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DIODERM 0.1% W/W CREAM

Active substance(s): HYDROCORTISONE

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PACKAGE LEAFLET Information for the user

hydrocortisone
Please read all of this leaflet carefully before you start using this product.
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. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours. If any of the side effects gets serious or if you notice any
side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. WHAT DIODERM IS AND WHAT IT
IS USED FOR
• Dioderm is a medicine for application to the
skin to treat eczema and dermatitis (areas of
dry, red, inflamed, itchy skin).
• Dioderm is suitable for use by adults, the
elderly, children and infants.
• The active ingredient in this product is
hydrocortisone. This is one of a group of
medicines called corticosteroids (which should
not be confused with ‘anabolic steroid’ tablets
or injections misused by some athletes).
• The product works by reducing the redness,
inflammation and itching associated with these
skin problems.
2. BEFORE YOU USE DIODERM
Do not use Dioderm:
• if you are allergic (hypersensitive) to
hydrocortisone or any of the other ingredients
of Dioderm listed in Section 6;
• to treat any other skin problems, especially
skin infections, as it may make them worse;
• on open wounds, ulcers or broken skin.
Take special care when using this product:
• Tell your doctor if at any stage you think any
of the skin area being treated has become
infected. Your doctor may advise you to stop
using Dioderm for a while and start using an
alternative anti-microbial treatment instead.
• Keep the product away from the eyes.
• Although hydrocortisone is generally regarded
as safe, even for long term use, do not use
this product excessively:
– avoid using this product continuously or
frequently for long periods (weeks or months
on end);
– this is especially important if you are using it
over large areas, on the face or under airtight
bandages or dressings;

– f or infants and babies it is very important
not to over-use this product, so treatment
should normally be limited to no longer than
7 days.
Using other medicines
Dioderm is not known to affect, or to be affected
by, any other medicines.
Pregnancy and breast-feeding
It is unclear whether this product is safe for use
during pregnancy and breast-feeding. Animal
birth defects have occurred with similar medicines
containing corticosteroids, so there may be a
very small risk of these problems in humans.
You should therefore not normally use this product
if you are pregnant or breast-feeding, unless
your doctor has recommended you to do so.
Driving and using machinery
Using this product is not known to affect your
ability to drive or use machinery.
Important information about one of the
ingredients of Dioderm
The product contains a small amount of propylene
glycol. This ingredient may cause skin irritation
in a small number of people who are sensitive
to it. If you have been told by your doctor that you
are sensitive to propylene glycol, please talk to
your doctor before using this product.
3. HOW TO USE DIODERM
Use Dioderm only on eczema and dermatitis.
Before you use this tube of cream for the first time,
unscrew the cap, turn it upside down and use the
sharp point in the top of the cap to pierce the tube
membrane.
For adults, the elderly and children:
• Apply Dioderm to the affected areas of skin
twice a day.
• Gently massage the cream into the skin
until it is absorbed.
• Always wash your hands after use.
CP3/15/1 201317

In this leaflet:
1. What Dioderm is and what it is used for
2. Before you use Dioderm
3. How to use Dioderm
4. Possible side effects
5. How to store Dioderm
6. Further information

continued…

For infants and babies (including in the treatment
of nappy rash):
• Follow the above instructions for adults, but
do not use continuously for longer than 7 days
unless advised by a doctor.
If the cream accidentally gets into the eyes
it may cause irritation. If it gets into the eyes,
rinse immediately with plenty of water. If rinsing
one eye, take care to avoid washing product into
the other eye. If irritation persists, tell your doctor
or pharmacist.
If you accidentally swallow some of the
cream, it is unlikely to harm you but you should tell
your doctor or pharmacist.
If you occasionally forget to use Dioderm,
do not worry, just carry on using it when you
remember.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dioderm can cause side
effects, although not everybody gets them:
• In rare cases skin irritation (such as redness or
itching) may occur. If this happens stop using
the product.
• If your eczema or dermatitis seems to get
worse during treatment, you may be allergic
to one of the ingredients in the cream.
• Topical corticosteroids are usually well tolerated
when used in the right amount and for the
correct length of time. However, prolonged,
excessive use, particularly in children or
on skin that is bandaged or wrapped up,
can cause local skin thinning (making the
skin damage easily), striae (stretch marks)
and adrenal suppression (a type of hormone
imbalance that causes generalised effects
on the body). Stopping treatment normally
corrects these side effects.
If you experience any of the above, or if you
experience any other side effect not mentioned
in this leaflet, stop using this product and tell
your doctor or pharmacist.
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 side effects directly (see details below). By
reporting side effects you can help provide more
information on the safety of this medicine.

United Kingdom
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
5. HOW TO STORE DIODERM
• Keep out of the reach and sight of children.
• Do not use Dioderm after the expiry date shown
on the fold of the tube and carton. The expiry
date refers to the last day of that month.
• Do not store above 25°C.
• Always replace the cap tightly after use.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Dioderm contains:
The active ingredient is hydrocortisone
(0.1% w/w).
The other ingredients are citric acid, emulsifying
wax, white soft paraffin, liquid paraffin, propylene
glycol and purified water.
What Dioderm looks like and contents of
the pack
• The product is a smooth, white cream.
• The product is available in tubes containing
30g, fitted with screw caps.
The Marketing Authorisation holder is:
Dermal Laboratories, Tatmore Place, Gosmore,
Hitchin, Hertfordshire, SG4 7QR, UK.
The Manufacturer is: Fleet Laboratories Ltd,
94 Rickmansworth Rd, Watford, Hertfordshire,
WD18 7JJ, UK.
This Patient Information Leaflet was last
revised in January 2015.
To listen to or request a copy of this leaflet in
Braille, large print or audio, please call free of
charge: 0800 198 5000 (UK only).
Please be ready to give the following information:
Dioderm, 00173/0047.
This is a service provided by the Royal National
Institute of Blind People (RNIB).

CP3/15/1 201317

When you can see that the skin condition is
getting better, you can start to apply Dioderm
less often, only once a day or even less.
The frequency of application should be reduced
to the minimum necessary to keep the skin
condition under control.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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