NIZORAL "2% CREAM"30G TUBE"

Name
NIZORAL 2% cream
Ketoconazole


What it is and what it is used for
NIZORAL contains an active substance called ketoconazole, which belongs to a group of drugs that cause the death of fungi, called antifungals.

NIZORAL cream is used against skin infections caused by fungi or yeasts, cutaneous candidiasis, which can cause problems such as:
• inflammation all over the body, which manifests itself with red lesions with the presence of fluid (candidiasis) or white to brown spots on the skin that sometimes appear after exposure to the sun (tinea versicolor);
• inflammation on limited parts of the body, such as the chest and/or back (tinea corporis), hands (tinea manus), feet (tinea pedis) or groin area (tinea cruris), which manifest themselves with red spots, blisters, peeling of the skin;
• dry or greasy flaking of the skin, called seborrheic dermatitis.
These conditions can cause itching.

NIZORAL cream can be used in adults over 18 years of age.


What you need to know before taking the medicine
Do not use NIZORAL
if you are allergic to the active substance 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:
• is elderly;
• has liver problems;
• has used medicines containing griseofulvin in the past, which are used to kill fungi.

Be careful with NIZORAL cream
• If you are using a lotion or cream on your skin that contains a corticosteroid (for example betamethasone or hydrocortisone):
- continue to apply a small amount of the lotion or cream containing the corticosteroid in the morning; apply NIZORAL cream in the evening;
- gradually reduce the amount of lotion or cream containing the corticosteroid during the first 2 - 3 weeks of treatment with NIZORAL cream;
- after 2-3 weeks use only NIZORAL. This will ensure that your symptoms do not worsen before NIZORAL begins to take effect.
• During treatment with NIZORAL, apply hygiene measures to avoid new infections or worsening of symptoms due to reinfection.
• Do not use NIZORAL cream on your eyes.

Like other medicines for local (topical) use, especially in case of prolonged therapy, NIZORAL cream can cause redness and itching (sensitization phenomena). If this should occur, stop the treatment and contact your doctor.


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

Tell your doctor if, while using NIZORAL cream, you notice:

Common side effects (may affect up to 1 in 10 people)
• redness or itching at the site where the cream was applied;
• burning sensation of the skin.

Uncommon side effects (may affect up to 1 in 100 people)
• redness, itching and burning due to irritation, bleeding, discomfort, dryness, loss of sensation (paraesthesia) or other lesions at the site where the cream was applied;
• more or less sudden appearance of skin lesions, for example spotty or widespread changes in colour (rash) or formation of blisters, skin inflammation (dermatitis), skin peeling;
• sticky skin;
• allergic reactions including redness and itching, with possible swelling of the face, eyes, throat and difficulty breathing.

Other side effects (the frequency of which has not been established)
• urticaria.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.