Ionil T
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ionil T Shampoo.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Coal tar solution 4.25% w/w, salicylic acid 2.0% w/w, benzalkonium chloride 0.2% w/w, polyoxyethylene (4) lauryl ether 7.2% w/w and polyoxyethylene (23) lauryl ether 14.4% w/w.
3. PHARMACEUTICAL FORM
Hydro-alcoholic solution for topical (cutaneous) application as a shampoo.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Psoriasis and seborrhoeic dermatitis of the scalp.
4.2. Posology and method of administration
Adults, elderly and children
Massage Ionil T Shampoo into wet hair and rinse out (not too much lather will be produced on first application).
Apply again, working into a lather, and allow to remain on the hair for five minutes before rinsing.
Repeat the treatment once or twice a week, or as directed by the doctor or pharmacist.
4.3. Contra-indications
None.
Avoid contact with the eyes. Upon accidental contact, flush with clean, warm water.
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Pregnancy and lactation
No special precautions required.
4.7. Effects on ability to drive and use machines
None.
4.8. Undesirable effects
None known.
4.9 Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
The active constituents of Ionil T Shampoo provide the product with keratolytic, antiseptic and anti-pruritic properties to effect symptomatic relief of psoriasis and seborrhoeic dermatitis of the scalp.
In animal models, coal tar has been demonstrated to suppress epidermal cell DNA synthesis.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Pre-clinical safety data
No specific information is presented given the widespread use of coal tar preparations on humans over many years.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Ethyl alcohol tetrasodium edetate, citric acid and purified water.
6.2. Incompatibilities
None known.
6.3. Shelf-life
Thirty six (36) months.
6.4. Special precautions for storage
Ionil T Shampoo should be stored below 25oC and away from direct heat. The product should be stored away from internal preparations and food.
As with all medicines, Ionil T Shampoo should be kept out of the sight and reach of children.
Nature and contents of container
6.5.
White polypropylene flat bottle with a white polypropylene snap cap or screw-cap as the closure.
Pack sizes 50ml and 200ml.
6.6 Special precautions for disposal
No special instructions
7 MARKETING AUTHORISATION HOLDER
Galderma (UK) Ltd Meridien House 69-71 Clarendon Road Watford Herts
WD17 1DS UK
8. MARKETING AUTHORISATION NUMBERS(S)
PL: 10590/0003.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
First authorised on 4 June 1991.
10 DATE OF REVISION OF THE TEXT
14/07/2008