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MERAZOL 2% SHAMPOO

Active substance(s): KETOCONAZOLE

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Package Leaflet Information for the User
Merazol 2% Shampoo
Ketoconazole
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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.
- You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Merazol Shampoo is and what
it is used for
What you need to know before you
use Merazol Shampoo
How to use Merazol Shampoo
Possible side effects
How to store Merazol Shampoo
Contents of the pack and other
information

1. What Merazol 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. Merazol 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’

2. What you need to know before you use
Merazol Shampoo
Do not use Merazol Shampoo if you:
 are allergic to ketoconazole, other antifungals or
to any of the other ingredients in the 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 Merazol Shampoo
treatment.
 This will stop your condition flaring up while
Merazol Shampoo starts to work.
If you have any questions about stopping your steroid
lotion or cream, ask your doctor or pharmacist.

Other medicines and Merazol Shampoo

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

How to use Merazol Shampoo

Always use Merazol Shampoo exactly as described in this
leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not
sure.
Merazol Shampoo is for use in adolescents and adults
and is not recommended for use in infants and children.
Merazol 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 Merazol 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.

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 Merazol Shampoo,
contact a doctor, pharmacist or your nearest casualty
department for advice at once.

If you forget to use Merazol 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.

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

4. Possible side effects

Always keep Merazol Shampoo in a safe place out of
the sight and reach of children, preferably in a locked
cupboard.

Like all medicines Merazol Shampoo can cause side
effects, although not everybody gets them.

Keep the shampoo in its original container at normal
room temperature. (Do not store above 25°C.)

Stop using Merazol 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.

Do not use after the expiry date shown on the
bottle or carton. The expiry date refers to the last day
of that month.

Tell your doctor or pharmacist if you notice or
suspect any of the following side effects:

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 Merazol Shampoo contains

The active ingredient (which makes the shampoo
work) is Merazol. Each gram of shampoo contains 20
milligrams of Merazol.

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

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.

Rare side effects (affects fewer than 1 in 1000
people)
 Taste impairment
 Irritation of the eyes
 Acne
 Flaking skin

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

Pack sizes

Marketing authorisation holder and manufacturer

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

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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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