Etrivex

Package leaflet: Information for the patient

Etrivex 500 micrograms/g shampoo

Clobetasol propionate
Please read this leaflet carefully before using 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Etrivex Shampoo contains an active substance called clobetasol propionate, which belongs to a class of medicines known as topical corticosteroids (or steroids). Topical corticosteroids are further classified into groups according to their potency; clobetasol propionate is a very potent corticosteroid.
"Topical" means that this medicine should 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 use Etrivex 500 micrograms/g shampoo

• If you are allergic (hypersensitive) to Clobetasol propionate or to any of the other ingredients of this medicine. Please check this by reading the list of excipients in section 6 below. If so, inform your doctor before starting treatment.
• If you have bacterial, viral, fungal, or parasitic skin infections, including facial herpes, chickenpox, herpes zoster, impetigo (a type of facial rash), ringworm, athlete’s foot, oral thrush, cutaneous tuberculosis, or skin manifestations of syphilis.
• If you have wounds (serous exudation 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. increased pressure in the eyes, and risk of cataract, which is clouding of the eye's lens).

Warnings and precautions
Be careful with Etrivex 500 micrograms/g shampoo

• Etrivex shampoo should be applied only to the scalp. Do not use this product as a regular shampoo or on other areas of the body, and do not use Etrivex shampoo as shower gel, body cleanser, or bath foam.
• During treatment with Etrivex shampoo on the scalp, do not cover the treated area; for example, do not wear a shower cap, as this could increase absorption of the active substance through the skin and potentially affect the function of other organs.
• During use of Etrivex shampoo, avoid contact of the product with the face, eyelids, armpits, eroded skin (cracked skin), and genital areas. If the product runs off the scalp, rinse immediately with water.
• If Etrivex shampoo gets into your eyes, thoroughly rinse the affected eye 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 weekly with your doctor whether continued use is still appropriate.

Other medicines and Etrivex 500 micrograms/g shampoo:
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those not requiring a prescription.
Pregnancy, breastfeeding and fertility:
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before using this medicine.
Driving and using machines:
The effect of Etrivex Shampoo on the ability to drive vehicles or operate machinery is none or
very slight.

3. How to use Etrivex 500 microgram/g shampoo

Always use Etrivex shampoo exactly as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist. The usual daily dose per application is approximately the amount contained in half a tablespoon (about 7.5 ml), sufficient to cover the entire scalp.

Unless otherwise instructed by your doctor, wash your hands and apply Etrivex Shampoo directly to the dry scalp once daily, taking care to thoroughly cover and massage the affected areas. Do not use large amounts of Etrivex shampoo; use only the quantity necessary to cover your dry scalp. Wash your hands thoroughly after application. Leave the product on for 15 minutes without occluding the treated areas; then add water, rinse, and dry your hair as usual. If another shampoo is needed to wash your hair, you may use your regular shampoo. Do not apply additional Etrivex shampoo to the hair.

Your doctor will inform you how long you should use Etrivex shampoo to control scalp psoriasis. Generally, treatment should not exceed 4 weeks. However, if your scalp psoriasis improves significantly before the end of the treatment period, consult your doctor. Conversely, if no improvement is observed by the end of the treatment period, you should still consult your doctor. This treatment must be carefully monitored; have regular check-ups so that your doctor can assess the progress of treatment. Do not use Etrivex shampoo for longer than prescribed by your doctor.

However, your doctor may ask you to restart treatment with Etrivex shampoo at a later time, after a treatment-free interval.

Use in children and adolescents
If this product has been prescribed for children or adolescents aged between 2 and 18 years, follow your doctor's instructions. Check with your doctor weekly to determine whether continued treatment is appropriate.

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

If you forget to use Etrivex shampoo
If you forget to use Etrivex shampoo, do not use a double dose in the next application to make up for the missed dose. Continue with your usual dosing schedule. If you miss multiple doses, inform your doctor.

If you stop using Etrivex shampoo
If you stop using Etrivex shampoo, consult your doctor. Stopping treatment with Etrivex shampoo may lead to worsening of the condition, especially if the product has been used for a prolonged period. If you notice such a worsening of scalp psoriasis, inform your doctor.

For any further questions about the use of this product, consult 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):

• Skin burning sensation
• 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 when applied to large areas or used for prolonged periods
• Stinging or burning sensation in the eyes
• Eye irritation
• Sensation of eyelids sticking together
• Glaucoma
• Hypersensitivity
• Headache
• Skin pain
• Skin discomfort
• Itching
• Acne
• Skin swelling
• Telangiectasia (blood vessels under the skin surface may become more visible)
• Worsening of psoriasis
• Hair loss
• Dry skin
• Hives
• Cutaneous atrophy (skin thinning)
• Skin irritation
• Skin tightness
• Allergic contact dermatitis
• Erythema
• Skin rash
• Irritation, itching, hives, couperosis or thinning of the skin around treated areas

These are generally mild to moderate in nature.

If you experience signs of local intolerance, such as a burning sensation or 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 worsening of your condition during treatment (this is more likely if you have used Etrivex shampoo for longer than prescribed), or if you develop swelling of the eyelids, face or lips, as you may be allergic to the product or have a skin infection.

Using large amounts of the product or leaving it on the scalp for more than 15 minutes may:

• cause skin thinning, making it more susceptible to damage;
• allow the active ingredient to pass through the skin; this may affect other organs, especially in children and pregnant women.

Repeated cycles of topical steroids over long periods may sometimes cause pustular eruptions (large pimples), changes in hair growth, and skin pigmentation. Stretch marks (striae) and purpura (bruising) may also become visible.

If you suffer from rosacea (facial redness associated with skin flushing and possible papules or pustules), applying Etrivex shampoo to the face may worsen this condition.

Applying Etrivex shampoo to the face may induce perioral dermatitis (red rash around the mouth).

Application of Etrivex shampoo on the skin may cause skin thinning; therefore, this medicine must never be used on the face or on any other skin areas apart from the scalp.

To avoid interaction with hair dye products, such as those used to change hair colour, Etrivex shampoo should be thoroughly rinsed off.

If you experience any unusual symptoms whose cause you do not understand, inform your doctor as soon as possible.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 carton. The expiry date refers to the last day of the month.
Store in the original plastic bottle to protect it from light.
Discard the bottle 6 months after first opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Etrivex 500 micrograms/g shampoo contains:

• The active substance is clobetasol propionate. Each gram (millilitre) of Etrivex shampoo contains 500 micrograms of the active substance clobetasol propionate.
• The other components are: ethanol, lauryl dimethylaminoacetic acid betaine, sodium laureth sulfate, polyquaternium-10, sodium citrate, citric acid monohydrate and purified water.

Description of the appearance of Etrivex shampoo and contents of the pack:
Etrivex shampoo is a dense, slightly transparent liquid shampoo with an alcoholic odour, ranging in appearance from colourless to pale yellow.
Etrivex shampoo is available by prescription only and comes in plastic bottles [high-density polyethylene (HDPE)] of 60 ml or 125 ml, white in colour, with snap caps made of polypropylene.
The 30 ml bottle made of high-density polyethylene (HDPE) is fitted with a screw cap in polypropylene. The bottles contain 30 ml, 60 ml or 125 ml of shampoo (it is possible that not all pack sizes are marketed).

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

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

This medicinal product is authorised in the European Economic Area countries under the following names:
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: