KETOZOLIN

KETOZOLIN 2% Shampoo

Important notes (mandatory information)

Ketozolin 2% Shampoo. Active ingredient: Ketoconazole. Areas of application: is used in adults for the treatment and prevention of the following types of fungal pityriasis: dandruff/cradle cap on the scalp, dandruff and scaly brown spots on the skin.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketozolin 2% Shampoo for adults
Active ingredient: Ketoconazole

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Ketozolin 2% must be used as directed to ensure the best possible treatment success.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 1 – 2 weeks, you must see a doctor.
• If any of the side effects listed here affect you significantly or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

This package leaflet contains

1. WHAT IS KETOZOLIN 2% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING KETOZOLIN 2%?
3. HOW SHOULD KETOZOLIN 2% BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KETOZOLIN 2% BE STORED?
6. FURTHER INFORMATION

1. WHAT IS KETOZOLIN 2% AND WHAT IS IT USED FOR?

Effect

Ketozolin 2% belongs to the group of medicines used to treat skin diseases caused by fungal infections. Ketozolin 2% is effective against a broad spectrum of fungi, including yeasts. The effect is based on a change in the cell membranes of the fungus. Ketozolin 2% acts superficially (topically) in the uppermost layer of the skin and does not enter the body.

Application

Ketozolin 2% is used in adults for the treatment and prevention of the following types of fungal pityriasis:

• Dandruff/cradle cap on the scalp
• Dandruff
• scaly brown spots on the skin.

Your doctor may have prescribed a different application for you. Please follow your doctor's instructions.

2. WHAT SHOULD YOU CONSIDER BEFORE USING KETOZOLIN 2%

Ketozolin 2% must not be used if you are allergic (hypersensitive) to ketoconazole or any of the other ingredients of this medicine. The use of Ketozolin 2% in children and adolescents is not recommended as there are no data on efficacy and safety for these age groups.

Special care should be taken when using Ketozolin 2%

is required

In rare cases, an increase in hair loss, which is normal in connection with these conditions, has been observed during the use of Ketozolin 2% against cradle cap and dandruff. Contact with the eyes should be avoided. If the shampoo gets into your eyes, rinse thoroughly with cold water. To avoid relapse after long-term treatment with adrenal cortex hormones (corticosteroids), it is recommended to first apply a mild corticosteroid in the morning and Ketozolin 2% in the evening. Treatment with the corticosteroid should be gradually discontinued over a period of two to three weeks.

When using Ketozolin 2%

with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. It is not known whether the use of Ketozolin 2% affects other medicines.

When using Ketozolin 2%

together with food and drink

No restrictions.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. There are no known risks associated with the use of Ketozolin 2% during pregnancy or breast-feeding.

Driving and using machines

Ketozolin 2% has no influence on occupational safety and the ability to participate safely in road traffic.

3. HOW SHOULD KETOZOLIN 2% BE USED?

This medicine is for external use only! Adults: Scaly brown spots on the skin: Treatment: once daily for five days. Prevention: once daily for a maximum of three days before summer time. Cradle cap and dandruff: Treatment: twice weekly for two to four weeks. Prevention: once weekly or every two weeks for three to six months. The affected areas are washed with the shampoo. Rinse out the shampoo after three to five minutes. Always use this medicine exactly as your doctor has told you. Individual needs vary. Treatment should only be changed or discontinued on medical advice.

If you have used more Ketozolin 2%

than you should

If Ketozolin 2% is accidentally ingested, please contact your doctor, the emergency room or a pharmacy. Vomiting should not be induced to avoid aspiration.

If you forget to use Ketozolin 2%

Continue treatment as prescribed by your doctor.

If you stop using Ketozolin 2%

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Serious side effects

Not known.

Non-serious side effects - Occasionally occurring side effects (in 1 to 10 out of 1,000 patients)

Impairment of taste, infections of the hair roots, eye irritation, increased tear flow, acne, hair loss, allergic or irritant contact dermatitis, dry skin, unusual hair structure, rash, burning of the skin, scaling of the skin, redness of the skin in the area of application, itching in the area of application.

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

Swelling of the face, lips, mouth, tongue or throat (angioedema), hives (urticaria), changes in hair colour (especially in chemically coloured, permed or grey hair).

Tell your doctor or pharmacist if you notice any side effect that persists or causes discomfort. Some side effects may need to be treated.

Reporting 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 Dept. of Pharmacovigilance Kurt-Georg-Kiesinger Allee 3 D-53175 Bonn Website: www.bfarm.de by reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD KETOZOLIN 2% BE STORED?

Keep out of reach of children. Do not use this medicine after the expiry date which is stated on the bottle and outer carton after "Use by". The expiry date refers to the last day of the month indicated. Shelf life after first opening the bottle: 6 months. Do not store above 25°C. The medicine must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

6. FURTHER INFORMATION

What Ketozolin 2%

contains

The active ingredient is ketoconazole. 1 g shampoo contains 20 mg ketoconazole (2 %). The other ingredients are: sodium dodecyl sulfate; 3-dodecyloxycarbonyl-2/3-sulfopropanoic acid, disodium salt; poly(oxyethylene)-120-methyl(D-glucopyranosid)dioleate; macrogolglycerolcocoates (Ph.Eur.) [7 EO units]; 1,1'-methylenebis[3-(3-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)urea];
tridodecylammonium polypeptides (MMG 2000); N,N-bis(2-hydroxyethyl)coconut fatty acid amide; sodium hydroxide; sodium chloride; Ponceau 4R (E124); hydrochloric acid 36 %; purified water.

What Ketozolin 2%

looks like and contents of the pack

Appearance: Clear reddish solution.
Pack sizes: Plastic bottles containing 60 ml or 120 ml.

Pharmaceutical entrepreneur

Dermapharm AG
Lil-Dagover-Ring 7
82031 Grünwald
Tel.: 089 / 641 86-0
Fax: 089 / 641 86-130

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
(a subsidiary of Dermapharm AG)

This package leaflet was last revised in August 2015.

Source: Information from the package leaflet
Status: 04/2016
Active ingredient: Ketoconazole. Areas of application: is used in adults for the treatment and prevention of the following types of fungal pityriasis: dandruff/cradle cap on the scalp, dandruff and scaly brown spots on the skin.