treatment.

Pregnancy & Breastfeeding use

No experience exists of use during pregnancy and nursing, therefore, the use of Rolifin Xl should be avoided during pregnancy and lactation. Reproductive toxicology studies showed no evidence of teratogenicity in laboratory animals but embryotoxicity was observed at high oral doses. The systemic absorption of amorolfine during and after topical administration is very low and therefore the risk to the human foetus appears to be negligible. Rolifin Xl Cream should not be used during pregnancy and/or lactation unless clearly necessary. Breast-feeding women must not use the cream in the breast area.

Contraindication

Rolifin Xl cream must not be reused by patients who have shown hypersensitivity to the active substance or to any of the excipients.

Acute Overdose

Rolifin Xl is for topical use. In the event of accidental oral ingestion, an appropriate method of gastric emptying may be used.

Storage Condition

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Innovators Monograph

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