Nizoral 2 % - medicinal shampoo

Nizoral is a medicated shampoo, a medicine, used to treat infections of the skin caused by fungi or yeasts in adolescents and adults.

Application

What is Nizoral and what is it used for?

Nizoral is a medicated shampoo, a medicine, used to treat infections of the skin caused by fungi or yeasts in young people and adults. The scalp can be treated with the shampoo.
It can be used for infections of the scalp, which you can recognise by the following symptoms:
Scalp dandruff (pityriasis simplex capillitii);

You can treat these infections with Nizoral 2%- medicated shampoo.

If you do not feel better or even worse, consult your doctor.

How is it applied?

What is Nizoral and what is it used for?

Nizoral is a medicated shampoo, a medicine, used to treat infections of the skin caused by fungi or yeasts in young people and adults. The scalp can be treated with the shampoo.
It can be used for infections of the scalp, which you can recognise by the following symptoms:

• Head dandruff (pityriasis simplex capillitii),

You can treat these infections with Nizoral 2% medicated shampoo.

If you do not feel better or even worse, consult your doctor.

What should you pay attention to before taking it?

What should you be aware of before using Nizoral?

Nizoral must not be used,
- if you are allergic to ketoconazole or any of the other ingredients of this medicine listed in section 6.
Symptoms of allergy (hypersensitivity) include itching and redness of the skin if they occur after treatment.

Warnings and precautions
Please talk to your doctor or pharmacist before using Nizoral.

As with other shampoos, be careful not to get it in your eyes. However, if foam gets into the eyes, rinse them with water.
Do not apply Nizoral 2 % - medicated shampoo to open wounds.

Increased hair loss is often a side effect of dandruff disease and may also occur in rare cases during treatment with Nizoral 2 % - medicated shampoo.

If any adverse effects occur (see section 4. "What are the possible side effects?"), discontinue treatment and consult a doctor. Medical advice is recommended if pregnancy occurs.

Use of Nizoral with other medicines
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

If you use corticosteroids (medicines containing cortisone) in the form of creams, ointments or lotions, talk to your doctor or pharmacist before starting treatment with Nizoral 2
% - medicated shampoo. You can start Nizoral treatment, but you must not stop the corticosteroid therapy from one day to the next. The skin may react with redness and itching.

Continue your corticosteroid treatment as follows:
- Maintain the same treatment as before for 1 week,
- Gradually reduce the frequency of corticosteroid treatment over the following 1 - 2 weeks,
- Then discontinue the use of corticosteroid treatment altogether.
If in doubt, ask your doctor or pharmacist.

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.

Nizoral 2% - medicated shampoo may be used during pregnancy and breast-feeding
as long as your doctor has carried out an appropriate risk-benefit assessment.

Trafficability and ability to operate machinery
No effects known.

How should the medicine be taken?

How to use Nizoral?

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Nizoral 2% - medicated shampoo is for use in adolescents and adults.

How to use:
For application to the hairy scalp

Wet the hair with warm water and apply Nizoral 2 % - medicated shampoo (corresponding to an amount of approx. 1-2 coffee spoons or 1 sachet) and make it foam. Leave the shampoo on for 3-5 minutes. Rinse hair and scalp thoroughly. The shampoo should not get into the eyes!

Dosage and duration of use:
The recommended dose is:

Treatment: use 2 times a week, for 2-4 weeks.
To prevent relapses: apply once every 1-2 weeks.

If the symptoms persist or if the expected success from the application does not occur, a medical consultation is required after 4 weeks at the latest.

Please talk to your doctor or pharmacist if you have the impression that the effect of Nizoral 2% - medicated shampoo is too strong or too weak.

If you have used a larger amount of Nizoral than you should
Nizoral 2% - medicated shampoo must not be swallowed. If Nizoral 2% -
medicinal shampoo is swallowed accidentally, contact a doctor.

Information for doctor:
If the shampoo is ingested accidentally, supportive and symptomatic measures should be taken. To avoid aspiration, do not induce vomiting or flush the stomach.

If you forget to use Nizoral
Do not use twice the amount if you have forgotten to use it before.

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

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What are the possible side effects?

How should Nizoral be stored?

Do not store above 25°C. Keep the bottle tightly closed.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the label and outer carton. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

How should Nizoral be stored?

Do not store above 25°C. Keep the bottle tightly closed.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the label and outer carton. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

What Nizoral contains:
- The active substance is: ketoconazole. 1 g shampoo contains 20 mg ketoconazole
- The other ingredients are: Imidurea, sodium lauryl ether sulphate, disodium lauryl ether sulphosuccinate, coconut fatty acid diethanolamide, laurdimonium hydrol. Animal Collagen, polyethylene (120)methylglucose dioleate, sodium chloride, hydrochloric acid, sodium hydroxide, perfume bouquet, erythrosine (E 127) and purified water.

What Nizoral looks like and contents of the pack
Pharmaceutical form: Clear, pink to pink-orange coloured shampoo.
White plastic bottle (HDPE) with plastic cap (PP): 60 ml and 100 ml
Plastic/aluminium foil sachets: 2x6 ml, 4x6 ml, 6x6 ml, 8x6 ml

Not all pack sizes may be marketed.

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