CLARELUX cutaneous foam


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CLARELUX cutaneous foam


CLARELUX 500 microgram/g cutaneous foam in pressurised container

(Clobetasol propionate)

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What CLARELUX is and what it is used for
2. Before you use CLARELUX
3. How to use CLARELUX
4. Possible side effects
5. How to store CLARELUX
6. Further Information

What Clarelux Is And What It Is Used For

CLARELUX is a foam to be applied to the skin, containing 500 microgram/g clobetasol propionate as the active ingredient. Clobetasol propionate belongs to a group of medicines known as topical corticosteroids.

CLARELUX is one of the stronger corticosteroids and is used as a short-term treatment for scalp conditions, e.g. psoriasis of the scalp, which do not respond satisfactorily to weaker corticosteroids.

Before You Use Clarelux Do not use CLARELUX: If you are allergic to clobetasol propionate, to other corticosteroids or any of the other ingredients of CLARELUX If you suffer from burns and other skin condition such as rosacea, acne, skin inflammation around the mouth, itching (pruritus) around the anus or genitals, or have a skin infection On any area of your body or face, apart from your scalp. Take special care with CLARELUX

As with all topical corticosteroids, CLARELUX can be absorbed through the skin and can cause side effects- see Section 4 for all possible side effects. Due to this:

Long-term treatment with CLARELUX should be avoided. CLARELUX should not be applied to a large surface area. The treated areas should not be bandaged or covered unless directed by your doctor

When your skin condition is better or after a maximum duration treatment of two weeks, your doctor should modify or change your treatment.

Inform your doctor:

If your condition does not improve after 2 weeks of treatment. If an infection occurs, as this may require discontinuation of treatment with CLARELUX. If you have a problem with your liver. If you start to experience problems with your vision, as this type of medicine may increase the development of cataracts.

Children and adolescents: Treatment is not recommended in children and adolescents.

Driving and using machines: CLARELUX should not affect your ability to drive or operate machines.

Using other Medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Pregnancy and breast-feeding

Please inform your doctor if you are pregnant, planning to become pregnant, breast-feeding or planning to breast-feed. CLARELUX should not be used during pregnancy or breast-feeding unless advised by your doctor.

Important information about some of the ingredients in CLARELUX

CLARELUX contains propylene glycol, which may cause skin irritation. It also contains cetyl and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

How To Use Clarelux


The canister contains a pressurised, flammable liquid.

Do not use or store near a naked flame, source of ignition, any heat generating material or electrical device in use.

Do not smoke whilst using or holding this can.

Always use CLARELUX exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Use this medication only for the condition for which it was prescribed. CLARELUX must only be applied to the scalp and should not be swallowed.

Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin.

Apply CLARELUX to the affected area of the scalp twice a day, once in the morning and once at night, as follows:

1. Shake the can well.

2. Turn the can upside down and squirt a small amount (the size of a walnut) either directly onto the scalp, or into the cap of the can, onto a saucer or other cool surface and then onto the scalp.
Clarelux should always be applied thinly, so use as little as possible when covering the affected areas. The exact amount you need depends on the size of the affected area.
Do not apply to the eyelids and take care to avoid contact with eyes, nose, and mouth.
Do not squirt CLARELUX onto your hands, as the foam will begin to melt immediately upon contact with warm skin.

3. Move the hair away from the foam and gently massage into the scalp, until it disappears and is absorbed. Repeat if necessary, to treat the entire affected area.

Wash your hands after applying CLARELUX and discard any unused foam.

Do not use CLARELUX on your face. If some foam accidentally gets into your eyes, nose or mouth, rinse immediately with cold water. You may feel a stinging sensation. Contact your doctor, if the pain continues.

The treated areas should not be bandaged or covered unless directed by your doctor.

Do not wash or rinse the treated scalp areas immediately after applying CLARELUX.

Do not use more than 50g of CLARELUX foam per week.

Treatment should not be given for more than 2 weeks. After this period CLARELUX may be used occasionally if needed. Alternatively your doctor may prescribe a weaker steroid to control your condition.

If you use more CLARELUX than you should

If you use CLARELUX Foam in a larger quantity or for a long period of time without your doctor’s knowledge you should tell your doctor immediately.

If you forget to use CLARELUX, use it as soon as you remember, then continue as before. If you only remember at the time of your next dose, use a single dose and continue as before (do not apply a double dose to make up for the forgotten dose). If you miss several doses, tell your doctor.

If you stop using CLARELUX

Do not stop using CLARELUX suddenly as this may harm you. Your doctor may need to discontinue the treatment gradually and you may need regular check-ups.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, CLARELUX can cause side effects, although not everybody gets them.

Stop using CLARELUX and contact your doctor immediately if hypersensitivity reactions occur, such as local irritation.

The side effects may include:

Common side effects (occurring in less than 1 in 10 people but more than 1 in 100):

Burning sensation Other skin reaction when applied to the skin

Very rare effects (occurring in less than 1 in 10,000 people):

Sensation of tingling or pricking Eye irritation Swollen veins Skin irritation and tenderness Skin tightness Itchy skin rash (contact dermatitis) Aggravated scaly skin rash (psoriasis aggravated) Redness at the application site Itching and sometimes with pain at the application site Presence of blood, protein and nitrogen in your urine may be detected by a doctor

Additional side effects may include:

Changes in hair growth (abnormal hair growth away from the application site and on unusual parts of the body ) Changes in skin colour Irritation of the hair follicules e.g. pain, heat and redness Mouth rashes Redness and eruptions on the face Delay in wound healing Effects on the eyes

Side effects caused by pronged use include:

White markings on skin (striae) and dilatation of the blood vessels of the skin As with other topical corticosteroids, when CLARELUX is used in large amounts and for a long period of time, this can lead to a disorder called Cushing’s syndrome which symptoms include a red, puffy and rounded face (called a moon face), high blood pressure, weight gain and changes in sugar levels in the blood and urine. Prolonged treatment with steroids may cause thinning of the skin.

In rare instances, treatment of psoriasis with corticosteroids (or on stopping treatment) may make the condition worse and a pustular form of the disease may occur. On stopping treatment with corticosteroids, sometimes, the scalp condition may return. Also pre-existing infections may worsen if CLARELUX is not used according to the instructions. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Clarelux The canister contains a pressurised, flammable liquid. Do not store near a naked flame, source of ignition, any heat generating material or electrical device in use. Do not expose to temperatures higher than 50?C or to direct sunlight. Do not pierce or burn the can even when empty. When you have finished your treatment, dispose of the can safely.

Keep out of the reach and sight of children.

Do not use CLARELUX after the expiry date which is stated on the can and the outer 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Clarelux Contains

1 g of CLARELUX contains 500 microgram of clobetasol propionate as active substance.

The other ingredients are: ethanol anhydrous, purified water, propylene glycol, cetyl alcohol, stearyl alcohol, polysorbate 60, citric acid anhydrous, potassium citrate and a propane/n-butane/isobutane propellant mixture.

What Clarelux Looks Like And Contents Of The Pack

CLARELUX is a cutaneous white foam. Each can of CLARELUX contains 50 or 100 grams.

Marketing Authorisation Holder : Pierre Fabre Dermatologie 45 place Abel Gance 92100 Boulogne France 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 EEA under the following names:

CLARELUX 500 microgram/g cutaneous foam in Austria, Belgium, Finland, Germany, Greece, Iceland, Ireland, Luxemburg, The Netherlands, Norway, Portugal, United-Kingdom and Spain.

OLUX 500 microgram/g cutaneous foam in Italy.

For any information on this product please contact:

Pierre Fabre Ltd Phone: + 44 (0)1962 874400

Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information:

United Kingdom: Clarelux PL20693/0004

Ireland: Clarelux PA1230/1/1

This is a service provided by the Royal National institute of the blind.

Clarelux is a trademark of Pierre Fabre Dermatologie.

Sold under Stiefel License - Patent n° GB 9504265

This leaflet was last approved in June 2008.

CLARELUX cutaneous foam

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