Nizoral

Description

Nizoral Dandruff 20mg/g
Shampoo
ketoconazole
Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription. However,
you still need to use Nizoral Dandruff Shampoo 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.
 If any of the side effects get serious or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet
1. What Nizoral Dandruff Shampoo is and what it is
used for.
2. Before you use Nizoral Dandruff Shampoo
3. How to use Nizoral Dandruff Shampoo
4. Possible side effects
5. How to store Nizoral Dandruff Shampoo
6. Further information
1. WHAT NIZORAL DANDRUFF SHAMPOO IS AND
WHAT IT IS USED FOR
Nizoral Dandruff Shampoo is used to treat and prevent
dandruff and dry or greasy scaling of the scalp
(seborrhoeic dermatitis), which is a more severe kind of
dandruff.
The shampoo contains ketoconazole, which is an
antifungal that targets an increased number of yeasts on
the skin called Malassezia. These yeasts occur naturally
on everyone’s skin; however, people with dandruff and
seborrhoeic dermatitis seem to have more
Malassezia.The shampoo also treats the inflammation
associated with dandruff, relieving scalp redness and
itching.
This product is for use in adults and adolescents aged 12
years and over.
2. BEFORE YOU USE NIZORAL DANDRUFF
SHAMPOO
This product is suitable for most adults and adolescents
aged 12 years and over, but a few people should not use
it. If you are in any doubt, talk to your doctor or
pharmacist.
Do not use this product…
 If you have ever had an allergic (hypersensitivity)
reaction to any of the ingredients.
If this applies to you, get advice from a doctor or
pharmacist without using Nizoral Dandruff Shampoo.
Pregnancy and breast-feeding
 You can use Nizoral Dandruff Shampoo if you are
pregnant, think you might be pregnant or are breastfeeding.
Take special care with Nizoral Dandruff Shampoo
 As with most shampoos, if any gets into your eyes
bathe them gently with water.
If you have been regularly using a lotion or cream,
which contains a steroid (such as betamethasone or
hydrocortisone) to control your dandruff or seborrhoeic
dermatitis, gradually use it less over 2 – 3 weeks as
you start to use Nizoral Dandruff Shampoo. This will
stop your condition flaring up while Nizoral Dandruff
Shampoo starts to work. If you have any questions
about stopping your steroid lotion or cream, speak to
your doctor or pharmacist.
Driving and using machines
Using Nizoral Dandruff Shampoo will not affect your
ability to drive or use machines.
3. HOW TO USE NIZORAL DANDRUFF SHAMPOO
Check the table below to see how much product to
use.
 For external use only.
 Do not use more often than directed in the table. If
you need to use a shampoo to wash your hair more
often, use your usual shampoo. If your hair is very
thick, you can wash with your usual shampoo and
then use Nizoral Dandruff Shampoo.
Adults and adolescents aged 12 years and over.
Age How to apply
Adults and adolescents
aged 12 years and over (for
dandruff and dry/greasy
scaling of the skin)
 Wet hair thoroughly
 Apply a small amount of
Nizoral Dandruff
Shampoo to your scalp
and massage into a
lather.
 Leave the lather on your
scalp for 3-5 minutes
 Rinse thoroughly
 Use every 3 or 4 days for 2-4 weeks
 If your scalp has not cleared within 4 weeks, speak to
your doctor or pharmacist.
 To keep your scalp clear and to prevent dandruff
returning, use Nizoral Dandruff Shampoo once every
1-2 weeks. If you stop using Nizoral Dandruff
Shampoo altogether, your symptoms may become a
problem again.
If anyone accidentally swallows this product
If anyone accidentally swallows Nizoral Dandruff
Shampoo, contact a doctor or your nearest Accident &
Emergency department (Casualty) taking this leaflet and
pack with you.
If you forget an application
If you forget to use Nizoral Dandruff Shampoo use as per
the directions next time you wash your hair.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nizoral Dandruff Shampoo can cause
side effects, although not everybody gets them.
Stop using Nizoral Dandruff Shampoo and tell your
doctor straight away if you notice or suspect any of
the following. You may need urgent medical
treatment.
 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 100 people
Effects which may occur include:
Uncommon side effects (affects fewer than 1 in 100
people)
 Taste impairment
 Infection of the hair roots
 Irritation of the eyes and increase in production of
tears
 Acne
 Unusual hair loss or thinning
 Skin rash and dry, flaking skin
 Inflammation of the skin
 Change in hair texture
 Skin burning sensation
 Problems at the site of application such as:
 skin redness
 skin irritation or blistering
 hypersensitivity or reaction
 itching
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
 swelling of the face, lips or throat
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
HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin
2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website:
www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting
side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE NIZORAL DANDRUFF SHAMPOO
 Keep this medicine out of the sight and reach of
children.
 Do not store above 25° C.
 Do not use this product after the expiry date
shown on the packaging.
6. FURTHER INFORMATION
What’s in this product?
The active ingredient in 1 g of Nizoral dANDRUFF
Shampoo is ketoconazole 20 mg
Other ingredients are: sodium lauryl ether sulfate,
disodium monolauryl ether sulphosuccinate, coconut fatty
acid diethanolamide, laurdimonium hydrolysed animal
collagen, macrogol 120 methyl glucose dioleate, sodium
chloride, sodium hydroxide, imidurea, hydrochloric acid,
erythrosine (E127) and purified water.
The product imported from Belgium also contains
Perfume mix
What the product looks like: Nizoral Dandruff
Shampoo is a pink liquid shampoo. It is available in
bottles containing 60ml, 100ml or 120ml contained in an
outer cardboard carton.