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PATIENT INFORMATION LEAFLET

Ketopine Dandruff Shampoo Ketoconazole 20 mg/g

Read all of this leaflet carefully because It contains Important Information for you.

This medicine is available without a prescription. However, you still need to use this product 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 after a few days.

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.

In this leaflet:

1.    What Ketopine Dandruff Shampoo is and what it is used for

2.    Before you use Ketopine Dandruff Shampoo

3.    How to use Ketopine Dandruff Shampoo

4.    Possible side effects

5.    How to store Ketopine Dandruff Shampoo

6.    Further information

1.    WHAT KETOPINE DANDRUFF SHAMPOO IS AND WHAT IT IS USED FOR

Ketopine Dandruff Shampoo is used for the treatment and prevention of infections of the scalp and skin associated with the fungus Pityrosporum such as:

•    Dandruff (Pityriasis capitis).

2.    BEFORE YOU USE KETOPINE DANDRUFF SHAMPOO Do not use Ketopine Dandruff Shampoo If you

•    are hypersensitive (allergic) to ketoconazole or any of the other ingredients of Ketopine Dandruff Shampoo

(see Section 6).

Take special care with Ketopine Dandruff Shampoo if

•    you get it in your eyes as it may irritate. If this happens, bathe them gently with cold water.

•    you have been using steroids such as betamethasone or hydrocortisone for a long period of time. You must gradually reduce the application of these over 2 to 3 weeks as you start to use Ketopine Dandruff Shampoo. This will help to stop your condition from flaring up while you are using Ketopine Dandruff Shampoo. If you have any questions about stopping your steroid treatment, speak to your doctor or pharmacist.

•    the scalp is not cleared within 4 weeks of treatment: consult a doctor or pharmacist.

Taking or using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine in pregnancy but, usually, Ketopine Dandruff Shampoo can be used during pregnancy and breast-feeding.

Driving and using machines

Use of Ketopine Dandruff Shampoo has no effect on your ability to drive or to use machinery.

3.    HOW TO USE KETOPINE DANDRUFF SHAMPOO

Always use Ketopine Dandruff Shampoo exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Ketopine Dandruff Shampoo is for use on your skin only. Do not swallow it.

For adolescents and adults (including the elderly):

•    Wet hair and scalp thoroughly with water.

•    Apply sufficient Shampoo to produce enough lather to wash the scalp and hair.

•    Gently massage the lather over the entire scalp.

•    Leave for 3-5 minutes, before rinsing off thoroughly.

Your usual shampoo can be used as necessary between Ketopine Dandruff Shampoo treatments. If the scalp is not cleared within 4 weeks of fra ttment: consult a doctor or pharmacist.    23LF00943PW

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Frequency of application:

•    twice a week for 2 - 4 weeks to relieve dandruff. There should be a minimum of 3 days between applications

•    to stop dandruff returning, use once every 1 -2 weeks

If you or someone else swallows Ketopine Dandruff Shampoo by mistake:

•    tell your doctor or pharmacist immediately (accidental swallowing of small quantities is normally harmless)

If you forget to use Ketopine Dandruff Shampoo

•    do not worry if you miss an application of Shampoo

•    restart your treatment 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, Ketopine Dandruff Shampoo can cause side effects, although not everybody gets them, and are usually mild. If you experience any of the following, stop using the medicine and talk to your doctor:

•    Severe allergic reactions including swelling of the face, lips, tongue or throat.

Uncommon side effects (less than 1 in 100 people) which may occur include:

•    Application site reactions including itching, irritation, blistering, red, dry or tender skin or a skin burning sensation

•    Inflamed hair follicles, hair loss or changes in hair texture

•    Increased tear production

•    Skin rash and dry skin

Rare side effects (less than 1 in 1000 people) which may occur include:

•    A change in the way some things tase

•    Eye irritation

•    Acne

•    Skin inflammation (dermatitis)

•    Flaking skin

•    Application site reactions including blistering and over-sensitivity (allergic reactions)

•    General allergic reaction (over sensitivity)

Other side effects which occur but it is unknown how often:

•    Flair discolouration and hives, which is known as nettle rash or urticaria

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 KETOPINE DANDRUFF SHAMPOO

Do not store above 25°C.

Keep out of the reach and sight of children.

Store in the original container, and keep the cap tightly closed.

Do not use Ketopine Dandruff Shampoo after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month.

Unused medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

Each 1g of Ketopine Dandruff 2% w/w Shampoo contains

•    Active ingredient: 20 mg ketoconazole

•    Other ingredients: sodium laureth sulfate paste 70%, disodium laureth sulfosuccinate liquid 40%, sodium chloride, citric acid monohydrate, benzyl alcohol, tetrasodium EDTA, quaternium-15, polyquaternium-7, dexpanthenol, laureth-2, sodium hydroxide, erythrosine (E127), perfume, purified water.

What Ketopine Dandruff Shampoo looks like and contents of the pack

Ketopine Dandruff Shampoo is a clear pink viscous solution, available in 60 ml and 100 ml white high density polyethylene (HDPE) bottles.

Marketing Authoris ation Holder and Manufacturer

Pinewood Laborator es Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PL 04917/0063

Text Revised: 06/20' 4.    23LF00943PW