Nizoral

Package Leaflet: Information for the User

Nizoral, 20 mg/g, Medicinal Shampoo

Ketoconazole
Read the package leaflet carefully before using this medicine because it contains important information for you.
This medicine should always be used exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Package 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 pack 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 scalp (flaking of the scalp in the form of white, easily removable scales).
• Seborrhoeic dermatitis (brown-red spots 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 spots on the skin of the chest).

2. Important Information Before Using Nizoral, Medicinal Shampoo

When Not to Use Nizoral, Medicinal Shampoo

• If you are allergic to ketoconazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Before using Nizoral, medicinal shampoo, you should consult a doctor or pharmacist.
You should consult a doctor, even if the following warnings refer to situations that have occurred in the past.
In the case of previous long-term topical corticosteroid treatment, in order to avoid worsening of symptoms after stopping their use, the doctor will recommend gradual (over 2 to 3 weeks) withdrawal of corticosteroid treatment. If corticosteroids are stopped too quickly, the skin may react 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 may 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 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, ask your doctor or pharmacist for advice before using this medicine.
Nizoral, medicinal shampoo may be used during pregnancy and breastfeeding when the doctor considers it absolutely necessary.

Nizoral Contains a Fragrance Composition

This medicine contains a fragrance composition that includes, among others, the following allergens: 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, amyl cinnamal, pentyl cinnamal, benzyl alcohol, benzyl benzoate, cinnamyl benzoate, cinnamal, cinnamyl alcohol, citral, citronellol, eugenol, oak moss, geraniol, hexyl cinnamal, hydroxycitronellal, d-limonene, linalool.
These substances may cause allergic reactions.

Nizoral Contains Benzyl Alcohol

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

Nizoral Contains Benzoic Acid

The medicine contains 1.2 µg of benzoic acid per gram of shampoo. Benzoic acid may cause local irritation.

Nizoral Contains Butylhydroxytoluene

The medicine may cause local skin reaction (e.g. contact dermatitis) or eye and mucous membrane irritation.

3. How to Use Nizoral, Medicinal Shampoo

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist.
In case of doubt, consult your 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 your 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 enough to wash only the scalp.
• 3. Massage 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: use twice a week for 2 to 4 weeks.
Prevention:
Seborrhoeic dermatitis and dandruff: use once a week or once every two weeks.
In case of any further doubts about 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.

Using More Than the Recommended Dose of Nizoral, Medicinal Shampoo

Topical use of Nizoral, medicinal shampoo in accordance with the indications and method of use does not pose a risk of overdose.
In case of accidental ingestion, contact your doctor 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, medicinal shampoo, 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 tear production, as well as hypersensitivity, folliculitis, acne, hair loss, contact dermatitis, dry skin, abnormal hair structure, rash, burning sensation, and skin disorders may occur.
Rarely (in less than 1 in 1000 patients), urticaria, angioedema, and changes in hair color have been reported after the marketing of Nizoral, medicinal shampoo.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Nizoral, Medicinal Shampoo

Keep out of the sight and reach of children.
Store in a temperature below 25 °C.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of the month stated.
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 Pack 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 lauryl sulfate, disodium lauryl ether sulfosuccinate, fatty acid diethanolamide, laurdimonium hydrolyzed animal collagen, macrogol 120 methyl glucose dioleate, fragrance composition T12047376 Bouquet 2 (containing, among others: 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, amyl cinnamal, pentyl cinnamal, benzyl alcohol (E 1519), benzyl benzoate, cinnamyl benzoate, cinnamal, cinnamyl alcohol, citral, citronellol, eugenol, oak moss, geraniol, hexyl cinnamal, hydroxycitronellal, d-limonene, linalool, benzoic acid (E 210), butylhydroxytoluene (E 321)), sodium chloride, imidurea, sodium hydroxide, hydrochloric acid, erythrosine sodium, purified water.

What Nizoral, Medicinal Shampoo Looks Like and What the Pack Contains

• The medicine is a medicinal shampoo.

Packaging
6 sachets made of polyester/aluminum/PE, each containing 6 ml of medicinal shampoo, placed in a cardboard box.
Bottles made of HDPE with a flip-off closure made of PP, containing 60 ml or 100 ml of medicinal shampoo, placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

Date of Last Revision of the Package Leaflet: