FLIXODERM 0,5 MG/G Krem

Treść ulotki

1. Flixoderm 0.05% cream, 0.005% ointment
   1. What is Flixoderm and what it is used for
   2. What you need to know before using Flixoderm
2. Flixoderm cream contains an excipient called imidurea. The body transforms
   1. How to use Flixoderm
   2. Possible side effects
   3. How to store Flixoderm
   4. Contents of the pack and other information

Flixoderm 0.05% cream, 0.005% ointment

Fluticasone propionate

Read this leaflet carefully before you start 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Flixoderm and what it is used for

Flixoderm contains fluticasone propionate which belongs to the group of medicines called
corticosteroids. Corticosteroids help to reduce swelling and irritation.
Flixoderm cream and Flixoderm ointment are used to help reduce redness and itching
caused by certain skin problems in adults and children one year of age and older
such as:

• eczema;
• prurigo nodularis (itchy nodules on the arms and legs);
• psoriasis ( thickened, red, inflamed patches of skin, often covered with silvery scales);
• neurodermatitis, including chronic lichen simplex (itchy thickened skin patches caused by scratching);
• lichen planus (a skin disease that causes itching, reddish-purple skin rashes, on the wrists, arms, legs);
• seborrheic dermatitis (itching that develops on the face, scalp, chest and back with red, scaly formations);
• allergic contact reactions;
• discoid lupus erythematosus (a skin disease that most often affects the face, ears and scalp causing scarring and increased skin sensitivity to sunlight);
• Generalized erythroderma in association with systemic steroid therapy, a skin condition characterized by widespread and uniform redness accompanied by scaling of lamellae of the stratum corneum of the epidermis;
• insect bites;
• miliaria rubra (acute inflammatory state of the skin characterized by the appearance of a pruritic rash caused by obstruction of the sweat glands and the consequent retention of sweat in the subcutaneous layers).

2. What you need to know before using Flixoderm

Do not use Flixoderm

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6)
• if your child is under one year of age
• to treat any of the following skin problems, which could otherwise worsen:
• acne
• severe redness of the skin and redness around the nose (rosacea)
• spotty rash around the mouth (perioral dermatitis)
• in case of viral skin infections (herpes simplex, chickenpox)
• itching in the anal and genital area (penis and vagina)
• infected skin (unless you are already undergoing anti-infective treatment for the infection)
• itching of the skin without inflammation
• in case of infection caused by fungi or bacteria Do not use Flixoderm if any of the above conditions apply to you or your child. If you have any doubts about correct use, consult your doctor or pharmacist.

Warnings and precautions
Consult your doctor or pharmacist before using Flixoderm:

• if you or your child have had a previous allergic reaction when using steroids;
• if you are applying a cream with an occlusive bandage (in children, a diaper can act as an occlusive bandage). The bandage may facilitate the passage of the active ingredient through the skin, in this way you may accidentally use too much medicine;
• if you are elderly and/or suffer from reduced kidney/liver function. In this case, it is advisable to use the smallest amount of medicine for the shortest time required to achieve the desired clinical benefit;
• if you have psoriasis, your doctor will want to visit you more frequently.
• Contact your doctor if you experience blurred vision or other visual disturbances.

If you are not sure whether any of the above conditions apply to you or your child, talk
to your doctor or pharmacist before using this medicine.

Other medicines and Flixoderm
Tell your doctor or pharmacist if you are taking, have recently taken, or may
take any other medicines.
In particular, be careful if you are taking ritonavir and itraconazole because
they increase the effect of the medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using
this medicine.
Pregnancy
Use the minimum amount of medicine for the shortest possible time.
Breastfeeding
If you use fluticasone propionate while breastfeeding, avoid applying it to the breast to
prevent the baby from ingesting it.

Flixoderm cream contains imidurea, cetostearyl alcohol and propylene glycol

Flixoderm cream contains an excipient called imidurea. The body transforms

imidurea into a degradation product called formaldehyde. Formaldehyde may
cause a skin reaction, including redness and itching.
Flixoderm cream contains cetostearyl alcohol. It may cause local skin reactions (e.g.
contact dermatitis).
Flixoderm cream contains propylene glycol. It may cause skin irritation.

Flixoderm ointment contains propylene glycol. It may cause skin irritation.

3. How to use Flixoderm

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
Cream - Application of the cream is indicated for lesions in any location and is
preferable in the treatment of delicate and moist skin surfaces.
Ointment - Skin irritations of a dry type benefit most from
application of the ointment.

• Apply a thin layer of cream or ointment sufficient to cover the entire affected area, up to a maximum of twice a day. The frequency can be reduced or can switch to a less potent corticosteroid if you notice an improvement in the skin.
• Use this cream or ointment only on the skin.
• Do not use this product on a large area of the body for a long time (every day for weeks or months) - unless prescribed by your doctor.
• Always clean the skin before each new application because germs that cause infections prefer warm and moist areas.
• If you are applying the cream or ointment to another person, be sure to wash your hands after use or wear disposable plastic gloves.
• If the problem you are treating does not improve, consult your doctor.

Therapy with topical corticosteroids should be gradually discontinued when the
disease is under control and treatment should continue with an emollient cream as
maintenance therapy.
Following the sudden interruption of the application of topical corticosteroids, in
particular with potent ones, a relapse of pre-existing dermatoses may occur.

Application on the face
Apply Flixoderm to the face only if recommended by your doctor. Applications to the face
cannot be prolonged for a long time because the skin of the face thins easily.
Do not apply the cream or ointment to the eyes.

If you use more Flixoderm than you should
If, by mistake, on some occasions you use more Flixoderm than you should, do not worry. If you accidentally ingest the medicine, you may feel unwell. Contact
your doctor or go to hospital as soon as possible.

If you forget to use Flixoderm

• If you forget to use Flixoderm, apply it as soon as you remember, then continue as before
• Do not apply an extra dose to make up for the missed one

If you stop using Flixoderm
If you use Flixoderm regularly, be sure to talk to your doctor before stopping
using it.
If you have any questions about using 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.

Stop using Flixoderm and tell your doctor as soon as possible if:

• the skin problem does not improve or gets worse, or if you notice swelling during treatment. Flixoderm may cause an allergy, you may have an infection or need other treatments. Stop using Flixoderm and call your doctor as soon as possible

Other side effects that may be noticed when using Flixoderm include:

Common(may affect up to 1 in 10 people)

• irritation or itching Uncommon(may affect up to 1 in 100 people)
• burning sensation during application Very rare(may affect up to 1 in 10,000 people) Long-term use of Flixoderm, or when using an occlusive dressing, may cause the following symptoms:
• weight gain
• moon face/rounding of the face
• obesity
• skin discoloration, which may cause stretch marks
• thinning of the skin which may reveal veins underneath
• skin lightening
• hirsutism, increased body hair

Other very rare reactions that may occur are:

• allergic reactions at the application site
• worsening of the condition
• redness
• rash or hives
• treatment of psoriasis with corticosteroids or, its discontinuation, may cause the appearance of the pustular form of the disease
• skin infection.

Not known (frequency cannot be estimated from available data)

• blurred vision

Additional side effects in children
The following symptoms may occur in children:

• slowing of growth
• delay in weight gain

Very rarely, abnormalities in parameters may be found following blood tests:

• decreased levels of endogenous cortisol
• hyperglycemia/glycosuria
• hypertension
• osteoporosis
• cataract
• glaucoma

If these situations occur, it is appropriate to talk to your doctor for further investigations.

If you get a side effect
Tell your doctor or pharmacistif any of the side effects listed

becomes serious or worrying, or if you notice any side effect not listed in

this leaflet.

Reporting of side effects
Reporting suspected adverse reactions that occur after authorisation of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of

the medicine. Healthcare professionals are requested to report any suspected adverse reactions through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa

5. How to store Flixoderm

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 after SCAD.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
Store at a temperature below 30°C.
Do not freeze.

6. Contents of the pack and other information

What Flixoderm contains
Flixoderm cream

• The active ingredient is fluticasone propionate. Each gram contains 0.5 mg of fluticasone propionate (0.05% w/w).

The other ingredients are: liquid paraffin; isopropyl myristate; cetostearyl alcohol;
polyoxyethylene cetyl stearyl ether (Cetomacrogol 1000); propylene glycol; imidurea; sodium
phosphate; citric acid monohydrate; purified water.
Flixoderm ointment

• The active ingredient is fluticasone propionate. Each gram contains 0.05 mg of fluticasone propionate (0.005% w/w).

The other ingredients are: propylene glycol; sorbitan sesquioleate; microcrystalline wax;
liquid paraffin.

Description of the appearance of Flixoderm and contents of the pack
Flixoderm 0.05% cream: tube of 30 g
Flixoderm 0.005% ointment: tube of 30 g

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - Verona

Manufacturer
Glaxo Operations UK Ltd. – Harmire Road - Barnard Castle - Great Britain

Other sources of information
More detailed information on this medicine is available on the AIFA website