Vaniqa · 4.6 Fertility, pregnancy and lactation · 1

HOS-084348 · has-adverse-reaction-information · PDF-Seite 4

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

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HOS-084344 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-084343 · has-indication-information · PDF-Seite 2

Treatment of facial hirsutism in women.

HOS-084346 · has-interaction-information · PDF-Seite 3

No interaction studies have been performed.

HOS-084347 · has-pregnancy-information · PDF-Seite 3

Pregnancy Throughout clinical trials data from a limited number of exposed pregnancies (22) indicate that there is no clinical evidence that treatment with Vaniqa adversely affects mothers or foetuses. Among the 22 pregnancies that occurred during the trials, only 19 pregnancies occurred while the patient was using Vaniqa. Of these 19 pregnancies, there were 9 healthy infants, 5 elective abortions, 4 spontaneous abortions and 1 birth defect (Down’s Syndrome to a 35 year old). To date, no other relevant epidemiological data are available. Animal studies have shown reproductive toxicity (see section 5.3). The potential risk to humans is unknown. Therefore, women who are pregnant or planning pregnancy should use an alternative means to manage facial hair. Breast-feeding It is not known whether eflornithine/metabolites are excreted in human milk. Women should not use Vaniqa whilst breastfeeding. Fertility There are no data available.

HOS-084345 · has-warning-information · PDF-Seite 3

Excessive hair growth can result from serious underlying disorders (e.g. polycystic ovary syndrome, androgen secreting neoplasm) or certain active substances (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. Vaniqa is for cutaneous use only. 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. This medicinal product contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) as well as methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).