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ULTRALANUM CREAM PLAIN

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Ultralanum® Ointment Plain

(fluocortolone and fluocortolone hexanoate)

Ultralanum® Cream Plain

(fluocortolone pivilate and fluocortolone hexanoate)
Read all of this leaflet carefully before you start using this
medicine.
• 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 get serious or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Ultralanum is and what it is used for
2. Before you use Ultralanum
3. How to use Ultralanum
4. Possible side effects
5. How to store Ultralanum
6. Further information
1. What Ultralanum is and what it is used for
Ultralanum contains the active ingredient fluocortolone, which
is a type of medicine known as a topical corticosteroid (or
steroid).
“Topical” means applied to the skin. Topical corticosteroids
are used to reduce the redness and itchiness caused by
certain skin problems.
Ultralanum can be used to treat
• Eczema and dermatitis of all types, including atopic eczema,
photodermatitis, irritant and allergic dermatitis and prurigo
nodularis
• Insect bite reactions
• Rashes known as lichen planus and lichen simplex
• Psoriasis
• Other inflammatory skin conditions

Ultralanum comes in two forms to suit different conditions of
the skin:
Ultralanum Ointment Plain is suitable for skin conditions
which are neither weeping nor very dry. It makes the skin
slightly greasy without retaining heat or fluid.
Ultralanum Cream Plain is suitable for weeping skin
conditions.
It allows secretions from the skin to drain away. It is also
suitable for moist, exposed and hairy areas of the body.
Your doctor will prescribe the correct product to treat your
specific condition.
2. Before you use Ultralanum
Do not use Ultralanum if you:
• are allergic (hypersensitive) to any of the ingredients of this
medicine (see section 6)
• have an inflammatory skin disease causing facial redness
called rosacea
• suffer from inflammation around the mouth (perioral
dermatitis)
• suffer from an eye disease
• have acne
• suffer from itching in the genital/anal area (unless
recommended by your doctor)
• suffer from a viral skin condition such as cold sores, herpes,
shingles, chickenpox
• have skin areas affected by syphilis or tuberculosis
• have a bacterial or fungal infection for which you are not
receiving treatment
• are pregnant or breast-feeding, unless advised otherwise
by your doctor
Tell your doctor if you believe any of the above conditions
apply to you.
Ultralanum should not be used to treat a nappy rash.
Take special care with Ultralanum and tell your doctor if you:
• suffer from psoriasis, because Ultralanum may make some
types of psoriasis worse.
• have a skin infection, since this may also worsen.
Ultralanum must not come into contact with your eyes. Rinse
with cold water if accidental contact occurs.
Avoid using Ultralanum for a long time because it increases
the risk of side-effects. This is particularly important for infants
and small children because continuous treatment for long
periods with Ultralanum may reduce the activity of the adrenal

glands causing a lower resistance to disease. Similar effects
may occur in a baby after extensive use of Ultralanum by its
mother during the last weeks of pregnancy or when she is
breast-feeding the baby.
Using dressings over the treatment area
You should only use dressings with Ultralanum if you are an adult
(over 18 years of age) and have been advised to do so by your
doctor. Your doctor will give you specific instructions for use.
Do not leave the dressing on for more than advised by your
doctor. If a new infection occurs during the treatment stop
using the dressing. If the skin looks more inflamed than before
or if any pimples containing pus have appeared stop using the
dressing and inform your doctor. You should not use dressings
over the area of skin being treated if this is on your face.
Taking other medicines
Ultralanum has not been shown to interact negatively with
any other medicines. Always tell your doctor or pharmacist
if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Pregnancy and breast-feeding
Even at the usual dose, the possibility of a very small risk to
the development of a baby in pregnant women treated with
Ultralanum cannot be entirely ruled out. Therefore, this
medicine should not be used if you are pregnant, trying to
become pregnant or are breast-feeding unless considered
essential by your doctor.
Driving and using machines
Ultralanum does not impair your ability to drive or operate
machinery.
Important information about some of the ingredients of
Ultralanum
Ultralanum Cream contains stearyl alcohol and may cause local
skin reactions (e.g. contact dermatitis). It also contains methyl
parahydroxybenzoate (E218) and propyl parahydroxybenzoate
(E216) which may cause allergic reactions (possibly delayed).
Ultralanum Ointment contains lanolin and may cause local
skin reactions (e.g. contact dermatitis).
3. How to use Ultralanum
It is important to use Ultralanum exactly as your doctor tells you.
Wash your hands before and after using Ultralanum.
Gently spread a thin layer of Ultralanum onto the affected
area of your skin. Do not use large amounts or apply more
frequently then your doctor has advised.


Patient information Leaflet

Dosage
Adults, including the elderly:
Your doctor will tell you how much to use and when. This will
usually be two or three times a day. When your condition
improves your doctor may suggest using Ultralanum only
once a day. If used on your face Ultralanum should not be
used for more than 5 days and should never be covered with
dressings.
Infants and children:
Your doctor will tell you how much to apply and when. Do not
use for longer than 5 days. Do not cover the treated area with
a dressing.
If accidentally swallowed
If you or someone else swallows Ultralanum contact you
doctor or pharmacist immediately.
If you forget to use Ultralanum
If you have forgotten to use your medicine, do not make up for
it by using extra. When you remember, use the next prescribed
dose and continue with your treatment schedule.
4. Possible side effects
Side effects may occur when Ultralanum is applied to large
areas of the body and used for long periods of time (more
than 4 weeks), especially if waterproof dressings are used.
Occasionally an allergic reaction to Ultralanum may occur,
resulting in symptoms such as rash, pain and swelling. If you
feel you have experienced an allergic reaction, stop using this
medicine and inform your doctor or pharmacist immediately.
If you experience the following symptoms while you are using
this medicine contact your doctor:
• thinning of the skin on or around the treated area
• acne-like spots
• stretch marks (striae)
• inflammation around the mouth (perioral dermatitis)
• groupings of fine blood vessels becoming prominent under
the skin (telangiectasia)
• increased hair growth (hypertichosis)
• secondary skin infection or skin irritation - if this occurs you
doctor will prescribe an additional medicine to treat it.
Extremely rarely Ultralanum can cause a decrease in the
production of natural hormones by the adrenal glands.
Symptoms include tiredness, weakness, dizziness, weight
loss and stomach ache.

If any of these side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. How to store Ultralanum
Keep out of the reach and sight of children.
Do not use after the expiry date on the pack.
Do not store above 25° C.
6. Further information
What Ultralanum contains:
Ultralanum Ointment Plain contains 0.25% fluocortolone and
0.25% fluocortolone hexanoate as the active ingredients.
It also contains bleached wax, lanolin, heavy liquid paraffin
white soft paraffin, Amphocerin KS, Dehymuls E, purified
water and citrus rose perfume oil.
Ultralanum Cream Plain contains 0.25% fluocortolone pivalate
and 0.25% fluocortolone hexanoate as the active ingredients.
It also contains polyoxyl-40-stearate [E431], stearyl alcohol,
heavy liquid paraffin, white soft paraffin, disodium edetate,
carbomer, sodium hydroxide, methyl parahydroxybenzoate
(E218), propyl parahydroxybenzoate (E216), purified water
and citrus rose perfume oil.
What Ultralanum looks like and contents of the pack:
Ultralanum is available in aluminium tubes containing 50 g of
Ultralanum Ointment Plain or 50 g Ultralanum Cream Plain.
Marketing authorisation holder:
Meadow Laboratories Limited
Unit 13, Falcon Business Centre
Ashton Road
Romford
Essex RM3 8UR
United Kingdom
Manufacturer:
Intendis Manufacturing SpA
Via E. Schering 21
20090 Segrate (MI)
Italy
This leaflet was last revised in February 2012
Great Britain 81037434

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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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