Please read this leaflet carefully before you apply ASCABIOL. This leaflet is a summary of important information about ASCABIOL. If you have any questions, or are not sure about anything to do with your treatment, ask your doctor or pharmacist for more information.

Keep this leaflet in a safe place. You may want to refer to it again.

The active ingredient in Ascabiol Emulsion is benzyl benzoate.

Ascabiol emulsion also contains the following inactive ingredients: stearic acid, triethanolamine, terpineol, cinnamon leaf oil, silicone and water.

Ascabiol is available in packs of 100ml and 200ml bottles.

Ascabiol is for the treatment of infestations with skin mites (scabies) or lice (pediculosis).

The Marketing Authorisation holder is Rhône-Poulenc Rorer, Eastbourne, East Sussex BN21 3YG. Ascabiol is manufactured by Natrapharm (Ireland) Ltd, Waterford, Ireland a member of the Rhône-Poulenc Rorer group of companies.

• Scabies is a skin infestation caused by a microscopic mite. The mite burrows under the skin and causes severe itching.
• Pediculosis is an infestation of the head, body or pubic area by lice.
• Ascabiol Emulsion kills both mites and lice.

If the answer is yes to any of the questions, you

should discuss the matter with your doctor or

pharmacist before applying Ascabiol Emulsion.

• Are you sensitive or allergic to benzyl benzoate or any other inactive ingredients listed above
• Are you pregnant?
• Are you breastfeeding?

• The emulsion is irritating to the eyes. Protect your eyes during application.
• The emulsion may damage plastic or acrylic bathroom furniture. Care should be taken not to splash the emulsion on such surfaces.

Shake the bottle well before use.

ALL members of your household should be treated to prevent infestation recurring.

After a hot bath and drying, apply the emulsion to the whole body except the face and the head. You may find it easier to apply using a paintbrush.

Special attention should be paid to:

• wrists, ankles, armpits, buttocks and groin area
• webs of the fingers and toes and under nails

Then allow the emulsion to dry, which usually takes about 10 minutes in a warm room.

It is desirable to put on clean underclothing and to have clean night garments and bed linen. Discarded clothes and linen are effectively disinfected by the ordinary process of washing and ironing.

If the application is thorough, one treatment is normally enough but a second application within five days will reduce the chance of any infestation remaining.

Alternatively, Ascabiol can be applied to the whole body, except the head and face, on three occasions at 12 hourly intervals.

You should have a hot bath 12 hours after the last application and change to clean clothes and bed linen. Discarded clothes and bed linen should be washed.

The affected area should be coated with the emulsion, as above. Wash off after 24 hours with soap and water. In severe cases this procedure may need to be repeated two or three times.

A further examination should be carried out a week after the last application to confirm that the lice have been killed.

Dilute the emulsion before application with an equal quantity of water for older children and with 3 parts of water for babies.

Contact your doctor or nearest hospital casualty department immediately.

Ascabiol may cause mild skin irritation or a short lived burning sensation.

This side effect may be more severe in sensitive patients. If the effect is severe, the emulsion should be washed off immediately with soap and water.

Excessive application of the emulsion has been reported to cause:

• difficulty in passing urine
• fits or convulsions in infants

If either of these occur, wash off the emulsion and contact your doctor immediately.

If you notice any other changes in your health whilst taking this medicine, tell your doctor immediately.

You should not use the emulsion after the expiry date. If you are not sure when this is, check with your doctor or pharmacist.

The expiry date can be found on the box and bottle label. It starts with the letters 'EXP'. in both places the date is written as the month number, followed by the last two numbers of the year. For example 03-97 means that the expiry date is the end of March 1997.

Keep your emulsion in a safe place and out of reach of children.

Store below 25°C

This leaflet was written in November 1995

© 1995 Rhône-Poulenc Rorer