PACKAGE LEAFLET Information for the user

DermaX

Therapeutic Shampoo

benzalkonium chloride 0.5% w/w

Read all of this leaflet carefully before using this product.

Keep this leaflet. You may need to read it again.

Askyour doctor or pharmacist ifyou need more information or advice. If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Dermax Therapeutic Shampoo is and what it is used for

2.    Before you use Dermax Therapeutic Shampoo

3.    How to use Dermax Therapeutic Shampoo

4.    Possible side effects

5.    How to store Dermax Therapeutic Shampoo

6.    Further information

1.    WHAT DERMAX THERAPEUTIC SHAMPOO IS AND WHAT IT IS USED FOR

•    Dermax Therapeutic Shampoo is a treatment for dry, scaly scalp conditions such as:

•    seborrhoeic eczema / seborrhoeic dermatitis (patches of red, scaly, itchy skin), and;

•    pityriasis capitis (severe dandruff).

•    Dermax Therapeutic Shampoo is for use by adults, the elderly and children.

•    The active ingredient in this product is benzalkonium chloride. It works by;

•    loosening the scales from the scalp and lifting them from the hair, and;

•    acting as a mild antiseptic to combat the micro-organisms that can make these scalp conditions worse.

2.    BEFORE YOU USE DERMAX THERAPEUTIC SHAMPOO

Do not use Dermax Therapeutic Shampoo if you are allergic (hypersensitive) to

benzalkonium chloride or any of the other ingredients of Dermax Therapeutic Shampoo listed in section 6.

Using other medicines

This product is not known to affect, or to be affected by, any other medicines.

Pregnancy and breast-feeding

This product can be used during pregnancy and whilst breast-feeding. The ingredients have been in widespread use in this and similar preparations for many years, without reports of problems. However, safety trials have not been conducted.

Driving and using machinery

Using this product is not known to affect your ability to drive or use machinery.

3. HOW TO USE DERMAX THERAPEUTIC SHAMPOO

Use Dermax Therapeutic Shampoo only to treat the scalp conditions that it is intended for.

For adults, the elderly and children:

Use as a shampoo, daily if necessary, until your scalp condition gets better:

•    Wet the hair thoroughly.

•    Apply a generous amount of shampoo to the scalp.

•    With the tips of the fingers, massage in thoroughly.

•    Remove as much lather as possible with the hands (this is important as it will take the scales with it).

•    Rinse out.

•    Repeat the steps above.

•    Rinse the hair thoroughly under running water, then dry as normal.

If the shampoo gets into the eyes

The product, or the lather, may cause irritation if it gets into the eyes. If it gets into the eyes, rinse with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, tell your doctor or pharmacist.

If you use too much of this product

Do not worry if you use too much shampoo, simply rinse hair under running water and continue as instructed above.

If you forget to use this product

Do not worry if you occasionally forget to use this product, just carry on using it when 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, Dermax Therapeutic Shampoo can cause side effects, although not everybody gets them. This product has been specially designed for use on dry or problem skin, but in some rare cases it can cause irritant or allergic skin reactions on extremely sensitive skin. These rare effects tend to occur during or soon after the first few uses.

Stop using the product and tell your doctor or pharmacist:

•    if your scalp condition seems to look or feel worse.

•    if any of the side effects get serious, or you notice any other side effects not mentioned in this leaflet.

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.gov.uk/yellowcard.

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

5.    HOW TO STORE DERMAX THERAPEUTIC SHAMPOO

•    Keep it out of the reach and sight of children.

•    Always replace the cap tightly after use.

•    Keep the bottle in the outer carton.

•    Do not store the product above 25°C.

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

•    Medicines should not be disposed of via household refuse. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION ABOUT DERMAX THERAPEUTIC SHAMPOO What Dermax Therapeutic Shampoo contains:

The active ingredient is benzalkonium chloride (0.5% w/w).

The other ingredients are sodium lauryl ether sulfate, coconut diethanolamide, dilute hydrochloric acid, phenoxyethanol, sodium chloride, lauryldimonium hydroxypropyl hydrolysed collagen, coconut oil and purified water.

What Dermax Therapeutic Shampoo looks like and contents of the pack

•    The product is a clear, pale yellow to straw-coloured viscous shampoo.

•    It is available in white plastic bottles containing 250ml fitted with dispensing caps. (25ml bottles are also available to medical and allied professionals.)

The Marketing Authorisation holder is Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK.

The Manufacturer is Fleet Laboratories Ltd,

94 Rickmansworth Rd, Watford,

Herts, WD18 7JJ, UK.

This leaflet was last revised in March 2015.

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: DermaxTherapeutic Shampoo, 00173/0198.

This is a service provided by the Royal National Institute of Blind People (RNIB).