Nizoral

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Nizoral
20 mg/g (2%) medicated shampoo
Ketoconazole
Nizoral and Низорал are the same trade names of the same medicine written in Polish and Bulgarian.
Please read this leaflet carefully because it contains important information for the patient.
This medicine should always be used as described in this patient leaflet or as directed by the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• 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 or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse, contact the doctor.

Table of contents of the leaflet

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 medicine contains the active substance 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 scale off as white or yellowish flakes).

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.
If the patient has previously undergone prolonged local treatment with corticosteroids, the doctor will recommend gradually discontinuing corticosteroid therapy over 2 to 3 weeks to avoid worsening of symptoms after stopping 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 the eyes. If contact occurs, rinse the 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 taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, 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 a fragrance composition
This medicine contains a fragrance composition which includes the following allergens: 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, amyl cinnamic aldehyde, pentyl cinnamic alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, cinnamic aldehyde, cinnamic alcohol, citral, citronellol, eugenol, oak moss, geraniol, hexyl cinnamic aldehyde, hydroxycitronellal, d-limonene, linalool.
These substances may cause allergic reactions.

Nizoral medicated shampoo contains benzyl alcohol
The medicine contains 0.08 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
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 your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is intended for topical application on the skin in adolescents (over 12 years of age) 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 – usually a handful of the product is sufficient for a single application (hair may be previously washed with regular shampoo).
2. Using a small amount of water, spread the shampoo evenly over the skin. For long hair, only the scalp needs to be washed.
3. Massage the shampoo into the skin until a lather forms.
4. Leave the lather on the skin for 3 to 5 minutes, then rinse thoroughly.
5. 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.
Use of more than the recommended dose of Nizoral medicinal shampoo
Topical use of Nizoral medicinal shampoo according to the indications and instructions for use 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 all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with Nizoral:
Uncommon (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, alopecia, contact dermatitis, dry skin, abnormal hair structure, rash, burning sensation, skin disorders, desquamation of the stratum corneum, and taste disturbances may occur.
Following the use of Nizoral medicated shampoo, urticaria, angioedema, and changes in hair color have very rarely occurred (in less than 1 in 10,000 patients).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 the medicine.

5. How to store Nizoral medicated shampoo

Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Keep 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 stated month.
Medicines must 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 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 laureth sulfate, disodium laureth sulfosuccinate, cocofatty acid diethanolamide, laurdimonium hydrolyzed animal collagen, polyethylene glycol-120 methyl glucose dioleate, fragrance composition Bouquet 2 (containing inter alia: 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, amyl cinnamic aldehyde, pentyl cinnamic alcohol, benzyl alcohol, benzyl benzoate, cinnamyl cinnamate, cinnamaldehyde, cinnamic alcohol, citral, citronellol, eugenol, oak moss, geraniol, hexyl cinnamic aldehyde, hydroxycitronellal, d-limonene, linalool, benzoic acid, butylhydroxytoluene), sodium chloride, imidourea, sodium hydroxide, hydrochloric acid concentrated, sodium erythrosine (E 127), purified water.

What Nizoral medicinal shampoo looks like and contents of the pack
The medicine is in the form of a medicinal shampoo.
Packaging:
White HDPE bottle with PP screw cap, containing 100 ml of medicinal shampoo, placed in a cardboard box.
For more detailed information, please contact the responsible entity or parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer:
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse
Belgium
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Bulgaria, country of export: 20010016
Parallel import authorisation number: 8/26