Cocois Ointment, coal tar 12.0% sulphur for external use 4.0%, salicylic acid 2.0%

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Coal tar solution; Sulphur for external use; Salicylic acid

Available from:

RPH Pharmaceuticals AB

ATC code:

D11AC; D11AC08

INN (International Name):

Coal tar solution; Sulphur for external use; Salicylic acid

Dosage:

12 % +4 %+2 percent

Pharmaceutical form:

Ointment

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Medicated shampoos; sulfur compounds

Authorization status:

Marketed

Authorization date:

1996-05-01

Patient Information leaflet

PATIENT INFORMATION LEAFLET: COCOIS OINTMENT
COAL TAR 12.0%, SULPHUR FOR EXTERNAL USE 4.0%, SALICYLIC ACID 2.0%
PATIENT INFORMATION LEAFLET: COCOIS OINTMENT, COAL TAR 12.0%, SULPHUR
FOR EXTERNAL USE 4.0%,
SALICYLIC ACID 2.0%.
Read all of this leaflet carefully because it contains important
information for you.
THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL
NEED TO USE COCOIS CAREFULLY
TO GET THE BEST RESULTS FROM IT.
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or advice
• You must contact a doctor if your symptoms worsen or do not
improve.
IN THIS LEAFLET:
1. What Cocois is for
2. Before you use Cocois
3. How to use Cocois
4. Possible side effects
5. How to store Cocois
6. Further information.
1. WHAT COCOIS IS FOR
Cocois contains coal tar, salicylic acid and sulphur for external use.
Coal tar and sulphur are mildly antiseptic and relieves itching.
Sulphur also has an antifungal action.
Coal tar, salicylic acid and sulphur help to reduce the excessive
hardening, thickening and scaling of
the skin.
Cocois acts by reducing the scaliness and irritation of the skin
associated with dry scaly skin
disorders.
Cocois is for the treatment of dry scaly skin disorders of the scalp
such as psoriasis, eczema, dandruff
and other inflammatory conditions causing irritation and scaliness.
2. BEFORE YOU USE COCOIS
DO NOT USE COCOIS IF:
• You are allergic to any of the ingredients in Cocois (see section
6)
• You have any acute infection of the skin
• You have broken or infected skin
• You suffer from any form of psoriasis which causes the appearance
of blisters filled with pus (acute
pustular psoriasis).
• You are a child under 6 years old.
If any of the above applies to you talk to your doctor or pharmacist.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Cocois.
Do not smoke or go near naked flames – risk of severe burns. Fabric
(clothing, bedding, dressings,
etc) that has been in contact with this product burn

Summary of Product characteristics

Health Products Regulatory Authority
11 August 2021
CRN00CHRZ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cocois Ointment, coal tar 12.0% sulphur for external use 4.0%,
salicylic acid 2.0%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS
% W/W
Coal Tar Solution
12.0
Sulphur for External Use
4.0
Salicylic Acid
2.0
Excipient: Contains cetostearyl alcohol 11% w/w.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
Khaki coloured unctuous solid.
4 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
Because of the theoretical risk of skin damage if used for long
periods, patients should be advised to consult their doctor if,
after the first week, the condition has not improved or if symptoms
persist after four weeks.
_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.
For all cases the affected area should be treated and shampooed off
approximately one hour later.
_CHILDREN 6-12 YEARS_
To be used under medical supervision only.
_CHILDREN UNDER 6 YEARS_
Not recommended.
Health Products Regulatory Authority
11 August 2021
CRN00CHRZ
Page 2 of 4
4.3 CONTRAINDICATIONS
The product is contraindicated in patients known to be sensitive to
sulphur, salicylates, in the presence of acute local infections,
or acute pustular psoriasis.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not use if the tube membrane is already perforated. Do not use on
inflamed or broken skin. Avoid contact with mouth,
m