CORTIFIL 0.05% CREAM

Active substance: FLUTICASONE PROPIONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Cortifil 0.05% cream
Fluticasone propionate
Read all 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 Cortifil is and what it is used for
2. Before you use Cortifil
3. How to use Cortifil
4. Possible side effects
5. How to store Cortifil
6. Further information
1.

WHAT Cortifil IS AND WHAT IT IS USED FOR

Cortifil 0.05% cream is one of a group of medicines known as corticosteroids, which have a
high anti-inflammatory effect when used on the skin (topically).
Fluticasone is a potent corticosteroid that is applied to the skin to treat a wide variety of
inflammatory skin diseases. It is used for the relief of inflamed skin, redness and itching in
several skin problems not caused by germs and responsive to corticosteroids.
2.

BEFORE YOU USE Cortifil

Do not use Cortifil
• if you are allergic (hypersensitive) to fluticasone or any of the other ingredients of
Cortifil.
• if you suffer from rosacea (flushing and inflammation of the facial skin), acne vulgaris
or perioral dermatitis (inflammatory rash around the mouth).
• if you have infections of the skin with viruses such as herpes simplex or chickenpox or
with bacteria, fungi or yeasts.
• if you suffer from perianal or genital pruritus (itching around the back passage and
genitals).
• If you suffer from ulcers in the skin, atrophy (thinning of skin) or fragile skin vessels.
• If you suffer from ichtyosis (skin disorders characterized by dryness and fishskin-like
scaling on the skin).
• If you suffer from juvenile dermatosis (any skin diseases characterized by inflammation)
or dermatosis in infants under 1 year of age, including dermatitis (inflammation of the
skin) and nappy rash.
• If you suffer from ulcerated injuries.
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Take special care with Cortifil
• If you are pregnant or think you may be pregnant or if you are breast-feeding (see
section Pregnancy and breast-feeding).
• If you use this medicine on large areas of the body for prolonged periods of time,
especially when treating children, since it may increase the absorption of the product
and the risk of toxicity.
• If you use it on the face, since it may cause atrophic changes like thinning skin. It is
important that you do not let the cream get in your eyes.
• If you use it in covered parts of the body. Do not use this product under occlusive
dressing (a dressing or sticking plaster that seals the skin from the air); the affected zone
has to be in contact with the air and not covered by dressing, tight clothes or similar. In
infants, a nappy can act as an occlusive dressing.
• If your doctor has prescribed you the cream for psoriasis. You should visit your doctor
regularly to review your progress at periodic intervals.
• If you are using other products (including cosmetics) on the affected skin areas, as they
can have a negative effect on the product’s activity. Check with your doctor if you are
not sure.
Use in children:
Do not use the product in children under 1 year.
Tell the doctor if the symptoms do not improve within one or two weeks of starting treatment.
Once the skin condition has improved (usually within one to two weeks), you should apply
the cream less frequently. Using the cream daily for more than 4 weeks is not recommended.
Cortifil should only be used in children to relieve inflamed skin, redness and itching caused
by atopic dermatitis under supervision of a medical specialist. You should consult a
dermatologist before using Cortifil in other types of dermatoses in children.
Taking/Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Driving and using machines
Fluticasone is not known to negatively affect the ability to drive or operate machinery.
Important information about some of the ingredients of Cortifil
As this product contains cetostearyl alcohol it may cause local skin reactions (e.g. contact
dermatitis).
As this product contains propylene glycol, it may cause skin irritation.
3.

HOW TO USE Cortifil

The doctor will prescribe an appropriate dosage for you.

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Always use Cortifil exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
For adults and children aged 1 year and over, apply a thin film of Cortifil to the affected skin
areas once to twice daily unless otherwise instructed by your doctor. Ask your doctor as to the
duration of the treatment.
In some diseases (such as psoriasis and atopic dermatitis), it is not advisable to stop the
treatment suddenly; you have to reduce progressively the number of applications. Follow
exactly the instructions your doctor gave to you.
The doctor will tell you an appropiate dosage for you if the symptoms appear again after a
recovery. The usual dosage is one application daily, 2 days per week.
It is not advisable to stop the treatment in some skin diseases like psoriasis or atopic
dermatitis. You should check with your doctor the best way to finalize it.
Instructions for use:
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Wash your hands
Apply a thin film of the cream and rub gently until it has all disappeared
Wash your hands unless the cream is used to treat your hands.

If your skin problems do not improve within one to two weeks of starting treatment, tell your
doctor.
If you use more Cortifil than you should
If you used more Cortifil than you should, especially in children, wash the affected areas of
skin carefully to remove all the cream and contact your doctor or pharmacist. In case of
accidental ingestion contact your doctor or pharmacist.
If you forget to use Cortifil
Do not use a double dose to make up for a missed one.
If you forget to apply your cream, apply the correct dose when you remember or if it is close
to your next application then wait until this time.
If you stop using Cortifil
Do not stop using the drug even if you feel healthy unless so advised by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cortifil can cause side effects, although not everybody gets them.
Common side effects (affecting more than 1 in 100 patients but less than 1 in 10 patients):
Itching (pruritus).

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Uncommon side effects (affecting more than 1 in 100 patients but less than 1 in 1000
patients):
Local burning sensation.
Very rare side effects (affecting more than 1 in 1000 patients but less than 1 in 10,000
patients):
Secondary infections (an infection that occurs during or following treatment of another
already existing infection), especially when occlusive dressings are used or when skin
folds are involved.
Hypersensitivity.
Hypercortisolism (increase of corticosteroids levels) due to the prolonged use of large
amounts of corticosteroids, or treatment of extensive areas. This is also known as
Cushing’s syndrome. Symptoms include weight gain, round face and weakness.
Widening of blood vessels near the skin, due to prolonged and intensive treatment. This
may cause flushing of the skin.
Allergic contact dermatitis (allergic skin reactions).
Worsening of signs and symptoms of dermatosis (skin reaction that involves skin
inflammation).
Pustular psoriasis caused by the treatment or its withdrawal.
Atrophic local changes of the skin like thinning, striae (stretch marks), hypertrichosis
(excessive hair growth in a defined area) and hypopigmentation (skin discolouration)
caused by prolonged and intensive treatment with potent corticosteroid preparations.
Not known (frequency cannot be estimated by available data):
Vascular purpura (a group of skin disorders characterized by purplish or brownish red
discoloration).
Skin fragility.
Peri-oral dermatitis (inflammation of the skin around the mouth).
Rosacea (flushing and inflammation of the facial skin).
Scab.
Leg ulcer.
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.
5.

HOW TO STORE Cortifil

Keep out of the reach and sight of children.
Do not use Cortifil after the expiry date which is stated on the package and the tube after
‘exp’. The expiry date refers to the last day of that month.
Do not store above 30ºC.

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Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose medicines no longer required. These measures will help to protect the
environment.

6.

FURTHER INFORMATION

What Cortifil contains
The active substance is fluticasone propionate. Each 100 g of cream contains 0.05 g of
Fluticasone propionate.
The other ingredients are macrogol cetostearyl ether, cetostearyl alcohol, isopropyl myristate,
paraffinum liquidum, purified water, propylene glycol, citric acid monohydrate, disodium
phosphate anhydrous, imidazolinyl urea.
What Cortifil looks like and contents of the pack
Cortifil is a white, viscous cream contained in a 30 g aluminium tube with a screw cap.
Marketing Authorisation Holder and Manufacturer
Laboratorios SALVAT, S.A.
C/ Gall, 30-36.
08950 Esplugues de Llobregat.
Barcelona (Spain)
This medicinal product is authorised in the Member States of the EEA under the
following names:
France:
Italy:
The Netherlands:
Portugal:
Spain:
United Kingdom:

Cortifil 0,05% crème
Cortifil crema 0,05% 30G
Cortifil 0,5 mg/g crème
Cortifil 0,05% creme
Cortifil 0,05% crema
Cortifil 0.05% cream

This leaflet was last approved in September 2009

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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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