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KETOCONOZOLE 2% SHAMPOO

Active substance(s): KETOCONAZOLE

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Final Package Leaflet: Information for the User
Ketoconazole 2% Shampoo
Ketoconazole
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
-

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 only. Do not pass it on to others. It may harm them even if their signs of
illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet

1. What Ketoconazole Shampoo is and
what it is used for
2. What you need to know before you
use Ketoconazole Shampoo
3. How to use Ketoconazole Shampoo
4. Possible side effects
5. How to store Ketoconazole Shampoo
6. Contents of the pack and other
information

1. What Ketoconazole Shampoo is and what
it is used for
Everyone has a type of fungus (yeast) called Malassezia on
their skin. It is natural and normally harmless. However,
people with dandruff and a greasy skin condition called
seborrhoeic dermatitis appear to have more Malassezia
than usual. Ketoconazole is a type of antifungal medicine,
which works by destroying Malassezia (and other fungi).
It is used to treat and prevent
 dandruff
 dry or greasy scaling of the scalp and other parts of the
body called ‘seborrhoeic dermatitis’
 another fungal infection called ‘tinea versicolor’ or
’pityriasis versicolor’ in which white to brown patches
develop on parts of the body after being in the sun.

2. What you need to know before you use
Ketoconazole Shampoo
Do not use Ketoconazole Shampoo if you:
 are allergic to ketoconazole, other antifungals or
to any of the other ingredients in this shampoo
(listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using this
medicine if:
 You use a lotion or cream on your hair that contains a
steroid, such as betamethasone or hydrocortisone:
 You should use less and less of the lotion or cream
during the first 2 to 3 weeks of Ketoconazole
Shampoo treatment.
 This will stop your condition flaring up while
Ketoconazole Shampoo starts to work.
If you have any questions about stopping your steroid
lotion or cream, ask your doctor or pharmacist.

Other medicines and Ketoconazole Shampoo
Ketoconazole Shampoo does not normally react with
other medicines. However, please tell your doctor or
pharmacist if you are taking, have recently taken or
might take any other medicines including medicines
you buy without a prescription and herbal medicines.

Pregnancy and breast-feeding

Ketoconazole Shampoo can be used if you are
pregnant or breast-feeding.
However, ask your doctor or pharmacist for advice
before taking any medicine if you are pregnant or
breast-feeding.

Driving and using machines

Ketoconazole Shampoo is not likely to affect you being
able to drive or use any tools or machines.
3.

How to use Ketoconazole Shampoo

Always use Ketoconazole Shampoo exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Ketoconazole Shampoo is for use in adolescents and
adults and is not recommended for use in infants and
children.
Ketoconazole Shampoo is for external use only and should
not be tasted or swallowed.
Shake the bottle well. Apply the shampoo onto the hair
or infected areas of skin. Leave it on for 3 to 5 minutes,
then rinse thoroughly.
Take care not to get Ketoconazole Shampoo in your
eyes. If it does, bathe them gently with cold water.

How much to use and for how long
For dandruff or greasy scaling of the skin
 Start by using the shampoo twice a week.
 You should use it every 3 or 4 days for 2 to 4 weeks.
 You should then use the shampoo once every 1 to 2
weeks to stop the symptoms coming back.
 Do not use the shampoo more often than your doctor
has told you.

For white to brown patches on the skin





You should use the shampoo on the white to
brown patches of skin once a day for up to 5 days.
If the white to brown patched become more
noticeable when you have been in the sun:
You should use the shampoo once a day for 3 days
before you next expose your skin to the sun.
Do not use the shampoo more often that your
doctor has told you.

Using normal shampoo



If you need to wash your hair between treatments,
use a normal shampoo.
If your hair is very thick or long, you can wash it
with your usual shampoo and then use
Ketoconazole Shampoo.

If you swallow the shampoo by mistake
If you accidentally swallow Ketoconazole Shampoo,
contact a doctor, pharmacist or your nearest casualty
department for advice at once.

If you forget to use Ketoconazole Shampoo
Do not worry if you forget to use the shampoo.
Continue with it as soon as you remember.
Do not us the shampoo twice to make up for a missed
treatment.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines Ketoconazole Shampoo can cause side
effects, although not everybody gets them.
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.
 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
 Acne
 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
 Some people with permanently waved or “permed”
hair have reported a loss of curl.

Reporting of side effects

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme, website:
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
Always keep Ketoconazole Shampoo in a safe place
out of the sight and reach of children, preferably in a
locked cupboard.
Keep the shampoo in its original container at normal
room temperature. (Do not store above 25°C.)
Do not use after the expiry date shown on the bottle
or carton. The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.
6.

Contents of the pack and other
information

What Ketoconazole Shampoo contains

The active ingredient (which makes the shampoo work)
is Ketoconazole. Each gram of shampoo contains 20
milligrams of Ketoconazole.
The shampoo also contains: sodium laureth sulphate,
disodium laureth sulphosuccinate, PEG-120 methyl
glucose dioleate, PEG-7-glycerol cocoate, imidurea,
lauryldimonium hydroxypropyl hydrolysed collagen,
cocamide DEA, sodium hydrocide, sodium chloride,
erythrosine (E127), concentrated hydrochloric acid and
purified water.

Pack sizes

Ketoconazole Shampoo is available from your pharmacist
in bottles of 60, 80, 100 or 120ml*.

Marketing authorisation
holder and manufacturer

Dr. Reddy’s Laboratories (UK)
Ltd., 6 Riverview Road,
Beverley, HU17 0LD, UK.
Leaflet last revised: March 2014
© Dr Reddy’s Laboratories
(UK) Ltd
Manufacturer: NextParma,
Pharbil Waltrop GmbH, Im
Wirrigen 25, D-45731 Waltrop,
Germany

Ketoconazole 2%
Shampoo
PL08553/0051
* Only Marketed
pack sizes will be
included

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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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