KETOCONAZOLE 2% W/W SHAMPOO
Active substance(s): KETOCONAZOLE
Frequency of application:
PATIENT INFORMATION LEAFLET
Ketopine Dandruff Shampoo
Ketoconazole 20 mg/g
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)
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
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.
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
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
WHAT KETOPINE DANDRUFF SHAMPOO IS AND WHAT IT IS USED FOR
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
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.
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 treatment; consult a doctor or pharmacist.
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).
POSSIBLE SIDE EFFECTS
Like all medicines, Ketopine Dandruff Shampoo can cause side effects, although not everybody gets them, and are usually mild.
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).
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
Rare side effects (less than 1 in 1000 people) which may occur include:
• A change in the way some things tase
• Eye irritation
• 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:
• Hair 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.
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.
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
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PL 04917/0063
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.