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MILDISON LIPOCREAM CREAM

Active substance(s): HYDROCORTISONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Mildison® Lipocream 1% w/w cream

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Hydrocortisone
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, pharmacist or nurse.
• This medicine has been prescribed for you. 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Mildison Lipocream is and what it is used for
2. What you need to know before you use Mildison Lipocream
3. How to use Mildison Lipocream
4. Possible side effects
5. How to store Mildison Lipocream
6. Contents of the pack and other information

1. What Mildison Lipocream is and what it is used for
Mildison Lipocream contains the active substance hydrocortisone, which
belongs to the group of mildly potent corticosteroids. These medicines are
used to reduce symptoms of inflammation such as itching and redness or
flakiness of the skin which may occur in certain skin disorders.

Mildison Lipocream is indicated in adults, children and infants. It is used to
treat a variety of skin conditions such as eczema and dermatitis (itching) of
all types including atopic (childhood) eczema, photodermatitis (a dermatitis
caused by exposure to light), otitis externa (inflammation of the ear canal),
dermatitis caused by skin irritants and allergies, intertrigo (inflammation
of skin folds), prurigo nodularis (a skin change associated with a nervous
condition), seborrhoeic dermatitis (eczema of areas of greasy skin) and
insect bite reactions. In general, corticosteroids do not remove the cause of
the symptoms.
2. What you need to know before you use Mildison Lipocream
Do not use Mildison Lipocream:
• if you are allergic to hydrocortisone or any of the other ingredients of this
medicine (listed in section 6).
• if your skin disorder is caused by a bacterial, viral or fungal infection.
Mildison Lipocream may worsen or hide these disorders. Your doctor will
check these.
• if you have wounds or scaly skin
• if you have skin problems due to syphilis (a sexually transmitted disease)
or skin lesions associated with tuberculosis appearing as jelly like nodules
or ulcerative nodules.
• if the skin around your mouth is inflamed. It might be the result of previous
treatment with corticosteroids.
• if you have (pubertal) spots
• if you have redness of the facial skin
Warnings and precautions
Talk to your doctor before using Mildison Lipocream if it was
prescribed to:
• treat facial or thin skin as these areas are particularly sensitive to
corticosteroids. You should not apply to your eyes or your eyelids.
• treat your child (see further information below).

Children and adolescents
Long term treatment of children should be avoided where possible. Treatment
should be limited to seven days if possible. Your doctor will advise on duration
of treatment for your child.
Other medicines and Mildison Lipocream
Tell your doctor or pharmacist if you are using, have recently used or might
use any other medicines.

Pregnancy and breast-feeding
You should not use Mildison Lipocream if you are pregnant or breast-feeding
unless clearly necessary.
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
using this medicine.
Driving and using machines
It is not likely that Mildison Lipocream affects your ability to drive or use
machines.

Mildison Lipocream contains cetostearyl alcohol and propyl
parahydroxybenzoate (E216)
Mildison Lipocream contains cetostearyl alcohol that may cause local skin
reactions and propyl parahydroxybenzoate (E216) that may cause allergic
reactions (possibly delayed).
3. How to use Mildison Lipocream
Always use this medicine exactly as your doctor has told you. Check with
your doctor, pharmacist or nurse if you are not sure.

Mildison Lipocream
Great Britain
LFT 118 x 298 mm
LFT_140
VTB 5578
Eq. to: N/A

06.07.2015
hb

Black

The recommended dose is a little Mildison Lipocream 2 or 3 times daily.

This medicine is for cutaneous use. Apply a thin layer of Mildison Lipocream
to the affected skin. Gently massage the cream into the affected area.

If you use more Mildison Lipocream than you should
If you have used too much Mildison Lipocream the side effects as mentioned
in section 4 “Possible side effects” can occur. Contact your doctor, pharmacist
or nurse immediately.
If you forget to use Mildison Lipocream
Do not use a double dose to make up for a forgotten dose.

If you stop using Mildison Lipocream
You should always consult your doctor, if you think of stopping treatment.

If you have any further questions on the use of this product, ask your doctor,
pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Mildison Lipocream may cause the following side effects:

Not known (frequency cannot be estimated from the available data)
• Redness of the skin, rash/inflammation, bruising, stretch marks and skin
thinning.
• Facial spots, redness of the skin around the mouth.
• Worsening of the skin condition after treatment has stopped.
• Discolouration of skin.
• Skin irritation.

If the cream is used for a long time it may affect the working of your adrenal
glands, symptoms of which may include an increase in weight, puffiness
around the face, muscle weakness, dizziness (particularly on standing),
excessive hair growth or hair loss. Your doctor should monitor you for any
signs or symptoms.

As with other creams of this kind, this is more likely in infants and children or
if the skin is covered by bandages or nappies.

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 via the Yellow Card Scheme at:
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 Mildison Lipocream
Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the tube
(EXP). The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original packaging.

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 to protect the environment.
6. Contents of the pack and other information
What Mildison Lipocream contains
• The active substance is hydrocortisone
• The other ingredients are cetostearyl alcohol, macrogol (25)
cetostearylether, liquid paraffin, white soft paraffin, benzyl alcohol, propyl
parahydroxybenzoate (E216), anhydrous citric acid, anhydrous sodium
citrate and purified water.
What Mildison Lipocream looks like and contents of the pack
Mildison Lipocream is a white cream and is available in 10 g, 15 g, 30 g or
100 g aluminium tubes with plastic screw caps. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Astellas Pharma Ltd.,
2000 Hillswood Drive,
Chertsey,
Surrey, KT16 0RS,
UK.
Manufacturer
Temmler Italia S.R.L.
Via delle Industrie 2
20061 Carugate (MI)
Italy

This leaflet was last revised in July 2015.

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© 1996 Astellas Pharma Ltd.

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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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