Olux

Package leaflet: Information for the user

OLUX 500 micrograms/g cutaneous foam in pressurised container

(Clobetasol propionate)
Please read all of this leaflet carefully before you start 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. 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 effect, including those not listed in this leaflet, contact 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 using 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 substance clobetasol propionate, which belongs to a group of medicines known as topical corticosteroids. Clobetasol propionate is a highly potent topical corticosteroid.
OLUX 500 micrograms/g foam in a pressurised container is a foam to be applied to the skin.
OLUX 500 micrograms/g foam in a pressurised container is used for the short-term treatment of steroid-responsive dermatoses of the scalp, such as psoriasis, which do not respond satisfactorily 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 to 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 disorders such as rosacea, acne, inflammation of the skin around the mouth, itching in the area around the anus or genitals.
• On any part of the body or face (including eyelids) other than the scalp.
• In children under 2 years of age.

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

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

Tell your doctor:

• if your condition does not improve after 2 weeks of treatment.
• if you develop an infection, as this may require discontinuation of OLUX treatment.
• if you start experiencing vision problems, as this type of medicine may promote the development of cataract and glaucoma.

Wash your hands thoroughly after each application.
In case of accidental contact 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
OLUX should not be used during pregnancy or breastfeeding unless advised by a doctor.
Driving and using machines
OLUX does not affect the ability to drive or use machinery.
Important information about some OLUX excipients
This medicine contains propylene glycol, which may cause skin irritation. It also contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use OLUX

WARNINGS:
The can contains a flammable liquid under pressure.
Do not use or store near open flames, ignition sources, or any other heat source or
electrical device in operation.
Do not smoke while using or handling the container.
Use OLUX exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Use this medicine only for the condition for which it was prescribed. OLUX must be
applied only to the scalp and must not be ingested.
It is recommended not to dispense the product directly into the palm of the hand, as the foam
melts immediately upon contact with warm skin.
Apply OLUX to the affected area of the scalp twice daily, once in the morning and once in the
evening, as follows:
Caution: For proper foam dispensing, it is essential to keep the container inverted!

1. Shake the container well

2. Invert the 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 small plate, or onto another cool surface, and then apply to the scalp. OLUX must always be applied as a thin layer; therefore, use the smallest amount necessary to cover the affected area. The exact amount required depends on the size 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 into the palm of the hand, as the foam begins to melt immediately upon contact with warm skin.

3. Part the hair to expose the scalp and gently massage the foam into the scalp until it disappears and is completely absorbed. If necessary, repeat the procedure to treat the entire affected area.

Wash your hands thoroughly after applying OLUX and dispose of 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 discomfort persists.
Treated areas must not be bandaged or covered unless specifically instructed by your doctor.
Do not wash or rinse the treated area of the scalp immediately after applying OLUX.
Do not use more than 50 g of OLUX foam per week.
Treatment must not exceed 2 weeks. After this period, OLUX may be used occasionally as needed.
Alternatively, your doctor may prescribe a less potent steroid to help control the condition.
If you use more OLUX than you should
Inform your doctor immediately if you have applied OLUX:

• in larger amounts than the prescribed dose
• for a longer period than prescribed

If you use OLUX Foam in large amounts or for a prolonged period without medical supervision, inform your doctor immediately.
If you forget to use OLUX
Apply it as soon as you remember, then continue with your regular dosing schedule. If you remember only at the time of your next dose, apply a single dose and continue as before. Do not apply a double dose to make up for a missed dose. If you have missed several doses, consult your doctor.
If you stop using OLUX
Do not discontinue OLUX treatment suddenly, as this may harm you. Your doctor may decide to gradually taper off the treatment with regular monitoring.
If you have any doubts about how to use OLUX, consult your doctor or pharmacist.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people but more 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 laxity
• skin tightness
• itchy skin rash (contact dermatitis)
• worsening of scaly skin eruption (worsening of psoriasis)
• redness at the application site
• itching sometimes accompanied by pain at the application site
• the doctor may detect the presence of blood, protein and nitrogen in the urine

Additional side effects may include:

• changes in hair growth (abnormal hair growth away from the application site and in unusual body areas)
• changes in skin colour
• irritation of hair follicles, for example pain, warmth and redness
• mouth rashes
• facial redness and rashes
• delayed wound healing
• eye effects (cataract, increased intraocular pressure)
• blurred vision

Side effects caused by prolonged use include:

• light-coloured streaks on the skin (stretch marks) and dilation of blood vessels in the skin
• As with other topical corticosteroids, prolonged use of large quantities of OLUX may lead to a condition known as Cushing's syndrome, whose symptoms include a red, swollen and rounded face (so-called "moon face"), high blood pressure, increased body weight, and changes in blood and urine glucose levels.
• Prolonged steroid treatment may cause thinning of the skin.

In rare cases, treating psoriasis with corticosteroids (or stopping treatment) may worsen the condition and lead to the development of pustular psoriasis. After stopping corticosteroid treatment, scalp dermatosis may sometimes reappear. If OLUX is not used correctly, pre-existing infections may also worsen.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 can contains a flammable liquid under pressure.
• Do not store near open flames, sources of ignition, or any other heat source or electrical device in use.
• Do not expose to temperatures above 50°C or to direct sunlight.
• Do not pierce or burn the container, even if it is empty.
• After treatment is completed, dispose of the container safely.

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

6. Package contents and other information

What OLUX contains
The active substance is clobetasol propionate; 1 g of cutaneous foam contains 500 micrograms of
clobetasol propionate.
The other components are: anhydrous ethanol, purified water, propylene glycol, cetyl alcohol, stearyl
alcohol, polysorbate 60, anhydrous citric acid, potassium citrate and a propellant mixture of 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 Authorization Holder
Giuliani S.p.a. – Via Palagi, 2 – 20129 Milan, Italy
Manufacturer
Aerosol Service Italiana S.R.L. (ASI)
Via del Maglio, 6
23868 Valmadrera (LC)
Italy
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
CLARELUX 500 micrograms/g cutaneous foam in Austria, Belgium, the Czech Republic, Finland, France, Germany, Greece, Ireland, Luxembourg, the Netherlands, Poland, Portugal, Slovakia, the United Kingdom and Spain.
OLUX 500 micrograms/g cutaneous foam in Italy.