KETOPINE 2% W/W SHAMPOO
PATIENT INFORMATION LEAFLET
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.
Ketopine 2% w/w Shampoo
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.
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.
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
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ketopine Shampoo can cause side effects, although not everybody gets them.
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.
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.
• 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. If you have
any questions about stopping your steroid treatment, speak to your 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
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.
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 adolescents 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.
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
Stop using Ketopine 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
• Severe irritation or reddening of the skin where the shampoo has been used, or other signs of allergy during
the first few days of treatment. This can affect fewer than 1 in 100 people
• 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
• Unusual hair loss or thinning
• Dry skin, rash, burning feeling
• Changes in how your hair feels
Rare side effects (affects fewer than 1 in 1000 people):
• Taste impairment
• Irritation of the eyes
• Flaking skin
The following side effects have been reported, however the precise frequency cannot be identified and therefore how often they
occur is classed as unknown:
• Hives (also known as nettle rash or urticaria)
• Hair colour changes
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 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: 06/2014
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.