Carbo-dome cream – patient leaflet, side effects, dosage

1. What Carbo-Dome Cream is and what it is used for

Carbo-Dome Cream contains the active substance, coal tar solution, which is used to relieve and prevent itching and promotes the softening of the outer layer of skin, the tar acids in coal tar have been shown to have anti-bacterial properties.

Carbo-Dome Cream is used to treat psoriasis.

2. What you need to know before you use Carbo-Dome Cream

Do not use Carbo-Dome Cream:

! if you are allergic to coal tar or any of the other

ingredients of this medicine (listed in section 6) ! if you suffer from inflammation of the hair follicles

(folliculitis) or acne

! if your skin reacts to sunlight (photosensitivity) ! if you suffer from a condition called lupus

erythematosus

! if you have inflamed or broken skin (open wound

or skin infections)

! on the genitals or rectal areas.

Warnings and precautions

Talk to your doctor or pharmacist before using Carbo-Dome Cream.

Take care when applying Carbo-Dome Cream to your face, avoid your eyes and other sensitive areas. If the cream gets into your eyes rinse them thoroughly with water.

Use this cream sparingly and with care especially around the skin folds (e.g. your elbows).

Avoid exposure to direct sunlight and UV lamps after applying as this increases the effects of the coal tar, particularly in the treatment of psoriasis. If you are going out into the sun or work outdoors, use a strong sun cream, wear a broad rimmed hat and loose clothes to protect the treated area from the sun.

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 burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Other medicines and Carbo-Dome Cream

There are currently no known interactions that may occur when Carbo-Dome Cream is used with other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

It is recommended that the use of coal tar in pregnancy and breast-feeding is limited to intermittent use in low concentrations, applied to a small area of the body.

Use during the first trimester of pregnancy should be avoided.

Carbo-Dome Cream contains methyl p-hydroxybenzoate and sodium lauryl sulphate

This cream contains methyl p-hydroxybenzoate which may cause allergic reactions (possibly delayed).

This cream contains 10 mg sodium lauryl sulphate in each 1 g. Sodium lauryl sulphate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.

3. How to use Carbo-Dome Cream

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

For external use on the skin only, not to be swallowed.

How and where to use

Use sparingly and with care on skin folds (e.g. elbow) and the delicate skin areas around the sex organs and scalp.

The recommended dose is:

Adults and children over 12 years of age

! Ensure the affected skin is clean before applying

the cream.

! Apply a thin layer of Carbo-Dome Cream over

the affected layer 2 - 3 times a day, massage in gently and leave to dry.

The elderly and children under 12 years of age

As for adults, but the cream may be diluted by mixing it with a few drops of freshly boiled, cooled water.

Some patients use a thin layer of moisturizing cream to keep the affected areas moist after the lotion has been applied.

If you swallow Carbo-Dome Cream

If you or anyone else swallows any of this cream, contact a doctor immediately or go to your nearest hospital casualty department and take the tube and this leaflet with you to show the doctor what you have used.

If you apply more Carbo-Dome Cream than you should

If you apply an unintentional extra dose it is unlikely to be harmful.

If you forget to apply Carbo-Dome Cream

If you forget to apply the cream, apply the missed dose as soon as you remember. Apply your next dose at the correct time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects are:

! some people may be more sensitive to the sun,

sunbeds and UV lamps while using coal tar cream. If this happens to you, avoid exposure to sunlight, sunbeds and UV lamps (unless this is required as for example part of your treatment for psoriasis)

! skin irritation may occur

! acne-type skin eruptions

! inflammation of the hair follicles in the skin.

An increased risk of skin cancer in psoriatic patients treated with a combination of coal tar and UVB radiation has been reported.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple

App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Carbo-Dome Cream

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Store in a cool place.

Do not use this medicine if you notice any visible signs of deterioration in your cream. Take it to your pharmacist for advice.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Carbo-Dome Cream contains

The active substance is coal tar. Each 1g of cream contains 100mg of coal tar solution BP.

The other ingredients are dehydag wax, beeswax, white soft paraffin, light liquid paraffin, glycerol, sodium lauryl sulphate, methyl p-hydroxybenzoate (E219) and purified water.

What Carbo-Dome Cream looks like and contents of the pack

Carbo-Dome Cream is a smooth, buff coloured semi-solid with an odour of coaltar.

Carbo-Dome Cream is available in 30g and 100g aluminium tubes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

Pharmasol Ltd

North Way, Walworth Industrial Estate, Andover, Hampshire, SP10 5AZ, United Kingdom.

This leaflet was last revised in February 2023. ® Carbo-Dome Cream (Coal tar)