Prescribing Information

Vaniqa 11.5% Cream Prescribing Information

(Please refer to full Summary of Product Characteristics [SmPC] before prescribing)
Product Name: Vaniqa 11.5% Cream.
Presentation: Cream containing 11.5% w/w eflornithine (as hydrochloride monohydrate). Refer to the SmPC for the list of excipients.
Indication: Treatment of facial hirsutism in women.
Dosage and Administration: A thin layer of the cream should be applied to clean and dry affected areas of face and under chin twice daily, at least eight hours apart. The cream should be rubbed in thoroughly. Hands should be washed after applying this medicine. For maximal efficacy, the treated area should not be cleansed within four hours of application. Cosmetics (including sunscreens) can be applied over the treated areas, but no sooner than five minutes after application. Improvement in the condition may be noticed within eight weeks of starting treatment. Continued treatment may result in further improvement and is necessary to maintain beneficial effects. The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment. Use should be discontinued if no beneficial effects are noticed within four months of commencing therapy. Patients may need to continue to use a hair removal method (e.g. shaving or plucking) in conjunction with Vaniqa. In that case, the cream should be applied no sooner than five minutes after shaving or use of other hair removal methods, as increased stinging or burning may otherwise occur. Elderly: (> 65 years) no dosage adjustment is necessary. Children and Adolescents: (< 12 years) safety and efficacy of Vaniqa have not been established. Hepatic/renal impairment: the safety and efficacy of Vaniqa in women with hepatic or renal impairment have not been established. Pregnancy and Lactation: Pregnant or breastfeeding women should not use Vaniqa.
Contra-indications: Hypersensitivity to eflornithine or to any of the excipients.
Special Warnings and Precautions: Excessive hair growth may be as a result of serious underlying disorders (e.g. polycystic ovary syndrome, androgen secreting neoplasm) or certain medications (e.g. cyclosporin, glucocorticoids, minoxidil, phenobarbitone, phenytoin, combined oestrogen-androgen hormone replacement therapy). These factors should be considered in the overall medical treatment of patients who might be prescribed Vaniqa. Contact with eyes or mucous membranes (e.g. nose or mouth) should be avoided. Transient stinging or burning may occur when the cream is applied to abraded or broken skin. If skin irritation or intolerance develops, the frequency of application should be reduced temporarily to once a day. If irritation continues, treatment should be discontinued and the physician consulted. It is recommended that hands are washed following use. This product contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Undesirable effects: The mostly skin related adverse reactions reported were primarily mild in intensity and resolved without discontinuation of Vaniqa or initiation of medical treatment. Most events were reported at similar rates between Vaniqa and vehicle. * denotes when higher levels in Vaniqa treated patients were reported: Very common (> 10%): acne. Common (> 1% to < 10%): pseudofolliculitis barbae, alopecia, stinging skin*, burning skin*, dry skin, pruritus, erythema*, tingling skin*, irritated skin, rash*, folliculitis. Prescribers should consult the Summary of Product Characteristics [SmPC] in relation to other undesirable effects.
Price: 60g Tube £54.28.
Legal Category: POM.
Marketing Authorisation Number: EU/1/01/173/001-003.
Marketing Authorisation Holder: Almirall S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain.
Date of Preparation: November 2010.
Further Information is Available from: Almirall Ltd, 4 The Square, Stockley Park, Uxbridge, UB11 1ET, UK.