Summary of Product Characteristics Updated 05-Apr-2018 | RPH Pharmaceuticals AB
Cocois (Coconut Oil Compound Ointment).
Coal Tar Solution BP
Precipitated Sulphur Ph.Eur
Salicylic Acid Ph.Eur
Ointment for topical application.
Cocois has mild, antipruritic, antiseptic and keratolytic properties. It is indicated in the treatment of scaly skin disorders of the scalp such as psoriasis, eczema, seborrhoeic dermatitis and dandruff.
Adults, children over 12 years and the elderly
To be used intermittently as an adjunctive treatment to be applied approximately once a week.
Psoriasis, eczema, seborrhoeic dermatitis and severe dandruff
To be used daily for three to seven days until improvement has been achieved. Intermittent repeated applications may be necessary to maintain improvement.
In all cases, the affected area should be treated and shampooed off using warm water approximately one hour later.
Children 6-12 years
To be used under medical supervision only.
Children under 6 years
The product is contraindicated in patients known to be sensitive to any of the ingredients including sulphur and salicylates, in the presence of acute local infections, or acute pustular psoriasis.
Do not use if the tube membrane is already perforated. Do not use on inflamed or broken skin. Avoid contact with mouth, mucous membranes and eyes and wash hands immediately after use. Discontinue use if irritation develops.
If symptoms persist after four weeks, a doctor should be consulted.
Cocois may stain fabrics and jewellery.
If possible Cocois should not be used during pregnancy or lactation. However, inadvertent, accidental exposure is not cause for clinical intervention. Minimal systemic absorption of salicylic acid may occur after topical application. There are no data on the use of coal tar in pregnant or lactation women. It is unknown whether coal tar crosses the placenta or is excreted in breast milk. There is no sufficient clinical experience to establish the safety of sulphur in general during pregnancy and lactation. It is unknown whether sulphur crosses the placenta or is excreted in breast milk.
Coal tar may cause skin irritation, folliculitis and rarely photosensitivity.
Cocois may cause skin irritations, acne like eruptions, dermatititis, folliculitis, alopecia and rarely photosensitivity and hypersensitivity. Discolouration of skin and hair may also occur.
Bronchospasm has been reported very rarely in patients with either pre-existing asthma or a family history of hypersensitivity to salicylates.
Although carcinogenicity of coal tar has been demonstrated in animal studies, no studies demonstrating an increased risk of skin cancer with normal therapeutic use in humans have been reported. There is no unequivocal evidence to link the use of topically applied coal tar products with skin cancer.
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 Yellow Card Scheme on the MHRA website (www.mhra.gov.uk/yellowcard).
Overdose is extremely unlikely. Treat symptomatically, if necessary.
Coal Tar is antipuritic, keratoplastic and a weak antiseptic.
Salisylic acid has keratolytic properties.
Sulphur is a keratolytic, with weak antiseptic and parasiticide properties.
Combinations of coal tar, salicylic acid and sulphur are widely used in the treatment of hyperkeratotic and scaling skin conditions.
No data is available for the proposed formulation.
White Soft Paraffin
Polyoxyethylene Glycerol Monostearate
Store between 10°C and 25°C.
Cocois is packed into internally lacquered, membrane sealed, aluminium tubes (5g, 15g, 40g and 100g) fitted with a polyurethane cap.
RPH Pharmaceuticals AB,
136 50 Haninge,
Date of first authorisation:
Date of renewal:
9th June 1997
6th November 1998