POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00551/0012 .
Fludroxycortide 0.0125% w/w Cream
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fludroxycortide 0.0125% w/w Cream
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What Fludroxycortide 0.0125% w/w Cream is and what it is used for
2. What you need to know before you use Fludroxycortide 0.0125% w/w Cream
3. How to use Fludroxycortide 0.0125% w/w Cream
4. Possible side effects
5. How to store Fludroxycortide 0.0125% w/w Cream
6. Contents of the pack and other information
1. WHAT FLUDROXYCORTIDE 0.0125% W/W CREAM IS AND WHAT IT IS USED FOR
Fludroxycortide 0.0125% w/w Cream is a white cream for application to the skin. Fludroxycortide 0.0125% w/w Cream belongs to a group of medicines called topical steroids and is used to treat skin conditions such as eczema and dermatitis of all types, especially when the skin is moist or weeping.
Fludroxycortide 0.0125% w/w Cream can be used in adults and children.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUDROXYCORTIDE 0.0125% W/W CREAM
Do not use Fludroxycortide 0.0125% w/w Cream
Do not use Fludroxycortide 0.0125% w/w Cream if you are allergic to fludroxycortide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Other medicines and Fludroxycortide 0.0125% w/w Cream
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
Do not use Fludroxycortide 0.0125% w/w Cream if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Important information about some of the ingredients of Fludroxycortide 0.0125% w/w Cream Fludroxycortide 0.0125% w/w Cream contains cetyl alcohol and propylene glycol
Fludroxycortide 0.0125% w/w Cream contains cetyl alcohol which may cause local skin reactions such as contact dermatitis and propylene glycol which may cause skin irritation.
3. HOW TO USE FLUDROXYCORTIDE 0.0125% W/W CREAM
Always use this medicine exactly as your doctor has told you. Check the label for how to use your medicine and how often to use it. Only put the cream on the parts of your skin your doctor wants to treat. Check with your doctor or pharmacist if you are not sure.
Only use Fludroxycortide 0.0125% w/w Cream on your skin. Do not put it in your mouth or eyes. Apply the cream gently to the affected area of skin two or three times each day. If you are elderly your skin may be thin so you will need to apply the cream sparingly.
If your doctor has told you to cover the skin tightly where you are using Fludroxycortide 0.0125% w/w Cream, you should only have to cover a small area.
If you forget to use Fludroxycortide 0.0125% w/w Cream
If you forget to use Fludroxycortide 0.0125% w/w Cream do not worry, just put on the next application when it is due.
If accidently swallowed, contact your nearest hospital casualty department or tell your doctor immediately. 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. Some patients may have one or more of the following side effects in the area where they apply Fludroxycortide 0.0125% w/w Cream:
The amount of sugar in your blood and urine may change or some of your hormones may be affected causing weight gain, menstrual irregularities and hair growth. These effects are very rare.
Some steroids are known to affect certain hormones. If your doctor thinks you need to be treated for longer periods of time, they may arrange for you to have hormone tests. If the cream is affecting your hormones, your doctor may tell you to stop using it. Then your hormones should return to normal.
Children treated with topical steroids have rarely had high fluid pressure in their skulls. This has caused headaches and swelling.
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card Scheme in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FLUDROXYCORTIDE 0.0125% W/W CREAM
Keep this medicine out of the sight and reach of children. Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the tube crimp and on the carton after EXP. 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 Fludroxycortide 0.0125% w/w Cream contains
What Fludroxycortide 0.0125% w/w Cream looks like and contents of the pack
Fludroxycortide 0.0125% w/w Cream is white and comes in a 60g aluminium tube.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
This leaflet was last revised in March 2019.
14D Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk, NR13 6LH
+44 (0)1603 722480
+44 (0)2037 694160
+44 (0)1603 722480