Derbac M Liquid 0.5% w/w cutaneous emulsion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Malathion

Available from:

LanesHealth (Ireland) Limited

ATC code:

P03AX; P03AX03

INN (International Name):

Malathion

Dosage:

0.5 percent weight/weight

Pharmaceutical form:

Cutaneous emulsion

Therapeutic area:

Other ectoparasiticides, incl. scabicides; malathion

Authorization status:

Marketed

Authorization date:

1993-07-13

Patient Information leaflet

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 HAVE
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 after 3 weeks.
WHAT IS IN THIS LEAFLET:
1. What Derbac M Liquid is and what it is used for
2. What you need to know before you use Derbac M Liquid
3. How to use Derbac M Liquid
4. Possible side effects
5. How to store Derbac M Liquid
6. Contents of the pack and other information
1. WHAT DERBAC M LIQUID IS AND WHAT IT IS USED FOR
Derbac M Liquid is a liquid emulsion containing the active
ingredient Malathion. It is used for the eradication of head
lice, pubic lice and their eggs and for the treatment of
scabies in adults, the elderly and children aged 6 months
and over.
As Derbac M does not contain alcohol, it may be
more suitable for those with asthma or eczema.
ADULTS, THE ELDERLY AND CHILDREN AGED 6 MONTHS AND OVER:
FOR TREATMENT OF HEAD LICE:
• Apply sufficient liquid to DRY hair to ensure that no part of the
scalp is left
uncovered. Work into the hair spreading the liquid evenly from root to
tip.
• Leave the hair to dry naturally in a warm but well ventilated
room.
• After 12 hours, or the next day, if preferred, shampoo hair in the
normal way.
• Rinse the hair and comb whilst wet to remove dead lice and eggs
(nits) using
a nit comb.
• The treatment should be repeated after 7 days.
FOR TREATMENT OF CRAB (PUBIC) LICE:
• Apply to the entire skin surface
• Pay particular attention to all hairy areas including beards and
moustaches.
Avoid any other areas above the neck.
• Leave on for at least 1 hour before washing but preferably l

Summary of Product characteristics

Health Products Regulatory Authority
08 December 2022
CRN00D9FX
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Derbac M Liquid 0.5% w/w cutaneous emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The liquid contains 0.5% w/w Malathion.
Also contains methyl parahydroxybenzoate (E218) 0.20% w/w and propyl
parahydroxybenzoate (E216) 0.08% w/w.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Emulsion.
Creamy white perfumed emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. For the treatment of severe infestation of the scalp or pubic with
lice (T. Pediculosis).
2. For the treatment of scabies.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical external use only
_ADULTS, THE ELDERLY AND CHILDREN AGED 6 MONTHS AND OVER:_
As this product does not contain alcohol, it may be more suitable for
those with asthma or eczema.
_TREATMENT OF HEAD LICE_
Rub the liquid into the scalp until all the hair and scalp is
thoroughly moistened. Leave the hair to dry naturally in a warm but
well ventilated room. After 12 hours, or the next day if preferred,
shampoo the hair in the normal way.
Rinse the hair and comb whilst wet to remove dead lice and eggs (nits)
using the Nit Comb.
Treatment should be repeated after 7 days.
_TREATMENT OF CRAB (PUBIC) LICE_
Apply Derbac-M Liquid to the entire skin surface. Pay particular
attention to all hairy areas including beards and moustaches.
Avoid any other areas above the neck. Leave on for at least one hour
before washing but preferably Derbac-M Liquid should
be left on overnight. Wash off in the usual manner.
Treatment should be repeated after 7 days.
_TREATMENT OF SCABIES_
Apply Derbac-M Liquid to the entire skin surface. In adults it may not
be necessary to apply above the neck but children under
the age of two years should have a thin film of Derbac-M Liquid
applied to the scalp, face and ears, avoiding the eyes and
mouth.
Do not wash off or bathe for 24 hours. If hands or any other parts
must be washed during this