PATIENT INFORMATION LEAFLET

DANDRAZOL 2% Shampoo

(Ketoconazole 20 mg/g)

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist This medicine hos been prescribed for you. Do not poss it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Please see section A

In this leaflet:

1.    What Dandrazol Shampoo is and what it is used for.

2.    Before you use Dondra/ol Shampoo.

3.    I low to use Dandrazol Shampoo.

A.    Possible side effects.

5.    How to store Dandrazol Shompoo.

6.    Further information.

1.    WHAT DANDRAZOL SHAMPOO IS AND WHAT IT IS USED FOR

Ketoconazole, the active ingredient, in Dandrazol Shampoo, is an antifungal medicine used to treat fungal infections of the skin.

Everyone has a type of fungus (yeast) colled Mo/ossezi'o (used to be called Pityrosporom) on their skin. It is natural and normally harmless. However, people with dandruff and a greasy skin condition called seborrhoeic dermatitis appear to have more Molossezia than usual Molossezia is also associated with Tinea versicolor (otherwise known as pityriasis versicolor), a condition which causes white to brown patches develop on parts of the body.

Dandrazol Shampoo works by destroying Molossezia (and other fungi) and can be used to treat and provont fungal infections on the scalp and body such as:

•    Dandruff

•    a dry or greasy scaling of scalp and other parts of the body (seborrhoeic dermatitis)

•    irregular white to brown patches which occur on the body and sometimes appear after being in the sun (tinea/pityriasis versicolor)

These conditions may be itchy.

2.    BEFORE YOU USE DANDRAZOL SHAMPOO Do not uso Dandrazol Shampoo if:

•    you are allergic to the active ingredient (Ketoconazole) or any of the other ingredients listed in section 6 of the leaflet.

Take special care with Dandrazol Shampoo

As with any other shampoo, take care not to get Dondrozol Shompoo into your eyes. If any does get into your eyes, bathe them gently with water.

Taking other medicines

The medicine in your shampoo is not absorbed into tho body and it is not known to interfere with other medicines, however, please tell your doctor or pharmacist if you ore taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you have been regularly using a lotion or cream containing a steroid (such as betamethasone or hydrocortisone) to control your dandruff, make sure you tell your doctor or pharmacist. They may tell you to stop using it. However, it is important not to suddenly stop using it but gradually use it less over 2-3 weeks. This will stop your condition flaring up while the shampoo starts to work.

If you have any questions about stopping your steroid lotion or cream, please speak to your doctor or pharmacist.

Pregnancy and breast-feeding

Dandrazol Shampoo can be used if you are pregnant or during breast feeding.

Driving and using machines

Dandrazol Shompoo does not affect driving or using machines.

3.    HOW TO USE DANDRAZOL SHAMPOO

Dandrazol Shampoo is for use in adolescents and adults. Always use Dandrazol Shampoo exactly as your doctor has told you. Dandrazol Shampoo is for external use only.

Instructions for uso

•    Shake the bottle well.

•    Wash the hair or affected skin thoroughly with water.

•    Apply a small amount of Dandrozol Shompoo to your scalp or skin. If used on the scalp massage into a lather.

•    Leave it on for 3 to 5 minutes, then rinse thoroughly with water.

Treatment lor dandruff or dry/greasy scaling of the sfein: Use Dondra/ol Shampoo twice weekly (every 3 or 4 days) (or 2-4 weeks. To prevent it coming back, use Dandrazol Shampoo once every 1 -2 woeks.

Treatment lor white to brown patches of the skin: Use Dandrazol Shampoo on the alfocted skin areas once a day for no more than 5 days. These patches can become more apparent on exposure to the sun, Dandrazol Shampoo can be used to reduce this offoct os a single 3-day course, applied immediately before exposure to sunshine.

Do not use Dandrazol Shampoo more often than directed. You con use your usual shampoo if you need to wash your hair between treatments. If you have very thick or long hair, you can wosh with your usual shampoo and then use Dandrazol Shampoo.

What if the shampoo is swallowed?

Dandrazol Shampoo is for external use only and should not be taken by mouth. Accidental swallowing is normally harmless but as with all externally used products contact your doctor, pharmacist or casualty department straight away for advice. Take the bottle with you so that the medicine can be identified.

If you forget to use Dandrazol Shampoo

Do not worry if you forget to use Dandrazol Shampoo. Continue with it as soon as you remember.

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Dandrazol Shompoo can cause side effects, although not everybody gets them Most people who use Dandrazol Shampoo do not have problems with it However, as with other normal shampoos, a local burning sensation, itching or skin irritalion/redness may occur on exposed areas. Oily and dry hair havo been reported rarely. Dandruff and Seborrhoeic dermatitis ore linked with increased hair loss, ond this has been rarely reported with Dandrazol Shompoo.

Some people with permanently waved or “permed' hair havo reported a loss of the curl. Rare instances of hair discolouration hove been reported. These mainly occur in patients with grey hair or hair that has been treated frequently such as the use of colours, bleaching or perms.

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 Yellow Card Scheme at: www.mhro.aov.uk/vellowcofd. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE DANDRAZOL SHAMPOO

Keep this and all medicines in a safe place out of the reach ond sight of children.

Keep Dandrazol Shampoo in its original container. Do not store above 25°C.

Do not use Dandrazol Shampoo after the expiry date which is stated on the bottle or carton. Expiry date refers to the last date of the month. Return any unused Dandrazol Shampoo which you no longer need to your pharmacist who will dispose of it properly.

6.    FURTHER INFORMATION

What Dandrazol Shampoo contains

Each gram of Dandrazol Shampoo contains 20 milligrams of Ketoconazole.

Dandrazol Shampoo also contains inactive ingredients: sodium laureth sulfate, disodium laureth sulfosuccinate, PEG-120 methyl glucose dioleote, PEG-7-glyceryl cocoate, imidurea, lauryldimonium hydroxypropyl hydrolysed collagen, cocamide DEA, sodium hydroxide, sodium chloride, erythrosine (El27), hydrochloric acid and purified water.

What Dandrazol Shompoo looks like and contents of the pack

Dandrazol Shampoo is dear pink solution stored in a white plastic bottle. It is available on prescription in bottles of 120 ml.

Marketing Authorisation Holder

Transdermal Limited, 35 Grimwade Avenue, Croydon, Surrey, CRO 5DJ, United Kingdom. Manufacturer

DDD Limited, Watford, Hertfordshire, WD18 7JJ, United Kingdom.

For any information about this medicine, please contact the Morketing Authorisation Holder.

This leaflet was revised in May 2015 Product Licence number; PL 14308/0004