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2. Clobetasol 500micrograms/G Shampoo

Etrivex® 500 micrograms/g shampoo

(clobetasol propionate)

The name of your medicine is Etrivex 500 micrograms/g shampoo but will be referred to as Etrivex shampoo throughout this leaflet.

In this leaflet:

1.    What is Etrivex shampoo and what it is used for

2.    Before you use Etrivex shampoo

3.    How to use Etrivex shampoo

4.    Possible side effects

5.    How to store Etrivex shampoo

6.    Further information

1.    What is Etrivex shampoo and what it is used for

Etrivex shampoo contains the active substance called clobetasol propionate; it belongs to a group of medicines called topical corticosteroids (or steroids). Topical corticosteroids are further classified into groups depending on their strength; clobetasol propionate is a very strong corticosteroid. “Topical' means that it should only be applied to the surface of the skin. Topical steroids reduce the redness, itchiness and inflammation associated with skin conditions.

Scalp psoriasis is caused by the skin cells of your scalp being produced too quickly. Etrivex shampoo is used to treat scalp psoriasis of moderate intensity in adults.

2.    Before you use Etrivex shampoo Do not use Etrivex shampoo

•    if you have been told that you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients in Etrivex shampoo. Please check by reading the list of ingredients below. If you answer yes, you must inform your doctor before starting treatment.

•    If you have bacterial, viral, fungal or parasitic skin infections such as cold sores, varicella (chicken pox), herpes zoster (shingles), impetigo (type of rash on the face), ringworm, athletes foot, thrush, skin tuberculosis or skin disease caused by syphilis.

•    If you have ulcerous wounds (weeping wounds) on your scalp

•    In children under two years old

•    Do not apply Etrivex shampoo in the eyes (risk of glaucoma which is high pressure in the eye)

Take special care with Etrivex shampoo

•    If this product has been prescribed for a child or adolescent below 18 years of age, you must check with your doctor every week before continuing to use this product.

•    When using Etrivex shampoo, it must only be used on the scalp, do not use it as a regular shampoo or on other areas of the body and do not use Etrivex shampoo as a shower gel, body wash or bath foam.

•    When treating the scalp with Etrivex shampoo you must not cover the area being treated, for example: a shower cap must not be used as it may make the active substance pass through the skin and affect the other parts of the body.

•    When using Etrivex shampoo, avoid contact with the face, eyelids, axillae (armpits), erosive skin (chapped skin) surface and genital regions. Rinse off immediately with water if any product runs from the scalp.

•    If you get Etrivex shampoo in your eye(s), wash the affected eye thoroughly with water. If any irritation persists, please seek advice from your doctor.

•    If you do not notice an improvement of your scalp psoriasis, please see your doctor.

Using other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without a prescription. Pregnancy and Breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine. Do not use Etrivex shampoo if you are pregnant or breastfeeding unless your doctor clearly tells you to.

Driving and using machines:

Etrivex shampoo has no or very little influence on the ability to drive and use machines.

3.    How to use Etrivex shampoo

Always use Etrivex shampoo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual daily dose per application is an amount equivalent to around a half tablespoon (around 7.5 ml) sufficient to cover the entire scalp.

Unless your doctor has instructed otherwise, wash your hands and apply Etrivex shampoo directly to your dry scalp once daily taking care to well cover and massage the affected areas. Avoid using large amounts of Etrivex shampoo; only use enough to cover your scalp when dry. Wash your hands carefully after application. Leave the product to work for 15 minutes without covering, and then add water, rinse and dry your hair as usual. Your regular shampoo can be used if more shampoo is required to wash your hair. Do not add more of Etrivex shampoo to your hair.

Your doctor will tell you how long you need to use Etrivex shampoo for to control your scalp psoriasis. Treatment should not normally continue for more than 4 weeks. However, if your scalp psoriasis is significantly improved before the end of treatment, please see your doctor. On the contrary, if no improvement is seen by the end of the treatment, please tell your doctor. This treatment needs careful supervision; you should let your doctor review your progress at regular intervals. Do not use Etrivex shampoo for longer than your doctor tells you.

Nonetheless, your doctor may ask you to use Etrivex shampoo again in the future following a period of no use.

If you forget to use Etrivex shampoo, do not use a double dose on the next application to make up for a forgotten dose. Go back to your regular schedule. If you miss several doses, tell your doctor.

If you stop using Etrivex shampoo, please see your doctor. It may be that worsening of the disease occurs when treatment with Etrivex shampoo is stopped, especially if it has been used for a long time. Tell your doctor if you observe such a worsening of your skin conditions.

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

4.    Possible side effects

Like all medicines, Etrivex shampoo can have side effects, although not everybody gets them.

•    The following are common side effects affecting less than 1 in 10 people: skin discomfort, acne and eye burning or stinging.

•    The following are uncommon side effects affecting fewer than 1 in a 100 people: irritation, itching, urticaria, visible small vessels or thinning skin around the treated areas. These are generally of a mild to moderate nature.

•    If you have a burning sensation or redness to the areas that have been treated, do not use Etrivex shampoo until these symptoms have disappeared.

•    Stop using the medicine and tell your doctor as soon as possible if you find your condition gets worse during treatment (this is more likely to happen if you have been using Etrivex shampoo longer than prescribed) or if you experience swelling of the eyelids, face or lips as you may be allergic to the product or have a skin infection.

•    Using large amounts or keeping the product on the scalp for more than 15 minutes may:

-    cause the skin to become thinner so that it can damage more easily

-    allow the    active substance to pass through the skin ; this can affect other parts of the body, especially in children, and during pregnancy

•    Repeated courses of topical steroids over a long time may sometimes cause acne, pustular eruptions (big pimples) and changes in hair growth and skin colour. Striae (stretch marks), purpura (bruising), surface veins, erythema (skin redness) and contact dermatitis (local allergic reactions) may become noticeable

•    If you have rosacea (severe flushing of skin on and around the nose) the application of Etrivex shampoo on the face may cause your rosacea to worsen.

•    Application    of Etrivex shampoo on the face may induce perioral dermatitis (spotty red rash around the mouth).

•    Application    of Etrivex shampoo to the skin may cause thinning of skin and therefore it should never be used on the face or on other areas of the    skin

than the scalp.

•    If you have any unusual discomfort that you do not understand, tell your doctor as soon as possible.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5.    How to store Etrivex shampoo

Keep out of the sight and reach of children.

Do not use Etrivex shampoo after the expiry date which is stated on the carton/bottle label after ‘Exp'.

Discard the bottle 4 weeks after first opening. Store in the original container.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to measures will help to protect the environment.

6.    Further information

What Etrivex shampoo contains:

The active substance is clobetasol propionate

Each gram of shampoo contains 500 micrograms clobetasol propionate.

The other ingredients are: ethanol, coco alkyl dimethyl betaine, sodium laureth sulphate, polyquaternium-10, sodium citrate, citric acid monohydrate and purified water.

What Etrivex shampoo looks like and contents of the pack:

Etrivex shampoo is a thick, colourless to pale yellow semi transparent liquid shampoo with an alcoholic smell.

Etrivex shampoo is available in bottles of 125 ml.

Manufactured by:

Laboratoires Galderma, Zone Industrielle - Montdesir 74540, alby-sur-cheran, France.

Procured from within the EU and repackaged by the Product Licence holder:

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Etrivex® 500 micrograms/g shampoo

PL No: 18799/2420    ,    ,

| POM |

Leaflet date: 24.11.2014

Etrivex is a registered trademark of Galderma group of companies.

The name of your medicine is Clobetasol 500 micrograms/g shampoo but will be referred to as Clobetasol shampoo throughout this leaflet.

In this leaflet:

1.    What is Clobetasol shampoo and what it is used for

2.    Before you use Clobetasol shampoo

3.    How to use Clobetasol shampoo

4.    Possible side effects

5.    How to store Clobetasol shampoo

6.    Further information

1.    What is Clobetasol shampoo and what it is used for

Clobetasol shampoo contains the active substance called clobetasol propionate; it belongs to a group of medicines called topical corticosteroids (or steroids). Topical corticosteroids are further classified into groups depending on their strength; clobetasol propionate is a very strong corticosteroid. “Topical' means that it should only be applied to the surface of the skin. Topical steroids reduce the redness, itchiness and inflammation associated with skin conditions.

Scalp psoriasis is caused by the skin cells of your scalp being produced too quickly. Clobetasol shampoo is used to treat scalp psoriasis of moderate intensity in adults.

2.    Before you use Clobetasol shampoo Do not use Clobetasol shampoo

•    if you have been told that you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients in Clobetasol shampoo. Please check by reading the list of ingredients below. If you answer yes, you must inform your doctor before starting treatment.

•    If you have bacterial, viral, fungal or parasitic skin infections such as cold sores, varicella (chicken pox), herpes zoster (shingles), impetigo (type of rash on the face), ringworm, athletes foot, thrush, skin tuberculosis or skin disease caused by syphilis.

•    If you have ulcerous wounds (weeping wounds) on your scalp

•    In children under two years old

•    Do not apply Clobetasol shampoo in the eyes (risk of glaucoma which is high pressure in the eye)

Take special care with Clobetasol shampoo

•    If this product has been prescribed for a child or adolescent below 18 years of age, you must check with your doctor every week before continuing to use this product.

•    When using Clobetasol shampoo, it must only be used on the scalp, do not use it as a regular shampoo or on other areas of the body and do not use Clobetasol shampoo as a shower gel, body wash or bath foam.

•    When treating the scalp with Clobetasol shampoo you must not cover the area being treated, for example: a shower cap must not be used as it may make the active substance pass through the skin and affect the other parts of the body.

•    When using Clobetasol shampoo, avoid contact with the face, eyelids, axillae (armpits), erosive skin (chapped skin) surface and genital regions. Rinse off immediately with water if any product runs from the scalp.

•    If you get Clobetasol shampoo in your eye(s), wash the affected eye thoroughly with water. If any irritation persists, please seek advice from your doctor.

•    If you do not notice an improvement of your scalp psoriasis, please see your doctor.

Using other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without a prescription. Pregnancy and Breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine. Do not use Clobetasol shampoo if you are pregnant or breastfeeding unless your doctor clearly tells you to.

Driving and using machines:

Clobetasol shampoo has no or very little influence on the ability to drive and use machines.

3.    How to use Clobetasol shampoo

Always use Clobetasol shampoo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual daily dose per application is an amount equivalent to around a half tablespoon (around 7.5 ml) sufficient to cover the entire scalp.

Unless your doctor has instructed otherwise, wash your hands and apply Clobetasol shampoo directly to your dry scalp once daily taking care to well cover and massage the affected areas. Avoid using large amounts of Clobetasol shampoo; only use enough to cover your scalp when dry. Wash your hands carefully after application. Leave the product to work for 15 minutes without covering, and then add water, rinse and dry your hair as usual. Your regular shampoo can be used if more shampoo is required to wash your hair. Do not add more of Clobetasol shampoo to your hair.

Your doctor will tell you how long you need to use Clobetasol shampoo for to control your scalp psoriasis. Treatment should not normally continue for more than 4 weeks. However, if your scalp psoriasis is significantly improved before the end of treatment, please see your doctor. On the contrary, if no improvement is seen by the end of the treatment, please tell your doctor. This treatment needs careful supervision; you should let your doctor review your progress at regular intervals. Do not use Clobetasol shampoo for longer than your doctor tells you.

Nonetheless, your doctor may ask you to use Clobetasol shampoo again in the future following a period of no use.

If you forget to use Clobetasol shampoo, do not use a double dose on the next application to make up for a forgotten dose. Go back to your regular schedule. If you miss several doses, tell your doctor.

If you stop using Clobetasol shampoo, please see your doctor. It may be that worsening of the disease occurs when treatment with Clobetasol shampoo is stopped, especially if it has been used for a long time. Tell your doctor if you observe such a worsening of your skin conditions.

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

4.    Possible side effects

Like all medicines, Clobetasol shampoo can have side effects, although not everybody gets them.

•    The following are common side effects affecting less than 1 in 10 people: skin discomfort, acne and eye burning or stinging.

•    The following are uncommon side effects affecting fewer than 1 in a 100 people: irritation, itching, urticaria, visible small vessels or thinning skin around the treated areas. These are generally of a mild to moderate nature.

•    If you have a burning sensation or redness to the areas that have been treated, do not use Clobetasol shampoo until these symptoms have disappeared.

•    Stop using the medicine and tell your doctor as soon as possible if you find your condition gets worse during treatment (this is more likely to happen if you have been using Clobetasol shampoo longer than prescribed) or if you experience swelling of the eyelids, face or lips as you may be allergic to the product or have a skin infection.

•    Using large amounts or keeping the product on the scalp for more than 15 minutes may:

-    cause the skin to become thinner so that it can damage more easily

-    allow the    active substance to pass through the skin ; this can affect other parts of the body, especially in children,    and during pregnancy

•    Repeated courses of topical steroids over a long time may sometimes cause acne, pustular eruptions (big pimples)    and changes in hair growth and

skin colour. Striae (stretch marks), purpura (bruising), surface veins, erythema (skin redness) and contact dermatitis (local allergic reactions) may become noticeable

•    If you have rosacea (severe flushing of skin on and around the nose) the application of Clobetasol shampoo on the face may cause your rosacea to worsen.

•    Application    of Clobetasol shampoo on the face may induce perioral dermatitis (spotty red rash around the mouth).

•    Application    of Clobetasol shampoo to the skin may cause thinning of skin and therefore it should never be used on the face or on other areas of the

skin than the scalp.

•    If you have any unusual discomfort that you do not understand, tell your doctor as soon as possible.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5.    How to store Clobetasol shampoo

Keep out of the sight and reach of children.

Do not use Clobetasol shampoo after the expiry date which is stated on the carton/bottle label after ‘Exp'. The expiry date refers to the last day of that month

Discard the bottle 4 weeks after first opening. Store in the original container.

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.

6.    Further information

What Clobetasol shampoo contains:

The active substance is clobetasol propionate

Each gram of shampoo contains 500 micrograms clobetasol propionate.

The other ingredients are: ethanol, coco alkyl dimethyl betaine, sodium laureth sulphate, polyquaternium-10, sodium citrate, citric acid monohydrate and purified water.

What Clobetasol shampoo looks like and contents of the pack:

Clobetasol shampoo is a thick, colourless to pale yellow semi transparent liquid shampoo with an alcoholic smell.

Clobetasol shampoo is available in bottles of 125 ml.

Manufactured by:

Laboratoires Galderma, Zone Industrielle - Montdesir 74540, alby-sur-cheran, France.

Procured from within the EU and repackaged by the Product Licence holder:

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Clobetasol 500 micrograms/g shampoo

PL No: 18799/2420    I POM I

Leaflet date: 24.11.2014