Ketoconazole 2% Shampoo
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Ketoconazole 20mg/g shampoo PL 10880/0072 02/04/14
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.
In case of hair loss during treatment with Ketoconazole shampoo, you should contact your doctor.
Avoid contact with the eyes. In case of contact with the eyes, rinse with water.
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.
In case of accidental oral intake
If you swallow small amounts of the shampoo it will usually not cause any problems. However, for security reasons, you should contact your doctor, pharmacist or poisoning centre in case you have inadvertently swallowed some of the shampoo.
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.
Uncommon (may affect up to 1 in 100people):
• Taste impairment
• Inflammation of the hair roots
• Irritation of the eyes, increase in production of tears
• Unusual hair loss or thinning, changes in how your hair feels
• Skin problems, acne, rash or itchy rash with signs like irritation or reddening of the skin, burning feeling, dry skin, flaking skin, allergic skin reaction after contact with Ketoconazole shampoo
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
02/04/14
This leaflet was lastrevised in 04/2014.
PIL.10880.0072.004.1A V012: Update SPC&PIL in line with P-RMS FAR + updates JH