- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Adults and children aged 12 years and older:Alphosyl '2 in 1' Shampoo is for topical application to the scalp.The hair should be wetted and sufficient Alphosyl '2 in 1' Shampoo applied to produce an abundant lather. The scalp and adjacent areas should be vigorously massaged with the fingertips. The hair should be then thoroughly rinsed and the procedure repeated. Taking both of these shampoo applications into consideration, the total leave on time for the shampoo should be 3 5 minutes.Alphosyl '2 in 1' Shampoo should be used once or twice weekly for the treatment of scalp disorders. The normal duration of use is 4 weeks, after which the condition should improve. Longer duration of therapy should be continued under the supervision of a physician.
Children:The safety and efficacy of Alphosyl '2 in 1' Shampoo in children under 12 years of age have not been established.Coal tar preparations have been used in children for many years, but since there is very little documented clinical data in this patient population, Alphosyl '2 in 1' Shampoo should be used with caution in children and only on the recommendation of a doctor or pharmacist.
Elderly:No dosage adjustment is necessary.
Renal Impairment:No dosage adjustment is necessary.
Hepatic Impairment:No dosage adjustment is necessary.
FertilityThere are no data on the effects of topical coal tar preparations on human fertility.
PregnancyThere are limited data from the use of coal tar preparations in pregnant women.Coal tar has been shown to be fetotoxic and teratogenic to the offspring of laboratory animals when administered topically, orally or by inhalation at high and maternally toxic doses (see Non-clinical Information).Use of coal tar preparations during pregnancy should only be considered if the expected benefit to the mother outweighs the potential risk to the foetus.The use of coal tar products should be avoided in the first trimester of pregnancy.
LactationThe safe use of topical coal tar preparations during lactation has not been established.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.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.If used during lactation, patients should be advised to ensure that any residual product is fully washed off the breast prior to breast-feeding in order to avoid accidental ingestion by the infant.
Immune system disordersRare: Hypersensitivity (including pruritus, angioedema, dyspnoea)
Eye disordersRare: Eye irritation
Skin and subcutaneous tissue disordersRare: Alopecia, dermatitis, hair colour changes, abnormal hair texture, photosensitivity reaction, skin irritation (including dry skin, erythema and skin burning sensation).
General disorders and administration site conditionsRare: Application site hypersensitivity, application site pain, application site rash, localised oedema. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Symptoms and signs:Topical coal tar overdose may increase the rate of skin irritation and photosensitivity. (See Adverse Reactions).
Treatment:Management should be clinically indicated or as recommended by the national poisons centre, where available.
ATC Code:D05AA Tars
Mechanism of actionCoal tars suppress DNA synthesis in hyperplastic skin inhibiting mitotic activity protein synthesis and cell reproduction.
Coal tarCoal tar decreases epidermal proliferation and dermal infiltration and thus promotes a return to normal keratinisation. Coal tar has anti-inflammatory, antibacterial, antipruritic, keratolytic, keratoplastic and vascoconstrictive effects.
Carcinogenesis and MutagenesisNo long term studies have been conducted with the product formulations.Coal tar contains certain chemicals that are mutagenic to microorganisms and mammalian cells in vitro. Topical and oral administration of high doses of coal tar to laboratory animals induces DNA adduct formation.High dose administration of coal tar to laboratory animals is carcinogenic However, epidemiological evidence that includes prospective and retrospective studies in thousands of patients receiving coal tar therapy followed for more than 40 years do not suggest a potential increased risk of skin or systemic cancer.
Reproductive ToxicologyCoal tar is foetotoxic and teratogenic at maternally toxic doses following dermal application, oral administration, or inhalation.
Omega Pharma Ltd
Omega Pharma Ltd, 1st Floor, 32 Vauxhall Bridge Road, London, SW1V 2SA, UK
+44 (0)203 598 9603
+44 (0)1748 828 860