PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Fluticrem 0,05% cream

Fluticasone propionate
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT Fluticrem IS AND WHAT IT IS USED FOR

Fluticrem 0.05% cream belongs to a group of medicines known as corticosteroids,
which, when used locally, are characterized by high anti-inflammatory activity.
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 diseases that are responsive to corticosteroids.

2. WHAT YOU NEED TO KNOW BEFORE USING Fluticrem

Do not use Fluticrem

If you are allergic to fluticasone or to any of the excipients of this medicine (listed in section 6).
If you suffer from rosacea (redness and inflammation of the facial skin), acne vulgaris, or perioral dermatitis (redness and inflammation around the mouth).
If you have viral skin infections (e.g. herpes simplex or chickenpox), bacterial, fungal, or yeast infections.
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 fragility of cutaneous blood vessels.
If you suffer from ichthyosis (disorders characterized by dry, scaly skin).
If you have juvenile dermatoses (all skin diseases characterized by inflammation) or infantile dermatitis (occurring in children under 1 year of age), including skin inflammations and diaper rashes.
If you have ulcerative lesions.

Warnings and precautions
Talk to your doctor or pharmacist before using Fluticrem

If you are 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 in children, as this may increase the absorption of the medicine and the risk of toxicity.
If you apply the medicine 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 apply the medicine to covered areas of the body. Do not use the medicine under 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. Wash the skin before applying a dressing. If your doctor has prescribed a cream for the treatment of psoriasis, attend regular follow-up visits with your doctor to monitor the progress of your condition.
If you are using other products (including cosmetics) on the affected skin areas, as they might negatively affect the medicine's activity. If in doubt, consult your doctor.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Do not use this medicine in children under 1 year of age.
If symptoms do not improve after one or two weeks of treatment, inform your doctor.
When improvement of the skin condition is observed (usually within one to two weeks), reduce the frequency of applications. Continuous daily treatment for more than 4 weeks is not recommended.
Fluticrem 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 Fluticrem for other types of dermatitis in children, consult a dermatologist.

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

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.

Pregnancy
Fluticrem should be used during pregnancy only if the expected benefit to the mother outweighs the potential risks to the unborn child.

Breastfeeding
It is not known whether fluticasone is excreted in human milk. Fluticrem should be used during breastfeeding only if the expected benefit to the mother outweighs the potential risks to the infant.

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

Fluticrem contains cetyl stearyl alcohol, imidurea, and propylene glycol.
This medicine contains cetyl stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
This medicine contains the preservative imidurea. Imidurea decomposes and releases a small amount of a chemical called formaldehyde. Formaldehyde may cause allergic reactions such as skin rash or itching when applied to the skin. The medicine contains propylene glycol, which may irritate the skin.

3. HOW TO USE Fluticrem

Your doctor will prescribe the appropriate dosage for your condition.
Always use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
For adults and children from one year of age, apply a thin film of Fluticrem 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 (e.g., psoriasis, atopic dermatitis, etc.), abrupt discontinuation of
treatment is not recommended; the number of applications should be gradually reduced.
Follow your doctor's instructions carefully.
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 diseases 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:

1 Wash your hands
2 Apply a thin film of cream and gently massage until it has completely disappeared
3 Wash your hands again, unless the cream is being used to treat the hands themselves.
If skin problems do not improve within one or two weeks after starting treatment, inform your
doctor.
If you use more Fluticrem than you should
If you have used more Flutrem than intended, 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 Fluticrem
Do not use 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 just before the next scheduled application, and then wait for the next regular application.
If you stop using Fluticrem
Do not stop treatment even if you feel better, unless instructed otherwise by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Common adverse reactions (reported in more than 1 in 100 patients but less than 1 in 10):

Pruritus.
Uncommon adverse reactions (reported in more than 1 in 1,000 patients but less than 1 in 100):
Local burning
Very rare adverse reactions (reported in more than 1 in 10,000 patients but less than 1 in 1,000):
Secondary infections, particularly when occlusive dressings are used or when skin folds are involved.
Hypersensitivity. Discontinue treatment with Fluticrem if a hypersensitivity reaction occurs.
Hypercortisolism (increased levels of corticosteroids) due to prolonged use of large amounts of corticosteroids or treatment of extensive skin areas. This effect is more likely to occur in neonates and children 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 dermatosis (skin reaction involving skin inflammation).
Pustular psoriasis due to treatment or its withdrawal.
Local skin atrophic 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 (frequency cannot be estimated from the available data):
Purpura (a group of skin disorders characterized by purplish 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
Blurred vision
If you experience any of the adverse reactions, inform your doctor or pharmacist. This also applies to any side effects not listed in this leaflet.

5. HOW TO STORE Fluticrem

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after 'EXP'. The expiry date refers to the last day of the month.
Do not store above 30°C.
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 Fluticrem if you notice any visible signs of deterioration.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Fluticrem 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, citric acid monohydrate, disodium phosphate anhydrous,
imidazolidinyl urea.
Description of the appearance of Fluticrem and packaging contents
Fluticrem is a white, viscous cream contained in an aluminum tube of 30 g or 60 g with a screw cap.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DIFA COOPER SpA
Via Milano 160
21042-Caronno Pertusella (Varese)
Italy
Manufacturer responsible for batch release:
INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.
Ctra. Cazoña-Adarzo, s/n
39011 Santander
Spain
This medicinal product is authorized in the Member States of the European Union under
the following names:
Belgium: Fluticrem 0.05% cream
Italy: Fluticrem 0.05% cream
Netherlands: Fluticrem 0.5 mg/g cream
Portugal: Fluticrem 0.5 mg/g cream
Spain: Fluticrem 0.5 mg/g cream
This summary of product characteristics was last approved on