- Approval Id
- bcf34d8974d37d5e
- Drug Approval Emc Name
- Cocois (Coconut Oil Compound Ointment)
- Drug Name
- Cocois (Coconut Oil Compound Ointment)
- Company Name
- RPH Pharmaceuticals AB
- Company Address
- Box 603, 101 32 Stockholm, Sweden
- Company Website
- //www.recipharm.com
- Company Telephone
- +44 (0)845 023 0467
- Company Medical Info Direct Line
- +44 207 862 1716
- Company Medical Info Email
- safety@elc-group.com
- Company Customer Care Direct Line
- +44(0)845 023 0467
- Company Stock Availability
- +44(0)845 023 0467
- Legal Category
- General Sales List
- Authorisation Holder
- RPH Pharmaceuticals AB
Box 603
101 32 Stockholm
Sweden
- Authorisation Number
- PL 36301/0022
- Authorisation Date
- | | |
| --- | --- |
| Date of first authorisation: Date of renewal: | 9th June 1997 6th November 1998 |
- Instruction Authorisation Holder
- RPH Pharmaceuticals AB
Box 603
101 32 Stockholm
Sweden
- Instruction Authorisation Number
- PL 36301/0022
- Instruction Authorisation Date
- | | |
| --- | --- |
| Date of first authorisation: Date of renewal: | 9th June 1997 6th November 1998 |
- Instruction Composition
- | | |
| --- | --- |
| Active ingredients | % w/w |
| Coal Tar Solution BP | 12.0 |
| Precipitated Sulphur Ph.Eur | 4.0 |
| Salicylic Acid Ph.Eur | 2.0 |
Excipient(s) with known effect: Contains cetostearyl alcohol 11.00% w/w
For the full list of excipients, see section 6.1
- Instruction Dosage Form
- Ointment for topical application.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
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.4.2 Posology and method of administration
\*\*Adults, children over 12 years and the elderly\*\*
\*Mild dandruff\*
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\*\*
Not recommended.4.3 Contraindications
Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1
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.4.4 Special warnings and precautions for use
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.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.4.5 Interaction with other medicinal products and other forms of interaction
None4.6 Pregnancy and lactation
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.4.7 Effects on ability to drive and use machines
None4.8 Undesirable effects
Coal tar may cause skin irritation, folliculitis and rarely photosensitivity.
Cocois may cause skin irritations, acne like eruptions, dermatitis, 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Overdose is extremely unlikely. Treat symptomatically, if necessary.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Coal Tar is antipuritic, keratoplastic and a weak antiseptic.
Salicylic 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.5.2 Pharmacokinetic properties
No data is available for the proposed formulation.5.3 Preclinical safety data
None stated.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Coconut Oil
White Soft Paraffin
Cetostearyl Alcohol
Glycerol
Liquid Paraffin
Polyoxyethylene Glycerol Monostearate
Hard Paraffin6.2 Incompatibilities
Not applicable6.3 Shelf life
2 years.6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
Cocois is packed into internally lacquered, aluminium tubes (5g, 15g, 40g and 100g) fitted with a polyethylene cap.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements
- Instruction Content
- ## Composition
| | |
| --- | --- |
| Active ingredients | % w/w |
| Coal Tar Solution BP | 12.0 |
| Precipitated Sulphur Ph.Eur | 4.0 |
| Salicylic Acid Ph.Eur | 2.0 |
Excipient(s) with known effect: Contains cetostearyl alcohol 11.00% w/w
For the full list of excipients, see section 6.1
## Pharmaceutical Form
Ointment for topical application.
## Clinical Particulars
4.1 Therapeutic indications
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.4.2 Posology and method of administration
\*\*Adults, children over 12 years and the elderly\*\*
\*Mild dandruff\*
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\*\*
Not recommended.4.3 Contraindications
Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1
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.4.4 Special warnings and precautions for use
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.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.4.5 Interaction with other medicinal products and other forms of interaction
None4.6 Pregnancy and lactation
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.4.7 Effects on ability to drive and use machines
None4.8 Undesirable effects
Coal tar may cause skin irritation, folliculitis and rarely photosensitivity.
Cocois may cause skin irritations, acne like eruptions, dermatitis, 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Overdose is extremely unlikely. Treat symptomatically, if necessary.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Coal Tar is antipuritic, keratoplastic and a weak antiseptic.
Salicylic 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.5.2 Pharmacokinetic properties
No data is available for the proposed formulation.5.3 Preclinical safety data
None stated.
## Pharmaceutical Particulars
6.1 List of excipients
Coconut Oil
White Soft Paraffin
Cetostearyl Alcohol
Glycerol
Liquid Paraffin
Polyoxyethylene Glycerol Monostearate
Hard Paraffin6.2 Incompatibilities
Not applicable6.3 Shelf life
2 years.6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
Cocois is packed into internally lacquered, aluminium tubes (5g, 15g, 40g and 100g) fitted with a polyethylene cap.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements
