NIZORAL*SHAMPOO FL 100G 20MG/G

NIZORAL 20 mg/g shampoo
Ketoconazole

What it is and what it is used for
NIZORAL contains an active ingredient called ketoconazole, which belongs to a group of medicines that kill fungi, known as antifungals. Like other shampoos, NIZORAL also contains other ingredients that are used to clean hair.

NIZORAL shampoo is used against scalp infections caused by a fungus (yeast) called Malassezia. This fungus is found on everyone's skin, but sometimes it can cause problems such as:
• dandruff;
• dry or greasy flaking of the skin, called seborrheic dermatitis.
These conditions can cause itching.

What you need to know before taking the medicine
Do not use NIZORAL
if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using NIZORAL if:
• you are elderly;
• you have liver problems;
• you have previously used medicines containing griseofulvin, which are used to kill fungi.

Be careful with NIZORAL shampoo
• If you are using a lotion or cream containing a corticosteroid (e.g., betamethasone or hydrocortisone) on your scalp:
- continue to apply a small amount of the lotion or cream containing the steroid;
- gradually reduce this amount during the first 2-3 weeks of treatment with NIZORAL shampoo;
- after 2-3 weeks, use only NIZORAL. This will prevent a worsening of symptoms before NIZORAL starts to take effect.
• Avoid contact with eyes. If this happens, rinse your eyes with plenty of cold water.

Like other topical medicines, especially with prolonged therapy, NIZORAL shampoo can cause redness and itching (sensitization phenomena). If this occurs, stop treatment and consult your doctor.

Children and adolescents
NIZORAL shampoo can be used in adolescents over 12 years of age.

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

Tell your doctor if, during the use of NIZORAL shampoo, you notice:
Uncommon side effects (may affect up to 1 in 100 people)
• redness, itching, and burning due to scalp irritation;
• burning or more or less sudden appearance of skin lesions, for example, patchy or widespread color changes (rash) also due to inflammation of hair follicles (folliculitis);
• increased tearing;
• alteration of hair structure, patchy hair loss (alopecia);
• dry skin;
• eye irritation;
• acne, skin inflammations (dermatitis), exfoliation or skin infections with pus (pustules) or other skin disorders;
• taste disturbances;
• allergic reactions including redness, itching, and burning of the skin and/or scalp, with possible swelling of the face, eyes, throat, and difficulty breathing.

Other side effects (frequency not established)
• hives;
• hair color changes;
• swelling of the face, eyes, lips, tongue, and throat with difficulty breathing (angioedema).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.