Derbac M Liquid 0.5% w/w Cutaneous emulsion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Malathion

Available from:

GR Lane Health Products Ltd

ATC code:

P03AX; P03AX03

INN (International Name):

Malathion

Dosage:

0.5 percent weight/weight

Pharmaceutical form:

Cutaneous emulsion

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other ectoparasiticides, incl. scabicides; malathion

Authorization status:

Not 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
DERBAC M LIQUID
Do not use Derbac M liquid:
•
If you are allergic to Malathion or any of the other
ingredients of this medicine listed in section 6
•
Do not use on infants less than 6 months old unless
your doctor tells you to.
WARNINGS AND PRECAUTIONS:
•
Prolonged or repeated use with this product should
be avoided
•
It should not be used more than once a week and
for not more than 3 consecutive weeks
•
If you are a healthcare professional treating a large
number of patients, then wear protective plastic or
rubber gloves
•
Avoid contact with the eyes
•
Use this medicine only on your skin
•
Do not use on broken or secondarily infected skin
•
This product should not be swallowed. If ingested,
contact a doctor or hospital immediately

Summary of Product characteristics

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 period, the
treatment
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