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CORTIFIL 0.05% CREAM

Active substance(s): FLUTICASONE PROPIONATE

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Package leaflet: Information for the user
Cortifil 0.05% cream
Fluticasone propionate
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 or pharmacist.
- This medicine has been prescribed for you only. 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 or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Cortifil is and what it is used for
What you need to know before you use Cortifil
How to use Cortifil
Possible side effects
How to store Cortifil
Contents of the pack and other 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 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.

What you need to know before you use Cortifil

Do not use Cortifil
• If you are allergic to fluticasone or any of the other ingredients of this medicine (listed
in section 6).
• 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 as herpes simplex or chickenpox.
• 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 napkin eruptions.
If you suffer from ulcerated injuries.
If you suffer from infected skin lesions caused by infection with fungi or bacteria.

Warnings and precautions
Talk to your doctor or pharmacist before using 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; 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. You should
wash your skin before changing the 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.
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 relief 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 type of dermatoses in children.
Other medicines and Cortifil
Tell your doctor if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this medicine.

Pregnancy
Cortifil should only be used during pregnancy if the expected benefit to the mother outweighs
the possible risk to the unborn child.
Breast-feeding
It is not known whether fluticasone is secreted in breast milk. Cortifil should only be used
during lactation if the expected benefit to the mother outweighs the possible risk to the child.
Driving and using machines
Fluticasone is not known to negatively affect the ability to drive or operate machinery.
Cortifil contains cetostearyl alcohol, imidurea and propylene glycol.
As this product contains cetostearyl alcohol it may cause local skin reactions (e.g. contact
dermatitis).
This product contains the preservative imidurea. Imidurea breaks down to release a very small
amount of chemical called formaldehyde. Formaldehyde may cause an allergic reaction such
as rash or itching when applied to the skin.
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.
Always use this medicine exactly as your doctor has told you. 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 one to twice daily unless otherwise instructed by your doctor. Ask your doctor as to the
duration of the treatment.
In some diseases (psoriasis, 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 of use:
1
2
3

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 forgotten 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (affecting more than 1 in 100patients but less than 1 in 10 patients):
ƒ Itching (pruritus).
Uncommon side effects (affecting more than 1 in 100 patients but less than 1 in
1000patients):
ƒ local burning sensation
Very rare side effects (affecting more than 1 in 1000 patients but less than 1 in 10,000
patients):
ƒ 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.
ƒ

Hypersensitivity. You should discontinue the use of Cortifil in case signs of
hypersensitivity appear.

ƒ

Hypercortisolism (increase of corticosteroids levels) due to the prolonged use of large
amounts of corticosteroids, or treatment of extensive areas. This is more likely to occur in
infants and children and if occlusive dressings are used.

ƒ

Dilatation of superficial blood vessels, due to prolonged and intensive treatment with
potent corticosteroid preparations.

ƒ

Allergic contact dermatitis (allergic skin reactions)

ƒ

Worsening of signs and symptoms of dermatosis (skin reaction that involves skin
inflammation)

ƒ

Pustular psoriasis caused by the treatment or its withdrawal

ƒ

Atrophic local changes of the skin like thinning, striae, 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):
ƒ Vascular purpura (a group of skin disorders characterized by purplish or browndish red
discoloration )
ƒ

Skin fragility

ƒ

Peri-oral dermatitis (inflammation of the skin around the mouth)

ƒ

Rosacea (flushing and inflammation of the facial skin)

ƒ

Scab

ƒ

Leg ulcer

ƒ

Acne

ƒ

Impaired healing

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via Yellow Card
Scheme (Tel: Freephone 0808 100 3352, http://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 Cortifil

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 package and the tube
after ‘exp’. The expiry date refers to the last day of that month.
Do not store above 30ºC.
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 protect the
environment.
Do not use this medicine if you notice any visible signs of deterioration.
6.

Contents of the pack and other 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
Marketing Authorisation Holder
Laboratorios SALVAT, S.A
C/Gall 30-36. 08950
Esplugues de Llobregat
Barcelona.Spain
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:

Cortoflam 0,05% crème
Flunutrac 0,5 mg/g crema
Cortifil 0,5 mg/g crème
Flunutra 0,5 mg/g creme
Flunutrac 0,5 mg/g crema
Cortifil 0.05% cream

This leaflet was last revised in 08/2013

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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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