NIZOBLUE 10 mg /G Szampon

Treść ulotki

1. NIZOBLUE 10 mg/g Shampoo
   1. What is NIZOBLUE and what is it used for
   2. What you need to know before you use NIZOBLUE
   3. How to use NIZOBLUE
   4. Possible side effects
   5. How to store NIZOBLUE
   6. Contents of the pack and other information

NIZOBLUE 10 mg/g Shampoo

Ketoconazole
Read this leaflet carefully before you use 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.
• Talk to your doctor if you do not get better or if your symptoms worsen.

Contents of this leaflet:

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

1. What is NIZOBLUE and what is it used for

NIZOBLUE contains ketoconazole which belongs to a group of medicines called “antifungals” used to
treat fungal infections. NIZOBLUE is used for the treatment of scalp conditions, such as
dandruff (resulting from fungal infection), greasiness, itching.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before you use NIZOBLUE

Do not use NIZOBLUE

• if you are allergic to ketoconazole or any of the other ingredients of this medicine (listed in section 6).
• in children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using NIZOBLUE.
Symptoms of allergy include severe itching and redness of the skin following application of
NIZOBLUE.
After prolonged treatment with anti-inflammatory medicines (corticosteroids) on the scalp:

• wait 15 days, before applying NIZOBLUE to the same skin area; or
• start treatment with NIZOBLUE immediately, continuing to apply the anti-inflammatory medicine (corticosteroid) gradually decreasing the amount until stopping it completely within 2 weeks.

Use NIZOBLUE with caution if:

• the person who needs to use it is elderly;
• you have been diagnosed with a liver disease;
• you have been previously treated with griseofulvin (another antifungal medicine).

As with other shampoos, avoid contact with eyes. If this happens, rinse your eyes with plenty of
water.
Use, especially if prolonged, of the product may lead to sensitization reactions; in this case it is necessary
to stop treatment and consult your doctor.

Children
Do not use NIZOBLUE in children under 12 years of age.

Other medicines and NIZOBLUE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Allergic reactions may occur following the use of NIZOBLUE with the following antifungal medicines:

• miconazole,
• econazole,
• isoconazole.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Although no risks associated with the use of NIZOBLUE have been identified to date, use this medicine only
under the control of your doctor during pregnancy or breastfeeding.

Driving and operating machinery
NIZOBLUE does not alter or alters negligibly the ability to drive vehicles or operate machinery.

NIZOBLUE contains: butylhydroxytoluene (E321), sodium benzoate (E211), benzyl alcohol and
fragrance oil.

• Butylhydroxytoluene (E321) may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
• This medicine contains 0.04 mg sodium benzoate (E211) per g of shampoo. Sodium benzoate may cause local irritation.
• This medicine contains 12.5 mg of benzyl alcohol per g of shampoo. Benzyl alcohol may cause allergic reactions and mild local irritation.
• This medicine contains a fragrance (fragrance oil) which in turn contains alpha-isomethyl ionone, benzyl alcohol, benzyl benzoate, benzyl salicylate, butylphenyl methylpropional, citral, citronellol, coumarin, eugenol, geraniol, hydroxycitronellal, isoeugenol, limonene and linalool, which may cause allergic reactions.

3. How to use NIZOBLUE

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.
Apply a sufficient amount of NIZOBLUE to wet hair and massage gently until a rich foam is obtained.
Leave the product on for 3-5 minutes, then rinse.
It is recommended to perform the treatment 2-3 times a week. The disappearance of symptoms generally occurs within the
4th week.
Do not exceed the recommended doses.
If you do not see any results after a short period of treatment, consult your doctor.

Use in children
Do not use this medicine in children under 12 years of age.

If you use more NIZOBLUE than you should
In case of accidental ingestion of an excessive dose of NIZOBLUE, immediately inform your doctor or go to the nearest hospital.
NIZOBLUE should not be ingested.
In case of accidental ingestion, symptomatic and supportive measures may be taken.
To avoid aspiration, vomiting should not be induced or gastric lavage performed.

4. Possible side effects

Like all medicines, NIZOBLUE can cause side effects, although not everybody gets them.
The following side effects have been observed with NIZOBLUE:

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

• Abnormal hair structure.
• Itching at the application site.

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

• Eye irritation.
• Skin exfoliation.
• Alopecia at the application site (hair loss).
• Dryness at the application site.
• Irritation at the application site.
• Rash at the application site.

Rare side effects (may affect up to 1 in 1000 people):

• Conjunctivitis (eye inflammation of the conjunctival membrane).
• Acne.
• Changes in hair color.
• Skin burning sensation.
• Hyperesthesia at the application site (hypersensitivity).
• Folliculitis (inflammation of the hair follicle) at the application site.
• Pustules at the application site.
• Reaction at the application site.
• Sensitivity at the application site.

Side effects with unknown frequency:

• Allergic reactions.
• Contact dermatitis.
• Angioedema (swelling of the face, mouth, lips and/or tongue).
• Generalized rash (red spots on the skin).
• Urticaria.

If you experience intolerance, discontinue treatment.

Reporting of side effects
If you get any side effects, talk to 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 NIZOBLUE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the packaging after the word Exp. The
expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Do not store at a temperature above 25°C.
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 NIZOBLUE contains
The active ingredient is ketoconazole.
One gram of shampoo contains 10 mg of ketoconazole.
The other ingredients are:

• Sodium laureth sulfate
• Citric acid
• Sodium cocoyl sarcosinate
• Cocoyl monoethanolamide
• Ethylene glycol distearate
• Polyquaternium-7 (contains sodium benzoate (E211))
• Hypromellose
• Tetrasodium edetate
• Fragrance oil
• Sodium chloride (to adjust viscosity)
• Sodium hydroxide (to adjust pH)
• Butylhydroxytoluene (E321)
• Benzyl alcohol
• Hydrochloric acid (to adjust pH)
• Brilliant Blue (E133)
• Purified water

Description of the appearance of NIZOBLUEand contents of the pack
Shampoo - 125 ml bottle.

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

PRODUCERS
Janssen Pharmaceutica NV, Turnhoutseweg, 30, B-2340 Beerse (Belgium)
Stada Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)