Label: information for the patient

Clobex 500 micrograms/g shampoo

clobetasol propionate

1. What it isClobex shampoo and its use

2. What you need to know before starting to use Clobex shampoo

3. How to useClobex shampoo

4. Possible adverse effects

5. Storage ofClobex shampoo

6. Contents of the package and additional information

Clobex shampoo contains the active ingredient called clobetasol propionate; it belongs to a group of medicines called corticosteroids (or steroids). “Topical” means it should be applied, only, to the surface of the skin. Topical steroids reduce redness, itching, and inflammation associated with skin diseases.

Psoriasis of the scalp is caused by a too rapid production of skin cells on the scalp. Clobex shampoo is used to treat moderate intensity scalp psoriasis in adults.

Topical corticosteroids (e.g. shampoos, creams, and ointments) are classified into four groups depending on their potency. They are divided into mild, moderately potent, potent, or very potent.

Clobetasol propionate is classified as a very potent corticosteroid.

Do not use Clobex shampoo

• If you are allergic to clobetasol propionate or any of the other components of this medication (listed in section 6). If your answer is affirmative, you must inform your doctor before starting treatment.
• If you have skin infections such as bacterial, viral, fungal, or parasitic infections, including herpes, chickenpox, herpes zoster (herpes), impetigo (a type of facial rash), ringworm, athlete's foot, aphthae, cutaneous tuberculosis, or a skin disease caused by syphilis.
• If you have ulcerous wounds (suppurating wounds)on your scalp.
• Under the age of 2 years.
• Do not apply Clobex shampoo to your eyes or eyelids (risk of glaucoma, which is high eye pressure, and risk of cataract, which is a loss of transparency of the crystalline lens in the eye).

Warnings and precautions

Consult your doctor or pharmacist before using Clobex shampoo if:

• You are using other oral/topical corticosteroids or medications to control your immune system (e.g., for autoimmune diseases or after a transplant). The combination of Clobex shampoo with these medications may lead to severe infections.

Be extra careful with Clobex shampoo

• When using Clobex shampoo, it should only be used on the scalp, do not use it as a daily shampoo or on other parts of the body, and do not use Clobex shampoo as a body wash, shower gel, or bath foam.
• When treating your scalp with Clobex shampoo, do not cover the area being treated, for example: do not use a shower cap as it may allow the active ingredient to pass through the skin and affect other parts of the body.
• When using Clobex shampoo, avoid contact with the face, eyelids, armpits (axillae), eroded skin surfaces(damaged skin)or genital areas. Rinse immediately with water if the product spreads to an area outside the scalp.
• If Clobex shampoo enters the eye(s), rinse the affected eye completely with water. If irritation persists, consult your doctor.
• If you do not notice an improvement in your scalp psoriasis, consult your doctor.
• Contact your doctor if you experience blurred vision and other visual disturbances.
• Consult your doctor or pharmacist if you experience new bone pain or worsening of previous bone symptoms during treatment with Clobex shampoo, especially if you have been using Clobex shampoo for a prolonged period or repeatedly.

Children and adolescents

• If this medication has been prescribed to a child or adolescent under 18 years old, you must consult with your doctor weekly before continuing to use this medication.

Using Clobex shampoo with other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Clobex shampoo has little or no influence on the ability to drive or operate machinery.

Clobex shampoo contains ethanol

This medication contains 100 mg of alcohol (ethanol) per gram, which is equivalent to 10% by weight. It may cause a burning sensation on damaged skin.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts. The normal daily dose for application is the amount equivalent to approximately half a teaspoonful (approximately 7.5 ml), sufficient to cover the entire scalp.

Unless your doctor has told you otherwise, wash your hands and apply Clobex shampoo directly to your dry scalp once a day, taking care to cover it well, and massage the affected areas. Avoid using large amounts of Clobex shampoo, use only enough to cover your scalp when it is dry. Wash your hands carefully after application. Leave the product to act on the scalp for 15 minutes, uncovered so that it can take effect, and then add water, rinse and dry your hair as usual. You can use your regular shampoo if you need more shampoo to wash your hair. Do not add more Clobex shampoo to your hair.

Your doctor will inform you for how long you need to use Clobex shampoo for the control of your scalp psoriasis. The treatment should not last more than 4 weeks. However, if your scalp psoriasis improves significantly before the end of treatment, please see your doctor. If, on the other hand, no improvement is seen at the end of treatment, please let your doctor know. This treatment needs to be carefully monitored; you should allow your doctor to evaluate your progress at regular intervals. Do not use Clobex shampoo for a longer time than indicated by your doctor.

However, your doctor may instruct you to use Clobex shampoo again in the future, after a period without using it.

Use in children and adolescents

If the medication has been prescribed to a child or adolescent between the ages of 2 and 18, follow the instructions given by the doctor. You should see the doctor every week before continuing with the treatment.

If you use more Clobex shampoo than you should

If you use more Clobex shampoo than you should, see your doctor. This medication is only for use on the scalp. Do not ingest it. If you ingest it accidentally, small amounts are not harmful. If you are unsure, see your doctor immediately.

If you forgot to use Clobex shampoo

Do not use a double dose to compensate for the missed doses. Continue with the treatment indicated by your doctor. If you have forgotten to use it several times, inform your doctor.

If you interrupt the treatment with Clobex shampoo

If you interrupt the treatment with Clobex shampoo, see your doctor. It may occur that, when stopping using Clobex shampoo, your psoriasis worsens, especially if it has been used for a long period of time. Inform your doctor if you observe a worsening of your scalp psoriasis.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.Clobex shampoo may cause the following side effects.

Frequent: may affect up to 1 in 10 people:

• Skin burning sensation.
• Inflammation of one or more hair follicles.

Rare: 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 for prolonged periods.
• Burning or stinging in the eyes.
• Irritation of the eyes.
• Tightness sensation in the eyes
• Glaucoma
• Hypersensitivity
• Headache
• Cutaneous pain
• Cutaneous discomfort
• Itching
• Acne
• Cutaneous edema
• Telangiectasias (the veins under the surface of your skin may become more visible)
• Worsening of psoriasis.
• Hair loss
• Skin dryness
• Urticaria
• Skin atrophy (skin thinning)
• Skin irritation.
• Skin tightness
• Contact dermatitis
• Erythema.
• Rash.

Unknown: the frequency cannot be estimated from available data:

• Blurred vision

• Irritation, itching, urticaria, small visible veins or skin thinning around treated areas are generally mild to moderate in nature. If you experience any signs of local intolerance such as burning sensation or redness in areas treated, do not use Clobex shampoo until these symptoms have disappeared.
• If your condition worsens during treatment (this is more likely to occur if Clobex shampoo is used for longer than indicated), or you experience swelling of the eyelids, face, or lips, indicating that you may be allergic to the product or have a skin infection, discontinue use of the medication and inform your doctor as soon as possible.
• Using larger amounts of the product or leaving it on the scalp for more than 15 minutes may:

- make the skin thinner and more prone to damage.

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

• Repeated courses of topical steroids for a long period of timemay occasionally produce pustular eruptions (large pimples) and changes in hair growth and skin color. Stretch marks (striae) and purpura (bruising) may be observed.
• If you have rosacea (facial erythema associated with skin redness and possible appearance of papulopustules) applying Clobex shampoo to the face may worsen your skin condition.
• Applying Clobex shampoo to the face may induce perioral dermatitis (rash around the mouth).
• Applying Clobex shampoo to the skin may cause skin thinning, so it should never be used on the face or other areas of skin other than the scalp
• To avoid interaction with hair dyes, such as changes in hair color, Clobex shampoo must be thoroughly rinsed.
• If you experience any unusual discomfort that you cannot explain, inform your doctor as soon as possible.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

.

Keep this medicationout of the reach and sight of children.

Do not usethis medicationafter the expiration date that appears on the packaging and on the bottle after EXP.The expiration date is the last day of the month indicated.

Store in the original plastic bottle to protect it from light.

Dispose of the bottle 6 months after first opening.

Medications should not be thrown away through drains or in the trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

Clobex Shampoo Composition

The active ingredient is clobetasol propionate.

Each gram (milliliter) of Clobex Shampoo contains 500 micrograms of the active ingredient clobetasol propionate.

The other components are: ethanol, coco alquil dimetil betaine, laureth sulfato sódico, poliquaternium-10, citrato sódico, ácido cítrico monohidrato, and purified water.

Product appearance and packaging contents

Clobex Shampoo is a thick, semi-transparent liquid shampoo with an alcohol odor and an incolor to light yellow appearance.

Clobex Shampoo must be obtained with a medical prescription from your doctor and is packaged in white high-density polyethylene (PEAD) plastic bottles of 60 ml or 125 ml with polypropylene pressure caps. The white high-density polyethylene (PEAD) plastic bottles of 30 ml are provided with polypropylene screw caps. The bottles contain 30 ml, 60 ml, or 125 ml of shampoo (Not all packaging may be marketed).

Marketing Authorization Holder and Responsible Manufacturer:

Marketing Authorization Holder

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Responsible Manufacturer

Laboratoires Galderma,

Z.I.- Montdésir

74540, Alby-sur-Chéran

France

or

Galderma Laboratorium GmbH

Toulouser Allee 23a

40211 Düsseldorf

Germany

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

United Kingdom (Northern Ireland), Italy, Ireland, and Portugal: Etrivex 500 micrograms/g shampoo

France, Belgium, Poland, Spain, Hungary, Netherlands, Malta, Sweden, Denmark, Austria, Luxembourg, Iceland, Czech Republic, Norway, Greece, Slovakia, and Finland: Clobex 500 micrograms/g shampoo

Last review date of this leaflet:November 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es