Prioderm Liquid
Common Technical Document Derbac M Liquid
Module 1 - Administrative and Prescribing Information
Module 1.3 - Product Information
Text to appear on the Patient Information Leaflet
Prioderm Liquid
0. 5. w/w Cutaneous Emulsion Malathion
PATIENT INFORMATION LEAFLET
Please read this leaflet carefully before using Prioderm Liquid.
• Keep this leaflet, you may wish to read it again.
• Ask your pharmacist if you need more information or advice.
1. What is Prioderm Liquid used for?
2. Before using Prioderm Liquid
3. How-to use Prioderm Liquid
4. Possible side-effects
5. How-to store Prioderm Liquid
6. What Prioderm Liquid contains
What is this liquid used for?
Prioderm Liquid is for the treatment of head lice, pubic lice and scabies.
Before using this liquid Do not use...
• If you are allergic to any of the ingredients in this product. See 'What this liquid contains' for the full list of ingredients.
• Do not use on infants less than 6 months old unless your doctor tells you to.
Take special care...
• 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 three consecutive weeks.
• If you are a healthcare professional treating a large number of children, then wear protective plastic or rubber gloves
• Avoid contact with the eyes
• For external use only. Do not use on a damaged or infected skin unless advised by your doctor or pharmacist.
Important information about some of the ingredients...
• This product contains methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding...
• Speak to your doctor before using this medicine
Driving and using machines
There are no known effects on driving or on operating machines whilst taking this product How to use this liquid
Should a member of your family need treatment check other members of your family for live lice with a detector comb and treat if necessary.
Adults, the elderly and children 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 the roots to the tips.
• 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.
• Wash hands after application.
• 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 one hour before washing but preferably leave on overnight. Wash off in the usual manner.
• Wash hands after application.
• The treatment should be repeated after 7 days.
For Treatment of Scabies
• Apply to the entire skin surface.
• In adults it may not be necessary to apply above the neck. If used in children under the age of two years, a thin film of the liquid should be 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 must be re-applied to those areas immediately.
• Wash hands after application.
• The treatment should be repeated after 7 days.
No special sterilisation of clothing is necessary, ordinary laundering or dry cleaning with hot-iron pressing are sufficient.
The infestation is cleared by the treatment. However, the itching and rash may persist for up to 7 days. An anti-irritant cream can be applied if necessary.
Family members and close contacts should also be treated simultaneously.
Children under 6 months:
• Do not use on children under 6 months unless your doctor tells you to.
If you accidentally swallow the liquid or get it in your eyes...
The liquid is for external use only. Protect the eyes at all times by covering the eye area with a towel.
If liquid enters the eyes, wash out with plenty of water.
If accidentally swallowed contact your doctor or pharmacist immediately.
Possible side effects
As with all medicines, this liquid can have side effects in some people,
If you experience any of the following, stop using the medicine immediately and go to the nearest hospital:
• Allergic reactions which cause difficulty in breathing or dizziness, or swelling of the face and throat, and swollen eyes.
Other reported side effects may include:
• Skin irritation
• Chemical burns
If you feel you are reacting badly to this medicine in any way, or notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the Internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in the paper form available from your local pharmacy.
How to store this liquid
• Keep out of reach and sight of children.
• Do not store above 25°C and protect from light. Store the bottle in the outer carton in order to protect from light.
• Do not use after the expiry date (EXP) shown on the label and carton.
• If you find that you still have this medicine after its expiry date, return it to your local pharmacist who will dispose of it properly.
What this liquid contains
Prioderm Liquid contains 0.5% wlw of the active ingredient malathion, which is highly effective against lice and:their eggs. It also contains methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), emulsifying wax, potassium citrate, citric acid, perfume HT 52 and purified water.
Prioderm Liquid is a white, creamy, perfumed liquid contained in amber glass bottles of 50 and 200ml.
Marketing Authorisation Holder: G R Lane Health Products Ltd. Sisson Road, Gloucester, GL2
0GR, UK.
Manufactured by Laboratoires Chemineau, 93 route de Monnaie, 37210, Vouvray, France Date of revision: January 2015 PL 01074/0241 PA 618/14/1
Manufactured for and distributed by:
Prioderm is a trade mark of the SSL Group
Reckitt Benckiser, Auckland (For Freephone consumer services please call 0508 73 1234)
January 2015 - LB