FLUNUTRAC 0.05 % Cream

Зміст інструкції

1. Flunutrac 0.05% cream
   1. What is Flunutrac and what is it used for
   2. What you need to know before using Flunutrac
   3. How to use Flunutrac
   4. Possible side effects
   5. How to store Flunutrac
   6. Contents of the pack and other information

Flunutrac 0.05% cream

Fluticasone propionate

Before using this medicine, read this leaflet carefully, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Never give it to others, even if their symptoms are the same as yours because it could be dangerous.
• If you notice any side effects, inform your doctor or pharmacist. This also applies to any possible side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

• 1. What is Flunutrac and what it is used for
• 2. What you need to know before using Flunutrac
• 3. How to use Flunutrac
• 4. Possible side effects
• 5. How to store Flunutrac
• 6. Contents of the pack and other information

1. What is Flunutrac and what is it used for

Flunutrac cream 0.05% belongs to the group of medicines known as corticosteroids which, when
used locally, are characterized by a high anti-inflammatory power.
Fluticasone is a potent corticosteroid that is applied to the skin to treat a wide
range of inflammatory skin conditions. It is used to relieve inflammation, redness and itching associated with various non-infectious skin conditions and sensitive to
corticosteroids.

2. What you need to know before using Flunutrac

Do not use Flunutrac

• If you are allergic (hypersensitive) to fluticasone or any of the excipients of Flunutrac (listed in section 6).
• If you suffer from rosacea (redness and inflammation of the facial skin), common acne or perioral dermatitis (redness from inflammation around the mouth).
• If you suffer from viral skin infections (e.g. herpes simplex or varicella).
• If you suffer from genital or perianal itching (itching near the anus and genitals).
• If you suffer from skin ulcers, atrophy (thinning of the skin) or fragility of the skin vessels.
• If you suffer from ichthyosis (disorders characterized by dryness and scaling of the skin).
• If you suffer from juvenile dermatosis (all skin conditions characterized by inflammation) or dermatosis in children under 1 year of age, including dermatitis (skin inflammation) and diaper rash.
• If you suffer from ulcerative lesions.
• If you suffer from skin lesions infected by fungal or bacterial infections.

Warnings and precautions
Talk to your doctor or pharmacist before using Flunutrac:

• If you are pregnant or think you may be, if you are breastfeeding (see section Pregnancy and breastfeeding).
• If you use this medicine on large areas of the body for prolonged periods, particularly in the treatment of children, as this may increase the absorption of the product and the risk of toxicity.
• If you use the product on the face, as this may induce atrophic changes (e.g. thinning of the skin). It is important to avoid getting the cream into your eyes.
• If you use the medicine on parts of the body covered. Do not use the product with occlusive dressings; the treated area must be exposed to the air and must not be covered by dressings, tight clothing or similar. In newborns, the diaper can act as an occlusive dressing. You must wash the skin before changing the dressing.
• If the doctor has prescribed a cream for the treatment of psoriasis. At periodic intervals, consult your attending physician who will assess the progress of your condition.
• If you are using other products (including cosmetics) on the affected skin areas, as these could negatively affect the activity of the medicine. If you have any doubts, consult your doctor.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children:
Do not use the product in children under 1 year of age.
If symptoms do not improve after one or two weeks of treatment, inform your doctor.
When you notice an improvement in skin condition (usually within one to two weeks), reduce the frequency of applications. Continuous daily treatment for more than 4 weeks is not recommended.
Flunutrac should be used in children only to relieve skin inflammation, redness and itching from atopic dermatitis and under the supervision of a specialist doctor.
Before using Flunutrac in other types of childhood dermatoses, consult a dermatologist.

Other medicines and Flunutrac
Tell your doctor if you are taking or have recently taken any other medicines, including those without a prescription.

Pregnancy and breastfeeding and fertility
Ask your doctor for advice before taking this medicine if you are pregnant or breastfeeding, if you think you may be pregnant or if you are planning a pregnancy.
Pregnancy
Flunutrac should be used during pregnancy only if the expected benefits for the mother outweigh the possible risks to the fetus.
Breastfeeding
It is not known whether fluticasone is excreted in breast milk. Flunutrac should be used during breastfeeding only if the expected benefits for the mother outweigh the possible risks to the fetus.

Driving and operating machinery
There is no evidence that fluticasone negatively affects the ability to drive vehicles or operate machinery.

Flunutrac contains cetostearyl alcohol, imidurea and propylene glycol
This product contains cetostearyl alcohol which may induce local skin reactions (e.g. contact dermatitis).
This product contains the preservative imidurea, which decomposes and releases a very small amount of a chemical called formaldehyde. When applied to the skin, formaldehyde can cause allergic reactions such as skin reactions or itching.
This product contains propylene glycol, which may irritate the skin.

3. How to use Flunutrac

Your doctor will prescribe the appropriate dosage for your condition.
When using Flunutrac, always follow your doctor's instructions. If you have any doubts, consult your doctor or the
pharmacist.
For adults and children from one year of age, apply a thin film of Flunutrac to the affected
skin areas one or two times a day, unless otherwise indicated by your doctor. Ask your doctor
for information on the duration of treatment.
In some conditions (psoriasis, atopic dermatitis, etc.), abrupt discontinuation of
treatment is not recommended as the number of applications should be reduced gradually.
Follow your doctor's instructions carefully.
In case of relapse and recurrence of symptoms, your doctor will indicate the appropriate dosage.
The usual dosage is one application per day, two days a week.
In some skin conditions, such as psoriasis or atopic dermatitis, it is not recommended to interrupt the
treatment. Ask your doctor for the best way to achieve optimal results.
Instructions for use:

• 1. Wash your hands.
• 2. Apply a thin layer of cream and massage gently until it disappears completely.
• 3. Wash your hands unless the cream is used to treat them.

If skin problems do not improve after one or two weeks of treatment, inform your doctor.

If you use more Flunutrac than you should
If you have used more Flunutrac than you should, especially in the treatment of children,
wash the affected areas thoroughly 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 Flunutrac
Do not apply a double dose to make up for a missed dose.
If you forget to apply the cream, apply the correct dose when you remember or, if it is the
time for the next application, wait for it to apply the product.

If you stop using Flunutrac
Do not stop treatment even if you feel better, unless your doctor tells you to.
If you have any doubts about the use of the product, consult 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 (reported in more than 1 in 100 patients but in less than 1 in 10):

• Itching.

Uncommon side effects (reported in more than 1 in 100 patients but in less than 1 in
1000):

• Local burning sensation

Very rare side effects (reported in more than 1 in 1000 patients but in less than 1 in
10000):

• Secondary infections (an infection that occurs during or following treatment for an existing infection), particularly when using occlusive dressings or when skin folds are involved.
• Hypersensitivity. Stop using Flunutrac if signs of hypersensitivity appear.
• Hypercortisolism (increased levels of corticosteroids) due to prolonged use of large amounts of corticosteroids or treatment of extensive areas. This is more likely to occur in children and infants and if occlusive dressings are used.
• Dilatation of superficial blood vessels due to prolonged and intensive treatment with potent corticosteroid preparations.
• Allergic contact dermatitis (allergic skin reactions).
• Worsening of signs and symptoms of dermatoses (skin reaction involving skin inflammation).
• Pustular psoriasis due to treatment or its discontinuation.
• Local atrophic skin changes such as thinning, appearance of striae, hypertrichosis (excessive hair growth in a specific body region) and

hypopigmentation (skin discoloration) due to prolonged and
intensive treatment with potent corticosteroid preparations.
Frequency unknown (the available data do not allow to estimate the frequency):

• Vascular purpura (group of skin disorders characterized by purplish or brownish-red discoloration).
• Skin fragility.
• Perioral dermatitis (inflammation of the skin around the mouth).
• Rosacea (redness and inflammation of the facial skin).
• Scabies.
• Ulcers on the lower limbs
• Acne
• Difficulty in wound healing
• Blurred vision

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting
side effects you can help provide more information on the safety of this
medicine.

5. How to store Flunutrac

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 pack and the tube after
‘EXP.’. The expiry date refers to the last day of the month.

Do not store above 30ºC.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
Do not use this medicine if you notice visible signs of deterioration.

6. Contents of the pack and other information

What Flunutrac contains

• The active ingredient is fluticasone propionate. 100 g of cream contains 0.05 g of fluticasone propionate.
• The other ingredients are macrogol cetostearyl ether, cetostearyl alcohol, isopropyl myristate, liquid paraffin, purified water, propylene glycol, citric acid monohydrate, disodium phosphate anhydrous, imidazolidinyl urea.

Description of the appearance of Flunutrac and contents of the pack
Flunutrac is a white, viscous cream contained in an aluminium tube of 30 g with a screw cap.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ISDIN S.r.l.
Viale Abruzzi, 3
20131 Milano
Italy

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 European Union with the following
names:
Italy: Flunutrac 0.05% cream
Netherlands: Cortifil 0.5 mg/g cream
Portugal: Flunutra 0.5 mg/g cream
Spain: Flunutrac 0.5 mg/g cream
England: Fluticasone propionate 0.05% cream