Nizoral® 2% Medicated Shampoo – Antifungal Shampoo with Ketoconazole for the Treatment of Dandruff

Further product information

Nizoral® 2% medicated shampoo is a medicine for the treatment and prevention of recurrent dandruff (Pityriasis simplex capillitii). The active ingredient, ketoconazole, is effective against certain fungi and yeasts that may be involved in the development of dandruff.

Unlike conventional cosmetic anti-dandruff shampoos, Nizoral® specifically targets sensitive yeasts of the Malassezia genus, which are often associated with dandruff and scalp irritation.

The medicated shampoo can reduce dandruff as well as associated symptoms such as itching, redness and scalp burning.

Treatment is carried out twice weekly for two to four weeks. To prevent dandruff from returning, Nizoral® can subsequently be used every one to two weeks.

The shampoo is suitable for adults and adolescents aged 12 years and over.

This set contains two packs of Nizoral® 2% medicated shampoo.

Features and benefits

• For dandruff: For the treatment of Pityriasis simplex capillitii.

• With ketoconazole: Antifungal active ingredient against sensitive fungi and yeasts.

• Combats a common cause of dandruff: Effective against yeasts of the Malassezia genus.

• Reduces dandruff formation: Supports the treatment of dandruff-prone scalp.

• For itchy scalp: Can relieve itching caused by dandruff.

• For redness and burning: For the treatment of associated scalp irritation.

• Prevention of recurrence: For regular use against recurrent dandruff.

• Only twice weekly: During the treatment phase.

• Short contact time: Three to five minutes.

• For different hair types: Also suitable for use on color-treated or chemically treated hair, although changes in hair structure or color may occur.

• Twin pack: Two packs of Nizoral® 2% medicated shampoo.

Nizoral® – Treating the cause of dandruff

Dandruff is a common problem that can be associated with various changes in the scalp.

Yeasts of the Malassezia genus play an important role in this, as they occur naturally on human skin.

Under certain conditions, these yeasts can contribute to the development of dandruff, itching and inflammation.

Nizoral® 2% medicated shampoo contains ketoconazole and specifically targets sensitive fungi and yeasts.

This means the medicine treats not only visible dandruff but also a common microbial cause of the symptoms.

What causes dandruff?

The scalp is continuously renewed.

During this process, dead skin cells are normally shed in very small, barely visible amounts.

When dandruff formation increases, larger groups of cells shed from the scalp and are perceived as visible flakes.

Possible associated symptoms include:

• Visible white or yellowish flakes

• Itching

• Redness

• Burning sensation

• Dry or irritated scalp

• Recurrent dandruff formation

Not all dandruff is caused by a fungal infection. Dry skin, eczema or other dermatological conditions can also cause similar symptoms.

Ketoconazole – Antifungal active ingredient

Ketoconazole belongs to the group of azole antifungals.

The active ingredient inhibits the formation of ergosterol, an important component of the cell membrane of many fungi.

This impairs the normal function of the fungal cells.

Ketoconazole is effective against various sensitive fungi and yeasts, especially Malassezia species.

Nizoral® for itchy and dandruff-prone scalp

Dandruff formation can be associated with unpleasant itching, burning or redness.

Nizoral® 2% medicated shampoo is used for the treatment of dandruff.

Due to its antifungal effect, the shampoo can help reduce dandruff formation and associated symptoms.

Visible results during treatment

With regular use, dandruff formation may improve within the first few weeks of treatment.

The recommended treatment duration is two to four weeks.

Even if the symptoms improve early, use should continue in accordance with the package leaflet.

Nizoral® for the prevention of recurrent dandruff

Dandruff can recur.

After successful treatment, Nizoral® can be used to prevent recurrence.

For this purpose, the shampoo is used once every one to two weeks.

Regular use can help reduce the recurrence of dandruff.

Suitable for different hair types

Nizoral® 2% medicated shampoo can be used on different hair types.

It can also generally be used on color-treated or chemically treated hair.

However, changes in hair structure or color may occur in individual users.

Active ingredient and composition

1 g of Nizoral® 2% medicated shampoo contains:

• Ketoconazole: 20 mg

This corresponds to an active ingredient concentration of 2%.

Other ingredients:

• Imidurea

• Sodium laureth sulfate

• Disodium laureth sulfosuccinate

• Coconut fatty acid diethanolamide

• Laurdimonium hydrolyzed animal collagen

• Polyethylene(120) methylglucose dioleate

• Sodium chloride

• Hydrochloric acid

• Sodium hydroxide

• Perfume bouquet

• Erythrosine (E 127)

• Purified water

Indications

Nizoral® 2% medicated shampoo is used:

• For the treatment of dandruff (Pityriasis simplex capillitii).

• For the prevention of recurrent dandruff.

• For the treatment of dandruff-related scalp irritation within the approved indications.

Application and dosage

Treatment of dandruff

Use Nizoral® twice weekly for two to four weeks.

Prevention of recurrence

Use once every one to two weeks.

Correct application

1. Thoroughly wet the hair and scalp with warm water.

2. Apply approximately one to two teaspoons of Nizoral® shampoo to the wet hair and scalp.

3. Distribute the shampoo evenly and lather.

4. Leave on for three to five minutes.

5. Then thoroughly rinse the hair and scalp with water.

Avoid contact with the eyes.

If the shampoo accidentally gets into the eyes, rinse them thoroughly with water.

Duration of treatment

The usual treatment duration is two to four weeks.

If there is no sufficient improvement after four weeks at the latest, or if the symptoms worsen, a medical examination should be sought.

Use in children and adolescents

Nizoral® 2% medicated shampoo is intended for adults and adolescents aged 12 years and over.

Its safety and efficacy in children under 12 years have not been sufficiently established.

Product details

• Product: Nizoral® 2% medicated shampoo – twin pack

• Product type: Antifungal medicine

• Dosage form: Medicated shampoo

• Active ingredient: Ketoconazole

• Active ingredient concentration: 2% (20 mg/g)

• Indications: Treatment and prevention of dandruff

• Medical name: Pityriasis simplex capillitii

• Application: Externally on the hairy scalp

• Frequency of treatment: Twice weekly

• Duration of treatment: Two to four weeks

• Preventive use: Once every one to two weeks

• Contact time: Three to five minutes

• Age group: Adults and adolescents aged 12 years and over

• Set contents: 2 × Nizoral® 2% medicated shampoo

Important information

Contraindications

Nizoral® must not be used by anyone with a known hypersensitivity to ketoconazole or any of the other ingredients.

Possible signs of hypersensitivity include itching, redness or skin reactions after use.

Concomitant use of corticosteroids

If corticosteroid creams, ointments or lotions are already being used on the scalp, medical or pharmaceutical advice should be sought before starting treatment with Nizoral®.

An existing corticosteroid treatment should not be discontinued abruptly.

According to the package leaflet, the following gradual reduction may be prescribed:

• Continue the previous corticosteroid treatment during the first week.

• Gradually reduce the frequency of use over the following one to two weeks.

• Then discontinue the corticosteroid treatment.

The exact procedure should be agreed with the treating doctor.

Pregnancy

Ketoconazole is absorbed systemically in only very small amounts when applied externally to the scalp.

Nizoral® 2% medicated shampoo can be used during pregnancy if a prior medical assessment of the benefits and risks has been carried out.

Breastfeeding

Nizoral® 2% medicated shampoo can be used during breastfeeding.

However, the shampoo should not be used in the breast area.

Contact between the baby and treated skin areas should be avoided.

Contact with the eyes

The shampoo must not get into the eyes.

If it accidentally gets into the eyes, rinse them thoroughly with water.

Possible side effects

Like all medicines, Nizoral® may cause side effects, although they do not occur in every user.

Occasional – may affect up to 1 in 100 treated:

• Taste disturbances

• Inflammation of the hair follicles (folliculitis)

• Eye irritation

• Increased tear flow

• Acne

• Hair loss

• Contact dermatitis

• Dry skin

• Changes in hair structure

• Skin rash

• Burning sensation on the skin

• Skin peeling

• Redness at the application site

• Skin irritation

• Hypersensitivity reactions

• Itching

• Pustules

Frequency unknown:

• Urticaria (hives)

• Angioedema with swelling of the skin and mucous membranes

• Changes in hair color

If intolerance reactions occur, treatment should be discontinued.

In the event of severe allergic reactions, especially swelling of the face or throat and difficulty breathing, medical help must be sought immediately.

When should a doctor be consulted?

If symptoms persist or worsen, if there is severe scalp inflammation, pronounced hair loss or no improvement after four weeks at the latest, a medical examination should be sought.

A dermatological assessment is also advisable for recurrent or unusual skin changes.

Storage

Keep out of reach of children.

Observe the storage instructions and shelf life stated in the current package leaflet.

Mandatory information

Nizoral® 2% medicated shampoo is a medicine containing the active ingredient ketoconazole for the treatment and prevention of dandruff in adults and adolescents aged 12 years and over.

For information on the effects and possible adverse effects, see the package leaflet or consult a doctor or pharmacist.