lotion

5% v/w Cutaneous Emulsion Coal Tar Solution

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 Exorex Lotion carefully to get the best results.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact your doctor if your symptoms worsen or do not improve.

•    If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist as soon as possible.

In this leaflet:

1.    What Exorex Lotion is and what it is used for

2.    Before you use Exorex Lotion

3.    How to use Exorex Lotion

4.    Possible side effects

5.    How to store Exorex Lotion

6.    Further information

1.    WHAT EXOREX LOTION IS AND WHAT IT IS USED FOR

Exorex Lotion is a skin lotion (also known as cutaneous emulsion) for external use only. It contains coal tar solution which relieves and prevents itching and promotes the softening of the outer layer of skin. The tar acids in coal tar have been shown to have antibacterial properties. Exorex Lotion is for the treatment of psoriasis.

2.    BEFORE YOU USE EXOREX LOTION

Do not use Exorex Lotion:

•    If you are allergic (hypersensitive) to coal tar or any of the other ingredients (see Section 6 for other ingredients).

•    If you suffer from inflammation of the hair follicles (folliculitis) or acne.

•    If your skin reacts badly to sunlight (you are photosensitive).

•    If you suffer from a condition called lupus erythematosus.

•    If you have inflamed or broken skin (you have open wounds or your skin is infected).

•    On the genital or rectal areas.

Take special care with Exorex Lotion:

•    When applying the lotion around the eyes and other sensitive areas of the body such as the mouth. If any lotion accidentally enters the eyes, rinse with water immediately.

•    Coal tar makes the skin more sensitive to sunlight. Exposure to direct sunlight (such as sunbathing) should therefore be avoided after application of the lotion. There may be a very small increase in the risk of skin cancer in patients with psoriasis who are treated with coal tar products, but this is not proven.

•    Exorex Lotion may cause staining of clothes or hair.

Taking or using other medicines

You can use Exorex Lotion whilst taking other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice before using Exorex Lotion. Important information about some of the ingredients of Exorex Lotion

Propyl hydroxybenzoate (E216) and methyl hydroxybenzoate (E218) may cause allergic reactions (possibly delayed). Hydrogenated polyoxyl castor oil may cause skin reactions.

3.    HOW TO USE EXOREX LOTION

Follow the instructions about when and how to use the product. If you have any further questions, ask your doctor or pharmacist.

Dosage and method of administration

Exorex Lotion is for the treatment of psoriasis of the skin and scalp.

Shake the bottle thoroughly before each use.

Adults and children over 12 years of age

•    Ensure that all areas of affected skin are clean.

•    Apply a thin layer of Exorex Lotion two to three times a day to affected areas.

•    Massage gently and leave to dry.

Children under 12 years and the elderly

•    As for adults, but the lotion can be diluted by mixing with a few drops of freshly boiled and cooled water if preferred.

Previous users have found the application of a thin layer of moisturising cream to be helpful in keeping the affected areas moist after application of the lotion.

If you use more Exorex Lotion than you should

This is unlikely to be harmful but may result in allergy (hypersensitivity) to coal tar.

If you accidentally swallow Exorex Lotion

If any Exorex Lotion is accidentally swallowed call your doctor immediately or go to the nearest hospital Accident & Emergency department. Take the bottle with you so that the product may be easily identified.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Exorex Lotion can cause side effects, although not everybody gets them.

You may experience skin irritation, increased sensitivity of the skin to sunlight, or acne-like outbreaks of the skin. If this happens consult your doctor or pharmacist.

If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist as soon as possible.

5.    HOWTO STORE EXOREX LOTION

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the pack after 'EXP' or 'Expiry Date'. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste.

Return any leftover lotion to your pharmacist for disposal. These measures will help to protect the environment.

6.    FURTHER INFORMATION What Exorex Lotion contains

Active ingredient: Coal Tar Solution 5% v/w.

Other ingredients: dl-alpha tocopherol, xanthan gum, vitamin F ethyl ester, hydrogenated polyoxyl castor oil, propyl hydroxybenzoate (E216), methyl hydroxybenzoate (E218), purified water.

What Exorex Lotion looks like and contents of the pack

Exorex Lotion is a smooth mustard-coloured cutaneous emulsion (skin lotion).

It is available in bottles of 100ml and 250ml.

MA Holder:

Forest Tosara Limited, Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Manufacturer

Purna Pharmaceuticals N.V., Rijksweg 17, 2870 Puurs, Belgium.

This leaflet was last revised: January 2011

Other formats:

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People.

Patients in the Republic of Ireland with visual impairment requiring this information in other formats should telephone Forest Laboratories UK Ltd on +44 (0) 1322 421 800

TBC

for health and for life