Nizoral

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
Read the entire leaflet carefully because it contains important information for the patient.
This medicine should always be used exactly as described in this patient information 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms do not improve or worsen, consult your doctor.

Table of contents

1. What Nizoral medicated shampoo is and what it is used for
2. Important information before using Nizoral medicated shampoo
3. How to use Nizoral medicated shampoo
4. Possible side effects
5. How to store Nizoral medicated shampoo
6. 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 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 known as Pityrosporum ):

• Pityriasis capitis (dandruff) – flaking of the scalp skin in the form of white, easily detachable scales.
• Seborrhoeic dermatitis – brownish-red patches on the chest and face, shedding in the form of 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 prolonged local treatment with corticosteroids, to avoid worsening of disease symptoms after discontinuation, the doctor will recommend gradually (over 2 to 3 weeks) withdrawing corticosteroid treatment. Stopping corticosteroids too quickly may cause skin reactions such as redness and itching.
Any doubts should be clarified with a doctor.
Avoid contact of the shampoo with eyes. If contact occurs, rinse eyes with water.
Seborrhoeic dermatitis and dandruff are often associated with increased hair loss, which may also occur, although rarely, during the use of Nizoral medicated shampoo.
Nizoral medicated shampoo and other medicines
No data available.
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may 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.

3. How to use Nizoral, medicinal shampoo

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

1. Apply a small amount of shampoo to the affected skin – typically one sachet or a handful of the product is sufficient for a single application (hair may be previously washed with a regular shampoo).
2. 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.
3. Massage the shampoo into the skin until lather forms.
4. Leave the lather on the skin for 3 to 5 minutes, then rinse off thoroughly.
5. A regular shampoo may be used on other days.

Treatment:
Pityriasis versicolor: apply once daily for one day.
Seborrhoeic dermatitis and dandruff: apply twice a week for 2 to 4 weeks.
Prophylaxis:
Seborrhoeic dermatitis and dandruff: apply once a week or once every two weeks.
If you have any further questions 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
Topical use of Nizoral medicinal shampoo according to the recommended indications and instructions does not pose a risk of overdose.
In case of accidental ingestion, contact a doctor immediately. To avoid aspiration of gastric contents, do not perform gastric lavage or induce vomiting.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
During treatment with Nizoral medicated shampoo, the following adverse drug reactions may occur:
Not common (in more than 1 in 1000 and less than 1 in 100 patients) at the site of application:
erythema, irritation, hypersensitivity, pruritus, reaction, and pustules. Not common may also be eye irritation, increased lacrimation, as well as 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.
After the introduction of Nizoral medicated shampoo to the market, very rare cases (in less than 1 in 10,000 patients) 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
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Nizoral medicinal 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 packaging. 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Nizoral medicated shampoo contains
The active substance is ketoconazole.

• 1 g of medicated shampoo contains 20 mg of ketoconazole.
• Other ingredients: sodium laureth sulfate, disodium lauryl sulfosuccinate, cocamide DEA, laurdimonium hydrolyzed animal collagen, PEG-120 methyl glucose dioleate, sodium chloride, imidurea, sodium hydroxide, concentrated hydrochloric acid, sodium erythrosine, purified water.

What Nizoral medicated shampoo looks like and contents of the pack
The medicinal product is a medicated shampoo.
Pack:
HDPE bottle in a cardboard box, containing 120 ml of medicated shampoo.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Ireland, 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Ireland, country of export: PA 126/315/002
Parallel import licence number: 312/24