NIZORAL 20 mg/g shampoo
Ketoconazole
Please read 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 experience 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 your doctor if you do not feel better or if you feel worse after 5 days.
What is in this leaflet?
What Nizoral shampoo is and what it is used for
What you need to know before you use Nizoral shampoo
How to use Nizoral shampoo
Possible side effects
How to store Nizoral shampoo
Contents of the pack and other information
1. WHAT NIZORAL SHAMPOO IS AND WHAT IT IS USED FOR
Nizoral shampoo is used in adolescents and adults for the external treatment and prevention of diseases caused by fungi (also called fungal infections). The use of Nizoral shampoo is not recommended in children under 12 years of age.
Nizoral shampoo is mainly indicated for the treatment of inflammatory skin conditions with scaling (i.e. peeling of the skin) caused by a certain yeast called Malassezia (formerly known as Pityrosporum). The signs of inflammation that occur on the skin as a result of this type of yeast include dandruff of the scalp, seborrhoeic dermatitis and pityriasis versicolor (a superficial fungal infection of the skin).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NIZORAL SHAMPOO
Do not use Nizoral shampoo
If you are allergic to the active substance or any of the other ingredients of this medicine listed in section 6.
If you are hypersensitive to medicines containing an imidazole derivative (ask your doctor or pharmacist for further information).
Warnings and precautions
After prolonged treatment with corticosteroids, it is recommended that this treatment be stopped gradually over a period of 2 to 3 weeks while using Nizoral shampoo at the same time.
As with other shampoos, contact with the eyes should be avoided. If this does occur, rinse the eyes with water.
Talk to your doctor or pharmacist before using Nizoral shampoo.
Other medicines and Nizoral shampoo
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
There are insufficient data regarding the use of Nizoral shampoo in pregnant women. Although there are no known risks associated with the use of Nizoral shampoo in pregnant or breast-feeding women, it is advisable to ask your doctor or pharmacist for advice.
Nizoral 20 mg/g shampoo contains a fragrance
This medicine contains a fragrance containing alpha-isomethyl ionone, amyl cinnamal, amylcinnamyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, cinnamal, cinnamyl alcohol, citral, citronellol, eugenol, oak moss extract, geraniol, hexyl cinnamal, hydroxycitronellal, limonene and linalool. These substances may cause allergic reactions.
3. HOW TO USE NIZORAL SHAMPOO
Nizoral shampoo is used in adolescents and adults.
Always use this medicine 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.
The shampoo is intended for external use on the scalp or hairy areas of the body.
Wash the affected area (e.g. chest, face, scalp) with Nizoral shampoo. Make sure that you wash the skin as well, not just the hair. Before rinsing, leave the shampoo on for 5 to 10 minutes.
The number of applications required will differ depending on whether you are treating an existing infection or simply preventing it from recurring.
Treatment
Dandruff: twice a week for 2 to 4 weeks
Seborrhoeic dermatitis: twice a week for 2 to 4 weeks
Superficial fungal infection of the skin (pityriasis versicolor): once daily for 1 to 5 days
Maintenance treatment
Dandruff: once a week or once every two weeks, depending on the result
Seborrhoeic dermatitis: once a week or once every two weeks, depending on the result
A small amount of shampoo in the palm of the hand (approximately 6 ml) is normally sufficient for one application.
If you use more Nizoral shampoo than you should
Using Nizoral shampoo more often than stated in section 3 “How to use Nizoral shampoo” does not cause any problems.
Nizoral shampoo must not be swallowed. Consult a doctor if Nizoral shampoo is accidentally swallowed.
Information for the doctor: In the event of accidental ingestion, general supportive and symptomatic measures are recommended. To avoid aspiration, gastric lavage should not be performed and vomiting should not be induced.
If too much Nizoral shampoo has been used or if the product has been swallowed, immediately contact your doctor, pharmacist or the Poison Control Centre (070/245.245).
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you use the shampoo immediately after, or as a replacement for, corticosteroid treatment, your skin may become irritated. This may appear as redness, a local burning sensation, possibly itching or swelling caused by hypersensitivity in areas exposed to the shampoo. General hypersensitivity reactions in the form of a skin rash, breathing problems or swelling have been reported. In this case, it is advisable to stop treatment and consult your doctor.
Uncommon reactions at the application site may occur, including: inflammation of the hair follicles, itching, irritation, burning sensation of the skin, redness, dry or sensitive skin, rash, hair loss, changes in hair texture, altered taste, local eczema and increased tearing.
In rare cases, hypersensitivity reactions (allergic reactions), eye irritation and reactions at the application site may occur, such as local hypersensitivity, spots, acne and scaling of the skin (i.e. peeling of the skin).
Hair discolouration, hives and a sudden accumulation of fluid in the skin and mucous membranes (e.g. throat and tongue) may also occur.
Reporting of side effects
If you experience 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:
Belgium:
Federal Agency for Medicines and Health Products – www.afmps – Vigilance Division
Website: www.notifieruneffetindesirable.be
E-mail: adr@fagg-afmps.be
Luxembourg:
Regional Pharmacovigilance Centre of Nancy or the Pharmacy and Medicines Division of the Health Directorate
Website: www.guichet.lu/pharmacovigilance
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE NIZORAL SHAMPOO
Keep out of the sight and reach of children.
Store at room temperature (15–25°C).
Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date is expressed as a month and a year. 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 dispose of medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nizoral shampoo contains
The active substance is ketoconazole. Each gram contains 20 mg of ketoconazole.
The other ingredients of this medicine are: sodium laureth sulfate, disodium monolaureth sulfosuccinate, coconut fatty acid diethanolamide, laurdimonium hydrolysed animal collagen, macrogol 120 methyl glucose dioleate, sodium chloride, sodium hydroxide, fragrance, imidurea, hydrochloric acid, erythrosine (E127) and distilled water.
What Nizoral shampoo looks like and contents of the pack
Nizoral shampoo is available in bottles containing 60, 100 or 200 ml of shampoo.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EG (Eurogenerics) SA
Esplanade Heysel b22
1020 Brussels
Belgium
Manufacturer
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
or
Johnson & Johnson Consumer NV/SA
Antwerpseweg 15-17
B-2340 Beerse
Belgium
or
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany
Marketing Authorisation Number
Nizoral 20 mg/g shampoo (60, 100 or 200 ml bottle): BE140113
Method of supply
Available without prescription.
This leaflet was last approved/revised in 11/2025 / 11/2025.
