What it is and what it is used for

for The name of your medicine is Nizoral 2% shampoo. It is called 'Nizoral Shampoo' or just 'shampoo' in this leaflet. Nizoral shampoo contains a medicine called ketoconazole. This belongs to a group of medicines called 'antifungals'. Like other shampoos, it also contains ingredients to clean your hair.

These conditions can be itchy. They are caused by a fungus (yeast) called 'Malassezia'. This fungus is found on everyone's skin, but sometimes it can overgrow and cause problems. Nizoral shampoo works by killing the fungus and stopping it from coming back.

Nizoral shampoo is used for fungal infections on the scalp and body such as:

• Dandruff
• Dry or greasy scaling of the scalp and other parts of the body called 'seborrhoeic dermatitis'
• White to brown patches on the body that sometimes appear after being in the sun called 'tinea versicolor' or 'pityriasis versicolor'

What you need to know before you take it

e Nizoral shampoo Do not use Nizoral shampoo if:

• You are allergic to anything in Nizoral shampoo (listed in section 6 below) Do not use this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Nizoral shampoo.

Warnings and precautions Talk to your doctor or pharmacist before using this medicine:

• This medicine contains 380mg/g sodium lauryl ether sulfate in each application, which is equivalent to 24% w/w. Sodium lauryl ether sulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.
• If you use a lotion or cream on your hair that contains a steroid, such as betamethasone or hydrocortisone:
• You should use less and less of the lotion or cream during the first 2 to 3 weeks of Nizoral shampoo treatment
• This will stop your condition flaring up while Nizoral shampoo starts to work

If you have any questions about stopping your steroid lotion or cream, ask your doctor or pharmacist.

Children and adolescents Nizoral shampoo is not recommended for use in infants and children.

Other medicines and Nizoral shampoo Nizoral shampoo does not normally react with other medicines. However, tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

Pregnancy and breast-feeding Nizoral shampoo can be used if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines Nizoral shampoo is not likely to affect you being able to drive or use any tools or machines.

How to take it

Nizoral shampoo Always use this medicine exactly as your doctor has told you. Nizoral shampoo is for use on your hair or skin only. Check with your doctor or pharmacist if you are not sure.

How often you should use Nizoral shampoo The recommended dose is: For dandruff or dry or greasy scaling of the skin

• Start by using the shampoo twice a week
• You should use it every 3 or 4 days for 2 to 4 weeks
• You should then use the shampoo once every 1 to 2 weeks to stop the symptoms coming back
• Do not use the shampoo more often than your doctor has told you For white to brown patches on the skin
• You should use the shampoo on the white to brown patches of skin once daily for 1 – 5 days
• Do not use the shampoo more often than your doctor has told you

Using Nizoral shampoo

• Wash your hair or infected part of skin with the shampoo
• Leave it on for 3 to 5 minutes
• Rinse thoroughly

If Nizoral shampoo gets in your eyes Gently bathe your eyes in cold water.

Using your normal shampoo

• If you need to wash your hair between treatments, use a normal shampoo
• If your hair is very thick or long, you can wash it with your usual shampoo and then use Nizoral shampoo

If you swallow Nizoral shampoo If you swallow any shampoo, tell your doctor straight away.

If you forget to use Nizoral shampoo

• If you miss a treatment with Nizoral shampoo, you should use it as soon as you remember
• Do not use the shampoo twice to make up for a missed treatment If you have any further questions on the use of this product, ask your doctor or pharmacist.

4 Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Nizoral shampoo and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.

• Allergic reaction, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing. This can affect fewer than 1 in 1000 people
• Severe irritation or reddening of the skin where the shampoo has been used, or other signs of allergy during the first few days of treatment. This can affect fewer than 1 in 100 people
• Peeling or blistering of the skin. This can affect fewer than 1 in 1000 people Tell your doctor or pharmacist if you notice or suspect any of the following side effects: Uncommon side effects (affects fewer than 1 in 100 people)
• Infection of the hair roots
• Increase in production of tears
• Unusual hair loss or thinning
• Dry skin, rash, burning feeling
• Changes in how your hair feels

Rare side effects (affects fewer than 1 in 1000 people)

• Taste impairment
• Irritation of the eyes
• Acne
• Flaking skin The following side effects have been reported, however the precise frequency cannot be identified and therefore how often they occur is classed as unknown
• Hives (also known as nettle rash or urticaria)
• Hair colour changes Reporting of side-effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report

Possible side effects

directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow Card' in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Nizoral shampoo Keep out of the sight and reach of children. Store below 25°C. Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

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.

Contents of the pack and other information

What Nizoral shampoo contains The active substance is ketoconazole. Each gram (g) of shampoo contains 20 milligrams (mg) of ketoconazole (2 % w/w). The other ingredients are sodium lauryl ether sulfate, disodium monolauryl ether sulphosuccinate, coconut fatty acid diethanolamide, laurdimonium hydrolysed animal collagen, macrogol 120 methyl glucose dioleate, sodium chloride, sodium hydroxide, imidurea, concentrated hydrochloric acid, erythrosine sodium (E127) and purified water.

For information in large print, tape, CD or Braille, telephone 01484 848164. This leaflet was last revised in March 2026.

What Nizoral shampoo looks like and contents of the pack Nizoral shampoo comes in a white bottle containing 120 ml of pink shampoo. Marketing Authorisation Holder and Manufacturer: Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK.

9388437 2602 GB