NERISONE FORTE OILY CREAM

Active substance: DIFLUCORTOLONE VALERATE

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Patient information Leaflet

Nerisone® Forte Ointment
Nerisone® Forte Oily Cream
(diflucortolone valerate)

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 gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Nerisone Forte is and what it is used for
2. Before you use Nerisone Forte
3. How to use Nerisone Forte
4. Possible side effects
5. How to store Nerisone Forte
6. Further information.

1. What Nerisone Forte is and what it is used for
Nerisone Forte contains the active ingredient diflucortolone
valerate, 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.
Nerisone Forte is used for the short term treatment of severe
and resistant inflammatory skin conditions such as eczema,
dermatitis and certain types of psoriasis, where there is no
infection and where milder treatments have not been effective.

Nerisone Forte comes in two forms to suit different conditions
of the skin:
Nerisone Forte Ointment is suitable for very dry skin conditions.
It provides a layer of oil to prevent water loss, helping to heal
dryness and scaling.
Nerisone Forte Oily Cream is suitable for skin conditions which
are neither weeping nor very dry. It makes the skin slightly greasy
without retaining heat or fluid.
Your doctor will prescribe the correct product to treat your
specific condition.

2. Before you use Nerisone Forte
Do not use Nerisone Forte if you:
• are allergic (hypersensitive) to any of its ingredients (see
section 6)
• have a skin problem on your face (especially eyes)
• have acne
• have a condition in the genital/anal area (unless recommended
by your doctor)
• suffer from a viral skin condition such as cold sores, herpes,
shingles or chicken pox
• have a skin reaction after a vaccination in the area to be
treated
• have a bacterial or fungal infection for which you are not
receiving treatment
• are pregnant
• are breast-feeding and have a skin condition on your breast
Tell your doctor if you believe any of the above conditions apply
to you.
Nerisone Forte should not be used to treat children under 5 years
old and should not be used to treat nappy rash.
Take special care with Nerisone Forte:
Tell your doctor if:
• you have a skin irritation on the lower legs related to circulatory
problems called stasis dermatitis or leg ulcers as you may
have an increased risk of allergic reaction to Nerisone Forte.
• a new infection occurs during the treatment as your doctor
may also prescribe a medicine to treat the infection.

• you suffer from psoriasis, because Nerisone Forte may make
some types of psoriasis worse.
• you have a skin infection, since this may also worsen.
• you suffer from glaucoma - high pressure in the eye which
may cause loss of vision
Do not apply more Nerisone or use it for longer than your doctor
tells you.
Nerisone Forte must not come into contact with your eyes.
Rinse with cold water if accidental contact occurs.
Do not use Nerisone Forte for more than one or two weeks
due to an increased risk of side effects. If treatment with Nerisone
Forte is necessary for longer than one week your doctor may
need to monitor closely the progression of your treatment. If
further treatment is needed a weaker strength of Nerisone should
be used.
Children
Nerisone Forte must not used in children less than 5 years of
age.
Avoid long term continuous treatment with this medicine. Nerisone
Forte 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 Nerisone Forte by its mother during the
last weeks of pregnancy or when she is breast-feeding the baby.
Using dressings over the treatment area
If your doctor has recommended that the affected areas of your
skin on which Nerisone Forte is used are also covered with a
dressing, you must follow his/her instructions on how often the
dressing needs to be changed and how much Nerisone Forte
you should use. Generally, each dressing should not be left for
more than 24 hours. In some cases doctor may recommend the
dressing is changed every 12 hours. Do not leave the dressing
for longer that you have been told to. Always look carefully at
the skin when you change the dressing. If your skin looks more
inflamed than before or if any pimples containing pus have
appeared, stop using the dressing and contact your doctor as
soon as possible. You should not use dressings on your face.
Taking other medicines
Nerisone Forte has not been shown to interact negatively with
any other medications. As a general precaution you should

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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 Nerisone
Forte 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.
If a doctor prescribes this medicine to you it should not be used
on large areas of the skin.
If you are breast-feeding, Nerisone Forte should not be applied
to your breasts.
Driving and using machines
Nerisone Forte does not impair your ability to drive or operate
machinery.

3. How to use Nerisone Forte
Always use your medication exactly as directed by your doctor.
Wash your hands before and after using Nerisone Forte. Gently
spread a thin layer of Nerisone Forte onto the affected area of
your skin. Do not use large amounts or apply more frequently
then your doctor has advised.
Dosage
Adults:
Typical dosage: apply thinly twice a day. When the condition
improves your doctor may suggest using Nerisone Forte once
a day. It is only intended for short-term use, 1–2 weeks. Nerisone
Forte is very strong and you should not use more than 60 g in
a week. After improvement if further treatment is necessary your
doctor may prescribe a weaker strength of Nerisone.
Children 5 years of age and over and adolescents:
Typical dosage: apply thinly twice a day. When your condition
improves your doctor may suggest using Nerisone Forte once
a day. Use Nerisone Forte with care and for no longer than 1-2
weeks.
Children under 5 years of age:
Nerisone Forte must not be used in children under 5 years of
age.

If accidentally swallowed
If you or someone else swallows Nerisone Forte it is unlikely to
be harmful but contact you doctor or pharmacist if you are at
all concerned.
If you forget to use Nerisone Forte
If you have forgotten to use you 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

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side effects not listed in this leaflet, please tell your doctor
or pharmacist.

5. How to store Nerisone Forte
Keep out of the reach and sight of children.
Do not use after the expiry date on the pack.

6. Further information
What Nerisone Forte contains:

Like all medicine Nerisone Forte can cause side effects, although
not everybody gets them.

Nerisone Forte Ointment and Nerisone Forte Oily cream contain
0.3% of the active ingredient diflucortolone valerate.

Rarely an allergic reaction to Nerisone Forte may occur. If you
feel you have experienced an allergic reaction, stop using this
medicine and inform your doctor or pharmacist immediately.

Inactive ingredients:

Sometimes after using Nerisone Forte, your skin might feel like
it is burning, itching or irritated. Your skin may also look red or
flushed.

Nerisone Forte Oily Cream: white beeswax, liquid paraffin,
white soft paraffin, Dehymuls E and purified water.

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 of the skin around the mouth (peri-oral dermatitis)
• groupings of fine blood vessels becoming prominent under
the skin (telangiectasia)
• increased hair growth (hypertrichosis)
• glaucoma (increased pressure in the eye)

Nerisone Forte Ointment and Nerisone Forte Oily Cream are
available in aluminium tubes containing 15 g.

Side effects are more likely to occur when Nerisone Forte is
applied to large areas (10% or more) of the body and used for
long periods of time (more than 2 weeks), especially if waterproof
dressings are used. The risk of glaucoma is also increased if
Nerisone Forte is applied to the skin around the eyes.
Extremely rarely Nerisone Forte can cause side effects such as
a decrease in the production of natural hormones by the adrenal
glands, which can lead to illness such as Cushing’s syndrome
(hypercorticism).
If any of these side effects gets serious, or if you notice any

Nerisone Forte Ointment: liquid paraffin, white soft paraffin,
Lunacera M (microcrystalline wax) and castor oil (hydrogenated).

What Nerisone Forte looks like and contents of the pack:

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 approved in November 2012.

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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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