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CLOBETASOL PROPIONATE 500 MICROGRAMS/G SHAMPOO

Active substance(s): CLOBETASOL PROPIONATE

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Assessed against UK PIL dated November 2007
By Aneela Mahmood at 11:19 am, Oct 08, 2015

PAITENT INFORMATION LEAFLET

Etrivex® 500 micrograms/g shampoo / Clobetasol Propionate 500 micrograms/g shampoo
(clobetasol propionate)
This product is available as any of the above names but will be referred to as Etrivex shampoo throughout the following leaflet.
Read all of this leaflet carefully before you start using this medicine.
− Keep this leaflet. You might need to read it again.
− If you have further questions, please ask your doctor or your pharmacist.
− This medicine has been prescribed for you personally and you should 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 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 this product has been prescribed for children or adolescents between the ages of 2 and 18 years, the instructions given by your
doctor must be followed. You must check with the doctor every week before continuing treatment.
If you have used Etrivex shampoo for much longer than you should, please see your doctor. This product is for use on the scalp
only. Do not swallow it. If you accidentally do so, small amounts are not harmful. If you are not sure, seek immediate medical advice.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.
5. How to store Etrivex shampoo
Keep out of the sight and reach of children.
Store in the original container.
Discard the bottle 4 weeks after first opening.
Do not use Etrivex shampoo after the expiry date which is stated on the bottle and the carton. The expiry date refers to the last day of
that month.
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.
If your medicine becomes discoloured or show signs of any deterioration, consult your doctor or pharmacist who will tell you what to do.
6. Further information
What Etrivex shampoo contains:
The active substance is clobetasol propionate.
One gram of shampoo contains 500 micrograms of clobetasol propionate.
The other ingredients are: ethanol, coco alkyl dimethyl betaine, sodium laureth sulfate, 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, semi transparent liquid shampoo with an alcoholic smell that is colourless to pale yellow in appearance.
Etrivex shampoo is available on prescription from your doctor in white high density polyethylene (HDPE) plastic bottles fitted with
polypropylene snap closure. Bottle contains 125 ml of shampoo.
PL: 15814/1135

POM

Manufactured by Laboratoires Galderma, Alby-sur-Cheran, France.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford,
Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 25.09.2015.
Etrivex is a registered trademark of Galderma, S.A., Switzerland.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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