NIZORAL 2 % Krem

Treść ulotki

1. NIZORAL 20 mg/g shampoo
   1. What is NIZORAL and what is it used for
   2. What you need to know before using NIZORAL
   3. How to use NIZORAL
   4. Possible side effects
   5. How to store NIZORAL
   6. Contents of the pack and other information
2. NIZORAL 2% cream
   1. What is NIZORAL and what is it used for
   2. What you need to know before using NIZORAL
   3. How to use NIZORAL
   4. Possible side effects
   5. How to store NIZORAL
   6. Contents of the pack and other information

NIZORAL 20 mg/g shampoo

Ketoconazole

Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse during treatment.

Contents of this leaflet:

• 1. What NIZORAL is and what it is used for
• 2. What you need to know before you use NIZORAL
• 3. How to use NIZORAL
• 4. Possible side effects
• 5. How to store NIZORAL
• 6. Contents of the pack and other information

1. What is NIZORAL and what is it used for

NIZORAL contains an active ingredient called ketoconazole, belonging to a group of medicines that
cause the death of fungi, called antimycotics. Like other shampoos, NIZORAL also contains other
ingredients that serve to clean the hair.
NIZORAL shampoo is used against infections on the scalp due to a fungus (yeast) called
Malassezia. This fungus is found on the skin of everyone, but sometimes it can cause problems such as:

• dandruff;
• dry or greasy scaling of the skin, called seborrheic dermatitis. These conditions can cause itching.

2. What you need to know before using NIZORAL

Do not use NIZORAL
if you are allergic to the active ingredient or to 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 on your scalp that contains a corticosteroid (e.g. betamethasone or hydrocortisone):
• continue to apply a small amount of the lotion or cream containing the steroid;
• gradually reduce the 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 begins to take effect.
• Avoid contact with eyes. If this happens, rinse your eyes with plenty of cold water.

Like other medicines for topical use, 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 the age of 12 years.

Other medicines and NIZORAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, you can use NIZORAL. However, ask your doctor or pharmacist for advice before using this
medicine.

Driving and operating machinery
NIZORAL does not impair the ability to drive vehicles and operate machinery

NIZORAL contains fragrance
This medicine contains a fragrance (bouquet 2 fragrance) which in turn contains alpha-isomethyl ionone,
amyl cinnamal, amyl cinnamyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, cinnamal, cinnamyl
alcohol, citral, citronellol, eugenol, evernia prunastri extract (oakmoss), geraniol, hexyl
cinnamal, hydroxycitronellal, limonene and linalool, which can cause allergic reactions.
Benzyl alcohol which can cause mild local irritation.
This medicine contains 0.0012 mg benzoic acid in each g of shampoo. Benzoic acid may cause
local irritation.
This medicine contains butylhydroxytoluene which can cause skin reactions (e.g.
contact dermatitis) or irritation to the eyes and mucous membranes.

3. How to use NIZORAL

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents over 12 years of age
Use NIZORAL shampoo 2 times a week for 2-4 weeks.
Method of use
Wash your hair with NIZORAL; a small amount of shampoo is sufficient to create an abundant foam on the scalp; leave the shampoo on for 3-5 minutes, then rinse thoroughly.
Do not exceed the dose of NIZORAL and do not apply it more frequently than indicated above. See your doctor if you do not notice any improvement or if your symptoms worsen.

If NIZORAL comes into contact with the eyes: rinse your eyes with plenty of cold water.

If you use more NIZORAL than you should
you may notice redness and/or the appearance or worsening of itching on the scalp.
In case of accidental ingestion of NIZORAL shampoo, do not try to induce vomiting: immediately notify your doctor or go to the nearest hospital, as appropriate measures may be necessary.

If you forget to use NIZORAL
If you forget to carry out a treatment, do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if, during use of NIZORAL shampoo, you notice:

Uncommon side effects(may affect up to 1 in 100 people)

• redness, itching and burning due to irritation of the scalp;
• burning or more or less sudden appearance of skin lesions, for example changes in colour in patches or widespread (rash) also due to inflammation of the hair follicles (folliculitis);
• increased tearing;
• change in hair structure, patchy hair loss (alopecia);
• dry skin;
• eye irritation;
• acne, skin inflammations (dermatitis), exfoliation or skin infections with the presence of pus (pustules) or other skin disorders;
• alterations of taste;
• 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(whose frequency has not been established)
• urticaria (hives);
• changes in hair colour;
• swelling of the face, eyes, lips, tongue and throat with difficulty breathing (angioedema).

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

5. How to store NIZORAL

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. This date applies to the product in intact packaging,
correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NIZORAL contains
The active ingredient is: ketoconazole.
One gram of NIZORAL shampoo contains: 20 mg of ketoconazole.
The other ingredients are: sodium lauryl ether sulfate; disodium monolauryl ether sulfosuccinate;
cocamide DEA; laurdimonium hydrolyzed (animal collagen); macrogol 120 methyl glucose dioleate;
fragrance bouquet 2; imidazolidinyl urea; hydrochloric acid; sodium chloride; sodium hydroxide; erythrosine; purified
water.

Description of the appearance of NIZORAL and contents of the pack
NIZORAL shampoo is available in 100 g bottles.

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milano

Manufacturer
Janssen Pharmaceutica N.V. Turnhoutseweg 30, B-2340 Beerse - Belgium
Stada Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel - Germany

NIZORAL 2% cream

Ketoconazole

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen during treatment.

Contents of this leaflet:

• 1. What NIZORAL is and what it is used for
• 2. What you need to know before using NIZORAL
• 3. How to use NIZORAL
• 4. Possible side effects
• 5. How to store NIZORAL
• 6. Contents of the pack and other information

1. What is NIZORAL and what is it used for

NIZORAL contains an active ingredient called ketoconazole, belonging to a group of drugs that
cause the death of fungi, called antimycotics.
NIZORAL cream is used against skin infections due to fungi or yeasts, cutaneous candidiasis, which
can cause problems such as:

• inflammations all over the body, which manifest with reddened lesions with the presence of liquid (candidiasis) or spots on the skin from white to brown that sometimes appear after exposure to the sun (tinea versicolor);
• inflammations on limited parts of the body, such as the chest and/or back (tinea corporis), the hands (tinea manus), the feet (tinea pedis) or the groin area (tinea cruris), which manifest with redness in patches, blister formation, skin flaking;
• dry or greasy scaling of the skin, called seborrheic dermatitis. These conditions can cause itching.

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

2. What you need to know before using NIZORAL

Do not use NIZORAL
if you are allergic to the active ingredient or to 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.

Take care with NIZORAL cream

• If you are using a lotion or cream containing a corticosteroid on your skin (e.g. 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 the 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 help to avoid a worsening of symptoms before NIZORAL starts to take effect.
• During treatment with NIZORAL, take hygienic measures to avoid new infections or worsening of symptoms due to reinfection.
• Do not use NIZORAL cream in your eyes.

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

Other medicines and NIZORAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, you can use NIZORAL. However, ask your doctor or pharmacist for advice before using this
medicine.

Driving and using machines
NIZORAL does not affect the ability to drive vehicles and operate machinery.

NIZORAL contains propylene glycol, cetyl alcohol and stearyl alcohol:

• This medicine contains 200 mg of propylene glycol per gram of cream; it may cause skin irritation; cetyl alcohol and stearyl alcohol; may cause localized skin reactions (e.g. contact dermatitis).

3. How to use NIZORAL

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
Adults
For skin infections of the trunk, groin, feet and hands, apply NIZORAL 2% cream
one or two times a day, to the affected area and immediately surrounding it.
Your doctor will tell you how often to use it and for how long. Depending on the type of skin infection,
treatment may last from 2 to 6 weeks.
For skin infections with brownish-red spots and yellow-white scales (seborrheic dermatitis), apply NIZORAL 2% Cream one or two times a day. Skin infections
will generally improve after 2-4 weeks.
Signs of improvement are usually noticed after 4 weeks. If this is not the case, consult your doctor.
Continue to use the cream for a few days after all symptoms have completely disappeared.
Even after all symptoms have disappeared, sometimes the cream must be applied once a week or once
every 2 weeks. This prevents the symptoms from recurring.
Method of use
To open the tube, unscrew the cap and pierce the tube seal with the tip on the outside of the cap.
Apply NIZORAL cream to the affected area and immediately surrounding it; do not use airtight (occlusive) dressings.
NIZORAL cream quickly soothes itching. Do not exceed the dose of NIZORAL and do not apply it more
frequently than indicated above. See your doctor if you do not notice improvement or if you notice a
worsening of symptoms after 4 weeks of treatment.

If you use more NIZORAL than you should
you may notice redness (erythema) and/or the appearance or worsening of itching, burning sensation or
swelling (edema).
In case of accidental ingestion of NIZORAL, immediately inform your doctor or go to the nearest
hospital, as appropriate measures may be necessary.

If you forget to use NIZORAL
If you forget to carry out a treatment, do not use a double dose to compensate for the forgotten dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you notice any of the following while using NIZORAL cream:

Common side effects(may affect up to 1 in 10 people)

• redness or itching at the site where the cream has been 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 (paresthesia) or other lesions at the site where the cream has been applied;
• more or less sudden appearance of skin lesions, for example changes in color in patches or widespread (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(frequency not known)

• urticaria (hives).

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

5. How to store NIZORAL

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after ‘Exp.’. The expiry date
refers to the last day of that month. This date applies to the product in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NIZORAL contains
The active ingredient is: ketoconazole.
One gram of NIZORAL cream contains: 20 mg of ketoconazole.
The other ingredients are:
propylene glycol (E1520), stearyl alcohol, cetyl alcohol, polysorbate 60, isopropyl myristate, sodium sulfite
anhydrous BP 80, polysorbate 80, sorbitan monostearate, distilled water.

Description of the appearance of NIZORAL and contents of the pack
NIZORAL cream is available in a 30 gram tube.

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan

Manufacturer
Janssen Pharmaceutica N.V. Turnhoutseweg 30, B-2340 Beerse - Belgium
(alternatively) JANSSEN - CILAG SpA Via C. Janssen - LATINA
Stada Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)