Use of this medicine during pregnancy should only be considered if the expected benefit to the mother outweighs the potential risk to the foetus. Coal tar preparations have been used, for many years, when recommended by a doctor to treat children however, there is very little documented clinical data in this patient population. Coal tar has been shown to be foetotoxic and teratogenic to the offspring of laboratory animals when administered topically, orally or by inhalation at high and maternally toxic doses (see section 5.3).

This medicine contains 1g benzyl alcohol per 100g of shampoo. Benzyl alcohol may cause allergic reactions and mild local irritation. Alopecia, dermatitis, hair colour changes, abnormal hair texture, photosensitivity reaction, skin irritation (including dry skin, erythema, and skin burning sensation). It is not known whether the topical application of coal tar preparations could result in sufficient systemic absorption to produce detectable amounts in breast milk.Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000), very rare (<1/10,000), including isolated reports and Not known (cannot be estimated from the available data). This medicine may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure of the scalp to sunlight should be avoided or minimised. Use of coal tar preparations during lactation should only be considered if the expected benefit to the mother outweighs the potential risk to the infant.