Nizoral shampoo 60 ml

PACKAGE LEAFLET: INFORMATION FOR THE USER 

NIZORAL 
shampoo
(ketoconazole) 

Read this leaflet carefully because it contains important information for you. 
This medicine is available without a prescription. However, you must use NIZORAL carefully according to the instructions to make the most of it. 
- Keep the package leaflet in case you need to read it again. 
- Ask your pharmacist if you need more information or advice. 
- If your symptoms get worse or faint in the case of pityriasis versicolor within 7 days, if you have lupus or seborrheic dermatitis within 5 weeks, you should consult a doctor.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. 

In this leaflet: 
1. What NIZORAL and what it is used 
for 2. What you need to know before you use NIZORAL use 
3. How to use NIZORAL used 
4. Possible side effects 
5. How to store NIZORAL 
6. Further information 

1 WHAT NIZORAL IS AND WHAT IT IS USED FOR 
NIZORAL shampoo is a medicine for the treatment of skin infections caused by fungi or yeasts.
Shampoo can be treated hairy part of the head even larger areas on the chest, torso or face. 

These skin disorders usually appear to be: 
- peeling of the scalp on the scalp in the form of white flakes; 
- red-brown spots with yellow or whitish scales, usually on the face or chest (seborrheic dermatitis); 
- Small brown or whitish colored spots of irregular shape appearing on the hull (pityriasis versicolor). 

Using NIZORAL shampoo, you can treat these infections and prevent infections. 

2. BEFORE YOU USE NIZORAL 
Do not use NIZORAL
- if you are hypersensitive (allergic) to the active substance or any of the other ingredients of NIZORAL shampoo.

Symptoms of hypersensitivity are marked by itching and reddening of the skin after shampooing. 

WHAT SPECIAL MEASURES WILL YOU NEED TO COMPLY? 
Try to prevent the shampoo from getting into your eyes. If this happens, rinse your eyes with water. 

Taking other medicines and other forms of interaction
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 

Corticosteroids (cortisone-type medicines) in the form of a cream, ointment or lotion.
If you are using these medicines, consult your doctor or pharmacist before taking NIZORAL shampoo. You can start treatment with NIZORAL shampoo immediately, but do not stop taking corticosteroids from day to day. The skin could react with redness and itching. 
In accordance with the doctor's recommendation, take the corticosteroid treatment as follows: 
- Apply corticoids once a week in the same way; 
- Continue to reduce the frequency of use for the next 1-2 weeks; 
- then you can stop treatment with corticoids completely. 

In case of any doubt, talk to your doctor or pharmacist. 

Using NIZORAL with food and drink
Not affected. 

Pregnancy and breast-feeding
NIZORAL Shampoo can be used during pregnancy and lactation. The risks associated with the use of NIZORAL shampoo during pregnancy or lactation are unknown. 

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

3. HOW TO USE NIZORAL 
NIZORAL Always use shampoo exactly as your doctor has told you. 
If you are not sure, talk to your doctor or pharmacist. 

Wash thoroughly affected areas on the skin, leave the shampoo for 3-5 minutes, then rinse. 
Make sure you have thoroughly washed your skin, not just your hair. 
For a single wash, a small amount of shampoo is usually sufficient for the shampoo.
Frequency of shampoo usage depends on the type of infection and also on whether you want to treat the disease or to prevent it from returning. 

Dizziness of the scalp on the scalp in the form of white flakes and red-brown spots with yellow or whitish scales, usually on the face or chest (seborrheic dermatitis). 
Treatment: 2x weekly for 2-4 weeks. 
Avoiding a disease return: once a week or once every two weeks. 

Small brown or whitish colored spots of irregular shape appearing on the hull (pityriasis versicolor). 
Treatment: once daily for five days. 
Preventing the return of the disease: Every year before the beginning of the summer, once a day three consecutive days. 

If you use more NIZORAL than you should
Nizoral Shampoo is not intended for internal use. 
If inadvertently swallowed, consult your doctor. 

Information for doctors in the event of overdose
In case of accidental ingestion, only supportive and sympathetic measures should be used. 
To avoid aspiration, it should not be induced to vomit or to make the stomach full. 

4. POSSIBLE SIDE EFFECTS
Like all medicines, NIZORAL can cause side effects, although not everybody gets them.
In less frequent cases, it is possible to observe saliva, skin peeling, pruritus, irritation, burning, redness, dry or sensitive skin at the site of shampooing; rash; local eczema; acne; hair loss, hair loss, hair structure change, eye irritation or increased tearing and taste disturbance. 
In rare cases, hypersensitivity (allergy) may occur: Sudden swelling of the skin or mucous membranes usually in the face, eyes or lips. 
In rare cases, you may notice a change in hair color and hives. 
If you do not get the shampoo well, stop the treatment.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 

5. HOW TO STORE NIZORAL
Keep out of the reach and sight of children. 
Do not store above 25 ° C. Close the bottle well. 
Do not use NIZORAL after the expiry date which is stated on the carton. 
Shelf life refers to the last day of that month. 

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of products you no longer need. These measures help to protect the environment. 

6. FURTHER INFORMATION
What NIZORAL contains
The active substance is ketoconazole (ketoconazole). 
NIZORAL Shampoo contains 20 milligrams of ketoconazole in one gram of solution. 
The NIZORAL shampoo also contains adjuvants: sodium lauremacrogol sulfate, cationic dilamide, quaternized collagen, macrogol-5500-methylglucosodioleate, sodium chloride, 35% hydrochloric acid, imidurea, perfume, sodium hydroxide, and purified water. 

What NIZORAL looks like and contents of the pack
NIZORAL shampoo is a pink, viscous solution, characteristic of the fragrance. 
NIZORAL shampoo is supplied in 60 ml and 100 ml bottles. 
Not all pack sizes may be marketed. 

Marketing Authorization Holder
McNeil Products Limited 
Johnson & Johnson 
Foundation Park, Roxborough Way 
Maidenhead, Berkshire 
SL6 3UG, United Kingdom 

Manufacturer
Janssen Pharmaceutica NV 
Turnhoutseweg 30 
2340 Beerse Belgium