PATIENT INFORMATION LEAFLET

DANDRAZOL

Anti-Dandruff Shampoo

(Ketoconazole 20 mg/g)

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 Dandrazol AntiDandruff Shampoo 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Please see section 4.

1.    What Dandrazol Anti-Dandruff Shampoo is and what i

2.    Before you use Dandrazol Anti-Dandruff Shampoo.

3.    How to use Dandrazol Anti-Dandruff Shampoo.

4.    Possible side effects.

5.    How to store Dandrazol Anti-Dandruff Shampoo.

6.    Further information.

1.    WHAT DANDRAZOL ANTI-DANDRUFF SHAMPOO IS AND WHAT IT IS USED FOR?

Ketoconazole, the active ingredient in Dandrazol Anti-Dandruff Shampoo, is an antifungal which is used to treat dandruff. It also treats inflammation associated with dandruff, relieving itching and redness.

Everyone has a type of fungus (yeast) called Malassezia (used to be called Pityrosporum] on their skin. It is natural and normally harmless. However, people with dandruff appear to have more Malassezia than usual. Ketoconazole works by destroying Malassezia (and other fungi) and can be used to treat and prevent dandruff caused by yeasts.

2.    BEFORE YOU USE DANDRAZOL ANTI-DANDRUFF SHAMPOO

Do not use Dandrazol Anti-Dandruff 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 Anti-Dandruff Shampoo

As with any other shampoo, take care not to get Dandrazol Anti-Dandruff Shampoo 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 the body and is not known to interfere with other medicines, however, please tell your doctor or pharmacist if you are 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 Anti-Dandruff Shampoo can be used if you are pregnant or during breast-feeding.

Driving and using machines

Dandrazol Anti-Dandruff Shampoo does not affect driving or using machines.

3.    HOW TO USE DANDRAZOL ANTI-DANDRUFF SHAMPOO

Dandrazol Anti-Dandruff Shampoo is for use in adolescents and adults. Dandrazol Anti-Dandruff Shampoo is used to treat dandruff and also to prevent dandruff from coming back again and is for external use only.

Instructions for use

•    Shake the bottle well.

•    Wet your hair thoroughly with water.

•    Apply a small amount of Dandrazol Anti-Dandruff Shampoo to your scalp and massage into a lather.

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

Treatment for dandruff: Use Dandrazol Anti-Dandruff Shampoo twice weekly (every 3 or 4 days) for 2-4 weeks. If your condition has not cleared by this time, please speak to your doctor or pharmacist.

To prevent dandruff from coming back: Use Dandrazol Anti-Dandruff Shampoo once every 1 -2 weeks.

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

What if the shampoo is swallowed?

Dandrazol Anti-Dandruff Shampoo is for external use only and should not be taken by mouth. Accidental swallowing is normally harmbss 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 Anti-Dandruff Shampoo

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

4.    POSSIBLE SIDE EFFECTS

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

Some people with permanently waved or "permed" hair have reported a loss of the curl. Rare instances of hair discolouration have 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.

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.

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.mhra.qov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE DANDRAZOL ANTI-DANDRUFF SHAMPOO

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

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

Do not use Dandrazol Anti-Dandruff 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 Anti-Dandruff Shampoo which you no longer need to your pharmacist, who will dispose of it properly.

6.    FURTHER INFORMATION

What Dandrazol Anti-Dandruff Shampoo contains

Each gram of Dandrazol Anti-Dandruff Shampoo contains 20 milligrams of Ketoconazole.

Dandrazol Anti-Dandruff Shampoo also contains inactive ingredients: Sodium bureth sulfate, disodium laureth sulfosuccinate, PEG-120 methyl glucose dioleate, PEG-7 glyceryl cocoate, imidurea, buryldimonium hydroxypropyl hydrolysed colbgen, cocamide DEA, sodium hydroxide, sodium chloride, Erythrosine (El27), hydrochloric acid and purified water.

What Dandrazol Anti-Dandruff Shampoo looks like and contents of the pack

Dandrazol Anti-Dandruff Shampoo is a clear pink solution stored in a white plastic bottle. It is available in bottles of 60 ml or 1 00 ml.

Marketing Authorisation Holder

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

DDD Limited, Watford, Hertfordshire, WD1 8 7JJ, United Kingdom.

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

This leafbt was revised in May 2015

Product Licence number: 14308/0006    LTF0600