OLUX <500 microgrammi/g Cutaneous foam

Зміст інструкції

1. OLUX 500 micrograms/g cutaneous foam in a pressurised container
   1. What OLUX is and what it is used for
   2. What you need to know before using OLUX
   3. How to use OLUX
   4. Possible side effects
   5. How to store OLUX
   6. Contents of the pack and other information
2. OLUX 500 micrograms/g cutaneous foam is a white cutaneous foam in a pressurized container.

OLUX 500 micrograms/g cutaneous foam in a pressurised container

(Clobetasol 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 they have the same symptoms as you, as it may 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 OLUX is and what it is used for
• 2. What you need to know before you use OLUX
• 3. How to use OLUX
• 4. Possible side effects
• 5. How to store OLUX
• 6. Contents of the pack and other information

1. What OLUX is and what it is used for

OLUX contains the active ingredient clobetasol propionate which belongs to a group of medicines
known as topical corticosteroids. Clobetasol propionate is a very potent topical corticosteroid.
OLUX 500 micrograms/g cutaneous foam in a pressurised container is a foam to be applied
to the skin.
OLUX 500 micrograms/g cutaneous foam in a pressurised container is used in the short-term treatment
of scalp dermatoses sensitive to steroids, such as: psoriasis, which do not
respond adequately to less potent corticosteroids.

2. What you need to know before using OLUX

Do not use OLUX:

• If you are allergic to clobetasol propionate or any of the other ingredients of this medicine (listed in section 6).
• If you have a skin infection, whether viral (e.g. herpes, herpes zoster, chickenpox…), bacterial (e.g. impetigo...), fungal (caused by microscopic fungi) or parasitic;
• If you have burns, ulcerated lesions or other skin conditions such as rosacea, acne, skin inflammation around the mouth, itching in the anal or genital area.
• On any other part of the body or face (including the eyelids) other than the scalp.
• In children under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using OLUX
Stop treatment immediately and consult your doctor if an allergic reaction occurs, the signs of which may include skin rash, itching or painless swelling of the tissue (edema).
Like all topical corticosteroids, OLUX can be absorbed through the skin and may cause
undesirable effects such as adrenal suppression – see section 4 for all possible undesirable effects.
For this reason:

• Avoid long-term treatment with OLUX.
• OLUX should not be applied to large areas.
• The treated areas should not be bandaged or covered unless directed by your doctor.
• The use of OLUX on wounds or ulcers is not recommended.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Inform your doctor:

• if your condition does not improve after 2 weeks of treatment.
• if an infection develops, as this may require stopping treatment with OLUX.
• if you start to experience vision problems, as this type of medicine may promote the development of cataracts and glaucoma.

Wash your hands thoroughly after each application.
If accidental contact occurs with the face or eyes, rinse thoroughly with water.

Children and adolescents
Treatment is not recommended in children under 12 years of age.

Other medicines and OLUX
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
OLUX should not be used during pregnancy or breastfeeding unless advised by your doctor.

Driving and using machines
OLUX does not affect the ability to drive vehicles or operate machinery.

Important information about some of the excipients of OLUX
This medicine contains propylene glycol, which can cause skin irritation. It also contains
cetyl alcohol and stearyl alcohol, which can cause local skin reactions (e.g. contact dermatitis).

3. How to use OLUX

WARNINGS:
The cylinder contains a flammable liquid under pressure.
Do not use or store near open flames, sources of ignition and any other source of heat or
switched-on electrical device.
Do not smoke while using or handling the container.
Use OLUX always following exactly the instructions of your doctor. If you have any doubts, consult your doctor or
pharmacist.
Use this medicine only for the condition for which it has been prescribed to you. OLUX must be
applied only to the scalp and must not be ingested.
It is recommended not to dispense the product directly onto the palm of your hand, as the foam
dissolves immediately upon contact with warm skin.
Apply OLUX to the affected area of the scalp 2 times a day, once in the morning and once in the
evening, as follows:
Attention: for correct dispensing of the foam, it is important to hold the container upside down!

• 1. shake the container well

• 2. turn upside downthe container and dispense a small amount (equivalent to the volume of a walnut) directly onto the scalp or into the cap of the container, onto a saucer or onto another cool surface and then onto the scalp. OLUX should always be applied in a thin layer, so use as little as possible to cover the affected area. The exact amount needed depends on the extent of the area to be treated. Do not apply the product to the eyelids and carefully avoid contact with eyes, nose and mouth. Do not dispense OLUX directly onto the palms of your hands as the foam starts to dissolve immediately upon contact with warm skin.

• 3. move the hair away from the foam and gently massage the foam into the scalp, until it disappears and is completely absorbed. If necessary, repeat the operation to treat the entire affected area.

Wash your hands thoroughly after applying OLUX and remove any unused excess foam.
Do not use OLUX on the face. If the foam accidentally comes into contact with eyes, nose or
mouth, rinse immediately with cold water. You may experience a burning sensation.
Inform your doctor if the pain persists.
The treated areas should not be bandaged or covered unless directed by your doctor.
Do not wash or rinse the treated area of the scalp immediately after applying OLUX.
Do not use more than 50g of OLUX foam per week.
The treatment should not exceed 2 weeks. After this period, OLUX can be used
occasionally as needed. Alternatively, your doctor may prescribe a less
potent steroid to keep the condition under control.

If you use more OLUX than you should
Immediately inform your doctor if you have applied OLUX:

• in a greater quantity than the prescribed dose
• for a longer period of time than prescribed.

If you use OLUX Foam in abundance or for a long period of time without medical supervision, inform your doctor immediately.

If you forget to use OLUX
Use it as soon as you remember and then continue applications as before. If you remember it at the time of the next dose, apply a single dose and continue as before
(do not apply a double dose to compensate for forgetting the dose). If you have forgotten several
applications, consult your doctor.

If you stop using OLUX
Do not suddenly stop treatment with OLUX as it may harm you. Your doctor
may decide to gradually stop the treatment by subjecting you to regular
check-ups.
If you have any doubts about the use of OLUX, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience hypersensitivity reactions, such as local irritation, stop using OLUX
500 micrograms/g cutaneous foam and inform your doctor immediately.
Side effects may include:

Common side effects (may affect up to 1 in 10 people but less than 1 in 100):

• burning sensation
• other skin reactions when applied to the skin

Very rare side effects (may affect up to 1 in 10,000 people):

• tingling or prickling sensation
• eye irritation
• venous dilation
• skin irritation and relaxation
• skin tension
• itchy rash (contact dermatitis)
• worsening of scaly rash (worsening of psoriasis)
• redness at the application site
• itching sometimes accompanied by pain at the application site
• blood, proteins and nitrogen may be detected in the urine by the doctor

Further side effects may include:

• changes in hair growth (abnormal hair growth away from the application site and in unusual parts of the body)
• changes in skin color
• irritation of hair follicles, for example, sensation of pain, heat and redness
• rashes on the mouth
• redness and rashes on the face
• delayed wound healing
• eye effects (cataract, high eye pressure)
• blurred vision

Side effects caused by prolonged use include:

• light-colored streaks on the skin (stretch marks) and dilation of blood vessels in the skin
• Similarly to other topical corticosteroids, using large quantities and for a long period of time of OLUX can lead to a condition called Cushing's syndrome, whose symptoms include a flushed, swollen and rounded face (known as moon face), high blood pressure, weight gain and changes in glucose levels in the blood and urine.
• Prolonged treatment with steroids can cause thinning of the skin.

In rare cases, treatment of psoriasis with corticosteroids (or discontinuation thereof) can lead to
worsening of the condition and the appearance of the pustular form thereof. Following
discontinuation of treatment with corticosteroids, sometimes, scalp dermatosis may
recur. If OLUX is not used correctly, pre-existing infections can also worsen.

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 http://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 OLUX

• The cylinder contains a flammable liquid under pressure.
• Do not store near open flames, ignition sources and any other source of heat orswitched-on electrical device.
• Do not expose to temperatures above 50°C or direct sunlight.
• Do not puncture or burn the container even if empty.
• At the end of treatment, dispose of the container safely.

Keep this medicine out of the sight and reach of children.
Do not use OLUX after the expiry date which is stated on the container and the package after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Do not refrigerate. Store in an upright position.
Do not dispose of any medicine in drains or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What OLUX contains
The active ingredient is clobetasol propionate and 1 g of cutaneous foam contains 500 micrograms of
clobetasol propionate.
The other ingredients are: anhydrous ethanol, purified water, propylene glycol, cetyl alcohol, stearyl
alcohol, polysorbate 60, anhydrous citric acid, potassium citrate and a mixture of propellants propane/ n-
butane/isobutane.

Description of the appearance of OLUX and contents of the pack

OLUX 500 micrograms/g cutaneous foam is a white cutaneous foam in a pressurized container.

Each container contains 50 or 100 grams.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Giuliani S.p.a. – Via Palagi, 2 – 20129 Milan

Manufacturer
Aerosol Service Italiana S.R.L. (ASI)
Via del Maglio, 6
23868 Valmadrera (LC)
Italy

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
CLARELUX 500 micrograms/g cutaneous foam in Austria, Belgium, Czech Republic, Finland, France,
Germany, Greece, Ireland, Luxembourg, Netherlands, Poland, Portugal, Slovakia, United Kingdom and
Spain.
OLUX 500 micrograms/g cutaneous foam in Italy.