Alliance Pharmaceuticals Ireland

Pentrax 4.3% w/v Shampoo

Fractar 5 7.71% w/v

(equivalent to coal tar 4.3% w/v)

For excipients, see Section 6.1.

Shampoo

A burgundy-brown liquid of medium viscosity and a coal-tar odour.

For the relief of itching, irritation, redness, flaking and/or scaling due to dandruff, seborrhoeic dermatitis, or psoriasis of the scalp.

For topical administration.

Adults:

Pentrax Shampoo should be massaged into wet hair and scalp to produce a lather. The hair should be rinsed and the procedure repeated applying a liberal amount of Pentrax and allowing the lather to remain on the hair for up to 10 minutes. Hair should be rinsed thoroughly.

Use at least twice weekly or as directed by a physician.

Children:

As for adults.

Elderly:

As for adults.

Pentrax Shampoo is contra-indicated in persons with a sensitivity to any of the ingredients.

Avoid contact with the eyes. If shampoo gets into the eyes rinse thoroughly with water.

If the condition worsens or does not improve after regular use of the product as directed, consult a physician.

None known.

The safety of Pentrax has not been established.

None known.

There have been no reports of adverse effects following the use of Pentrax Shampoo. However, coal tar may cause irritation to the skin. Erythema and hypersensitivity to coal tar has been reported. Although carcinogenicity of coal tar has been demonstrated in animal studies, no studies demonstrating an increased risk of skin cancer with normal therapeutic use in humans have been reported. There is no unequivocal evidence to link the use of topically applied coal tar products with skin cancer.

There is no evidence of systemic absorption following the use of this shampoo. There are no reports available of its ingestion.

Coal tar is an antipruritic, keratolytic and a weak antiseptic.

There is no evidence of systemic absorption following the use of Pentrax Shampoo.

Tar preparations have been in wide use for many years. Although coal tar preparations containing polycyclic aromatic hydrocarbons (PAHs) have been demonstrated to be carcinogenic in the skin of experimental animals, present evidence, based upon epidemiology studies in humans and following-up trials, reveals no evidence of increased risk of skin or internal cancer, particularly when the product is used as directed.

Dioctyl sodium sulphosuccinate

Isopropyl myristate

Sodium lauryl sulphate

Squalane

Laureth-23

Polyethylene glycol 8

Cocamide DEA

Lauramine oxide

None known.

48 months.

Do not store above 30ºC.

Pentrax Shampoo is supplied in a polyvinylchloride bottle with a polypropylene screw cap with triseal. Each bottle contains either 30ml, 120ml or 240ml of Pentrax Shampoo.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

No special requirements.

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire SN15 2BB

United Kingdom

PA 943/10/1

Date of first authorisation: 26 October 1995

Date of last renewal: 26 October 2005

April 2006