Package leaflet: Information for the patient

Flubason 0.25% cutaneous emulsion

desoximetasone
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Flubason is and what it is used for

Flubason contains desoximetasone, which belongs to a class of medicines called
"dermatological corticosteroids".
Due to its high anti-inflammatory and antipruritic (anti-itch) activity, Flubason is indicated for the treatment of the most important skin diseases of various origins:

allergic dermatitis (contact dermatitis and eczema);
psoriasis, a chronic inflammatory skin disease.

2. What you need to know before using Flubason

Do not use Flubason

if you are allergic to desoximetasone, to similar medicines (corticosteroids), or to any of the other ingredients of this medicine (listed in section 6),
if you have tuberculosis (a bacterial infection mainly affecting the lungs),
if you have local viral infections such as herpes or chickenpox,
if you have a sexually transmitted infection called "syphilis",
if you have diseases caused by vaccines (vaccinopathies),
if you are pregnant (see "Pregnancy and breastfeeding"),
if you are breastfeeding (see "Pregnancy and breastfeeding"),
if you suffer from a skin condition called "atopic dermatitis", Flubason must not be used with non-breathable (occlusive) dressings.

Flubason must not be used for the eyes (ophthalmic use).
Flubason lotion contains paraffin which may cause leakage or rupture of latex condoms.
Avoid contact between Flubason and latex condoms.
Warnings and precautions
Talk to your doctor or pharmacist before using Flubason.
Topical application of Flubason for skin conditions (dermatoses) over large areas and/or for prolonged periods may lead to systemic adverse effects due to absorption into the body, such as:

high blood pressure (arterial hypertension),
muscle weakness (asthenia),
severe lack of energy (adynamia),
heart rhythm disturbances,
low potassium levels in the blood (hypokalaemia),
changes in the acid-base balance in the blood (metabolic alkalosis).

Repeated or prolonged application of Flubason near the eyes should be performed only under strict medical supervision, as it may over time cause increased intraocular pressure.
The use, especially if prolonged, of topical medicines may lead to allergic reactions (sensitization). If this occurs, inform your doctor, as treatment with Flubason may need to be discontinued and appropriate therapy initiated.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
Flubason should be administered to newborns and young children only under strict medical supervision, at the lowest effective dose and for short periods, as in this age group the risk of systemic adverse effects due to drug absorption (e.g. growth retardation) is higher.
Other medicines and Flubason
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
To date, no problems due to concomitant use of other medicines with Flubason (interactions) are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Flubason during pregnancy or breastfeeding, as desoximetasone may be absorbed into the body and could harm the fetus or infant.
Driving and using machines
Flubason does not affect the ability to drive or operate machinery.
Flubason contains cetostearyl alcohol
This ingredient may cause local skin reactions (e.g. contact dermatitis).

3. How to use Flubason

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:
A thin layer applied 2–3 times daily to the affected area of skin, gently massaged in if
possible.
Later, after improvement, once daily application may be sufficient.
If you use more Flubason than you should
Systemic effects in the body may occur following absorption of large amounts of
desoximetasone, particularly after application of Flubason to extensive skin areas or for prolonged periods.
In such a case, your doctor will reduce your dose or discontinue treatment.
If you forget to use Flubason
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following skin reactions may occur at the treated skin site, especially with prolonged treatment or if non-breathable dressings (occlusive dressings) are used:

skin infection (folliculitis),
increased hair growth (hypertrichosis),
acne,
lightening or darkening of the skin (hyper- or hypopigmentation),
dilation of superficial blood vessels (telangiectasias),
skin streaks (striae),
thinning of the skin (atrophy),
skin maceration.

Rarely, Flubason may cause skin allergies (local hypersensitivity reactions) such as:

redness,
swelling (edema),
scaling,
itching.

If used over large areas or for prolonged periods, or if applied under non-breathable (occlusive) dressings, Flubason may be absorbed and produce systemic effects.
Frequency not known (frequency cannot be estimated from the available data):

increased blood sugar levels (hyperglycemia),
blurred vision,
chorioretinopathy, a disorder of the eye characterized by fluid accumulation under the retina, which may reduce vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can 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 Flubason

Do not store above 25°C.
Use the single-dose sachet on the same day.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Flubason contains

The active substance is desoximetasone. 1 g of emulsion contains 2.5 mg of desoximetasone.
The other ingredients are white vaseline, isopropyl myristate, lanoceric alcohol, cetyl alcohol, aluminum stearate, magnesium stearate and purified water.

Description of the appearance of Flubason and package contents
Flubason is available as:
Cutaneous emulsion, water/oil.
15 single-dose sachets of 2 g each.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A - 35031 Abano Terme (PD)
Manufacturer
Sanofi Winthrop Industrie
196 rue du Maréchal Juin, 45200 Amilly - France