Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Nizoral, 20 mg/g, medicated shampoo
Ketoconazole
Please read this leaflet carefully because it contains important information for the patient.
This medicine should always be used according to the instructions provided in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet for future reference.
Consult your pharmacist if you need advice or further information.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If symptoms do not improve or worsen, consult your doctor.

Table of contents

What Nizoral medicated shampoo is and what it is used for
Important information before using Nizoral medicated shampoo
How to use Nizoral medicated shampoo
Possible side effects
How to store Nizoral medicated shampoo
Contents of the pack and other information

1. What Nizoral medicated shampoo is and what it is used for

Nizoral medicated shampoo is an antifungal medicine intended for topical application to the skin. The active substance is ketoconazole.
Indications
Nizoral medicated shampoo is indicated for the treatment and prevention of the following skin conditions caused by Malassezia yeasts (previously called Pityrosporum ):

Dandruff (scaling of the scalp skin in the form of white, easily detachable flakes).
Seborrhoeic dermatitis (brownish-red patches on the chest and face, which flake off as white or yellowish scales).

Nizoral medicated shampoo is also indicated for the treatment of:

Pityriasis versicolor (small white spots on the skin of the chest caused by Pityriasis versicolor).

2. Important information before using Nizoral medicated shampoo

When not to use Nizoral medicated shampoo

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 medicated shampoo, consult a doctor or pharmacist.
Consult a doctor even if the warnings below refer to conditions that occurred in the past.
In case of previous long-term topical treatment with corticosteroids, to avoid worsening of symptoms after stopping their use, the doctor will recommend gradually discontinuing corticosteroid treatment over a period of 2 to 3 weeks. Skin may react to too rapid withdrawal of corticosteroids with redness and itching.
Any doubts should be clarified with a doctor.
Avoid contact of the shampoo with the eyes. If contact occurs, rinse eyes thoroughly with water.
Seborrhoeic dermatitis and dandruff are often associated with increased hair loss, which may also occur, although rarely, during treatment with Nizoral medicated shampoo.

Nizoral medicated shampoo and other medicines
No data available.
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient intends to use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Nizoral medicated shampoo may be used during pregnancy and breastfeeding if, in the opinion of the doctor, it is clearly necessary.

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

Nizoral medicated shampoo contains benzoic acid
The medicine contains 1.2 μg of benzoic acid in each gram of shampoo. Benzoic acid may cause local irritation.

Nizoral medicated shampoo contains butylated hydroxytoluene (BHT)
The medicine may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Nizoral, medicinal shampoo

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for topical application to the skin in adolescents (over 12 years of age) and adults.
Dosage
Unless otherwise advised by a doctor, Nizoral medicinal shampoo is usually used as described below:

Apply a small amount of shampoo to the affected skin area – usually one sachet or a handful of the product is sufficient for a single application (hair may have been previously washed with regular shampoo).
Using a small amount of water, spread the shampoo evenly over the skin. In the case of long hair, only the scalp needs to be washed.
Gently massage the shampoo into the skin until a lather forms.
Leave the lather on the skin for 3 to 5 minutes, then rinse thoroughly.
A regular shampoo may be used on other days.

Treatment:
Pityriasis versicolor: use once daily for one day.
Seborrhoeic dermatitis and dandruff: use twice a week for 2 to 4 weeks.
Prophylaxis:
Seborrhoeic dermatitis and dandruff: use once a week or once every two weeks.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Children
Do not use 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.
Overdose of Nizoral medicinal shampoo
When used topically as directed, Nizoral medicinal shampoo does not pose a risk of overdose.
In case of accidental ingestion, seek immediate medical advice.
To avoid aspiration of gastric contents, do not perform gastric lavage or induce vomiting.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
During treatment with Nizoral medicated shampoo, the following adverse drug reactions may occur:
Uncommonly (in more than 1 in 1,000 and less than 1 in 100 patients) at the site of application: erythema, irritation, hypersensitivity, pruritus, reaction and pustules. Uncommonly, eye irritation, increased lacrimation, hypersensitivity, folliculitis, acne, hair loss, contact dermatitis, dry skin, abnormal hair texture, rash, burning sensation and skin disorders, desquamation of the stratum corneum, and taste disturbances may occur.
Very rarely (in less than 1 in 10,000 patients) since the marketing of Nizoral medicated shampoo, cases of urticaria, angioedema, and hair discoloration have been reported.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Nizoral medicated shampoo

Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Nizoral medicinal shampoo contains

The active substance is ketoconazole.
20 mg of ketoconazole is contained in 1 g of medicinal shampoo.
The other ingredients are: sodium lauryl ether sulfosuccinate, disodium lauryl ether sulfosuccinate, fatty acid diethanolamide of coconut oil, laurdimonium hydrolysed animal collagen, polyethylene glycol 120 methyl glucose dioleate, sodium chloride, imidourea, sodium hydroxide, concentrated hydrochloric acid, erythrosine sodium (E 127), purified water.

What Nizoral medicinal shampoo looks like and contents of the pack

The medicinal product is in the form of a medicinal shampoo.

Packaging
HDPE bottle containing 120 ml of medicinal shampoo, placed in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Ireland, 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, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Marketing Authorisation Number in Ireland, country of export: PA 126/315/002
Parallel Import Authorisation Number: 168/23