Active ingredients: Clobetasol (Clobetasol propionate)
OLUX® 500 micrograms / g cutaneous foam in pressurized container
Indications Why is Olux used? What is it for?
OLUX contains the active substance clobetasol propinate which belongs to a group of medicines known as topical corticosteroids. OLUX is a very potent topical corticosteroid.
OLUX is a foam to be applied to the skin.
OLUX is used in the short-term treatment of scalp dermatoses, for example scalp psoriasis, which do not respond satisfactorily to less potent corticosteroids.
Contraindications When Olux should not be used
Do not use OLUX:
- If you are allergic to clobetasol propionate, other corticosteroids or any of the other ingredients of OLUX.
- If you have an infectious skin disease, whether viral (for example herpes, shingles, chicken pox ...), bacterial (for example impetigo ...), fungal (caused by microscopic fungi) or parasitic;
- If you have burns, ulcerated lesions or other skin dermatoses such as rosacea, acne, inflammation of the skin around the mouth, itching in the area around the anus or genitals.
- Anywhere else on the body or face (including the eyelids) other than the scalp.
Precautions for use What you need to know before taking Olux
Talk to your doctor or pharmacist before using OLUX
Stop treatment immediately and see your doctor if you experience an allergic reaction, the signs of which may include a rash, itching or painless swelling of the tissue (edema).
Like all topical corticosteroids, OLUX can be absorbed into the skin and can cause side effects such as adrenal suppression - see section 4 for all possible side effects. For this reason:
- Avoid long-term treatment with OLUX.
- OLUX must not be applied over large areas.
- the treated areas should not be bandaged or covered unless instructed by the physician.
- The use of OLUX on wounds or ulcers is not recommended
Tell your doctor:
- if your condition does not improve after 2 weeks of treatment.
- if an infection develops, as this may require discontinuation of treatment with OLUX.
- if you start to have problems with your eyesight, as this type of medicine could promote the development of cataracts 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 and adolescents.
Interactions Which drugs or foods can modify the effect of Olux
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
OLUX should not be used during pregnancy or breastfeeding unless advised to by your doctor.
Driving and using machines:
OLUX does not affect the ability to drive or use machines.
Important information about some of the ingredients 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 (eg contact dermatitis).
Dose, Method and Time of Administration How to use Olux: Posology
WARNINGS: The cylinder contains a flammable liquid under pressure.
Do not use or store near open flames, ignition sources and any other heat source or electrical device that is on.
Do not smoke while using or handling the container.
Always use OLUX exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Only use this medicine for the condition for which it was prescribed. OLUX should only be applied to the scalp and should not be swallowed.
It is recommended not to dispense the product directly on the palm of the hand, as the foam dissolves immediately in contact with hot 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:
Warning: for correct dispensing of the foam, it is important to keep the container upside down!
- shake the container well
- invert the container and dispense a small amount (equivalent to the volume of a walnut) directly on the scalp or in the cap of the container, on a saucer or on another fresh surface and therefore on the scalp. OLUX must always be applied in one layer thin, 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 on the eyelids and carefully avoid contact with eyes, nose and mouth. Do not dispense OLUX directly on the palms of the hands as the foam begins to dissolve immediately upon contact with warm skin.
- remove the hair from the foam and gently massage the foam on 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 gets into your eyes, nose or mouth, rinse immediately with cold water. You may feel a burning sensation. Tell your doctor if pain persists.
Treated areas should not be bandaged or covered unless directed by the physician.
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.
Treatment should not exceed 2 weeks. After this period OLUX can be used occasionally in case of need. Alternatively, the doctor may prescribe a less potent steroid to control the condition.
Overdose What to do if you have taken too much Olux
If you use more OLUX than you should
If you use OLUX Foam in large quantities or for a long time without medical supervision, tell your doctor immediately.
If you forget to use OLUX,
You use it as soon as you remember and then continue the applications as before. In case you remember 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 forgotten dose). If you have forgotten several applications, please contact your doctor.
If you stop using OLUX
Do not stop treatment with OLUX suddenly as it may harm you. Your doctor may decide to have you stop your treatment gradually by having you undergo regular checks.
If you have any further questions on the use of OLUX, ask your doctor or pharmacist.
Side Effects What are the side effects of Olux
Like all medicines, OLUX can cause side effects, although not everybody gets them. If hypersensitivity reactions occur, such as local irritation, discontinue use of OLUX and inform your doctor immediately.
Side effects can include:
Common side effects (affects less than 1 in 10 but more than 1 in 100 patients):
- burning sensation
- other skin reactions when applied to the skin
Very rare side effects (affects less than 1 user in 10,000):
- tingling or stinging sensation
- eye irritation
- venous dilation
- skin irritation and sagging
- 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
- the presence of blood, protein and nitrogen in the urine may be detected by the doctor
Additional 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 the hair follicles, for example a sensation of pain, heat and redness
- rash in the mouth
- redness and rashes on the face
- slowed wound healing
- eye effects (cataracts, high eye pressure)
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, the use of large quantities and for a long period of time of OLUX can lead to a condition called Cushing's syndrome whose symptoms include a red, swollen and rounded face (called a full moon face), high blood pressure, weight gain and changes in blood and urine glucose levels.
- Prolonged steroid treatment can cause skin thinning.
In rare cases, the treatment of psoriasis with corticosteroids (or the suspension of the same) can lead to a worsening of the disease and the appearance of the pustular form of the same. After discontinuation of corticosteroid treatment, scalp dermatosis can sometimes reappear. If OLUX is not used correctly, pre-existing infections can also be aggravated.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
- The cylinder contains a flammable liquid under pressure.
- Do not store near open flames, ignition sources and any other heat source or electrical device that is turned on.
- Do not expose to temperatures above 50 ° C or direct sunlight.
- Do not pierce or burn the container even if it is empty.
- After treatment is complete, safely dispose of the container.
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 carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25 ° C. Do not refrigerate. Store upright.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What OLUX contains
1 g of OLUX cutaneous foam contains 500 micrograms of clobetasol propionate as the active ingredient.
The other ingredients are: anhydrous ethanol, purified water, propylene glycol, cetyl alcohol, stearyl alcohol, polysorbate 60, anhydrous citric acid, potassium citrate and propane / n-butane / isobutane propellant mixture.
Description of the appearance of OLUX and contents of the package
OLUX is a white skin foam in a pressurized container. Each container contains 50 or 100 grams. Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
OLUX 500 MCG / G SKIN FOAM IN CONTAINER UNDER PRESSURE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of skin foam contains 500 mcg of clobetasol propionate.
For the full list of excipients, see section 6.1.
Excipients: also contains cetyl alcohol 11.5 mg / g, stearyl alcohol 5.2 mg / g and propylene glycol 20.9 mg / g.
03.0 PHARMACEUTICAL FORM
Skin foam in pressurized container.
White foam that disintegrates on contact with the skin.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Short-term treatment of scalp dermatoses that respond to steroid therapy, such as psoriasis, but do not respond satisfactorily to less active steroid therapy.
04.2 Posology and method of administration
OLUX is an extremely potent topical corticosteroid; therefore, limit the treatment to no more than 2 consecutive weeks and do not exceed the dosage of 50 g / week.
Note: for correct foam delivery, hold the container upside down and press the dispenser.
Route of administration: for cutaneous use.
Avoid contact with eyes, nose and mouth. Do not use the product near an open flame.
Use in adults
OLUX should be applied to the affected area twice a day. There are no data from clinical studies aimed at evaluating the effectiveness of a single daily application.
Invert the container and dispense a small amount (equivalent to a walnut or a teaspoon) of OLUX directly on the lesions, or dispense a small amount into the cap of the container, on a saucer or on another cool surface, taking care to avoid contact with eyes, nose and mouth. It is not recommended to dispense the product directly on the palm of the hand, as the foam dissolves immediately in contact with the hot skin. Gently massage the affected area until the foam is completely absorbed and disappeared. Repeat the operation treating the entire affected area. Move the hair or hairs from the affected area, so as to proceed with the application on each affected area.
Use in children and adolescents
Since there are no data on the use of OLUX in children and adolescents, its use in such patients is not recommended.
04.3 Contraindications
OLUX is contraindicated in patients with hypersensitivity to clobetasol propionate, other corticosteroids or to any of the excipients. OLUX is also contraindicated in patients suffering from burns, rosacea, acne vulgaris, perioral dermatitis, perianal and genital itching.
OLUX is also contraindicated in the treatment of primary skin lesions caused by infections of a viral, fungal or bacterial nature.
OLUX should not be applied to the face.
04.4 Special warnings and appropriate precautions for use
Prolonged and continuous topical treatment should be avoided, as it can easily lead to adrenal suppression even in the absence of an occlusive dressing. When the lesions disappear, or after a treatment period not exceeding two weeks, switch to intermittent therapy or consider the possibility of substitution with a less potent steroid. In case of chronic intermittent use, it is advisable to periodically check the functionality of the hypothalamic-pituitary-adrenal axis (HPA).
Secondary infections may arise, necessitating the discontinuation of topical corticosteroid treatment and the administration of adequate antimicrobials.
Particular caution is required in patients with proven hepatic dysfunction.
Topical corticosteroids can be risky, as relapses can occur following the onset of tolerance phenomena. Patients may also be exposed to the risk of developing generalized pustular psoriasis and local or systemic toxicity due to the alteration of the barrier function of the skin. Careful monitoring of the patient is therefore important.
Unless under the supervision of a physician, OLUX should not be used with occlusive dressings.
Cases of cataract formation have been reported in the literature in patients undergoing prolonged treatment with corticosteroids. Although systemic corticosteroids cannot be ruled out as a causative factor, prescribers should be aware of the possible role of corticosteroids in cataract formation.
The medicine contains propylene glycol, which can cause skin irritation. It also contains cetyl alcohol and stearyl alcohol, which can cause local skin reactions (for example, contact dermatitis).
As no data are available on the use of OLUX in children and adolescents, its use in such patients is not recommended.
04.5 Interactions with other medicinal products and other forms of interaction
No interaction studies have been performed with OLUX.
04.6 Pregnancy and lactation
Administration of corticosteroids to pregnant animals may cause abnormalities of fetal development (see Section 5.3 Preclinical safety data). There have been no adequate and controlled studies of clobetasol propionate in pregnancy. Epidemiological studies conducted on pregnant women following the administration of oral corticosteroids have shown the absence or limited presence of the risk of cleft palate.
OLUX should not be used during pregnancy unless clearly necessary.
The safety of use of clobetasol propionate during breastfeeding has not been established. Since glucocorticosteroids are excreted with breast milk, OLUX should not be used during lactation unless strictly necessary.
04.7 Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed.
04.8 Undesirable effects
The most common adverse reactions associated with the use of skin foam formulations of clobetasol propionate observed in clinical studies are application site reactions, including burning (5%) and other unspecified reactions (2%).
Adverse reactions are classified by System Organ Class and Frequency, using the following convention: Very common (≥ 1/10), Common (≥ 1/100 to
Nervous system disorders - Very rare: paraesthesia.
Eye disorders - Very rare: eye irritation.
Vascular pathologies - Very rare: venous dilation.
Skin and subcutaneous tissue disorders - Very rare: dermatitis not otherwise specified, contact dermatitis, worsening of psoriasis, skin irritation, skin tenderness, skin tightness.
General disorders and administration site conditions - Common: burning at the application site, reaction at the application site not otherwise specified.
Very rare: application site erythema, application site itching, tenderness not otherwise specified.
Diagnostic tests - Very rare: presence of blood in the urine, increase in mean cell volume, presence of protein in the urine, azotemia.
As with other topical corticosteroids, prolonged use of large quantities or treatment of large areas may lead to adrenal suppression, usually transient in nature if the weekly dosage is not greater than 50 g in adults.
Prolonged and intensive treatment with a highly active corticosteroid preparation can cause local atrophic changes in the skin, such as thinning, striae and dilation of the superficial blood vessels, particularly when using occlusive bandages or when skin folds are involved.
In rare cases, the treatment of psoriasis with corticosteroids (or the suspension of the same) has been considered responsible for the appearance of the pustular form of the disease (see Paragraph 4.4 Special warnings and precautions for use).
Pigmentation changes and hypertrichosis have been observed following the administration of topical steroids.
If signs of hypersensitivity appear, applications should be discontinued immediately, as symptoms may worsen.
Other local adverse events associated with glucocorticosteroid treatment include: perioral dermatitis, rosacea dermatitis, late wound healing, rebound phenomenon that can result in corticosteroid dependence and ocular effects. The side effects of glucocorticosteroids also include increased intraocular pressure and an increased risk of cataracts. A contact allergy to OLUX or to one of the excipients may also occur. If the product is not used correctly, bacterial, viral, parasitic and fungal infections may be hidden and / or aggravated. Cases of folliculitis have also been reported.
04.9 Overdose
No cases of overdose have been reported. Following topical application, OLUX can be absorbed in quantities sufficient to determine systemic effects. If hypercortical phenomena are observed, the administration of topical steroids should be gradually suspended, under direct medical supervision, due to the risk of suppression of adrenal activity.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Very potent corticosteroids (group IV)
ATC code: D07A D01
Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive properties. The exact mechanism of the anti-inflammatory action of topical steroids in the treatment of dermatoses that respond to steroid therapy is generally uncertain. However, corticosteroids are thought to act by induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. These proteins are hypothesized to control the biosynthesis of potent inflammatory mediators, such as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
A study on vasoconstrictors has shown that OLUX is characterized by a power comparable, on the basis of skin whitening, to that of other formulations based on clobetasol propionate.
05.2 "Pharmacokinetic properties
Topical corticosteroids can be absorbed from intact, healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by numerous factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and / or other pathological processes of the skin can also lead to increased absorption. percutaneous.
Once absorbed through the skin, topical corticosteroids follow pharmacokinetic pathways similar to those of systemically administered corticosteroids. They are metabolized, mainly in the liver, and subsequently excreted via the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.
In a controlled pharmacokinetic study, 3 of 13 subjects experienced reversible adrenal suppression at any time during the 14 days of treatment with OLUX, in at least 20% of body surface area.
05.3 Preclinical safety data
Parenteral administration of corticosteroids, including clobetasol propionate, in pregnant animals can cause abnormal fetal development - for example, cleft palate and intrauterine growth retardation -. Animal studies have shown that intrauterine exposure to corticosteroids can contribute to the development of cardiovascular and metabolic diseases during adult life, but there is no evidence that these effects can also occur in humans. (you see Paragraph 4.6 Pregnancy and lactation).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Anhydrous ethanol
Purified water
Propylene glycol
Cetyl alcohol
Stearyl alcohol
Polysorbate 60
Anhydrous citric acid
Potassium citrate
Propellant: propane /n-butane / isobutane
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Do not store above 25 ° C. Do not refrigerate. Store upright.
The container contains a flammable liquid under pressure. Do not use near an open flame. Do not expose to temperatures above 50 ° C or direct sunlight. Do not puncture or burn the container, even if empty.
06.5 Nature of the immediate packaging and contents of the package
Pressurized aluminum container with shut-off valve, containing 50g or 100g of foam. The container is internally coated with a double coat of transparent epoxy-phenolic paint. Each filled container is inserted into a dispenser complete with dust cap.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Sandoz S.p.A
Largo U. Boccioni, 1
21040 Origgio (VA)
08.0 MARKETING AUTHORIZATION NUMBER
0.05% skin foam - 50 g pressurized container - A.I.C. 036580013 / M
0.05% skin foam - 100 g pressurized container - A.I.C. 036580025 / M
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
0.05% skin foam - 50 g pressurized container - 3 November 2005 / March 2009
0.05% cutaneous foam - container under pressure of g 100 - 3 November 2005 / March 2009
10.0 DATE OF REVISION OF THE TEXT
April 2012
