Lyclear 5% w/w Dermal Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Permethrin

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

P03AC; P03AC04

INN (International Name):

Permethrin

Dosage:

5 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Pyrethrines, incl. synthetic compounds; permethrin

Authorization status:

Marketed

Authorization date:

1995-07-05

Patient Information leaflet

Reason for update: Variation to register Pharbil Waltrop GmbH as an
additional packaging site and QP release site
Market: IE
Agency Approval Date:
Text Date: 29/09/2020
Text Issue and Draft No.: Issue 5 draft 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LYCLEAR
5% W/W 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.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1
. What Lyclear Dermal Cream is and what it is used for
2
. What you need to know before you use Lyclear Dermal Cream
3
. How to use Lyclear Dermal Cream
4.
Possible side effects
5
. How to store Lyclear Dermal Cream
6.
Contents of the pack and other information
1.
WHAT LYCLEAR DERMAL CREAM IS AND WHAT IT IS USED FOR
Lyclear 5% w/w Dermal Cream belongs to a group of medicines called
pyrethroids, which are anti-parasitic
agents.
Lyclear Dermal Cream is used to treat scabies and crab louse
infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LYCLEAR DERMAL CREAM
DO NOT USE LYCLEAR DERMAL CREAM

if you are allergic to permethrin, other pyrethrins, or any of the
other ingredients of this medicine (listed
in section 6), or to chrysanthemums.
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.

Lyclear Dermal Cream is for cutaneous use only. Do not swall

Summary of Product characteristics

Health Products Regulatory Authority
16 June 2021
CRN00C0NJ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lyclear 5% w/w 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 butylhydroxytoluene
(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 and
crab louse infestations in adults and children > 2 months of
age.
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.
TREATMENT OF SCABIES
Posology
Unless otherwise directed by the physician, the recommended dosage is
as follows:
_Adults and adolescents over 12 years of age:_
Apply up to 30 g of cream (corresponding to one 30 g tube).
Paediatric population
_Children aged from 6-12 years:_
Apply up to 15 g of cream (corresponding to ½ of a 30 g tube)
Health Products Regulatory Authority
16 June 2021
CRN00C0NJ
Page 2 of 7
_Children aged from 2 months-5 years:_
Up to 7.5 g of cream (corresponding to ¼ of a 30 g tube).
The safety and efficacy of Lyclear in children under 2 months of age
have not been established. No data are availa