Nizoral

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Nizoral

20 mg/g, medicinal shampoo

Ketoconazole
You should carefully read the contents of the leaflet, as it contains important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or
pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a pharmacist if you need advice or additional information.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, you should contact your doctor.

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 medicine for topical use on the skin. The medicine 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 hairy scalp (flaking of the scalp in the form of white, easily removable scales).
• Seborrhoeic dermatitis (brownish-red patches 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 patches 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, you should consult a doctor or pharmacist.
You should consult a doctor, even if the following warnings concern situations that have occurred in the past.
In the case of previous long-term local treatment with corticosteroids, in order to avoid exacerbation of the disease symptoms after stopping their use, the doctor will recommend gradual (over 2 to 3 weeks) withdrawal from corticosteroid treatment. The skin may react to too rapid discontinuation of corticosteroids with redness and itching.
Any doubts should be clarified with a doctor.
You should avoid contact of the medicine with the eyes. 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 medicines

No data available.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Nizoral, medicinal shampoo may be used during pregnancy and breastfeeding, when in the doctor's opinion it is clearly necessary.

3. How to use Nizoral, medicinal shampoo

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.
The medicine 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 medicine 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. For everyday use, a normal shampoo can be used.

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.
If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

Children

Do not use in children under 12 years of age.
The safety and efficacy of using Nizoral, medicinal shampoo in infants and children under 12 years of age have not been established.

Using a higher dose of Nizoral, medicinal shampoo than recommended

Topical use of Nizoral, medicinal shampoo in accordance with the indications and method of use does not pose a risk of overdose.
In the event of accidental ingestion of the medicine, you should immediately contact a doctor. In order to avoid choking on stomach contents, do not perform gastric lavage or induce vomiting.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. During treatment with Nizoral, medicinal shampoo, the following symptoms of 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 epidermis, and taste disorders may occur.
After the introduction of Nizoral, medicinal shampoo to the market, very rarely (in less than 1 in 10,000 patients) urticaria, angioedema, and changes in hair color have occurred.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. 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.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

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 medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nizoral, medicinal shampoo contains

The active substance of the medicine is ketoconazole.

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

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

The medicine is in the form of a medicinal shampoo.

Packaging

HDPE bottles in a cardboard box, containing 120 ml of medicinal shampoo.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Ireland, the country of export:

Clonmel Healthcare Ltd
Waterford Road
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
D-61118, Bad Vilbel
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Ireland, the country of export: PA 126/315/002
Parallel import authorization number: 312/24

Date of approval of the leaflet: 30.07.2024

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