What it is and what it is used for

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Ketoconazole

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skin associated with the fungus Pityrosporum such as + Seborrhoeic dermatitis – a dry or greasy scaling of the scalp and other parts of the body. + Dandrutt Pityriasis capitis). + Pityriasis versicolor – a condition causing white to brown patches to develop on parts of the body.

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BEFORE YOU USE KETOCONAZOLE SHAMPOO

Do not use Ketoconazole Shampoo If you = are hypersensitive (allergic) to ketoconazole or any of the other ingredients of Ketoconazole 2% Shampoo

(ce Section 6). 'Take special care with Ketoconazole Shampoo If you get it in your eyes as it may irritate. If this happens, bathe them gently with cold water. + have been using steroids such as betamethasone or hydrocortisone for a long period of time. You must gradually reduce the your application over 2 upto 3while weeksyou asareyouusing start Ketoconazole to use Ketoconazole Fhis wil help to stop conditionof these from flaring Shampoo.Shampoo. If you have

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any questions about stopping your steroid treatment, speak to your doctor or pharmacist.

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'Taking or using other medicines Pease to your doctor if you are taking or have recently taken any other medicines, including medicines obtained without

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Pregnancy and breast-feeding |Ask your doctor or pharmacist for advice before taking any medicine in pregnancy but, usually, Ketoconazole Shampoo can be © used used d during Pregnaney and d breast-feed breastfeeding. Driving and using machines

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

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How to take it

KETOCONAZOLE SHAMPOO

|Always use Ketoconazole Shampoo exactly as your doctor or pharmacist has told you. You should check with your doctor or ipharmacist if you are not sure. Ketoconazole 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 Ketoconazole 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. lYour usual shampoo can be used as necessary between treatments with Ketoconazole Shampoo.

Frequency of application: For dandrutt (Pityriasis capitis) or dry/areasy scaling of the scalp (Seborrhoeic dermatitis) use Ketoconazole Shampoo: + twice fp week for2 – 4 weeks to relieve the condition + _oncewpvery 1-2 weeks to stop it returning 23LF01277PW

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restart your treatment as soon as you remember

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If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

Ketoconazole 2% w/w Shampoo is a medicated shampoo used for the treatment and prevention of infections of the scalp and

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For white to brown patches on the skin (Pityriasis versicolor) use Ketoconazole Shampoo: + once daily for a maximum of 5 days to relieve the condition

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

Stop using Ketoconazole Shampoo and tell your doctor straight away if you notice or suspect any of the following.

'You may need urgent medical treatment. + Allergic reaction, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing. This can affect fewer than 1 in 1000 people +

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Severe irritation or reddening of the skin where the shampoo has been used, or other signs of allergy during

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the first few days of treatment. This can affect fewer than 1 in 100 people

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+ Peeling or blistering of the skin. This can affect fewer than 1 in 1000 people Tell your doctor or pharmacist If you notice or suspect any of the following side effects: Uncommon side effects (affects fewer than 1 In 100 people):

• Infection of the hair roots + Increase in production of tears +

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Unusual hair loss or thinning

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Dry skin, rash, burning feeling Changes in how your hair feels

Rare elde effects 'aecte fewer than 1 In 1000 people: tation of the eyes

• Acne + Flaking skin The folowing side fects nave been reported, however the precise requency cannctbe identified an therefore how often they

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occur is classe Hives (alse known as nettle rash or urticaria)

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+ Hair colour changes Reporting of side Ifyou 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. HOWTO STORE KETOCONAZOLE SHAMPOO Do not store above 25°C.

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Keep out of the sight and reach of children.

Store in the original container, and keep the cap tightly closed. Do not use Ketoconazole 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 Ketoconazole 2% w/w Shampoo contains + Active Ingredient: 20mg 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 Ketoconazole Shampoo looks Ike and contents of the pack

Ketoconazole Shamjoo is a clear pink viscous solution, available in 120ml white high density polyethylene (HDPE) bottles. Marketing Authorisation Holder and Manufacturer Pinewood Laboratorips Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PL 04917/0039 'Text Revised: 08/20 23LF01277PW

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