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EXOREX LOTION 5% V/W CUTANEOUS EMULSION

Active substance(s): COAL TAR SOLUTION

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Package leaflet: Information for the user

lotion

5% v/w Cutaneous Emulsion
Coal Tar Solution

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 has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If 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 your doctor if you do not feel better or if you feel worse.
What is in this leaflet:
1. What Exorex Lotion is and what it is used for
2. What you need to know before you use Exorex Lotion
3. How to use Exorex Lotion
4. Possible side effects
5. How to store Exorex Lotion
6. Contents of the pack and other 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 anti-bacterial properties. Exorex Lotion is for the treatment of psoriasis.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE EXOREX LOTION
Do not use Exorex Lotion:
• If you are allergic to coal tar or any of the other ingredients of this medicine (listed in section 6).
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before using Exorex Lotion.
• Be careful 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.
Other medicines and Exorex Lotion
You can use Exorex Lotion whilst taking other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before using this medicine.
Exorex Lotion contains propyl hydroxybenzoate (E216), methylhydroxybenzoate (E218) and
hydrogenated polyoxy castor oil.
Propyl hydroxybenzoate (E216) and methylhydroxybenzoate (E218) may cause allergic reactions (possibly
delayed). Hydrogenated polyoxyl castor oil may cause skin reactions.
3. HOW TO USE EXOREX LOTION
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
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.

Exorex Cutaneous 5% Emulsion 250 ml PIL UK

approved for print/date

item no:

AAAI0613

dimensions: 148 x 210

print proof no:

4

pharmacode:

origination date:

19.6.15

min pt size:

originated by:

db

revision date:

3.7.15

Technical Approval

revised by:

db

date sent:

19.6.15

supplier:

Purna

approved:

3.7.15

colours/plates:
1. black
2.
3.
4.

9.2 pt

5.
6.
Non Printing Colours
1.
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

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 in
the palm of the hand 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
and Emergency department. Take the bottle with you so that the product may be easily identified.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE EXOREX LOTION
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after ‘EXP’ or ‘Expiry
Date’. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use.
These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Exorex Lotion contains
The active substance is: Coal Tar Solution 5% v/w.
The other ingredients are: polysorbate 80, ethanol, 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.
Not all packs may be marketed.
Marketing Authorisation 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 in June 2015
Other sources of information

If you would like a leaflet with larger text,
please contact 01271 311257.

AAAI0613

Exorex Cutaneous 5% Emulsion 250 ml PIL UK

approved for print/date

item no:

AAAI0613

dimensions: 148 x 210

print proof no:

4

pharmacode:

origination date:

19.6.15

min pt size:

originated by:

db

revision date:

3.7.15

Technical Approval

revised by:

db

date sent:

19.6.15

supplier:

Purna

approved:

3.7.15

colours/plates:
1. black
2.
3.
4.

9.2 pt

5.
6.
Non Printing Colours
1.
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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