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KETOCONAZOLE 2% W/W SHAMPOO

Active substance(s): KETOCONAZOLE

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PATIENT INFORMATION LEAFLET
Ketopine 2% w/w Shampoo
Ketoconazole 20mg/g
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
- 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:
1. What Ketopine Shampoo is and what it is used for
2. Before you use Ketopine Shampoo
3. How to use Ketopine Shampoo
4. Possible side effects
5. How to store Ketopine Shampoo
6. Further information
1.

WHAT KETOPINE SHAMPOO IS AND WHAT IT IS USED FOR

Ketopine 2% w/w Shampoo is a medicated shampoo used for the treatment and prevention of infections of the scalp and skin
associated with the fungus Pityrosporum such as:
• Seborrhoeic dermatitis - a dry or greasy scaling of the scalp and other parts of the body.
• Dandruff (Pityriasis capitis).
• Pityriasis versicolor - a condition causing white to brown patches to develop on parts of the body.
2.

BEFORE YOU USE KETOPINE SHAMPOO

Do not use Ketopine Shampoo if you
• are hypersensitive (allergic) to ketoconazole or any of the other ingredients of Ketopine 2% Shampoo
(see Section 6).
Take special care with Ketopine Shampoo if you
• get it in your eyes as it may irritate. If this happens, bathe them gently with cold water.
• use the product for dandruff or seborrhoeic dermatitis (scaling of the scalp); on rare occasions you may get an
increase in irritation and normal hair loss which are associated with these conditions.
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.
Especially tell your doctor or pharmacist if 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 Shampoo.
This will help to stop your condition from flaring up while you are using Ketopine Shampoo.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine in pregnancy but, usually, Ketopine Shampoo can be
used during pregnancy and breast-feeding.
Driving and using machines
Use of Ketopine Shampoo has no effect on your ability to drive or to use machinery.
3.

HOW TO USE KETOPINE SHAMPOO

Always use Ketopine Shampoo exactly as your doctor or pharmacist has told you. You should check with your doctor or
pharmacist if you are not sure.
Ketopine Shampoo is for use on your skin only. Do not swallow it.
For children and adults (including the elderly) :
• Wet hair and scalp thoroughly with water.
• Apply sufficient Ketopine 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 treatments with Ketopine Shampoo.

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Frequency of application :
For dandruff (Pityriasis capitis) or dry/greasy scaling of the scalp (seborrhoeic dermatitis) use Ketopine Shampoo:
• twice a week for 2 - 4 weeks to relieve the condition
• once every 1-2 weeks to stop it returning
For white to brown patches on the skin (Pityriasis versicolor) use Ketopine Shampoo:
• once daily for a maximum of 5 days to relieve the condition
• if your patches usually return after exposure to the sun, apply once a day for the 3 days BEFORE exposure to
the sun to stop them returning.
If you or someone else swallows Ketopine Shampoo by mistake :
• tell your doctor or pharmacist immediately (accidental swallowing of small quantities is normally harmless).
If you forget to use Ketopine Shampoo
• do not worry if you miss an application of Ketopine 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 Shampoo can cause side effects, although not everybody gets them.
As with other shampoos, you may feel the following on your scalp or skin:
Common side effects (affecting fewer than 1 in 10 but more than 1 in 100 users):
• local burning feeling
• itching
• redness / irritation or allergy
If you get Ketopine in your eyes it may irritate. If this happens, bathe them gently with cold water.
Rare side effects (affecting fewer than 1 in 1000 but more than 1 in 10,000 users):
• oily or dry hair
• discoloration of hair which is grey or chemically damaged
• an increase in irritation and normal hair loss which are associated with dandruff or seborrhoeic dermatitis
In very rare cases (affecting less than 1 in 10,000 cases, including isolated reports):
• hair loss, rashes, hives, dry skin and other local skin reactions may occur.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5.

HOW TO STORE KETOPINE 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 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 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 Ketopine Shampoo looks like and contents of the pack
Ketopine Shampoo is a clear pink viscous solution, available in 120ml white high density polyethylene (HDPE) bottles.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL 04917/0039
Text Revised: August 2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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