NIZORAL CREAM 2% 15G

ATC code: D01AC08 

Active substances: Ketoconazolum

Vendor, principal: Janssen Pharmaceut.. 

 Prescription drug (℞) 

NIZORAL 20MG/1G 100ML

Package leaflet: Information for the user Nizoral, 20 mg/g shampoo
Ketoconazole

Read all of this leaflet carefully before you start using this medicine because 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.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
-   You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

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

1. What Nizoral is and what it is used for

Nizoral shampoo is an antifungal medicine (skin fungus, yeasts, such as candidiasis). The shampoo is used to treat ketoconazole-sensitive fungal skin diseases, the symptoms of which are:
-   flaking of the scalp (dandruff);
-   scalp inflammation with sebum secretion (seborrheic dermatitis).
Nizoral shampoo treats and helps prevent the listed conditions.

2. What you need to know before you use Nizoral shampoo Do not use Nizoral shampoo

If you are allergic to ketoconazole or any of the other ingredients of this medicine (listed in section 6). Allergy is indicated by redness and itching of the skin after using the shampoo.

Warnings and precautions

As with other shampoos, avoid contact with the eyes. In the case of contact, rinse with plenty of water.

Other medicines and Nizoral

Corticosteroids (cortisone-type medicines) in the form of a cream, ointment or solution: if you use this type of medicine, ask your doctor or pharmacist for advice before starting treatment with Nizoral shampoo. You may start treatment with Nizoral shampoo immediately but you should not stop using corticosteroids abruptly. The skin may turn red and start itching. Continue treatment with corticosteroids as follows:
-   use the same quantities for a week;
-   during the following 1-2 weeks, gradually reduce the frequency of use;
-   then stop using corticosteroids altogether.
If in doubt, talk to your doctor or pharmacist.

Pregnancy and breast-feeding

Nizoral shampoo may be used during pregnancy and breast-feeding. There are no known risks in connection with using Nizoral shampoo during pregnancy or breast-feeding.

3. How to use Nizoral shampoo

Nizoral 20 mg/g shampoo is indicated in adults and adolescents.
Wash the infected areas and let the shampoo take effect for 3-5 minutes before rinsing.
Make sure to also wash the scalp, not only the hair. A handful of shampoo is sufficient for one wash. Frequency of use depends on the disease.
In the case of dandruff and seborrhoea, wash twice a week for 2-4 weeks. To prevent the recurrence of the disease, use the shampoo once a week or every other week.

If you use more Nizoral than you should

Nizoral shampoo must not be ingested. In the case of accidental ingestion, talk to your doctor.
Information for the doctor in the case of an overdose
In the case of accidental ingestion, take supportive and symptomatic measures. To prevent the risk of aspiration, do not induce vomiting or carry out a gastric lavage.

4.   Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon side effects (> 1/1,000 to < 1/100):
-   administration site reactions (redness, irritation symptoms of the skin, itching, another skin reaction);
-   dryness of the skin, rash, hair loss, change in the hair structure, burning sensation of the skin;
-   increased lacrimation;
-   taste disorders;
-   hair follicle inflammation.
Rare side effects (> 1/10,000 to < 1/1,000):
-   hypersensitivity reaction;
-   eye irritation;
-   acne, contact dermatitis,    skin damage, skin flaking;
-   hypersensitivity of the administration site, abscesses at the administration site;
-   taste disorder.
Side effects of unknown frequency (cannot be estimated from available data):
-   angioedema (swelling of the face and mucosal membranes);
-   hives;
-   changes in hair colour.
If you are intolerant to the shampoo, stop the treatment.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Nizoral shampoo

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 25 °C.
The medicine remains usable only for a certain time even in an unopened package. Do not use this medicine after the expiry date which is stated on the package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nizoral contains

-   The active substance is ketoconazole. One gram of shampoo contains 20 milligrams of ketoconazole.
-   The other ingredients are sodium lauryl ether sulphate, disodium monolauryl ether sulfosuccinate, coconut fatty acid diethanolamide, laurdimonium - hydrolysed animal collagen, macrogol 120-methyl glucose dioleate, sodium chloride, hydrochloric acid, imidurea, flavourings, sodium hydroxide, sodium erythrosine and purified water.

What Nizoral looks like and contents of the pack

Nizoral shampoo is a transparent, pink, viscous liquid with a specific fragrance.
White HDPE bottle with a polypropylene cap.
Nizoral shampoo is available in 60 and 100 millilitre bottles.
Marketing Authorisation Holder McNeil Products Limited c/o Johnson & Johnson Limited Foundation Park, Roxborough Way Maidenhead, Berkshire, SL6 3UG United Kingdom

Manufacturer

Janssen Pharmaceutica N.V. Turnhoutseweg 30 B-2340 Beerse Belgium

This leaflet was last revised in August 2013