ETRIVEX 500 MCG/G Szampon

Treść ulotki

1. Etrivex 500 micrograms/g shampoo
   1. What is Etrivex shampoo 500 micrograms/g and what is it used for
   2. What you need to know before using Etrivex shampoo 500 micrograms/g
   3. How to use Etrivex 500 micrograms/g shampoo
   4. Possible side effects
   5. How to store Etrivex 500 micrograms/g shampoo
   6. Package Contents and Other Information

Etrivex 500 micrograms/g shampoo

Clobetasol propionate

Read this leaflet carefully before you use 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Etrivex shampoo 500 micrograms/g is and what it is used for
• 2. What you need to know before you use Etrivex shampoo 500 micrograms/g
• 3. How to use Etrivex shampoo 500 micrograms/g
• 4. Possible side effects
• 5. How to store Etrivex shampoo 500 micrograms/g
• 6. Contents of the pack and other information

1. What is Etrivex shampoo 500 micrograms/g and what is it used for

Etrivex Shampoo contains an active ingredient called clobetasol propionate which belongs to
a class of medications called topical corticosteroids (or steroids). Topical corticosteroids are
further classified into groups depending on their potency; clobetasol propionate is a
very potent corticosteroid.
“Topical” means that this medication must be applied only to the surface of the skin. Topical
steroids reduce redness, itching and inflammation associated with various skin conditions.
Scalp psoriasis is caused by an accelerated production of skin cells on the
scalp. Etrivex Shampoo is indicated for the treatment of moderate scalp psoriasis in adults.

2. What you need to know before using Etrivex shampoo 500 micrograms/g

Do not useEtrivex 500 micrograms/g shampoo

• If you are allergic (hypersensitive) to Clobetasol propionate or to any of the other ingredients of this medicine. Please, verify this information by reading the list of excipients reported in paragraph 6 below. If so, inform your doctor before starting treatment.
• If you suffer from bacterial, viral, fungal or parasitic skin infections including facial herpes, chickenpox, herpes zoster, impetigo (a type of facial rash), ringworm, athlete's foot, thrush, cutaneous tuberculosis or skin manifestations of syphilis.
• If you have wounds (serous exudates from skin lesions) on the scalp.
• In children under 2 years of age.
• Do not apply Etrivex shampoo to the eyes or eyelids (risk of glaucoma, i.e. high pressure in the eyes and risk of cataract, which is an opacity of the eye's lens).

Warnings and precautionsBe careful withEtrivex 500 micrograms/g shampoo

• Etrivex shampoo must be applied only to the scalp. Do not use this product as a normal shampoo or on other areas of the body and do not use Etrivex shampoo as a shower gel, body cleanser or foam bath.
• During treatment with Etrivex shampoo on the scalp, do not occlude the area you are treating: for example, do not use a shower cap, as this could allow the active ingredient to penetrate through the skin and compromise the function of other organs.
• During the use of Etrivex shampoo, avoid contact of the product with the face, eyelids, armpits, eroded skin (cracked skin) and the genital area. If the product should drip from the scalp, rinse immediately with water.
• If Etrivex shampoo gets into your eyes, wash the affected eye thoroughly with water. If irritation persists, consult your doctor.
• If you do not notice any improvement in scalp psoriasis, consult your doctor.

Children and adolescents

• If this product has been prescribed for children or adolescents under 18 years of age, check with your doctor every week to see if it is appropriate to continue using it.

Other medicines and Etrivex 500 micrograms/g shampoo:
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.

Pregnancy, breastfeeding and fertility:
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your
doctor or pharmacist for advice before using this medicine.

Driving and operating machinery:
The effect of Etrivex Shampoo on the ability to drive vehicles or operate machinery is nil or
very slight.

3. How to use Etrivex 500 micrograms/g shampoo

Always use Etrivex shampoo exactly as your doctor has instructed. If you have any doubts, ask your
doctor or pharmacist. The usual daily dose for application is equivalent to approximately
the amount of product contained in half a tablespoon (about 7.5 ml), sufficient to
cover the entire scalp.
Unless otherwise indicated by your doctor, wash your hands and apply Etrivex Shampoo directly to the

dry scalponce a day, being careful to thoroughly cover and massage the
affected areas. Do not use large quantities of Etrivex shampoo, use only the amount necessary
to cover your dry scalp. Wash your hands thoroughly after application. Leave
the product on for 15 minutes without occludingthe treated areas; then add
water, rinse and dry your hair as usual. If you need to use another shampoo to wash your hair,
you can use your usual shampoo. Do not apply any other Etrivex
shampoo to your hair.
Your doctor will tell you how long you should use Etrivex shampoo to control
scalp psoriasis. Generally, treatment should not exceed 4 weeks.
However, if your scalp psoriasis should improve significantly before the end
of treatment, consult your doctor. If, on the other hand, no
improvement occurs by the end of treatment, consult your doctor anyway. This treatment
must be carefully monitored; have regular check-ups so that
your doctor can monitor the progress of the treatment. Do not use Etrivex shampoo for longer than
as indicated by your doctor.
However, your doctor may ask you to resume treatment with Etrivex shampoo in the future,
after a period of interruption of therapy.

Use in children and adolescents
If this product has been prescribed for children or adolescents between the ages of 2 and 18, follow
your doctor's instructions. Check with your doctor every week to see if it is appropriate
to continue treatment.

If you use moreEtrivex shampoothan you should
If you have used Etrivex shampoo for a longer period than recommended, consult your
doctor. This product is only intended for the scalp. Do not
ingest. In case of accidental ingestion, small amounts are not harmful. If you are not
sure whether you have ingested a minimal amount of product, seek immediate medical
assistance.

If you forget to useEtrivex shampoo
If you forget to use Etrivex shampoo, do not use a double dose
in the next application to make up for forgetting the previous dose.
Continue with your usual application schedule. If you miss more doses, tell your
doctor.

If you stop using Etrivex shampoo
If you stop using Etrivex shampoo, consult your doctor. When you
stop treatment with Etrivex shampoo, a worsening of the disease may occur,
especially if the product has been used for a long period. If you
notice a similar worsening of scalp psoriasis, tell your
doctor. For any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Etrivex shampoo may cause the following side effects:
Common side effects (may affect up to 1 in 10 people):

• Burning sensation of the skin
• Inflammation of one or more hair follicles

Uncommon side effects (may affect up to 1 in 100 people):

• Endocrine disorders (such as adrenal suppression, Cushing's syndrome) have been observed with potent topical steroids, especially if applied to large areas or used for prolonged periods
• Stinging or burning sensation in the eyes
• Eye irritation
• Feeling of closed eyes
• Glaucoma
• Hypersensitivity
• Headache
• Skin pain
• Skin discomfort
• Itching
• Acne
• Skin edema
• Telangiectasia (veins under the skin surface may become more visible)
• Worsening of psoriasis
• Hair loss
• Skin dryness
• Urticaria
• Skin atrophy (thinning of the skin)
• Skin irritation
• Skin tightness
• Allergic contact dermatitis
• Erythema
• Rash
• Irritation, itching, urticaria, couperose or thinning of the skin around the treated areas
• are generally mild to moderate in nature.
• If you experience signs of local intolerance, such as a burning sensation or notice redness in the treated areas, do not use Etrivex shampoo until these symptoms disappear.
• Stop using the medicine and consult your doctor as soon as possible if you notice a worsening of your condition during treatment (this is more likely to occur if you have used Etrivex shampoo for a longer period 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 of product or leaving the product on the scalp for more than 15 minutes may:
• cause thinning of the skin, which can then be damaged more easily;
• allow the active ingredient to pass through the skin; this can compromise other organs, especially in children and pregnant women.
• Repeated cycles of topical steroids for long periods can sometimes also cause pustular eruptions (large pimples) and changes in hair growth and skin color. Striae (stretch marks) and purpura (bruising) can also become evident.
• If you suffer from rosacea (facial erythema associated with skin redness with possible papules and pustules), applying Etrivex shampoo to the face may worsen this condition.
• Applying Etrivex shampoo to the face may induce perioral dermatitis (red patchy rash around the mouth).
• Applying Etrivex shampoo to the skin may cause it to thin and, therefore, this medicine should never be used on the face or on other areas of the skin other than the scalp.
• In order to avoid interaction with hair dyeing products, such as those for changing hair color, Etrivex shampoo must be rinsed thoroughly.
• If you experience any unusual discomfort of which you do not understand the cause, tell your doctor as soon as possible.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
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 Etrivex 500 micrograms/g shampoo

Keep this medicine out of the sight and reach of children.
Do not use Etrivex shampoo after the expiry date stated on the bottle and the packaging. The expiry date refers to the last day of the month.
Store in the original plastic bottle in order to protect it from light.
Dispose of the bottle 6 months after its first opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Etrivex 500 micrograms/g shampoo contains:

• The active ingredient is clobetasol propionate. Each gram (millilitre) of Etrivex shampoo contains 500 micrograms of the active ingredient clobetasol propionate.
• The other ingredients are: ethyl alcohol, lauryl amino dimethyl acetobetaine, sodium laureth sulfate, polyquaternium-10, sodium citrate, citric acid monohydrate and purified water.

Description of the appearance of Etrivex shampoo and package contents:
Etrivex shampoo is a dense, semi-transparent liquid shampoo, with an alcoholic odour, with an
appearance from colourless to pale yellow.
Etrivex shampoo is available on prescription only and is available in plastic [high density polyethylene (HDPE)] bottles of
60 ml or 125 ml, white, with snap-on caps made of
polypropylene.
The 30 ml bottle in high density polyethylene (HDPE) is equipped with a screw cap made of
polypropylene. The bottles contain 30 ml, 60 ml or 125 ml of shampoo (not all pack sizes may be
marketed).

Marketing Authorisation Holder:
GALDERMA Italia S.p.A.
Via dell’Annunciata 21, Milan

Manufacturer:
Laboratoires Galderma, Z.I., Montdésir
74540, Alby-sur-Chéran
France

This medicinal product is authorised in the Member States of the European Economic
Area with the following denominations:
United Kingdom, Italy, Ireland and Portugal: Etrivex 500 micrograms/g shampoo
France, Germany, Belgium, Poland, Spain, Hungary, Netherlands, Sweden, Denmark, Austria,
Luxembourg, Iceland, Czech Republic, Norway, Greece, Slovakia and Finland: Clobex 500
micrograms/g shampoo

This leaflet was last approved on: