Meted Shampoo

1. Name Of The Medicinal Product

Meted 3% & 5% w/w Shampoo

2. Qualitative And Quantitative Composition

Salicylic acid USP 3.0% w/w

Colloidal sulphur HSE 6.25% w/w

(equivalent to sulphur 5.0% w/w)

3. Pharmaceutical Form

Shampoo

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

For topical administration.

Adults:

The hair should be thoroughly wetted and sufficient Meted Shampoo applied to produce an abundant lather. The hair should be rinsed and the procedure repeated.

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

Children:

As for adults.

Elderly:

As for adults.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

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.

Excessive prolonged use may result in symptoms of salicylism.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No limitations to the use of Meted Shampoo during pregnancy or lactation are known.

Safety has not been established in either humans or animals during pregnancy and lactation. However, with the small amounts of salicylic acid absorbed transdermally from Meted it is unlikely that use will cause any adverse effects.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

There have been no reports of adverse effects following the use of Meted Shampoo. However, salicylic acid is a mild irritant and may cause dermatitis.

As with other topical preparations containing salicylic acid prolonged use may result in symptoms of salicylism.

4.9 Overdose

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

Early symptoms are ringing in the ear tinnitus with deafness, epistaxis, nausea, vomiting, sensitivity and dryness of the mucous membranes. If this occurs treatment must be stopped immediately.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Sulphur is a keratolytic and mild antiseptic. Salicylic acid has keratolytic and fungicidal properties.

5.2 Pharmacokinetic Properties

There is no evidence of systemic absorption of sulphur or salicylic acid following use of Meted Shampoo.

5.3 Preclinical Safety Data

None presented.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Magnesium aluminium silicate

Hypromellose

Panthenol

Sodium laureth sulphate

Sodium cocoyl sarcosinate

Cocamido propyl betaine

Fragrance - 430 015

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 30ºC.

6.5 Nature And Contents Of Container

Meted Shampoo is supplied in a white HDPE bottle with a white polypropylene screw cap. Each bottle contains either 30ml or 120ml of Meted Shampoo.

6.6 Special Precautions For Disposal And Other Handling

For external use only.

Keep out of reach of children.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

8. Marketing Authorisation Number(S)

PL 16853/0072

9. Date Of First Authorisation/Renewal Of The Authorisation

1st July 1999

10. Date Of Revision Of The Text

February 2009