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Package leaflet: Information for the user

Tarmed Shampoo Coal tar solution 4%

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 Tarmed 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.

- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

In this leaflet:

1. What Tarmed is and what it is used for

2. Before you use Tarmed

3. How to use Tarmed

4. Possible side effects

5. How to store Tarmed

6. Further information

1. What Tarmed is and what it is used for

Tarmed contains the active ingredient coal tar.

Tarmed is used to treat scalp conditions such as psoriasis (thickened patches of inflamed, red skin, often covered by silvery scales), seborrhoeic dermatitis (red, scaly, itchy scalp), eczema (itchy skin rash), itchiness and scaling due to these conditions and dandruff.

2. What you need to know before you use Tarmed

Don’t use Tarmed if you are allergic to coal tar or any of the ingredients of Tarmed.

To treat any of the following skin problems, it could make them worse:

- infected open or damaged skin

- Sore or acute pustular psoriasis (parts of skin becomes red and covered by tender pus

filled blisters)

Warnings and precautions

Not established for use in children under the age of 12 years.

Tarmed may cause irritancy if in contact with sensitive areas, such as broken or inflamed skin. Stop using Tarmed if irritation develops.

Take care to make sure you do not get Tarmed into your eyes. If you should accidentally get Tarmed in your eyes wash them well with water.

Tarmed can stain skin and clothes and in rare instances has caused temporary changes to hair colour. Skin stains will wear off after treatment is stopped.

Tarmed may cause sensitivity to sunlight (photosensitivity). Avoid using sunlamps and spending a long time in the sun while using Tarmed

Check with your doctor if you think any of these may apply to you.

Other medicines and Tarmed

Tell your doctor or pharmacist if you’re taking any other medicines, if you’ve taken any recently, or if you start taking new ones. This includes medicines bought without a prescription.

Tarmed can increase the sensitivity of your skin to sunlight. Take care if you are taking any other medicines which may also increase your sensitivity to sunlight. These include:

• thiazides (a type of water tablet)

• certain antibiotics including tetracyclines, fluoroquinolones and sulphonamides

• phenothiazines (used to treat conditions such as mental health disorders)

Tell your doctor or pharmacist if you are using any of these medicines.

Pregnancy and breast-feeding

There is limited information about the safety of Tarmed in pregnant women.

Don’t use Tarmed in the first trimester of pregnancy.

Tell your doctor if you are pregnant, if you think you could be pregnant, or if you are

planning to become pregnant.

If you do become pregnant during treatment with Tarmed, stop using Tarmed and tell your doctor.

It is not known whether the ingredients of Tarmed can pass into breast milk. If you are breastfeeding, you must check with your doctor before you use Tarmed.

If you do breast-feed your baby while you are using Tarmed ensure that you wash-off all traces of Tarmed from your breasts before you begin breast-feeding.

3. How to use Tarmed

Use Tarmed once or twice a week for four weeks. Use for longer than this should only be on the advice of a doctor.

1. Wet your hair.

2. Use enough Tarmed so that the lather is abundant to cover your scalp, hair and adjacent areas, if also affected.

3. Massage the scalp and adjacent areas, if needed, well using your fingertips.

4. Rinse your scalp and hair thoroughly.

5. Repeat steps 2 to 4.

Tarmed should be in contact with your scalp for a total time of three to five minutes over the two applications.

If you forget to use Tarmed

If you forget to use Tarmed just apply the next day instead.

If you use more Tarmed than you should

If you use more Tarmed than recommended or use more often than recommended, you may be more likely to get skin irritation or skin sensitivity to sunlight.

4. Possible side effects

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

Side effects with frequencies that cannot be estimated from the available data include:

Severe allergic reactions:

• raised and itchy rash (hives)

• swelling of the face or mouth (angioedema)

• difficulty in breathing

Contact a doctor immediately if you get these symptoms. Stop using Tarmed immediately.

• eye irritation

• unusual hair loss or thinning

• eczema (itchy skin rash)

• hair colour changes

• abnormal hair texture

• sensitivity to sunlight

• skin irritation, skin may be dry, red or itchy, you may feel a burning sensation of the

skin

• skin pain, rash or swelling at the application site

Some of these effects can also be symptoms of the condition you are treating. However, if you experience any of these effects for the first time after starting to use Tarmed or you experience worsening of these effects stop using Tarmed and tell your doctor or pharmacist.

If you get side effects

^ Tell your doctor or pharmacist if any of the side effects listed becomes severe or troublesome, or if you notice any side effects not listed in this leaflet.

5. How to store Tarmed

Keep out of the reach and sight of children.

Do not use Tarmed after the expiry date shown on the the bottle and the outer packaging. The expiry date refers to the last day of that month.

Storage

Tarmed should not be stored at above 25°C

6. Contents of the pack and other information What Tarmed contains-

The active ingredient is coal tar

The other ingredients are

• Sodium lauryl ether sulphate

• Cocamidopropyl betaine

• Disodium phosphate dihydrate

• Citric acid monohydrate

• Benzyl alcohol

• Macrogol 150 distearate

• Hexylene glycol

• Oleyl alcohol

• Polyquaternium-10

• Fruitier timotei fragrance AF17050

• Purified water

What Tarmed looks like and contents of the pack

Tarmed is provided in plastic bottles with plastic caps, in sizes 25ml, 150ml and 250ml. Not all pack sizes may be marketed.

The marketing authorisation holder is Stiefel, 980 Great West Road, Brentford, Middlesex, TW8 9GS, U.K. and all enquiries should be sent to this address.

Manufactured by

Stiefel Laboratories (Ireland) Ltd., Finisklin Business Park, Sligo, Ireland.

More Information

If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you. Other sources of information are:

National Eczema Society, Hill House, Highgate Hill, London N19 5NA The Psoriasis Association, 2 Queensbridge, Northampton, NN4 7BF You may also be able to find out more from books in public libraries.

Other formats

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name Tarmed

Reference number 00079/0714

This is a service provided by the Royal National Institute of Blind People. Leaflet date: November 2013.