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Summary of Product Characteristics last updated on the eMC: 24/09/2003

SPC	Prioderm Cream Shampoo

Table of Contents

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 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

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1. NAME OF THE MEDICINAL PRODUCT

Prioderm Cream Shampoo.

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Malathion USP 1.0% w/w.

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3. PHARMACEUTICAL FORM

Cream shampoo.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

The source of infestation should be sought and treated. For the treatment of head louse and pubic louse infection.

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4.2 Posology and method of administration

For topical external use only. As this product does not contain alcohol, it may be more suitable for those with asthma or eczema. Adults, the elderly and children aged 6 months and over: For head lice: Wet the hair thoroughly with warm water and apply sufficient shampoo to work up a rich lather and ensure that no part of the scalp is uncovered. Pay special attention to the back of the neck and the area behind the ears. Take care to avoid the eyes. Leave for at least five minutes. Rinse thoroughly with clean warm water and repeat procedure. While the hair is still wet, comb with an ordinary comb. The fine-toothed louse comb can then be used to remove the dead lice and eggs. This treatment should be carried out a total of three times at three day intervals, and should not be repeated within a 3 week period. For pubic lice: Application and dosage are as for the head. Apply the lotion to the pubic hair and the hair between the legs and anus. Children aged 6 months and under: On medical advice only.

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4.3 Contraindications

None stated.

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4.4 Special warnings and precautions for use

As with all shampoos, avoid contact with the eyes. Children under 6 months should only be treated under medical supervision. When Prioderm Cream Shampoo is used by a school nurse or other health officer in the mass treatment of large numbers of children, it is advisable that protective plastic or rubber gloves be worn. Continued prolonged treatment with this product should be avoided. It should not be used for more than three times at three day intervals, and then not repeated within a three week period. Keep out of the reach of children.

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4.5 Interaction with other medicinal products and other forms of interaction

None stated.

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4.6 Pregnancy and lactation

Prioderm Cream Shampoo is not known to have any effect on fertility, pregnancy and lactation. Its use in pregnant or lactating women is not recommended unless there is an overdue need.

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4.7 Effects on ability to drive and use machines

None stated.

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4.8 Undesirable effects

None stated.

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4.9 Overdose

In the event of deliberate or accidental ingestion, empty stomach contents by gastric lavage and keep patient warm. In the event of massive ingestion, atropine or pralidoxime may be required to counteract cholinesterase inhibition.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Prioderm Cream Shampoo 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.

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5.2 Pharmacokinetic properties

Prioderm Cream Shampoo is applied topically to the affected area.

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5.3 Preclinical safety data

None stated.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Sodium Lauryl Sulphate paste; Cetostearyl Alcohol; Lauric Diethanolamide; Ethoxylated Lanolin (50%); Methyl Hydroxybenzoate; Propyl Hydroxybenzoate; Hydrochloric Acid; Citric Acid (anhydrous); Dibasic Sodium Phosphate; Colour Yellow (E110); Sodium Edetate; Perfume M&B 1658; Purified Water.

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6.2 Incompatibilities

None stated.

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6.3 Shelf life

18 months unopened.

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6.4 Special precautions for storage

Store at or below 20^oC.

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6.5 Nature and contents of container

Cartoned, internally lacquered aluminium tube with polyethylene caps containing 40 g of product.