Final Package Leaflet: Information for the User Ketoconazole 2% Shampoo

Ketoconazole

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Ketoconazole Shampoo is and what it is used for

2.    What you need to know before you use Ketoconazole Shampoo

3.    How to use Ketoconazole Shampoo

4.    Possible side effects

5.    How to store Ketoconazole Shampoo

6.    Contents of the pack and other information

1. What Ketoconazole Shampoo is and what it is used for

Everyone has a type of fungus (yeast) called Malassezia on their skin. It is natural and normally harmless. However, people with dandruff and a greasy skin condition called seborrhoeic dermatitis appear to have more Malassezia than usual. Ketoconazole is a type of antifungal medicine, which works by destroying Malassezia (and other fungi).

It is used to treat and prevent

•    dandruff

•    dry or greasy scaling of the scalp and other parts of the body called ‘seborrhoeic dermatitis’

•    another fungal infection called ‘tinea versicolor’ or ’pityriasis versicolor’ in which white to brown patches develop on parts of the body after being in the sun.

2. What you need to know before you use Ketoconazole Shampoo

Do not use Ketoconazole Shampoo if you:

•    are allergic to ketoconazole, other antifungals or to any of the other ingredients in this shampoo (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using this

medicine 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 Ketoconazole Shampoo treatment.

•    This will stop your condition flaring up while Ketoconazole Shampoo starts to work.

If you have any questions about stopping your steroid

lotion or cream, ask your doctor or pharmacist.

Other medicines and Ketoconazole Shampoo

Ketoconazole Shampoo does not normally react with other medicines. However, please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines you buy without a prescription and herbal medicines.

Pregnancy and breast-feeding

Ketoconazole Shampoo can be used if you are pregnant or breast-feeding.

However, ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Ketoconazole Shampoo is not likely to affect you being able to drive or use any tools or machines.

3. How to use Ketoconazole Shampoo

Always use Ketoconazole Shampoo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Ketoconazole Shampoo is for use in adolescents and adults and is not recommended for use in infants and children.

Ketoconazole Shampoo is for external use only and should

not be tasted or swallowed.

Shake the bottle well. Apply the shampoo onto the hair or infected areas of skin. Leave it on for 3 to 5 minutes, then rinse thoroughly.

Take care not to get Ketoconazole Shampoo in your eyes. If it does, bathe them gently with cold water.

How much to use and for how long

For dandruff 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 a day for up to 5 days.

•    If the white to brown patched become more noticeable when you have been in the sun:

•    You should use the shampoo once a day for 3 days before you next expose your skin to the sun.

•    Do not use the shampoo more often that your doctor has told you.

Using 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 Ketoconazole Shampoo.

If you swallow the shampoo by mistake

If you accidentally swallow Ketoconazole Shampoo, contact a doctor, pharmacist or your nearest casualty department for advice at once.

If you forget to use Ketoconazole Shampoo

Do not worry if you forget to use the shampoo. Continue with it as soon as you remember.

Do not us 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 Ketoconazole Shampoo can cause side effects, although not everybody gets them.

Stop using Ketoconazole 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

•    Some people with permanently waved or “permed” hair have reported a loss of curl.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine

5. How to store

Always keep Ketoconazole Shampoo in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Keep the shampoo in its original container at normal room temperature. (Do not store above 25°C.)

Do not use after the expiry date shown on the bottle or carton. 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.

6. Contents of the pack and other information

What Ketoconazole Shampoo contains

The active ingredient (which makes the shampoo work) is Ketoconazole. Each gram of shampoo contains 20 milligrams of Ketoconazole.

The shampoo also contains: sodium laureth sulphate, disodium laureth sulphosuccinate, PEG-120 methyl glucose dioleate, PEG-7-glycerol cocoate, imidurea, lauryldimonium hydroxypropyl hydrolysed collagen, cocamide DEA, sodium hydrocide, sodium chloride, erythrosine (E127), concentrated hydrochloric acid and purified water.

Pack sizes

Ketoconazole Shampoo is available from your pharmacist in bottles of 60, 80, 100 or 120ml*.

Marketing authorisation holder and manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, UK. Leaflet last revised: March 2014 © Dr Reddy’s Laboratories (UK) Ltd

Manufacturer: NextParma, Pharbil Waltrop GmbH, Im Wirrigen 25, D-45731 Waltrop, Germany