EXOREX LOTION 5 %v/w Cutaneous Emulsion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

COAL TAR SOLUTION

Available from:

Forest Tosara Limited

ATC code:

D05AA

INN (International Name):

COAL TAR SOLUTION

Dosage:

5 %v/w

Pharmaceutical form:

Cutaneous Emulsion

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Tars

Authorization status:

Authorised

Authorization date:

1998-10-16

Patient Information leaflet

Exorex Cutaneous 5% Emulsion 250 ml PIL UK EIRE
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TECHNICAL APPROVAL
black
AAAJ4935
3
2.12.16
db
2.2.17
db
Purna
148 x 210
9.2 pt
2.12.16
15.12.16
* 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.
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 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.
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Exorex Lotion 5% v/w Cutaneous Emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is coal tar solution 5 % v/w.
Excipients with known effect:
Methyl hydroxybenzoate (E218)
0.10 % w/w
Propyl hydroxybenzoate (E216)
0.05 % w/w
Hydrogenated polyoxyl castor oil 0.45 % w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous emulsion
A smooth mustard coloured emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Exorex is for the treatment of psoriasis of the skin and scalp.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 12 years of age:
Ensure that the lesions are clean. Apply a thin layer of Exorex two or three times per day to the affected areas. Massage
gently and leave to dry.
For young children under 12 years of age and the elderly:
The emulsion may be diluted by mixing with a few drops of freshly boiled and cooled water in the palm of the hand.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Presence of folliculitis and acne vulgaris.
Exorex should not be used on patients who have disease characterised by photosensitivity such as lupus erythematosus or
allergy to sunlight.
Exorex should not be applied to inflamed or broken skin (open exuding wounds or infection of the skin).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Coal tar may cause skin irritation. If irritation occurs the treatment should be reviewed and discontinued if necessary.
Coal tar enhances photosensitivity of the skin and exposure to direct sunlight after application of Exorex should be
avoided.
Use with care near the eyes and mucous membranes. If any emulsion should accidentally enter the�