NIZORAL

NIZORAL 2% Cream

Important notes (mandatory information)

Nizoral 2% Cream. Active ingredient: Ketoconazole. Areas of application: is used for fungal infections of the skin (dermatomycoses) such as ringworm (e.g. athlete's foot, ringworm of the lower leg) and skin fungus caused by microsporia as well as infections caused by yeast fungi (candidiasis).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Nizoral 2% Cream, for use in adults
Active ingredient: Ketoconazole

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 14 days, contact your doctor.

What this package leaflet contains

1. WHAT IS NIZORAL 2% CREAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING NIZORAL 2% CREAM?
3. HOW TO USE NIZORAL 2% CREAM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE NIZORAL 2% CREAM?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS NIZORAL 2% CREAM AND WHAT IS IT USED FOR?

Nizoral 2% Cream is a fungicidal medicine for external treatment of fungal skin infections (antimycotic). Nizoral 2% Cream is used for fungal infections of the skin (dermatomycoses) such as ringworm (e.g. athlete's foot, ringworm of the lower leg) and skin fungus caused by microsporia as well as infections caused by yeast fungi (candidiasis). Nizoral 2% Cream is intended for use in adults.

2. WHAT SHOULD YOU CONSIDER BEFORE USING NIZORAL 2% CREAM?

Nizoral 2% Cream must not be used if you are allergic to ketoconazole or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Nizoral 2% Cream must not come into contact with the eyes. If you are currently using topical corticosteroid medicines for your symptoms, consult your doctor or pharmacist. You can start using Nizoral 2% Cream immediately, but you should not stop using the corticosteroid medicine from one day to the next. Your skin could react with redness or itching.

Follow the treatment plan:

• Apply the corticosteroid medicine in the morning and Nizoral 2% Cream in the evening for one week.
• After that, apply the corticosteroid medicine every 2 to 3 days in the morning and Nizoral 2% Cream every evening for one to two more weeks.
• Then stop using the corticosteroid medicine and, if necessary, only use Nizoral 2% Cream.

Please ask your doctor or pharmacist if you are not entirely sure.

Using Nizoral 2%

Cream together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. There is no evidence that Nizoral 2% Cream affects the action of other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Risks associated with the use of Nizoral 2% Cream during pregnancy and breast-feeding are not known. If you are pregnant or breast-feeding, you should nevertheless only use Nizoral 2% Cream after consulting a doctor. Please do not use Nizoral 2% Cream in the breast area while breast-feeding. This will prevent the infant from coming into direct contact with Nizoral 2% Cream.

Driving and using machines

No special precautions are necessary.

Nizoral 2%

Cream contains stearyl alcohol, cetyl alcohol and propylene glycol

Stearyl alcohol and cetyl alcohol can cause localised skin irritation (e.g. contact dermatitis). Propylene glycol can cause skin irritation.

3. HOW TO USE NIZORAL 2% CREAM?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Apply a sufficient amount of cream once a day, twice a day in case of severe infestation, to the affected skin and the surrounding skin area (approx. 1-2 cm).

Method of administration

Before using for the first time, pierce the seal of the tube with the tip located in the cap. Massage the cream in with your finger until it has been absorbed.

Precautions for use

Avoid contact of Nizoral 2% Cream with the eyes! Wash your hands thoroughly after using the cream.

Duration of use

The symptoms of the condition usually recede significantly within the first 14 days after starting treatment with Nizoral 2% Cream. Continue treatment for at least a few days after the symptoms have disappeared to prevent recurrence. The total treatment time is on average 2-3 weeks for candidiasis, 3-4 weeks for ringworm depending on the location, and up to 6 weeks for ringworm on the feet. If the symptoms of the condition do not recede within the first 14 days after starting treatment, you must consult a doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Nizoral 2% Cream is too strong or too weak.

If you have used a larger amount of Nizoral 2%

Cream than you should

Excessive or more frequent than indicated use on the skin can lead to skin redness (erythema), fluid retention in the skin (oedema) and burning. These symptoms disappear after discontinuation of treatment. Nizoral 2% Cream should not be taken orally. If you accidentally swallow Nizoral 2% Cream, talk to your doctor.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects

Common (may affect up to 1 in 10 people):

• Burning
• Skin redness (erythema), itching at the site of application.

Uncommon (may affect up to 1 in 100 people):

• Hypersensitivity
• Blistering, inflammation of the skin, rash, skin flaking, fluid retention in the skin (oedema)
• Skin reactions at the site of application: bleeding, slight pain, dry skin, inflammation, skin irritation, paraesthesia.

Not known (frequency cannot be estimated from the available data):

• Hives

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE NIZORAL 2% CREAM?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and the tube after "Use by". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Medicines should be disposed of in accordance with local requirements. Therefore, ask your pharmacist how to dispose of the medicine when you no longer use it. This will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Nizoral 2%

Cream contains

The active substance is: Ketoconazole. 1 g of cream contains 20 mg of ketoconazole. The other ingredients are: Propylene glycol, stearyl alcohol (Ph. Eur.), cetyl alcohol (Ph. Eur.), sorbitan stearate, polysorbate 60, isopropyl myristate (Ph. Eur.), sodium sulphite (E221), polysorbate 80, purified water.

What Nizoral 2%

Cream looks like and contents of the pack

Nizoral 2% Cream is a white emulsion. Nizoral 2% Cream is available in aluminium tubes containing 15 g and 30 g of cream. Not all pack sizes may be marketed.

Further information

Ketoconazole, the active ingredient in Nizoral 2% Cream, has a broad spectrum of action (against skin, yeast, mould and other fungi) and is thus effective against almost all pathogens that cause fungal skin infections. Before using Nizoral 2% Cream, you should wash the affected skin areas and then dry them thoroughly. Use fresh towels every day - preferably disposable towels. This will prevent the fungi from being spread to other areas of the skin by the towel. After each application, you should wash your hands carefully to prevent the fungal infection from being transmitted to other parts of the body or to other people. In most cases, Nizoral 2% Cream provides relief from the symptoms (itching) and heals the affected skin areas after a few days. Even if there are no more visible skin changes, you should continue treatment for at least a few more days. There are still fungi in the deeper layers of the skin that can lead to a recurrence of the fungal infection.

Pharmaceutical entrepreneur

McNeil GmbH & Co. oHG
Postfach 210411
41430 Neuss
Tel.: 00800 260 260 00 (free of charge)

Manufacturer

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
2340 Beerse
Belgium

This package leaflet was last revised in May 2013.

Source: Information from the package leaflet
Status: 11/2016
Active ingredient: Ketoconazole. Areas of application: is used for fungal infections of the skin (dermatomycoses) such as ringworm (e.g. athlete's foot, ringworm of the lower leg) and skin fungus caused by microsporia as well as infections caused by yeast fungi (candidiasis).