Prioderm Lotion

1. Name Of The Medicinal Product

Prioderm Lotion.

2. Qualitative And Quantitative Composition

Malathion 0.5% w/v

3. Pharmaceutical Form

Cutaneous solution

4. Clinical Particulars

4.1 Therapeutic Indications

For the eradication of head lice infestation.

4.2 Posology And Method Of Administration

Adults, the elderly and children aged 6 months and above:

For topical external use only.

For head lice:

Rub the lotion gently into the scalp until all the hair and scalp is thoroughly moistened. Allow to dry naturally in a well ventilated room. Do not use a hairdryer or other artificial heat. Live lice will be eradicated after a minimum treatment period of two hours. However, the lotion should be left on the head for a further period of 8-10 hours to ensure that all lice eggs are totally eradicated.

Shampoo in the normal manner. Rinse and comb the hair whilst wet to remove the dead lice.

In the event of early reinfestation, Prioderm Lotion may be applied again provided 7 days have elapsed since the first application.

Residual protective effect is variable of short duration and should not be relied upon.

Not to be used on children under the age of 6 months, except on medical advice.

4.3 Contraindications

Not to be used on infants less than 6 months old except under medical supervision. Known sensitivity to malathion.

4.4 Special Warnings And Precautions For Use

Avoid contact with eyes. Protect the eyes at all times by covering the eye area with a towel. In the event of contact with the eyes, rinse thoroughly with water. If there is persistent irritation, seek medical advice IMMEDIATELY.

Do not cover the head until the hair has dried completely.

It is advisable that nursing staff involved in repeated applications should wear gloves when carrying out treatment.

Prioderm Lotion is for external use only and should be kept out of the reach of children. Keep away from exposed flames or lighted objects (e.g. cigarettes, gas and electric fires) during application and while hair is wet.

Continued prolonged treatment with Prioderm Lotion should be avoided. It should not be used more than once a week and for not more than three consecutive weeks. Alcohol based products may cause a stinging sensation on patients with sensitive skin or wheezing in asthmatic people. In such cases, it may be more appropriate to use a liquid that does not contain isopropyl alcohol.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

No known effects in human pregnancy and lactation. However, as with all medicines, use with caution.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Skin irritation and hypersensitivity reactions such as anaphylaxis, angioedema, and swollen eyes have been reported with malathion products. Chemical burns have also been reported.

4.9 Overdose

In the event of deliberate or accidental ingestion, empty stomach by gastric lavage.

Treatment

Atropine and pralidoxime may be required to counteract cholinesterase inhibition.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Prioderm Lotion contains malathion, a widely used organophosphorus insecticide which is active by cholinesterase inhibition. It is effective against a wide range of insects, but is one of the least toxic organophosphorus insecticides since it is rapidly detoxified by plasma carboxylesterases. Malathion kills insects by inhibiting their nervous system.

5.2 Pharmacokinetic Properties

Prioderm Lotion is applied topically to the affected area.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber, which are additional to that included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Isopropyl alcohol

D-Limonene 17449

Terpineol 18689

Shellsol T (Naphtha (petroleum), heavy alkylate)

Citric acid

Perfume Loxol P6160

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25^oC. Keep container in the outer carton.

6.5 Nature And Contents Of Container

Cartoned, clear or amber glass bottles with low density polyethylene caps and high density polypropylene sprinkler inserts containing either 50, 55. 100. 160. 200 or 210 ml of product.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Seton Products Ltd

Tubiton House

Oldham

OL1 3HS.

8. Marketing Authorisation Number(S)

PL 11314/0123.

9. Date Of First Authorisation/Renewal Of The Authorisation

11/06/1999

10. Date Of Revision Of The Text

November 2007