Lyclear Creme Rinse 1% w/w Cutaneous solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Permethrin

Available from:

Chefaro Ireland DAC

ATC code:

P03AC; P03AC04

INN (International Name):

Permethrin

Dosage:

1 percent weight/weight

Pharmaceutical form:

Cutaneous solution

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

PACKAGE LEAFLET: INFORMATION FOR THE USER
Lyclear Crème Rinse
Cutaneous Solution
Permethrin 1%
Kills head lice and their
eggs
10 MINUTES
Contact time
Suitable for asthmatics
Pleasant smell
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still
need to use Lyclear Creme Rinse
carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must contact a doctor if the symptoms worsen or do not improve.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist straight away.
IN THIS LEAFLET
:
1.
What Lyclear Creme Rinse is and what it is used for
2.
Before you use Lyclear Creme Rinse
3.
How to use Lyclear Creme Rinse
4.
Possible side effects
5.
Storing Lyclear Creme Rinse
6.
Further information
7.
Health guide on Head Lice
L.
WHAT LYCLEAR CREME RINSE IS AND WHAT IT IS USED FOR
Lyclear Creme Rinse is used as a treatment to get rid of head lice and
their eggs. It contains the
ingredient permethrin which belongs to a group of medicines called
pyrethroids which kill insects
such as head lice.
Lyclear Creme Rinse is for use on adults and children over 6 months of
age.
2
.
BEFORE YOU USE LYCLEAR CREME RINSE
DO NOT USE THIS MEDICINE IF
:

You are allergic (hypersensitive) to any of the ingredients of Lyclear
Creme Rinse (see section 6)
or to other pyrethroids or pyrethrins.

If you are known to be allergic to chrysanthemums or other compositae
- you should only use
Lyclear Crème Rinse after speaking to your doctor.
CHILDREN UP TO 3 YEARS
Do not use Lyclear Crème Rinse in newborns and infants less than 6
months of age, unless your
doctor tells you so. There is no adequate experience in infants and
toddlers. Treatment to children up
to 3 years of age should only be given under close medical
supervision.

Summary of Product characteristics

Health Products Regulatory Authority
17 January 2024
CRN00DV90
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lyclear Creme Rinse 1% w/w Cutaneous solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10mg permethrin
Excipients with known effect:
Cetyl Alcohol 2.05% w/w, Stearalkonium Chloride 3.1500 % w/w, Methyl
Parahydroxybenzoate (E218) 0.2% w/w, Propyl
Parahydroxybenzoate (E216) 0.08% w/w, Propylene Glycol 0.0784% w/w and
Sunset Yellow (E110) 0.0016% w/w.
This medicine contains fragrance with:
Amyl cinnamal 0.005% w/w, Amylcinnamyl alcohol <0.001% w/w, Anise
alcohol 0.003% w/w, Benzyl alcohol 0.289% w/w, Benzyl
benzoate 0.497% w/w, Benzyl cinnamate 0.051% w/w, Benzyl salicylate
4.331% w/w, Cinnamal 0.002% w/w, Cinnamyl alcohol
0.043% w/w, Citral (neral + geranial) 0.054% w/w, Citronellol 0.289%
w/w, Coumarin 0.104% w/w, Eugenol 0.522% w/w,
Farnesol 0.005% w/w, Geraniol 0.443% w/w, Hexyl cinnamal 3.728% w/w,
Hydroxycitronellal <0.001% w/w, Isoeugenol 0.015%
w/w, Butylphenyl methylpropional <0.001% w/w, D-limonene 1.795% w/w,
Linalool 1.112% w/w, Hydroxyisohexyl
3-cyclohexene carboxaldehyde <0.001% w/w, Methyl 2-octynoate <0.001%
w/w, Alpha-isomethyl ionone 1.051% w/w, Evernia
prunastri extract <0.001% w/w, Evernia furfuracea extract <0.001% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution.
An orange coloured cream rinse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of _pediculosis capitis_.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical preparation – applied to scalp and hair.
ADULTSANDCHILDREN OVER 6 MONTHS OFAGE
Lyclear Crème Rinse should be used after hair has been washed with a
mild non conditioning shampoo and towel l
ed dry. The
bottle should be shaken thoroughly and enough Lyclear Crème Rinse
applied to saturate the hair and scalp. Particular attention
should be given to areas behind the ears and at the nape of the neck.
Lyclear Crème Rinse should be left on the hair for 10 minutes