Document: spc-doc_PL 44673-0053 change

• spc-doc_PL 00036-0098
• spc-doc_PL 44673-0053

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Permethrin Creme Rinse 1% w/w

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Contains permethrin 1% w/w.

For Excipients, see 6.1

3 PHARMACEUTICAL FORM

Shampoo

A thick white lotion

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Permethrin Creme Rinse 1% w/w is indicated for the treatment of head lice and their nits, Pediculus humanus capitis.

4.2 Posology and method of administration

Adults, elderly and children over 6 months of age:

For topical administration.

Permethrin Creme Rinse 1% w/w should be shaken before use.

Permethrin Creme Rinse 1% w/w should be used after the hair has been washed with a non-medicated shampoo and towel-dried. The Creme Rinse should be applied in a sufficient quantity to saturate the hair, paying particular attention to the nape of the neck and behind the ears. Once the Creme Rinse has been on the hair for 10 minutes, it should be thoroughly rinsed off, and the hair dried in the normal way.

One bottle of Creme Rinse should be sufficient to cover shoulder-length hair of average thickness. More may be used if required, although it is most unlikely that more than two bottles will be required for any one course of treatment.

The residual activity may persist for up to six weeks.

The dead nits need not be combed out unless desired for cosmetic reasons.

Permethrin Creme Rinse 1% w/w is not suitable for application to children under six months of age, unless on the advice of a physician.

4.3 Contraindications

The use of Permethrin Creme Rinse 1% w/w is contraindicated in people with hypersensitivity to permethrin, any synthetic pyrethroid or pyrethrin, or to chrysanthemums.

4.4 Special warnings and precautions for use

Keep out of the reach of children. For external use only. Gloves may be worn to avoid possible irritation to the hands of nursing staff who routinely use Permethrin Creme Rinse 1% w/w. Avoid contact with eyes. In case of contact, rinse immediately with water. If a reaction occurs, discontinue use and consult your doctor.

Shake thoroughly before using.

As with all medicines, if you are currently taking any other medicines, consult your doctor or pharmacist before using this product.

If symptoms persist, consult your doctor.

This product may be used as normal in asthmatics.

Keep out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

There is inadequate evidence of the safety in human pregnancy. Permethrin Creme Rinse 1% w/w should only be used when the expected benefits outweigh the potential risks.

It is not known if permethrin is excreted in human milk, although it is unlikely that concentrations would present any risk to the infant. It is recommended that nursing be discontinued or treatment withheld if it is not possible to discontinue nursing.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Permethrin Creme Rinse 1% w/w is generally well tolerated. In a few individuals erythema, rash and/or irritation of the scalp have been reported following its application, but as an infestation with head lice is often associated with scalp irritation, it is difficult in most instances to determine the underlying cause.

If severe or prolonged signs or symptoms of scalp irritation, skin discomfort or other undesirable effects occur, these should be brought to the attention of a doctor or pharmacist.

4.9 Overdose

On the basis of animal and human-volunteer studies, it is extremely unlikely, even with misuse or excessive application, that the amount of permethrin required to produce clinically relevant toxic effects would be reached. The most likely symptoms and signs following repeated, excessive application would be hypersensitivity-type reactions, for which symptomatic treatment would be indicated.

Theoretically, if swallowed by a small child, alcoholic intoxication could occur due to the isopropyl alcohol content of Permethrin Creme Rinse 1% w/w.

In the event of accidental ingestion by a child, a doctor should be consulted immediately. Gastric lavage should be considered within two hours of ingestion and management should be aimed at treatment of any possible alcoholic intoxication.

5.1 Pharmacodynamic properties

Permethrin is rapidly absorbed across the insect cuticle. The principle physiological lesion is the induction of electrochemical abnormalities across the membranes of excitable cells, leading to sensory hyperexcitability, incoordination and prostration. When presented in an aqueous base, the ovicidal activity of permethrin is increased by the addition of an alcohol.

5.2 Pharmacokinetic properties

Permethrin is rapidly metabolised by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. The application of cream rinse to the hair of volunteers for the recommended application time resulted in extremely low or undetectable levels of permethrin metabolites in plasma and urine samples. In vitro studies have shown that permethrin levels on hair were not affected by chlorine in concentrations used in swimming pools.

5.3 Preclinical safety data

In-vitro and in-vivo genetic toxicity studies on permethrin have all been negative, with no potential to induce mutagenic change.

Permethrin has been shown to have very low acute toxicity in animals, likely to be due to its rapid metabolic degradation to inactive constituents and incomplete absorption from the gastrointestinal tract. Overall, there is little evidence of chronic toxicity with permethrin use. The findings of repeated long-term bioassays in mice and rats do not indicate a significant oncogenic potential for permethrin in humans.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Carbomer Isopropyl Alcohol Lauryl Alcohol

Polyoxyethylene 4 Lauryl Ether Polyquaternium-24 Propylene glycol Stearalkonium Chloride

Triethanolamine Purified water

6.2    Incompatibilities

None known

6.3    Shelf life

24 months

6.4 Special precautions for storage

Do not store above 25 °C.

Do not refrigerate or freeze.

Keep container in the outer carton

6.5    Nature and contents of container

High density polyethylene (HDPE) bottle used with a polypropylene screw cap containing 50 ml 55ml, 60ml 100ml or 200 ml of creme rinse

6.6    Special precautions for disposal

Shake the bottle before use. Avoid contact with eyes.

Permethrin is not affected by the chlorine in swimming pools.

The patient should be advised to not use hair mousses, gels, sprays or conditionsers immediately before or after treatment as these may reduce the effectiveness of Quellada P Creme Rinse.

It is possible that treatment could affect permed, bleached or coloured hair. To avoid this, it is advisable to test the product on a small area of hair before applying to the whole head.

7    MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

980 Great West Road

Brentford