Medine.co.uk

Ketopine Dandruff Shampoo

Document: leaflet BOOTS_PL 04917-0063 change

148 mm

148 mm


information for the user

Anti - Dandruff Ketoconazole 2% w/w Shampoo

210 mm


This medicine is available without    Other important information

prescription to treat and prevent dandruff. Avoid contact with the eyes.

However, you still need to use it carefully ? |f shampoo accidentally comes into contact to get the best results from it.    with the eyes use cold water to gently

Keep this leaflet, you may need to read bathe the eyes, it again    If you are using a steroid product on your

Ask your pharmacist if you need more    scalp, when you stop using the steroid

information or advice    product your dandruff may worsen.

You must contact a pharmacist or doctor if Reducing the steroid over a period of your symptoms worsen or do not improve 2 to 3 weeks whilst using the shampoo after 4 weeks of treatment    will reduce the chance of the dandruff

becoming worse.

What this medicine is for /How to use this medicine


Read all of this leaflet carefully because it contains important information for you.


Shake the bottle well before use.

Age

How much to use

How often to use

Adults and

Wet hair and

Use twice

adolescents

scalp and apply

a week, at

enough shampoo

least three

to cover the

days

scalp and

apart, for

produce a foam

the first 2

(lather). Leave for

to 4

3-5 minutes before rinsing.

weeks


I This medicine contains Ketoconazole ; which belongs to a group of medicines ' called anti-fungals, which act to treat ! fungal infections.

; It can be used to treat and prevent ! dandruff, which you may notice as visible ! flaking of dry skin from the scalp.

! Dandruff is associated with the presence ! of a yeast (fungus) called Pityrosporum | Ovale. This yeast lives naturally on the skin ; of everyone, but people with dandruff ' appear to have more than usual.

! Ketoconazole works by destroying the ! yeast associated with dandruff.

i Before you use this medicine

| This medicine can be used by adults and ; adolescents. However, some people should ' not use this medicine or should seek the ! advice of their pharmacist or doctor first.

XDo not use:

!• If you are allergic to any of the ingredients

if Talk to your pharmacist or doctor:

;• If you are using a steroid product ; (e.g. betamethasone or hydrocortisone) i on your scalp (see "Other important i information")

;• If you are pregnant or breastfeeding

After 2 to 4 weeks you can use the shampoo once every 1 to 2 weeks to keep dandruff under control.

For use on the hair and scalp only.

Do not use more than the amount recommended above.

If your symptoms do not improve after 4 weeks talk to your pharmacist or doctor.

If symptoms do not go away within 4 weeks talk to your pharmacist or doctor. If you accidentally swallow some of the shampoo: Swallowing this shampoo is normally harmless. Talk to a doctor if you are concerned and take this shampoo with you. Do not make yourself sick.    23LF00944PW

Possible side effects

Most people will not have problems, but some may get some, which are usually mild.

! If you get any of these serious side effects, stop using the shampoo.

See a doctor at once:

•    Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

If you get any of the following side effects see your pharmacist or doctor:

Uncommon side effects:

(less than 1 in every 100 people are affected)

•    Localised reactions including redness, irritation and itching of the skin

•    Dry skin, skin rash or a burning sensation of the skin

•    Swelling of the hair follicles, hair loss or changes in the hair texture

•    An increase in tear production Rare side effects:

(less than 1 in every 1000 people are affected)

•    Changes in taste of food

•    Eye irritation

•    Other skin reactions such as flaky skin, acne, contact dermatitis (redness and swelling of the skin)

•    Other localised allergic reactions including small blisters on the surface of your skin

Other side effects:

(It is unknown how often these may occur)

•    Changes in hair colour

•    Raised, red itchy skin (symptoms of urticaria, which is often known as hives or nettle rash)

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

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 Schemeatwww. mhra.aov.uk/vellowcard.


How to store this medicine

Do not store above 25°C. Store in the original container. Keep the container tightly closed.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each gram of shampoo contains Ketoconazole 20 mg, which is the active ingredient.

As well as the active ingredient, the shampoo also contains sodium laureth sulfate paste, disodium laureth sulfosuccinate, sodium chloride, citric acid monohydrate, benzyl alcohol, tetrasodium EDTA, quaternium-15, polyquaternium-7, dexpanthenol, laureth-2, sodium hydroxide, perfume, purified water, erythrosine (E127).

The pack contains 60 or 100 ml of clear, pink, thick shampoo.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Pinewood Laboratories Ltd., Ballymacarbry Clonmel Co. Tipperary Ireland

Leaflet prepared June 2014 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA

Other formats

To 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: Boots Anti-Dandruff Ketoconazole 2% w/w Shampoo Reference number: 04917/0063

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


23LF00944PW