Ketoconazole 2% Shampoo
Sandoz Limited Patient Information Leaflet
Ketoconazole 20mg/g shampoo PL 10880/0072 16/05/14
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ketoconazole 20 mg/g shampoo
Ketoconazole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any 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 the 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
Ketoconazole shampoo is a clear and reddish solution for shampooing.
Ketoconazole is used to treat fungal infections caused for example by yeast fungi, on greasy, reddish, inflamed scalp in adults and adolescents.
2 What you need to know before you use Ketoconazole shampoo Do not use Ketoconazole shampoo
- if you are allergic to ketoconazole or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions
Talk to your doctor or pharmacist before using Ketoconazole shampoo.
If cortisone ointments, such as betamethasone or hydrocortisone, are being used
- on the same area,
- for a long period and
- you decide to stop this treatment:
Reduce the cortisone therapy gradually over 2-3 weeks while also using Ketoconazole.
Other medicines and Ketoconazole shampoo
No interactions with other medicines are known.
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Pregnancy and breast-feeding
There are no risks known for the use of ketoconazole shampoo in pregnancy or lactation.
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Ketoconazole shampoo has no influence on the ability to drive or use machines.
3 How to use Ketoconazole shampoo
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is for:
Adults and adolescents:
Fungal infections in the scalp:
Wash the infected area with the shampoo and rinse after 3-5 minutes. Treatment: Twice weekly for 2-4 weeks.
Preventive treatment: Once weekly or once every second week.
If Ketoconazole shampoo gets in your eyes
Gently bathe your eyes in cold water.
If you swallow Ketoconazole shampoo
If you swallow any shampoo, tell your doctor straight away.
If you forget to use Ketoconazole shampoo
- If you miss a treatment with Ketoconazole 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 medicine, 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 Ketoconazole shampoo and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.
Uncommon (may effect up to 1 in 100 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.
Rare (may effect up to 1 in 1,000 people)
• Allergic reaction, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
• Peeling or blistering of the skin.
Tell your doctor or pharmacist if you notice or suspect any of the following side effects:
Uncommon (may effect up to 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 (may effect up to 1 in 1,000 people)
• Taste impairment
• Irritation of the eyes
• Acne
• Flaking skin
Not known (frequency cannot be estimated from the available data):
• 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 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 (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 Ketoconazole shampoo
Keep this medicine out of the sight and reach of children.
Do not store above 25° C.
Do not use Ketoconazole shampoo after the expiry date which is stated on the packaging. 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 substance is ketoconazole. 1 g of shampoo contains 20 mg ketoconazole (2%)
- The other ingredients are sodium lauryl ether sulphate, disodium monolauryl ether sulphosuccinate, macrogol 120 methyl glucose dioleate, macrogol 7 glyceryl cocoate, imidurea, laurdimonium hydroxypropyl hydrolysed animal collagen, coconut fatty acid diethanolamide, sodium hydroxide, sodium chloride, Ponceau 4 R (E124), hydrochloric acid, concentrated, purified water.
What Ketoconazole shampoo looks like and contents of the pack
Ketoconazole shampoo is a clear, reddish solution.
Pack sizes: 60 ml and 120 ml.
Marketing Authorisation Holder
Hexal AG Industriestrasse 25 83607 Holzkirchen Germany
Manufacturer
Next Pharma Pharbil Waltrop GmbH Im Wirrigen 25 45731 Waltrop Germany
This leaflet was lastrevised in 05/2014.
PIL.10880.0072.0045d V014: Update SPC&PIL in line with P-RMS FAR JG