Summary of medicine characteristics - IONIL T
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.
For the full list of excipients, see section 6.1
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.
Cutaneous use (to use only on the scalp)
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
Subjects with a history of photo-induced or photo-aggravated disease (such as photosensitive dermatoses, systemic lupus erythematosus, acute or sub-acute cutaneous lupus erythematosus or any other skin or systemic condition worsened by sun exposure)
Unstable or swollen psoriasis, exudative eczema
Children under 2 years of age
4.4 Special warnings and precautions for use
Avoid contact with the eyes. Upon accidental contact, flush with clean, warm water. Avoid contact with mucosa.
In case of open wounds or cutaneous infections, the product should not be applied.
Avoid exposure to direct sunlight during the treatment period with this product.
This medicine can cause allergic reactions to sunlight if the shampoo remains on the scalp. Therefore, it is recommended to gently rinse the hair to eliminate completely the shampoo after application of the product.
In addition, caution should be exercised with ultra-violet lamps (UV lamps).
4.5 Interaction with other medicinal products and other forms of interaction
It is not recommended to use it concomitantly with medicines with phototoxic or photo allergic potential (such as tetracyclines, methoxalene, trioxalene, psoralene or tretinoin). Additive photo-sensitizing effects can occur.
The effects of other keratolytic products applied on the same area could be potentiated.
4.6 Fertility, pregnancy and lactation
No special precautions required.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
| MedDRA- system organ class | Frequency | Undesirable Effect |
| Immune system disorders | Not known (cannot be estimated from the available data) | Hypersensitivity |
| General disorders and administration site conditions | Not known (cannot be estimated from the available data) | Pain |
| Skin and subcutaneous tissue disorders | Not known (cannot be estimated from the available data) | Erythema, skin irritation skin burning sensation Photosensitivity reaction |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9 Overdose
4.9 OverdoseSymptoms:
The excessive use of the product does not produce more rapid and better results and on the contrary it might produce intense irritation. In case of intense irritation, treatment should be discontinued.
Abuse of salicylic acid may result in necrosis of healthy skin. In case of accidental ingestion of the product, nausea and vomiting might occur.
Treatment:
Symptomatic treatment should be applied, such as active carbon administration. If it is necessary, abundant water and antacids should be given.
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 Preclinical safety data
5.3 Preclinical safety dataNo 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.
6.5 Nature and contents of container
6.5 Nature and contents of containerWhite polypropylene flat bottle with a white polypropylene snap cap or screwcap as the closure.
Pack sizes 50ml and 200ml.
6.6 Special precautions for disposal
No special instructions
7 MARKETING AUTHORISATION HOLDER
LABORATOIRES BAILLEUL S.A.
10–12 AVENUE PASTEUR
2310 LUXEMBOURG
LUXEMBOURG
8 MARKETING AUTHORISATION NUMBER(S)
PL 48335/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
First authorised on 4 June 1991.