Nizoral

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Nizoral, 20 mg/g, medicinal shampoo

Ketoconazole

It is necessary to carefully read the contents of the leaflet, as it contains important information for the patient.

This medicinal product should always be used in accordance with the description in the patient information leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept so that it can be read again if necessary.
• A pharmacist should be consulted if advice or additional information is needed.
• If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.
• If there is no improvement or the patient feels worse, a doctor should be contacted.

Table of contents of the leaflet

• 1. What is Nizoral, medicinal shampoo, and what is it used for
• 2. Important information before using Nizoral, medicinal shampoo
• 3. How to use Nizoral, medicinal shampoo
• 4. Possible side effects
• 5. How to store Nizoral, medicinal shampoo
• 6. Contents of the packaging and other information

1. What is Nizoral, medicinal shampoo, and what is it used for

Nizoral, in the form of a medicinal shampoo, is an antifungal medicinal product for topical use on the skin. The medicinal product contains the active substance ketoconazole.

Indications for use

Nizoral, medicinal shampoo, is indicated for the treatment and prevention of the following skin diseases caused by yeast of the genus Malassezia(previously called Pityrosporum):

• Dandruff of the scalp (flaking of the scalp in the form of white, easily removable scales).
• Seborrhoeic dermatitis (brownish-red spots on the chest and face, which flake off in the form of white or yellow scales). Nizoral, medicinal shampoo, is also indicated for the treatment of:
• Pityriasis versicolor (small, white spots on the skin of the chest).

2. Important information before using Nizoral, medicinal shampoo

When not to use Nizoral, medicinal shampoo

Warnings and precautions

Before starting to use Nizoral, medicinal shampoo, a doctor or pharmacist should be consulted.
It is necessary to consult a doctor, even if the following warnings concern situations that have occurred in the past.
In the case of previous long-term topical corticosteroid treatment, in order to avoid exacerbation of disease symptoms after discontinuation of their use, the doctor will recommend gradual (over 2 to 3 weeks) withdrawal from corticosteroid treatment. The skin may react with redness and itching if corticosteroids are discontinued too quickly.
Any doubts should be clarified with a doctor.
Contact of the medicinal product with the eyes should be avoided. If this happens, the eyes should be rinsed with water.
Seborrhoeic dermatitis and dandruff are often accompanied by increased hair loss, which can also occur, although rarely, during the use of Nizoral, medicinal shampoo.

Nizoral, medicinal shampoo and other medicinal products

No data available.
The doctor or pharmacist should be informed about all medicinal products currently being taken or recently taken by the patient, as well as about medicinal products that the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicinal product.
Nizoral, medicinal shampoo, may be used during pregnancy and breastfeeding if, in the doctor's opinion, it is absolutely necessary.

Nizoral, medicinal shampoo contains benzyl alcohol

The medicinal product contains 0.8 μg of benzyl alcohol in each gram of shampoo. Benzyl alcohol may cause mild local irritation and allergic reactions.

Nizoral, medicinal shampoo contains benzoic acid

The medicinal product contains 1.2 μg of benzoic acid in each gram of shampoo. Benzoic acid may cause local irritation.

Nizoral, medicinal shampoo contains butylhydroxytoluene

The medicinal product may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use Nizoral, medicinal shampoo

This medicinal product should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
The medicinal product is intended for topical use on the skin in adolescents (over 12 years of age) and adults.

Dosage

Unless otherwise directed by a doctor, Nizoral, medicinal shampoo, is usually used as described below.

• 1. Apply a small amount of shampoo to the infected skin - usually 1 sachet or a handful of the medicinal product is sufficient for a single application (hair can be washed beforehand with a normal shampoo).
• 2. Using a small amount of water, spread the shampoo evenly over the skin. In the case of long hair, it is sufficient to wash only the scalp.
• 3. Rub the shampoo into the skin until a lather is obtained.
• 4. Leave the lather on the skin for 3 to 5 minutes, then rinse.
• 5. A normal shampoo can be used for everyday washing.

Treatment:
Pityriasis versicolor: use once a day for one day.
Seborrhoeic dermatitis and dandruff of the scalp: use twice a week for 2 to 4 weeks.
Prevention:
Seborrhoeic dermatitis and dandruff of the scalp: use once a week or once every two weeks.
In case of any further doubts about the use of this medicinal product, a doctor or pharmacist should be consulted.

Children

The medicinal product should not be used in children under 12 years of age.
The safety and efficacy of Nizoral, medicinal shampoo, in infants and children under 12 years of age have not been established.

Use of a higher than recommended dose of Nizoral, medicinal shampoo

Topical use of Nizoral, medicinal shampoo, in accordance with the indications and method of administration, does not pose a risk of overdose.
In case of accidental ingestion of the medicinal product, a doctor should be contacted immediately.
To avoid aspiration of gastric contents, gastric lavage should not be performed, nor should vomiting be induced.

4. Possible side effects

Like all medicinal products, this medicinal product can cause side effects, although not everybody gets them.
During treatment with Nizoral, medicinal shampoo, the following side effects may occur:
Uncommon (in more than 1 in 1000 and less than 1 in 100 patients): at the site of application, redness, irritation, hypersensitivity, itching, reaction, and pustules may occur. Uncommonly, eye irritation and increased tearing, as well as hypersensitivity, folliculitis, acne, hair loss, contact dermatitis, dryness of the skin, abnormal hair structure, rash, burning sensation, and skin disorders, exfoliation of the skin, and taste disturbances may occur.
Very rare (in less than 1 in 10,000 patients): after the marketing of Nizoral, medicinal shampoo, urticaria, angioedema, and changes in hair color have been reported.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 (22) 49 21 301
fax: +48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will allow for the collection of more information on the safety of the medicinal product.

5. How to store Nizoral, medicinal shampoo

Keep out of sight and reach of children.
Do not store above 25°C.
Do not use this medicinal product after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicinal products should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicinal products that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Nizoral, medicinal shampoo contains

• The active substance is ketoconazole.
• 1 g of medicinal shampoo contains 20 mg of ketoconazole.
• The other ingredients are: sodium lauryl sulfate, disodium lauryl ether sulfosuccinate, diethanolamide of fatty acids of coconut oil, laurdimonium hydrolyzed animal collagen, macrogol 120 methyl glucose dioleate, sodium chloride, imidurea, sodium hydroxide, hydrochloric acid, erythrosine sodium (E 127), purified water.

What Nizoral, medicinal shampoo looks like and what the pack contains

• The medicinal product is a medicinal shampoo.

Packaging
A 120 ml bottle of medicinal shampoo in an HDPE bottle, placed in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Ireland, the country of export:

Clonmel Healthcare Ltd.
Clonmel, Co. Tipperary, Ireland

Manufacturer:

Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse, Belgium
McGregor Cory Ltd
Middleton Close, Banbury, Oxon OX16 4RS, United Kingdom
Clonmel Healthcare Ltd.
Clonmel, Co. Tipperary, Ireland
STADA Arzneimittel AG
Stadastrasse 2-18, Bad Vilbel, Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Ireland, the country of export, authorization number: PA 126/315/002

Parallel import authorization number: 168/23

Date of approval of the leaflet:23.08.2023
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