Patient leaflet - ETRIVEX 500 MICROGRAMS / G SHAMPOO
Etrivex® 500 micrograms/g shampoo
(clobetasol propionate)
Patient Information Leaflet
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
-
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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Etrivex 500 micrograms/g shampoo but will be referred to as Etrivex shampoo throughout the leaflet.
What is in this leaflet:
What Etrivex shampoo is and what it is used for
22) What you need to know before you use Etrivex shampoo
How to use Etrivex shampoo
^4) possible side effects
How to store Etrivex shampoo
j5^ contents of the pack and other information
J) What Etrivex shampoo is 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.
[a What you need to know 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 listed in section 6 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 or on eyelids (risk of glaucoma which is high pressure in the eye and risk of cataract which is a clouding of the lens in the eye).
Warnings and precautions
Take special care with Etrivex shampoo
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.
-
Contact you doctor if you experience blurred vision or other visual disturbances.
Children and adolescent
-
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.
Other medicines and Etrivex shampoo
Tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without a prescription.
Pregnancy, breast-feeding and Fertility
If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Etrivex shampoo has no or very little influence on the ability to drive and use machines.
[3b How to use Etrivex shampoo
Etrivex® 500 micrograms/g shampoo
(clobetasol propionate)
Patient Information Leaflet (continued)
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 effect (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 syndrome), have been observed with potent topical steroids, especially when applied on large surface areas or used for prolonged periods
-
Eye stinging or burning
-
Eye irritation
-
Ocular tight sensation
-
Glaucoma
-
Hypersensitivity
-
Headache
-
Pain of skin
-
Skin discomfort
-
Itching
-
Acne
-
Skin oedema
-
Telangiectasia (veins under the surface of your skin may becoming more noticeable)
-
Psoriasis aggravation
-
Hair loss
-
Dryness of the skin
-
Urticaria
-
Skin atrophy (thinning of your skin)
-
Skin irritation
-
Skin tightness
-
Allergic contact dermatitis
-
Erythema
-
Rash
Not known (frequency cannot be estimated from the available data)
-
Blurred vision
Irritation, itching, urticaria, visible small vessels or thinning skin around the treated areas are generally of a mild to moderate nature.
-
If you have any sings of local intolerance, such as 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 also sometimes cause, pustular eruptions (big pimples) and changes in hair growth and skin colour. Striae (stretch marks) and purpura (bruising) may become noticeable
-
If you have rosacea (facial erythema associated with flushing of the skin, and possible papulopustules) the application of Etrivex shampoo on the face may cause your skin condition 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.
-
In order to avoid interaction with hair colour dying product, such as hair colour changes, Etrivex shampoo should be thoroughly rinsed.
-
* If you have any unusual discomfort that you do not understand, tell your doctor as soon as possible.
How to store Etrivex shampoo
Keep out of the sight and reach of children.
Store in the original container to protect it from light.
Discard 6 months after opening.
Do not use this medicine after the expiry date shown on the carton or bottle label. The expiry date refers to the last day of that month.
If your doctor tells you to stop using the medicine, take any remaining medicine back to the pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration, ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via waterwaste or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
What Etrivex shampoo contains:
The active substance is clobetasol propionate.
One gram of Etrivex Shampoo contains 500 micrograms of clobetasol propionate.
Also contains: 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 viscous, translucent, colourless to pale yellow liquid shampoo with alcoholic odour.
Each carton contains 1×125 ml bottle
Manufacturer and Licence Holder
Manufactured by Laboratoires Galderma, Z.I.- Montdesir, 74540, Alby-sur-Cheran, France and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
POM PL 15184/1519
Etrivex is a registered trademark of GALDERMA, S.A.
Leaflet revision date: 24/08/20
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet in a format suitable for you