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Patient Information Leaflet: Cocois® Coconut Oil compound Ointment

Coal tar 12%w/w, Salicylic acid 2%w/w and sulphur for external use 4%w/w


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 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).

•    If the patient is under 6 years old.

If any of the above applies to you talk to your doctor or pharmacist.

Tell your doctor if you are taking any of the following medicines:

•    Any other medicine, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Cocois Ointment should not be used during

pregnancy or if breast-feeding.

3. How to use Cocois

Follow these instructions about how to use your medicine. If you are unsure about anything, ask your pharmacist.

Remember:

•    Avoid any contact with your eyes and mouth.

•    Cocois may stain clothes and jewellery. Care should be taken to protect or remove these before application.

•    Cocois should only be used under medical supervision in children aged 6-12 years.

•    It is not recommended for use in children under the age of six years.

•    Do not use Cocois if the tube membrane is broken.

Instructions for use

•    Pierce the tube membrane by inverting the cap.

•    Attach the scalp applicator to the threaded portion of the tube.

•    Part your hair and apply a thin ribbon of Cocois to the affected areas of your scalp.

•    Take care to avoid contact with your eyes.

•    Gently rub in the ointment and leave in contact with the scalp for approximately one hour.

•    Wash your hands afterwards.

•    After one hour, Cocois should be shampooed out of the hair with warm water.

•    Take care to avoid getting the application in your eyes.

•    Always wash your hands immediately after use.

•    In severe scaly scalp conditions, it is usually necessary to apply Cocois daily for three to seven days until control has been obtained.

•    With mild scaliness, use intermittently as necessary, e.g., once a week.

•    If, after the first week, the condition does not improve, or symptoms persist after four weeks, consult your doctor.

If you accidentally get Cocois in your eyes,

wash it out immediately with plenty of cold

water. If your eyes become irritated, talk to

your doctor or pharmacist.

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If you use more Cocois than you should If you use more Cocois than you should it is unlikely to lead to any serious side effects. If you accidentally swallow any Cocois, immediately tell your doctor or contact your nearest hospital casualty department.

4. Possible side effects

Like all medicines, Cocois can cause side effects, although not everybody gets them. These include:

•    Irritation of the skin

•    Inflammation of the hair follicles

•    Acne like eruptions

•    Hair loss

•    Discolouration of skin and hair

•    A rash from sensitivity to sunlight. This is rare.

•    If you have asthma or if anyone in your family is allergic to asprin, Cocois may cause difficulty in breathing or tightness in your chest. This is very rare.

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5.    How to store Cocois

Keep out of the reach and sight of children.

Do not use after the expiry date shown on the label. The expiry date refers to the last day of that month.

Store between 10°C and 25°C.

Medicines should not be disposed of via wastewater or household waste. Return all unused medicine to your pharmacist.

6.    Further information

What Cocois contains:

The active ingredients are: Coal tar 12%w/w, Salicylic acid 2%w/w and sulphur for external use 4%w/w.

The other ingredients are: coconut oil, white soft paraffin, cetostearyl alcohol, glycerol, liquid paraffin, polyoxyethylene glycerol monostearate, hard paraffin

What Cocois looks like

Cocois is a buff coloured ointment. It comes in aluminium tubes with a plastic cap. It is supplied in 5 g, 15 g, 40 g or 100 g tubes. Not all pack sizes may be marketed.

Marketing Authorisation Holder

RPH Pharmaceuticals AB, Lager vagen 7,

136 50 Haninge, Sweden.

Manufacturer

Bioglan AB, PO Box 50310, S-202 13, Malmo, Sweden

Distributed by Focus Pharmaceuticals Ltd. This leaflet was last updated in March 2012.

If this leaflet is difficult to read and you would like it in a different format, please contact

RPH Pharmaceuticals AB, Lagervagen 7,

136 50 Haninge,

Sweden.

FOCUS

910035