Nizoral

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Nizoral

20 mg/g, medicinal shampoo

Ketoconazole

Read the leaflet carefully because it contains important information for

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

• This leaflet should be kept in case it needs to be read again.
• 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 or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Leaflet

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

1. What is Nizoral 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 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 spots on the chest and face, which flake off in the form of white or yellow scales). Nizoral is also indicated for the treatment of:
• Pityriasis versicolor (small, white spots on the skin of the chest).

2. Important Information Before Using Nizoral

When Not to Use Nizoral

• if the patient is allergic to ketoconazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Before starting to use Nizoral, a doctor or pharmacist should be consulted.
A doctor should be consulted, 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, a doctor will recommend gradual (over 2 to 3 weeks) withdrawal from corticosteroid treatment. If corticosteroids are stopped too quickly, the skin may react with redness and itching.
Any doubts should be clarified with a doctor.
Contact of the medicine 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.

Nizoral and Other Medicines

No data available.
A doctor or pharmacist should be informed about all medicines that the patient is currently taking or has recently taken, as well as about medicines that the patient plans to take.

Pregnancy and Breastfeeding

In pregnancy and during breastfeeding, or if there is a suspicion that the woman is pregnant or plans to become pregnant, a doctor or pharmacist should be consulted before using this medicine.
Nizoral may be used during pregnancy and breastfeeding if, in the doctor's opinion, it is absolutely necessary.

3. How to Use Nizoral

This medicine should always be used in accordance with the description in the patient information leaflet or as directed by a doctor or pharmacist.
In case of doubts, a doctor or pharmacist should be consulted.
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 is usually used as described below.

• 1. Apply a small amount of shampoo to the infected skin - usually a handful of the medicine is sufficient for a single application (the 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 every day.

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 medicine, a doctor or pharmacist should be consulted.

Children

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

Using More Than the Recommended Dose of Nizoral

Topical use of Nizoral in accordance with the indications and method of use does not pose a risk of overdose.
In case of accidental ingestion of the medicine, a doctor should be contacted immediately.
To avoid aspiration of gastric 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, the following side effects may occur:
Uncommon (in more than 1 in 1000 and less than 1 in 100 patients): at the application site, 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 may occur. Rarely (in less than 1 in 1000 patients), exfoliative dermatitis and skin discoloration may occur. Very rarely (in less than 1 in 10,000 patients), 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 this leaflet, the doctor or pharmacist 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 help to gather more information on the safety of the medicine.

5. How to Store Nizoral

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Store the bottle tightly closed.
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. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Nizoral 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 Looks Like

The medicine is a pink, viscous medicinal shampoo.
Packaging:
HDPE bottle containing 120 ml of shampoo, 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,
D-61118, Bad Vilbel
Germany

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Ireland, the Country of Export:PA 126/315/002

Parallel Import Authorization Number: 422/22 Date of Approval of the Leaflet: 05.12.2022

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