Lyclear 5% dermal cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Permethrin

Available from:

Omega Pharma Ltd

ATC code:

P03AC04

INN (International Name):

Permethrin

Dosage:

50mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100400; GTIN: 5012616172601

Patient Information leaflet

PATIENT
INFORMATION LEAFLET
LYCLEAR
® DERMAL CREAM
PERMETHRIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
WHAT IS IN THIS LEAFLET
1. What Lyclear Dermal Cream is and what it is used for
4. Possible side effects
2. What you need to know before you use Lyclear Dermal Cream 5. How to
store Lyclear Dermal Cream
3. How to use Lyclear Dermal Cream
6. Contents of the pack and other information
1. WHAT LYCLEAR DERMAL CREAM IS AND WHAT IT IS USED FOR
Lyclear Dermal Cream is used to treat infestations of scabies and crab
lice on the body. It contains the ingredient permethrin which belongs
to a group of medicines called pyrethroids which kill mites such as
scabies and crab lice.
You must talk to a doctor if the symptoms worsen or do not improve.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LYCLEAR DERMAL CREAM
DO NOT USE LYCLEAR DERMAL CREAM:
• If you are allergic to Permethrin or any of the other ingredients
of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor 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 compositae
- you should only use Lyclear Dermal Cream after speaking to your
doctor.
Do not smoke or go near naked flames - risk of severe burns. Fabric
(clothing, bedding, dressings etc) that has been in contact with this
product burns more easily and is a serious fire hazard. Washing
clothing and bedding may reduce product build-up but not totally
remove it.
For cutaneous use only! Do not swallow this medicine.
Avoid contact with eyes or mucous membranes (inside the nose or
throat, genital region) or open wounds.
Lyclear Dermal Cream may worsen symptoms of asthma or eczema.
Carers who apply permethrin are advised to wear gloves.
CHILDREN UP TO

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
LYCLEAR Dermal Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Permethrin, Medical Grade 5.0% w/w (Cis/Trans Isomer 25/75)
Excipients with known affect:
Permethrin 5.0% w/w/ contains:
0.020% w/w Butylated hydroxytoluene (E321)
0.278 % w/w Formaldehyde solution
0.01% w/w Lanolin
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream for topical application.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lyclear Dermal Cream is indicated for the treatment of scabies in
adults and children
aged from 2 months, and crab lice in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
TREATMENT OF SCABIES
Adults and adolescents over 12 years of age:
Apply up to 30 g of cream (corresponding to one tube of 30 g). The
application should
be repeated 7 – 14 days after the first treatment.
Paediatric population
_Children aged from 6 - 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 aged from 2 months - 5 years: _
Up to 7.5 g of cream (corresponding to ¼ tube of 30 g). The
application should be
repeated 7 – 14 days after the first treatment.
The safety and efficacy of Lyclear Dermal Cream in children under 2
months of age
have not been established. No data are available.
TREATMENT OF CRAB LICE
Adults over 18 years of age:
Apply up to 30 g of cream (corresponding to one tube of 30 g).
_ _
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).
_ _
_For treatment of scabies: _
Adults, adolescents and children over 2 years 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),