Permethrin 5% w/w Cream – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Permethrin 5% w/w Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Permethrin Medical Grade 5% w/w (cis:trans isomer 25:75)

For excipients, see 6.1.

3 PHARMACEUTICAL FORM

Cream for topical application.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Permethrin 5% w/w Cream is indicated for the treatment of scabies in adults and children > 2 months of age.

4.2 Posology and method of administration

Posology

Adults, the elderly & adolescents over 12 years of age

Apply up to 30 g of cream (corresponding to one tube of 30 g). A few adults may need to use an additional tube for full body coverage but should not use more than 2 tubes (60g in total) at each application. The application should be repeated 7 – 14 days after the first treatment.

Children 6 to 12 years

Apply up to 15 g of cream (corresponding to ½ tube of 30 g). The application should be repeated 7 – 14 days after the first treatment.

Children 1 to 5 years

Up to 7.5g of cream (corresponding to ¼ tube of 30g). The application should be repeated 7 – 14 days after the first treatment.

Children 2 months to 1 year

Up to 3.75g of cream (corresponding to ⅛ of 30g). The application should be repeated 7 – 14 days after the first treatment.

Permethrin 5% w/w Cream is suitable for adults, children of 2 months of age and above, and the elderly.

Method of administration

Permethrin 5% w/w Cream is for cutaneous use only and should not be applied to broken skin, mucous membranes or near the eyes. The medicinal product must not be swallowed.

Permethrin 5% w/w Cream should be applied to skin which is clean dry and cool. It should not be used immediately after a hot bath.

Permethrin 5% w/w Cream is a vanishing cream and when rubbed gently into the skin it will disappear. Therefore, there is no need to continue to apply cream to the skin until it remains detectable on the surface.

Reapply the cream to the hands if they are washed within 8 hours of treatment. The whole body should be washed thoroughly 8-12 hours after application.

Children under 2 years should only be treated under medical supervision. Older children should be supervised by an adult when applying the cream to ensure that a thorough treatment is administered.

Carefully apply a thin layer of cream to the skin (cutaneous use).

Adults & children over 2 years:

Adults should apply the cream uniformly to the whole body including the neck, palms of the hands and soles of the feet. The head and face can be spared unless scabies efflorescences are present in this region. On application, the areas between the fingers and toes (also under the finger- and toe-nails), the wrists, armpits, external genitalia, breasts and buttocks should be carefully treated.

Elderly:

Elderly patients (over 65 years) should use the cream in the same way as adults, but in addition, the face, ears and scalp should also be treated. Pay particular attention to the areas between fingers and toes, under nails, wrists, armpits, external genitalia, breasts and buttocks. Care should be taken to avoid applying the cream to areas of skin around the eyes.

Children under 2 years:

Children should apply the cream uniformly to the whole body, including the palms of the hands, soles of the feet, neck, face, ears, and scalp. Parts of the skin around the mouth (because the cream could be licked off) and the eyes should be spared.

Children should be kept from licking the cream from the hands. If necessary, children should wear gloves.

Only limited experience is available with Permethrin in children aged 2 months to 23 months. Therefore treatment must be given only under close medical supervision in this age group.

The safety and efficacy of Permethrin in children under 2 months of age have not been established. No data are available.

Approximately 90% of individuals are cured after a single application. If there are no signs of the original lesions healing or if new lesions have appeared, a second application can be made 7 – 14 days after the first application.

4.3 Contraindications

Hypersensitivity to the active substance permethrin or other substances of the pyrethrin or pyrethroids group or to any of the excipients listed in section 6.1. In such cases treatment should be switched to a chemically different antiscabies agent.

4.4 Special warnings and precautions for use

In the case of hypersensitivity to chrysanthemums or other compositae, treatment should only be given if strictly indicated. In such cases treatment should be switched to a chemically different agent.

Carers who apply permethrin are advised to wear gloves.

When using Permethrin 5%, care should be taken not to allow the cream to get into the eyes or come into contact with mucous membranes (e.g. nasopharyngeal space, genital area) or open wounds. because the cream itself may cause marked irritation.

Permethrin is not an eye irritant but contact of Permethrin 5% w/w Cream with the eyes should be avoided because the cream itself may cause marked irritation.

In the event of inadvertent eye contamination, the affected area should be rinsed immediately with plenty of water or, if readily available, normal saline.

Paediatric population

Only limited experience is available with Permethrin 5% w/w Cream in children aged 2 months to 23 months. Therefore treatment must be given only under close medical supervision in this age group.

There is an increasing body of data specifically relating to the use of Permethrin 5% w/w Cream for the treatment of scabies in the elderly and in view of these data it is considered that there is no need for any special precautions for use in this age group.

Instruct patients not to smoke or go near naked flames - risk of severe burns. Healthcare professionals should be aware that if this product comes into contact with dressings, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product.

Permethrin 5% w/w Cream should be kept out of the sight and reach of children.

Permethrin 5% w/w Cream is for external use only.

Excipients

Permethrin creams contains 0.45g benzyl alcohol per tube. Benzyl alcohol may cause allergic reactions.

4.5 Interaction with other medicinal products and other forms of interaction

No interactions are known.

The treatment of eczematous-like reactions with corticosteroids should be withheld prior to treatment with Permethrin 5% w/w Cream, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite. The likelihood of interactions between the two treatments leading to potentiated adverse reactions or reduced efficacy is, however small.

4.6 Fertility, pregnancy and lactation

Pregnancy

The limited data available on the use of Permethrin 5% w/w Cream in pregnancy which provide no indication of any risk to the foetus. The amount of permethrin absorbed systemically following a whole body application is extremely low. However, some permethrin may pass the placental barrier. The negative mutagenicity tests and the very low mammalian toxicity suggest that there is minimal risk to the foetus following treatment with permethrin. However, treatment should be considered during pregnancy only if clearly needed.

Lactation

It has been shown that very low concentrations of permethrin are excreted in milk following oral administration of permethrin in cattle. It is not known whether permethrin is excreted in human breast milk. However, because only extremely small amounts of permethrin are absorbed systemically and in theory only a very small percentage of this will pass into the breast milk, it is unlikely that the concentrations of permethrin in the milk will present any risk to the neonate/infant. Consideration should be given to withholding treatment during nursing or temporarily discontinuing nursing.

Fertility

Reproduction studies in mice, rats and rabbits given oral dosage of 200 to 400 mg/kg bodyweight/day revealed no evidence of impaired fertility. In addition permethrin did not show any adverse effects on the reproductive function of rats given an oral dosage of 180 mg/kg bodyweight/day in a three generation study.

There was no evidence of teratogenicity in reproduction studies in mice, rats and rabbits.

4.7. Effects on Ability to Drive and Use Machines

None known.

4.8 Undesirable effects

In scabies patients, skin discomfort (paraesthesias), usually described as burning, stinging or tingling, occurs in a few individuals soon after Permethrin 5% w/w Cream is applied. This occurs more frequently in patients with severe scabies and is usually mild and transient.

Other transient signs and symptoms of irritation, including erythema, oedema, eczema, rash and pruritus which may follow treatment of scabies with Permethrin 5% w/w Cream are generally considered to be part of the natural history of scabies.

In patients treated for scabies, itching may persist for up to 4 weeks post-treatment. This is generally regarded as due to an allergic reaction to the dead mites under the skin and is not necessarily indicative of a treatment failure.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions viathe Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

4.9 Overdose

There are no reports of overdosage of Permethrin 5% w/w Cream.

Application of a full tube (30 g) of cream to a 2-month old would result in a dose of approximately 350 mg/kg bodyweight. Even if 100% of the permethrin absorbed, this dose would be unlikely to cause overt signs of systemic toxicity.

It is possible that excessive application of Permethrin 5% w/w Cream to the skin might result in localised adverse reactions or more severe skin reactions. Treatment of hypersensitivity-type reactions should be symptomatic.

Symptoms of overdose may include nausea, headache, vomiting, dizziness and convulsion.

In the event of accidental ingestion of the contents of a tube of Permethrin 5% w/w Cream by a child, gastric lavage should be considered if consultation is within 2 hours of ingestion.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Ectoparasiticides, scabicides, pyrethrines; ATC code: P03AC04

The principal physiological action in susceptible parasites exposed to permethrin is induction of electrochemical abnormalities across the membranes of excitable cells, leading to sensory hyper-excitability, inco-ordination and prostration. It is assumed that the mode of action against arachnids (mites) is similar.

Paediatric population

Newborns and infants:

The safety and efficacy of permethrin in newborns and infants under 2 months of age have not been established since no data are available from prospective trials or larger case series. A limited number of case reports in the treatment of children under 2 months of age presenting with scabies do not suggest specific safety concerns for the use of topical permethrin in this age group, but no definite conclusion can be drawn.

5.2 Pharmacokinetic properties

Permethrin is rapidly metabolised in mammals by ester hydrolysis to inactive metabolites which are excreted principally in the urine. The principal metabolites of permethrin are detectable in the urine within 7 hours of whole body application of the cream to healthy volunteers or scabies patients. The highest levels of excretion are detectable within 48 hours but very low levels of metabolite are still detectable in the urine of some individuals 28 days after treatment. The overall pattern of excretion indicates a mean of approximately 0.5% of applied permethrin is absorbed during the first 48 hours.

Investigations with the 5 % cream in humans revealed an average percutaneous absorption rate of 0.47 ± 0.3 % in healthy subjects and of 0.52 ± 0.3 % in patients.

Pharmacokinetic properties were studied in adult subjects only (6 healthy volunteers and 6 patients with scabies).

Absorbed permethrin is rapidly broken down by esterases as well as hydrolases. After oral administration, peak plasma concentrations are reached in approximately 4 hours. The isomeric mixture is then excreted in the urine in the form of glucuronides, sulfates etc as cis- trans CI2CA [(3- (2,2-dichlorovinyl)-2,2-dimethylcyclopropane-1-carboxylic acid)] and after oxidation to 3 PBA (3- phenoxybenzoic acid). After oral application, up to 6 % is excreted unchanged in the faeces whilst on dermal application, unchanged permethrin is virtually undetectable.

5.3 Preclinical safety data

In vitro and in vivo genetic toxicity studies were all negative, revealing no potential for permethrin to induce mutagenic changes.

In repeated long-term bioassays for carcinogenic potential performed in rats, no evidence of oncogenicity was observed. Similar studies in mice have shown species specific increases in pulmonary adenomas, a common benign tumour of mice of high spontaneous background incidence. In one of these studies, there was an increased incidence of benign liver adenomas and of pulmonary alveolar cell carcinomas only in female mice when permethrin was given in their food at 1:5000 parts per million (approximately 750 mg/kg bodyweight/day) for two years. It is considered that these findings do not indicate a significant oncogenic potential for permethrin in humans.

From acute and chronic toxicity studies there is no evidence indicating the occurrence of previously unknown adverse effects in humans. Furthermore, there is no evidence on relevant genotoxic or carcinogenic potential. In studies on the reproductive toxicity in mice, rats and rabbits after repeated oral administration of permethrin effects were observed only for doses largely exceeding the exposure expected for the topical use of the 5% cream. Following the intended use of this active substance a serious harmful effect on aquatic organisms (daphnia and fish) and terrestric organisms (plants) is expected after passage of the sewage treatment plant.

Environmental risk assessment studies have shown that permethrin may pose a risk for surface water, sediment, ground water and soils

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cetostearyl alcohol

White soft paraffin

Macrogol cetostearyl ether

Isopropylmyristate

Benzyl alcohol

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 freeze.

6.5. Nature and Contents of Container

Aluminium tube with polypropylene cap. Contains 30g of cream.

6.6. Instruction for Use/Handling

None

7 MARKETING AUTHORISATION HOLDER

Sandoz Limited,

Park View, Riverside Way,

Watchmoor Park, Camberley,

Surrey,

GU15 3YL,

United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

PL 04416/0456

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

16/12/2008

10 DATE OF REVISION OF THE TEXT

12/09/2025