LYCLEAR DERMAL CREAM

12000000112270

Patient leaflet in accordance with the

Pharmacists' Regulations )Preparations( – 1986

The medicine is dispensed according to

a physician's prescription only

Lyclear Dermal Cream

The tube contains Permethrin 5% w/w.

List of the additional ingredients detailed in section 6.

Read the entire leaflet carefully before using the medicine.

This leaflet contains concise information about the medicine. If

you have any other questions, refer to the physician or the

pharmacist.

This medicine has been prescribed for you. Do not pass it on to

others. It may harm them even if it seems to you that their medical

condition is similar.

The medicine is not intended for babies under the age of

2 months old.

1.

What is the medicine intended for?

Lyclear Dermal Cream is used to treat scabies.

Therapeutic group: Lyclear Dermal Cream belongs to a group of

medicines called pyrethroids, which are anti-parasitic agents.

2.

Before using the medicine

Do not use the medicine if:

you are sensitive )allergic) to permethrin, other pyrethrins,

to any of the additional ingredients contained in the

medicine )listed in section 6) or to chrysanthemums.

Special warnings regarding the use of the medicine

Talk to your physician or pharmacist before using Lyclear Dermal

Cream

If you are treating infants, see below in the section “Children

up to 23 months of age”.

If you are known to be allergic to chrysanthemums or other

plants from the compositae family, you should only use

Lyclear Dermal Cream after talking to your physician.

Lyclear Dermal Cream is used for cutaneous use only. Do not

swallow this medicine.

Avoid contact with the eyes or mucous membranes )inside

the nose or throat, genital region) or open wounds. In the

event of eye contact, rinse immediately with water or saline

)salt solution 0.9%) )if readily available).

People routinely involved in treating others may wish to wear

gloves to avoid any possible irritation to the hands.

Stop using Lyclear Dermal Cream if you experience skin irritation

and consult a physician if it doesn’t improve.

Lyclear Dermal Cream may worsen symptoms of asthma or

eczema.

Children up to 23 months of age:

Do not use Lyclear Dermal Cream in newborns and infants less

than 2 months of age, unless your physician tells you so. There is

no adequate experience in infants and toddlers. Treatment of

children up to 23 months of age should only be given under close

medical supervision.

Other medicines and Lyclear Dermal Cream

If you are taking or have recently taken other medicines

including non-prescription medicines and food supplements,

tell the physician or the pharmacist. Especially inform the

physician or the pharmacist if you are currently taking a type of

medicine called a corticosteroid before you use this medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant

or are planning to have a baby, consult the physician or the

pharmacist before using this medicine.

Driving and using machines

Lyclear Dermal Cream is not known to affect your ability to drive

or operate machines.

Important information about some ingredients of the

medicine

Lyclear Dermal Cream contains formaldehyde and butylated

hydroxytoluene. These may cause local skin reactions

)e.g. contact dermatitis) or irritation to the eyes and mucous

membranes.

Lyclear Dermal Cream also contains liquid paraffin.

This excipient of the cream may reduce the efficiency and hence

the reliability of latex products )e.g. condoms, diaphragms) used

at the same time.

3.

How should you use the medicine?

Always use according to the physician's instructions. You should

check with the physician or the pharmacist if you are unsure.

Ensure the skin is clean, dry and cool.

If you take a warm bath prior to treatment, you should allow

the skin to cool before the cream is applied.

Carefully apply a thin layer of the cream to the skin )see “How

and when should you use Lyclear Dermal Cream?”)

The cream rubs easily into the skin. It is not necessary to

apply more cream until you can see it on the surface.

Usually a single application clears the infection. If you are in

doubt about the success of treatment, consult your physician.

Lyclear Dermal Cream is not suitable for use in babies under

2 months of age.

The dosage and treatment will be determined only by the

physician. The usual dosage is:

Adults and children over 12 years:

Up to one tube

Children:

6 to 12 years:

Up to half of a tube

1 to 5 years:

Up to a quarter of a tube

2 months to 1 year:

Up to an eighth of a tube

Newborns and infants under 2 months of age:

There is only limited data available in this age group and no

dosage can be recommended )see also section 2 under “Special

warnings regarding the use of the medicine”).

The above information is merely a guide. The dosage can be

adjusted according to the needs of the patient and the individual

body surface area. For example, some adults require a larger

amount of cream. A few adults may need to use an additional

tube, but do not apply more than two tubes.

How and when should you use Lyclear Dermal Cream?

Lyclear Dermal Cream is for cutaneous use only.

Take care not to allow the cream to get into the eyes or come into

contact with mucous membranes )inside the nose or throat,

genital region) or open wounds. If accidental contact occurs, rinse

thoroughly with water.

Adults should apply the cream to the whole body including the

neck, palms of the hands and soles of the feet. The head and face

can be spared unless this area includes places affected by

scabies )itch mites). When applying the cream, the area between

the fingers and toes )also under the finger- and toe-nails), the

wrists, elbows, armpits, external genitalia and buttocks should be

especially carefully treated.

In women, cream should also be applied to the breasts.

Children

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.

Keep your child from licking the cream from the hands. If

necessary, children should wear gloves.

There is no adequate experience in infants and toddlers.

Treatment to children up to the age of 23 months should therefore

only be treated under close medical supervision.

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. Care should be taken to avoid applying the cream to

areas around the eyes.

How long should you use Lyclear Dermal Cream?

One application of Lyclear Dermal Cream is usually sufficient.

Leave the cream on the skin for at least eight hours, for example,

overnight. Avoid bathing, showering or washing during this period,

because this could endanger the success of treatment. If, by way

of an exception, you have to wash your hands within the eight

hour period, then reapply the cream to the hands and wrist area.

The same applies if you have to wash other parts of treated skin

)buttocks, external genitalia).

After at least 8 hours, take a shower or wash the skin with soap

and water.

Provided these instructions for use are followed, a single

application is generally sufficient for successful treatment.

However, in cases of persistent or renewed infestation, it may be

necessary to repeat the treatment after 7 days.

Do not exceed the recommended dose

For external use only

What to do if the cream is accidentally swallowed

If a child has accidentally swallowed the medicine, refer

immediately to a physician or to a hospital emergency room and

bring the package of the medicine with you.

If you accidently have taken a higher dosage

If you use more than you should, wash the excess cream with

soap and warm water. If there are any signs of irritation, consult a

physician.

Persist with the treatment as recommended by the physician.

Do not take medicines in the dark! Check the label and the dose

each time you take medicine. Wear glasses if you need them.

If you have any other questions regarding the use of the medicine,

consult the physician or the pharmacist.

4.

Side effects

As with any medicine, use of Lyclear Dermal Cream may cause

side effects in some of the users. Do not be alarmed by reading

the list of side effects. You may not experience any of them.

If severe hypersensitivity reactions occur, please consult a

physician immediately. In this case you must not use Lyclear

Dermal Cream any more.

Common )may affect up to 1 in 10 people(:

Itching )pruritus), reddening of the skin or unusual sensations on

the skin )paraesthesia) such as tingling, prickling, skin burning

sensation as well as dry skin are common. However, such

symptoms can also occur as a result of the disease itself.

Moisturisers and bath oils are recommended as follow up

treatment for dry skin. The itching and a skin rash )post-scabies

eczema) may persist for up to 4 weeks after the end of treatment.

This is caused by a reaction to the killed scabies mites.

If after using Lyclear Dermal Cream you have the impression that

the disease is persisting, please talk to your physician before

applying the cream again.

Very rare )may affect up to 1 in 10,000 people(:

Skin lesions )excoriations), inflammation of the hair follicles

)folliculitis) and reduced skin pigmentation have been reported at

the time Lyclear Dermal Cream is used.

Sensitive/allergic persons have reported breathing difficulties at

the time substances from the pyrethrin group were being used.

Not known )frequency cannot be estimated from the available

data(:

Nettle rash which may spread beyond the area of skin treated.

If a side effect has appeared, if any of the side effects get worse

or when you suffer from a side effect that has not been mentioned

in the leaflet, you should consult the physician. Adverse events

can be reported to the Ministry of Health by clicking the link

“Report Side Effects of Drug Treatment” that is located on the

Ministry of Health home page )www.health.gov.il), which refers to

on-line form for adverse events reporting, or by entering the link:

https://forms.gov.il/globaldata/getsequence/getsequence.

aspx?formType=AdversEffectMedic@moh.gov.il

5.

How to store the medicine?

Avoid poisoning! This medicine and any other medicine

should be kept in a closed place out of the sight and reach of

children and/or infants in order to avoid poisoning. Do not

induce vomiting without an explicit instruction from the

physician.

Do not use the medicine after the expiry date )exp. date)

appearing on the package. The expiry date refers to the last

day of that month.

Do not store above 25°C. Do not freeze.

Use within 6 months after first opening, but not past the

expiry date.

6.

Additional information

In addition to the active ingredient the medicine also contains -

Triglycerides )medium chain), glyceryl monostearate,

macrogol )2) cetyl ether, glycerol, isopropyl myristate,

cetomacrogol 1000, wool alcohols, formaldehyde solution

)see section 2), liquid paraffin )see section 2), carbomer

974P, butylated hydroxytoluene )E321) )see section 2),

sodium hydroxide and purified water.

What does the medicine look like and what is the content of

the package -

Lyclear Dermal Cream is a white to off-white cream and

comes in tube containing 30 g of cream.

License Holder: GlaxoSmithKline )Israel) Ltd., 25 Basel St.,

Petach Tikva.

Manufacturer: Aspen Bad Oldesloe GmbH, Bad Oldesloe,

Germany.

This leaflet was checked and approved by the Ministry of

Health in: October 2016.

Registration number of the medicine in the National Drug

Registry of the Ministry of Health: 060-18-27015

Trade marks are owned by or licensed to the GSK group of

companies.

©2019 GSK group of companies or its licensor.

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The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in October2016

LYCLEAR

DERMAL CREAM

1. NAME OF THE MEDICINAL PRODUCT

Lyclear

Dermal Cream

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Permethrin 5% w/w (equivalent to 50 mg/g)

Excipients with known effect: Contains formaldehyde solution 0.278% w/w and butylated

hydroxytoluene (E321) 0.02% w/w

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cream

A white to off-white cream.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Lyclear Dermal Cream is indicated for the treatment of scabies.

4.2 Posology and method of administration

Lyclear Dermal Cream is suitable for use by adults and children of 2 months of age and above.

Lyclear Dermal Cream is also suitable for use by the elderly.

Keep this medicine out of sight and reach of children.

Lyclear Dermal Cream should be applied to clean, dry, cool skin. If the patient has taken a warm

bath prior to treatment the skin should be allowed to cool before the cream is applied.

Lyclear Dermal 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.

Older children should be supervised by an adult when applying the cream to ensure that a thorough

treatment is administered.

Posology

For adults and children over 12 years of age, up to one 30g tube may be used as a single application.

A few adults may need to use more than one tube to ensure total body coverage, but not more than

two tubes (60g in total) should be used for a single application.

For children 12 years and under, the following table indicates the approximate amount of cream to

be used as a single application. These drug recommendations are only approximate and are intended

to serve as a guide. (Recommendations are based on the use of a 30g tube).

Children aged:

2 months to 1 year

up to

⅛ of a tube

1-5 years

up to ¼ of a tube

6-12 years

up to ½ of a tube

The safety and efficacy of Lyclear in children under 2 months of age have not been established. No

data are available.

Method of Administration

For cutaneous use only.

The medicinal product must not be swallowed.

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

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, elbows, armpits, external genitalia and the buttocks should be especially carefully treated.

In cases where the head, neck, scalp and ears are treated (see below) the dosage may be increased to

ensure total body coverage.

In women, the whole body application should include the breasts.

The whole body should be washed thoroughly 8-12 hours after treatment.

During the treatment period, Lyclear Dermal Cream should be re-applied to the hands if they are

washed with soap and water.

Approximately 90% of individuals are cured with a single application of cream. If necessary, a

second application may be given, not less than 7 days after the initial application, if there are no

signs of the original lesions healing or if new lesions are present.

Paediatric population

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 in children aged 2 months to 23 months. Therefore, treatment

must be given only under close medical supervision in this age group.

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. Care should be taken to avoid applying the cream to

areas of skin around the eyes.

4.3 Contraindications

Hypersensitivity to the active substance permethrin, other substances of the pyrethrin group, any of

the excipients listed in section 6.1, or to chrysanthemums. 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.

When using Lyclear Dermal Cream, 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.

Paediatric population

Only limited experience is available with Lyclear Dermal Cream in children aged 2 months to 23

months. Therefore treatment must be given only under close medical supervision in this age group.

For cutaneous use only.

Lyclear Dermal Cream is for external use only and should be kept out of the sight and reach of

children.

Permethrin is not an eye irritant, but contact of Lyclear Dermal Cream with the eyes should be

avoided because other components of the product can 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.

In the event of accidental ingestion of permethrin, please seek immediate medical attention.

It is important to ensure that the course of treatment is followed as directed because treatment

failure has been reported when this has not occurred.

Nursing staff who routinely apply Lyclear Dermal Cream may wish to wear gloves to avoid any

possible irritation to the hands.

Direct contacts should be treated. If no improvement occurs consult the doctor. Pyrethrins are used

as an agricultural and horticultural insecticide, the potential for sensitisation through this route

should be kept in mind.

Elderly patients: There is an increasing body of data specifically relating to the use of Lyclear

Dermal 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.

Excipients – Important Information

Note: The excipient of the cream, liquid paraffin, can reduce the functioning and hence the

reliability of latex products (e.g. condoms, diaphragms) used at the same time.

Lyclear Dermal Cream contains formaldehyde and butylated hydroxytoluene (E321) which may

cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

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 Lyclear Dermal 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 reduce efficacy is, however, considered small.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are limited data on the use of Lyclear Dermal Cream in pregnancy which provide no

indication of any risk to the foetus. Furthermore, the amount of permethrin absorbed systemically

following a whole body application is extremely low, less than 0.5% of the applied dose is

absorbed. These data together with the negative mutagenicity tests and the very low mammalian

toxicity would suggest that any risk to the foetus following treatment with Lyclear Dermal Cream is

minimal.

Women who are pregnant should use permethrin only after prior consultation with a

healthcare professional.

Breast-feeding

Studies, following oral administration of permethrin in cattle have indicated that very low

concentrations of permethrin are excreted in milk. It is not known whether permethrin is excreted in

human breast milk, although there are very limited data, which suggest that suckling infants are

unaffected following maternal use of permethrin containing products. However, because only

extremely small amounts of permethrin are absorbed systemically following treatment with Lyclear

Dermal Cream and in theory only a very small percentage of this systemic permethrin may pass into

the breast milk, it is unlikely that the concentrations of permethrin in the milk will present any risk

to the neonate/infant.

Women who are breastfeeding should only use permethrin containing

products after consultation with a healthcare professional.

4.7 Effects on ability to drive and use machines

Permethrin is unlikely to have any effects on the ability to drive and use machines.

4.8 Undesirable effects

Adverse reactions are listed below by MedDRA system organ class and frequency. Frequencies are

defined as: very common (1/10), common (1/100 to 1/10), uncommon (1/1000 to 1/100),

rare (1/10,000 to 1/1000) and very rare (1/10,000) including isolated reports.

System

Organ

class

Common

(≥1/100

<1/10)

Rare

(≥1/10,000 to

<1/1,000)

Very rare

(<1/10,000)

known

(cannot

be estimated from the

available data)

Nervous system

disorders

Paresthesia,

skin

burning

sensation

Respiratory,

thoracic

mediastinal

Dyspnoea

sensitive/allergic

patients)

disorders

Skin

subcutaneous

tissue disorders

Pruritus,

erythematous

rash, dry skin

Excoriation,

folliculitis,

skin

hypopigmentation

Urticaria

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. Any suspected

adverse events should be reported to the Ministry of Health according to the National Regulation by

using an online form

(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh

.health.gov.il). Additionally, you should also report to GSK Israel (il.safety@gsk.com).

4.9 Overdose

On the basis of animal and human volunteer studies, it is unlikely, even with misuse or excessive

topical application that the amount of permethrin required to produce clinically relevant toxic

effects would be reached.

In the event of accidental ingestion of permethrin, please seek immediate medical attention.

Symptoms

Symptoms of overdose are generally likely to occur after accidental or deliberate oral ingestion due

to swallowing and in rare cases because of skin absorption following excessive topical application

and may include dizziness, loss of appetite, nausea, vomiting, headache, weakness, seizures, and

loss of consciousness.

It is possible that excessive application of Lyclear Dermal Cream might result in localised adverse

reactions as described in the side-and adverse effects section or more severe skin reactions.

Managment

Symptomatic treatment is indicated should hypersensitivity-type reactions occur.

In the event of overdose or accidental ingestion of the contents of a tube of Lyclear Dermal 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: Pyrethrines, incl. synthetic compounds, ATC code: P03AC04

The principle physiological action in insects (lice) exposed to permethrin is induction of

electrochemical abnormalities across the membranes of excitable cells, leading to sensory

hyperexcitability, in co-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

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

Non-clinical data reveal no special hazards for humans based on studies of acute and repeated dose

toxicity, genotoxicity and carcinogenic potential. Effects in reproductive studies were only seen at

exposures considered sufficiently in excess of the exposure expected for the topical use of a 5%

cream.

Environmental risk assessment studies have shown that permethrin may pose a risk for aquatic

organisms (daphnia and fish) and terrestric organisms (plants) (See section 6.6).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Triglycerides, medium chain

Glyceryl monostearate

Macrogol (2) cetyl ether

Glycerol

Isopropyl myristate

Cetomacrogol 1000

Wool alcohols

Formaldehyde solution

Liquid paraffin

Carbomer 974P

Butylated hydroxytoluene (E321)

Sodium hydroxide

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The expiry date of the product is indicated on the label and packaging.

Use within 6 months after opening.

6.4 Special precautions for storage

Do not store above 25ºC. Do not freeze.

6.5 Nature and contents of container

Lyclear Dermal Cream is supplied in 30 g aluminium foil/polyolefin laminate tubes.

7. MANUFACTURER

Aspen Bad Oldesloe GmbH, Bad Oldesloe, Germany.

8. LICENSE HOLDER

GlaxoSmithKline (Israel) Ltd., 25 Basel St., Petach Tikva.

9. LICENSE NUMBER

060-18-27015

Lyc DR v.5.1

Trade marks are owned by or licensed to the GSK group of companies.

©2019 GSK group of companies or its licensor.