Package leaflet: Information for the user

Flunutrac 0.05% cream

Fluticasone propionate
Before using this medicine, read this leaflet carefully because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult 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, as it may be harmful.
If you notice any side effects, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Flunutrac is and what it is used for

Flunutrac 0.05% cream belongs to a group of medicines known as corticosteroids which, when used locally, are characterised by high anti-inflammatory potency.
Fluticasone is a potent corticosteroid 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 disorders that are responsive to corticosteroids.

2. What you need to know before using Flunutrac

Do not use Flunutrac

If you are allergic (hypersensitive) to fluticasone or to any of the excipients in Flunutrac (listed in section 6).
If you have rosacea (redness and inflammation of the facial skin), vulgaris acne, or perioral dermatitis (redness and inflammation around the mouth).
If you have viral skin infections (e.g., herpes simplex or chickenpox).
If you have genital or perianal pruritus (itching around the anus and genital organs).
If you have skin ulcers, atrophy (thinning of the skin), or cutaneous vascular fragility.
If you have ichthyosis (disorders characterized by dry and scaly skin).
If you have juvenile dermatoses (all inflammatory skin conditions) or dermatoses in children under 1 year of age, including skin dermatitis and diaper rash.
If you have ulcerative skin lesions.
If you have infected skin lesions caused 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 pregnant, or if you are breastfeeding (see section Pregnancy and breastfeeding).
If you use this medicine over large areas of the body for prolonged periods, especially when treating children, as this may increase absorption of the product and the risk of toxicity.
If you apply the product to the face, as it may cause atrophic changes (e.g., skin thinning). It is important to avoid contact of the cream with the eyes.
If you use the medicine on covered body areas. Do not use the product with occlusive dressings; the treated area should be exposed to air and not covered by dressings, tight clothing, or similar materials. In infants, diapers may act as occlusive dressings. You should wash the skin before changing the diaper.
If your doctor has prescribed this cream for the treatment of psoriasis. Visit your doctor periodically to monitor the progress of your condition.
If you are using other products (including cosmetics) on the affected skin areas, as these may negatively affect the medicine's activity. If in doubt, consult your doctor.

Contact your doctor if blurred vision or other visual disturbances occur.
Caution for athletes: This product contains substances prohibited in doping. Any use differing from the therapeutic indications, dosage regimen, or route of administration specified is prohibited.

Children:
Do not use this 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 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 due to atopic dermatitis and under the supervision of a specialist doctor.
Before using Flunutrac for other types of childhood dermatoses, consult a dermatologist.

Other medicines and Flunutrac
Inform your doctor if you are taking or have recently taken any other medicines, including those not requiring a prescription.

Pregnancy, breastfeeding, and fertility
Ask your doctor for advice before taking this medicine if you are pregnant, breastfeeding, think you may be pregnant, or are planning a pregnancy.

Pregnancy
Flunutrac should be used during pregnancy only if the expected benefits to the mother outweigh the possible risks to the fetus.

Breastfeeding
It is not known whether fluticasone is excreted in human milk. Flunutrac should be used during breastfeeding only if the expected benefits to the mother outweigh the possible risks to the infant.

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

Flunutrac contains cetyl stearyl alcohol, imidurea, and propylene glycol
This product contains cetyl stearyl alcohol, which may cause localized skin reactions (e.g., contact dermatitis).
This product contains the preservative imidurea, which degrades and releases a very small amount of a chemical called formaldehyde. Formaldehyde may cause localized skin reactions (e.g., contact dermatitis).
This medicine contains 100 mg of propylene glycol per 1 gram of cream.

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 pharmacist.
For adults and children from one year of age, apply a thin film of Flunutrac to the affected skin areas once or twice daily, unless otherwise directed by your doctor. Ask your doctor for information regarding the duration of treatment.
In certain conditions (such as psoriasis, atopic dermatitis, etc.), abrupt discontinuation of treatment is not recommended, as the number of applications should be gradually reduced.
Carefully follow your doctor's instructions.
In case of relapse or recurrence of symptoms, your doctor will advise you on the appropriate dosage.
The usual dosage is one application per day, two days per week.
In certain skin conditions such as psoriasis or atopic dermatitis, discontinuation of treatment is not recommended. Ask your doctor for the best way to achieve optimal results.

Instructions for use:

Wash your hands.
Apply a thin layer of cream and gently massage until completely absorbed.
Wash your hands again, unless the cream is being applied to the hands themselves.

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 recommended, especially when treating children, thoroughly wash the affected areas 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 the missed dose.
If you forget to apply the cream, apply the correct dose as soon as you remember, or if it is almost time for the next application, wait and apply the product at the next scheduled time.
If you stop using Flunutrac
Do not stop treatment even if you feel better, unless your doctor advises you to do so.
If you have any doubts about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this drug can cause side effects, although not everyone experiences them.

Common side effects (reported in more than 1 patient out of 100 but less than 1 patient out of 10):

Itching.

Uncommon side effects (reported in more than 1 patient out of 1,000 but less than 1 patient out of 100):

Local burning sensation.

Very rare side effects (reported in less than 1 patient out of 10,000):

Secondary infections (an infection occurring during or following treatment for an existing infection), particularly when occlusive dressings are used or when skin folds are involved.
Hypersensitivity. You must stop using Flunutrac if signs of hypersensitivity occur.
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 neonates, and when occlusive dressings are used.
Dilation 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 cutaneous inflammation).
Pustular psoriasis due to treatment or its withdrawal.
Local atrophic skin changes such as thinning, appearance of striae, hypertrichosis (excessive hair growth in a specific body area), and hypopigmentation (skin discoloration), due to prolonged and intensive treatment with potent corticosteroid preparations.

Frequency not known (available data do not allow estimation of frequency):

Vascular purpura (a group of skin disorders characterized by purple or reddish-brown discoloration).
Skin fragility.
Perioral dermatitis (inflammation of the skin around the mouth).
Rosacea (redness and inflammation of the facial skin).
Scabies.
Leg ulcers.
Acne.
Impaired wound healing.
Blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via 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 stated on the carton and tube after 'EXP.'. The expiry date refers to the last day of the month.
Do not store above 30°C.
Use within 6 months after first opening.
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 any visible signs of deterioration.

6. Package contents and other information

What Flunutrac contains

The active substance is fluticasone propionate. 100 g of cream contain 0.05 g of fluticasone propionate.
The other components are macrogol cetostearyl ether, cetostearyl alcohol, isopropyl myristate, liquid paraffin, purified water, propylene glycol (E 1520), citric acid monohydrate, disodium phosphate anhydrous, imidazolinyl urea.

Description of the appearance of Flunutrac and contents of the pack
Flunutrac is a white, viscous cream contained in a 30 g aluminium tube with a screw cap.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
ISDIN S.r.l.
Via Statuto, 4
20121 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 under 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