Nizoblue

Patient Information Leaflet

NIZOBLUE 10 mg/g Shampoo

Ketoconazole
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement 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 using 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 NIZOBLUE is and what it is used for

NIZOBLUE contains ketoconazole, which belongs to a group of medicines called "antifungals" used to treat fungal infections. NIZOBLUE is used to treat scalp conditions such as dandruff (caused by fungal infection), oiliness, and itching.
If you do not feel better or if you feel worse, talk to your doctor.

2. What you need to know before using NIZOBLUE

Do not use NIZOBLUE

• if you are allergic to ketoconazole or to 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 skin redness 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, while continuing to apply the anti-inflammatory medicine (corticosteroid), gradually reducing the amount until completely discontinued within 2 weeks.

Use NIZOBLUE with caution if:

• the person using it is elderly;
• you have been diagnosed with liver disease;
• you have previously been treated with griseofulvin (another antifungal medicine).

As with other shampoos, avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with plenty of water.
Prolonged or repeated use of the product may lead to sensitization reactions; if this occurs, discontinue treatment and consult your doctor.
Children
Do not use NIZOBLUE in children under 12 years of age.
Other medicines and NIZOBLUE
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Allergic reactions may occur when using NIZOBLUE together with the following antifungal medicines:

• miconazole,
• econazole,
• isoconazole.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Although no risks associated with the use of NIZOBLUE have been identified to date, use this medicine only under medical supervision during pregnancy or breastfeeding.
Driving and using machines
NIZOBLUE has no effect or has negligible effect on the ability to drive or operate machinery.
NIZOBLUE contains: butylated hydroxytoluene (E321), sodium benzoate (E211), benzyl alcohol and perfumed oil.

• Butylated hydroxytoluene (E321) may cause localized skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
• This medicine contains 0.04 mg of sodium benzoate (E211) per gram of shampoo. Sodium benzoate may cause local irritation.
• This medicine contains 12.5 mg of benzyl alcohol per gram of shampoo. Benzyl alcohol may cause allergic reactions and mild local irritation.
• This medicine contains fragrance (perfumed oil) which itself 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 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 gently massage until a rich foam is formed. Leave the product on for 3-5 minutes, then rinse thoroughly.
It is recommended to carry out the treatment 2-3 times a week. Symptoms usually disappear within 4 weeks.
Do not exceed the recommended doses.
If there is no improvement 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, contact your doctor immediately or go to the nearest hospital.
NIZOBLUE must not be ingested.
In case of accidental ingestion, symptomatic and supportive measures may be taken.
To avoid aspiration, vomiting should not be induced and gastric lavage should not be performed.

4. Possible side effects

Like all medicines, NIZOBLUE may cause side effects, although not everyone experiences 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.
• Skin rash at the application site.

Rare side effects (may affect up to 1 in 1,000 people):

• Conjunctivitis (inflammation of the conjunctival membrane of the eye).
• Acne.
• Changes in hair colour.
• Burning sensation of the skin.
• Hyperesthesia at the application site (increased sensitivity).
• 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).
• Generalised rash (red spots on the skin).
• Urticaria.

If you experience intolerance, discontinue treatment.
Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report side effects directly via 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 stated on the packaging after the word "Exp".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original undamaged packaging, properly stored.
Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NIZOBLUE contains
The active substance is ketoconazole.
One gram of shampoo contains 10 mg of ketoconazole.
The other components 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)
• Butylated hydroxytoluene (E321)
• Benzyl alcohol
• Hydrochloric acid (to adjust pH)
• Brilliant Blue (E133)
• Purified water

Description of the appearance of NIZOBLUE and pack sizes
Shampoo – 125 ml bottle.
Marketing Authorization Holder and Manufacturer
EG S.p.A., Via Pavia 6, 20136 Milan, Italy
MANUFACTURERS
Janssen Pharmaceutica NV, Turnhoutseweg, 30, B-2340 Beerse, Belgium
Stada Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany