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Clarazole shampoo contains a medicine called ketoconazole. This
belongs to a group of medicines called ‘antifungals’. Like other
shampoos, it also contains ingredients to clean your hair.
Clarazole shampoo is used for fungal infections on the scalp and
body such as:
• dandruff
• dry or greasy scaling of the scalp and other parts of the body called
‘seborrhoeic dermatitis’
• white to brown patches on the body that sometimes appear after
being in the sun called ‘tinea versicolor’ or ‘pityriasis versicolor’
These conditions can be itchy. They are caused by a fungus (yeast)
called ‘Malassezia’. This fungus is found on everyone’s skin, but
sometimes it can overgrow and cause problems. Clarazole shampoo
works by killing the fungus and stopping it from coming back.
Do not use Clarazole shampoo if:
You are allergic to anything in Clarazole shampoo (listed in section 6
below).
Do not use this medicine if the above applies to you. If you are not
sure, talk to your doctor or pharmacist before using Clarazole
shampoo.
Take special care with Clarazole
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 Clarazole shampoo treatment
• this will stop your condition flaring up while Clarazole shampoo
starts to work
If you have any questions about stopping your steroid lotion or
cream, ask your doctor or pharmacist.
Children and adolescents
Clarazole shampoo is not recommended for use in infants and
children.
Taking other medicines
Clarazole shampoo does not normally react with other medicines.
However, tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines that you
buy without a prescription or herbal medicines.
Pregnancy and breast-feeding
Clarazole shampoo can be used if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine
if you are pregnant or breast-feeding.
Effects on ability to drive and use machines:
Clarazole shampoo is not likely to affect you being able to drive or
use any tools or machines.
3. HOW TO USE CLARAZOLE
Always use Clarazole shampoo exactly as your doctor has told you.
Clarazole shampoo is for use on your hair or skin only. Check with your
doctor or pharmacist if you are not sure.
How often you should use Clarazole shampoo
The recommended dose is:
For dandruff or dry 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 patches 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 than your doctor has told you
Using Clarazole shampoo
• wash your hair or infected part of skin with the shampoo
• leave it on for 3 to 5 minutes
• rinse thoroughly
If Clarazole shampoo gets in your eyes
Gently bathe your eyes in cold water.
Using your 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 Clarazole shampoo
If you swallow Clarazole shampoo
If you swallow any shampoo, tell your doctor straight away.
If you forget to use Clarazole shampoo
• if you miss a treatment with Clarazole shampoo, you should use it
as soon as you remember
• do not use 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.
Like all medicines, Clarazole shampoo can cause side effects,
although not everybody gets them.
Stop using Clarazole 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 (fewer than 1 in 1000 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
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 pharmacist.
To report any side effects please contact:
National Pharmacovigilance Center (NPC)
Fax: +966-11-205 7662
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
- Do not store above 30oC.
- Keep out of the reach of children.
- Do not use after the expiry date stated on the label.
- Do not use if there is any physical change on the product.
- 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.
What Clarazole shampoo contains
The active ingredient is: Ketoconazole 2% w/v.
Inactive ingredients are: Imidurea, Texapon N70, Texapon SB3,
Comperlan COD, Glucamate DOE-120, Sodium Chloride,
Lamequate-L, Erythrosine Colour (FD&C Red Colour No.3), FD&C
Red Colour No.40, Eglantine Perfume, Sodium Hydroxide,
Hydrochloric acid and Purified water.
Medpharma Pharma. & Chem. Ind’S (L.L.C.)
P.O.Box:25235, Industrial Area No: 13, Street No: 37, Sharjah,
U.A.E.
Tel: +971 6 514 8801
Fax: +9716 544 0500
E-mail: infomedpharma@valeant.com
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Prevention and treatment of infections in which the yeast Malassezia (previously called
Pityrosporum) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea
(pityriasis) versicolor.
For topical administration.
Clarazole shampoo 2% is for use in adolescents and adults:
Wash affected areas and leave for 3-5 minutes before rinsing.
Treatment:
Dandruff and seborrhoeic dermatitis: Wash hair twice weekly for 2-4 weeks.
Tinea versicolor: Once daily for a maximum of 5 days.
Prophylaxis:
Dandruff and seborrhoeic dermatitis: Use once every 1-2 weeks.
Tinea versicolor: Once daily for a maximum of 3 days before exposure to
sunshine.
In patients who have been on prolonged treatment with topical corticosteroids, it is
recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks,
while using Clarazole 2% shampoo, to prevent any potential rebound effect.
Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with
water.
No interaction studies have been performed
There are no adequate and well-controlled studies in pregnant or lactating women. Data on a
limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole
on pregnancy or on the health of the foetus/newborn child. Animal studies have shown
reproductive toxicity at doses that are not relevant to the topical administration of
ketoconazole. No effects on the breastfed newborn/infant are anticipated. (See
Pharmacokinetic properties, section 5.2)
Plasma concentrations of ketoconazole were not detectable after topical administration of
Ketoconazole Shampoo 2% to the scalp of non-pregnant humans. Plasma levels were
detected after topical administration of Ketoconazole Shampoo 2% on the whole body.
There are no known risks associated with the use of Ketoconazole Shampoo 2% in
pregnancy or lactation.
Not relevant
The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in
22 clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or
skin. Based on pooled safety data from these clinical trials, there were no ADRs reported
with an incidence ≥1%.
The following table displays ADRs that have been reported with the use of Ketoconazole
2% Shampoo from either clinical trial or postmarketing experiences.
The displayed frequency categories use the following convention:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated form the available clinical trial data).
System Organ Class Adverse Drug Reactions
Frequency Category
Uncommon
(≥1/1,000 to <1/100)
Rare
(≥1/10,000 and <1/1,000)
Not Known
Immune System
disorders
Hypersensitvity
Nervous System
Disorders
Dysgeusia
Infections and
Infestations
Folliculitis
Eye Disorders Increased lacrimation Eye irritation
Skin and Subcutaneous
Tissue Disorders
Alopecia
Dry skin
Hair texture abnormal
Rash
Skin burning sensation
Acne
Dermatitis contact
Skin disorder
Skin exfoliation
Angioedema
Urticaria
Hair colour changes
General Disorders and
Administration Site
Application site
erythema
Application site
hypersensitivity
Conditions Application site irritation
Application site pruritus
Application site reaction
Application site pustules
Reporting of suspected reactions:
The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc
In the event of accidental ingestion, supportive and symptomatic measures should be carried
out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.
Pharmacotherapeutic group: Imidazole and triazole derivatives
ATC Code: D01AC08
Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including
Malassezia and dermatophytes. Its broad spectrum of activity is already well known.
Plasma concentrations of ketoconazole were not detectable after topical administration of
Ketoconazole 2% shampoo on the scalp. Plasma levels were detected after topical
administration of Ketoconazole 2% shampoo on the whole body.
Effects in non-clinical studies were observed only at exposures considered sufficiently in
excess of the maximum human exposure indicating little relevance to clinical use.
Imidurea
Texapon N 70 (Sodium Lauryl Ether Sulphate)
Texapon SB3 (Disodium Laureth Sulfosuccinate)
Comperlan COD (Coconut Fatty Acid Diethanolamide)
Glucamate DOE-120 (PEG-120 Methyl Glucose Dioleate)
Sodium Chloride
Lamequate L (Lauryldiamonium Hydroxypropyl Hydrolyzed
Collagen)
Erythrosine Colour (FD&C Red No.3)
FD&C Red Colour No.40
Eglantine Perfume
Hydrochloric Acid 36-38% concentrated (11.5M)
Sodium Hydroxide Pellets
Purified Water
None Known.
Do not store above 30° C.
Clarazole Shampoo clear, faint pink to orange homogenously colored shampoo, with pleasant
characteristic odor, it is free from any undispersed and extraneous matter. 100 ml filled in
labeled HDPE white plastic bottle. The bottle covered with white plastic cap. It is packed in a
box along with a leaflet.
No special instructions.
