VANIQA

Posology Vaniqa cream should be applied to the affected area twice daily, at least eight hours apart. Efficacy has only been demonstrated for affected areas of the face and under the chin. Application should be limited to these areas.

Maximal applied doses used safely in clinical trials were up to 30 grams per month. 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. 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. Special population Elderly: (> 65 years) no dosage adjustment is necessary.

Paediatric population:

The safety and efficacy of Vaniqa in children aged 0 to 18 years has not been established. There is no data available to support use in this age group. Hepatic/renal impairment: the safety and efficacy of Vaniqa in women with hepatic or renal impairment have not been established.

As the safety of Vaniqa has not been studied in patients with severe renal impairment, caution should be used when prescribing Vaniqa for these patients. No data are available. Method of administration A thin layer of the cream should be applied to clean and dry affected areas.

The cream should be rubbed in thoroughly. The medicinal product should be applied such that no visual residual product remains on the treated areas after rub-in. Hands should be washed after applying this medicinal product. 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.

The mostly skin related adverse reactions reported were primarily mild in intensity and resolved without discontinuation of Vaniqa or initiation of medical treatment. The most frequently reported adverse reaction was acne, which was generally mild.

In the vehicle- controlled trials (n= 596), acne was observed in 41% of patients at baseline; 7% of patients treated with Vaniqa and 8% treated with vehicle experienced a worsening of their condition. Of those with no acne at baseline, similar percentages (14%) reported acne following treatment with Vaniqa or vehicle.

The following listing notes the frequency of adverse skin reactions seen in clinical trials, according to MedDRA convention. MedDRA conventions for frequency are very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data) including isolated reports.

Note that over 1350 patients were treated with Vaniqa in these trials for 6 months to one year, while only slightly more than 200 patients were treated with vehicle for 6 months. Most events were reported at similar rates between Vaniqa and vehicle.

The skin effects of burning, stinging, tingling, rash and erythema were reported at higher levels in Vaniqa treated patients compared to vehicle, as indicated by the asterisk (*). Frequency of adverse skin reactions seen in Vaniqa clinical trials, (according to MedDRA frequency convention).

Skin and subcutaneous tissue disorders Very common (≥1/10) Acne Common (≥1/100 to <1/10) Pseudofolliculitis barbae, alopecia, stinging skin*, burning skin*, dry skin, pruritus, erythema*, tingling skin*, irritated skin, rash*, folliculitis Uncommon (≥1/1,000 to <1/100) Ingrown hair, oedema face, dermatitis, oedema mouth, papular rash, bleeding skin, herpes simplex, eczema, cheilitis, furunculosis, contact dermatitis, abnormal hair texture and abnormal hair growth, hypopigmentation, flushing skin, lip numbness, skin soreness Rare (≥1/10,000 to <1/1,000) Rosacea, seborrheic dermatitis, skin neoplasm, maculopapular rash, skin cysts, vesiculobullous rash, skin disorder, hirsutism, skin tightness Paediatric population The adverse reactions observed in adolescents are similar to the ones observed in adults.

g. 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.

Vaniqa is for cutaneous use only. 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. g. contact dermatitis) as well as methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

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