CLOBEX 500 micrograms/g SHAMPOO

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

Do not use Clobex shampoo

• If you are allergic to clobetasol propionate or any of the other ingredients of this medicine (listed in section 6). If your answer is yes, you should inform your doctor before starting treatment.
• If you have bacterial, viral, fungal, or parasitic skin infections, such as herpes, chickenpox, shingles (herpes), impetigo (a type of rash on the face), ringworm, athlete's foot, thrush, cutaneous tuberculosis, or a skin disease caused by syphilis.
• If you have ulcerative lesions (suppurating wounds) on your scalp.
• In children under 2 years of age.
• Do not apply Clobex shampoo to the eyes or eyelids (risk of glaucoma, which is high pressure in the eye, and risk of cataract, which is a loss of transparency of the lens in the eye).

Warnings and precautions

Consult your doctor or pharmacist before using Clobex shampoo if:

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

Be 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 areas of the body, and do not use Clobex shampoo as a shower gel, body soap, 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 this can cause 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 (underarms), eroded skin surface (cracked skin), or genital areas. Rinse immediately with water if the product spreads to an area outside the scalp.
• If Clobex shampoo gets into your 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 long time or repeatedly.

Children and adolescents

• If this medicine has been prescribed to a child or adolescent under 18 years of age, they should consult their doctor weekly before continuing to use this medicine.

Using Clobex shampoo with other medicines:

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

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

Driving and using machines

Clobex shampoo has no or negligible influence on the ability to drive or use machines.

Clobex shampoo contains ethanol

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

3. How to use Clobex shampoo

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

Unless your doctor has indicated 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 on the scalp for 15 minutes, without covering, to allow it to 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 how long you need to use Clobex shampoo to control 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 consult your doctor. If, on the other hand, no improvement is seen at the end of treatment, please tell your doctor. 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 period than indicated by your doctor.

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

Use in children and adolescents

If the medicine has been prescribed to a child or adolescent between 2 and 18 years of age, follow the instructions given by the doctor. You should consult the doctor every week before continuing treatment.

If you use more Clobex shampoo than you should

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

If you forget to use Clobex shampoo

Do not use a double dose to make up for forgotten doses. Continue with the treatment indicated by your doctor. If you have forgotten to use it on several occasions, inform your doctor.

If you stop using Clobex shampoo

If you stop using Clobex shampoo, consult your doctor. It may happen that when you stop using Clobex shampoo, your psoriasis worsens, especially if you have used it for a long time. Inform your doctor if you notice a worsening of your scalp psoriasis.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Clobex shampoo may cause the following side effects.

Frequent: may affect up to 1 in 10 people:

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

Uncommon: 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 extensive areas or for prolonged periods.
• Irritation or burning sensation in the eyes.
• Eye irritation.
• Eye tension
• Glaucoma
• Hypersensitivity
• Headache
• Skin pain
• Skin discomfort
• Itching
• Acne
• Skin edema
• Telangiectasias (the veins under the surface of your skin may become more visible)
• Worsening of psoriasis.
• Hair loss
• Skin dryness
• Urticaria
• Skin atrophy (thinning of the skin)
• Skin irritation.
• Skin tension
• Contact allergic dermatitis
• Erythema.
• Rash.

Unknown: frequency cannot be estimated from the available data:

• Blurred vision

• Irritation, itching, urticaria, small visible veins, or skin thinning around the treated areas are generally mild to moderate. If you have any signs of local intolerance, such as a burning sensation or redness in the areas that have been treated, do not use Clobex shampoo until these symptoms have disappeared.
• If your disease worsens during treatment (this is more likely to happen if you use Clobex shampoo for longer than indicated), or you experience swelling of the eyelids, face, or lips, which indicates that you may be allergic to the product or have a skin infection, stop using the medicine 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 easily damaged.
• allow the active ingredient to pass through the skin; this can affect other parts of the body, especially in children and during pregnancy.
• Repeated courses of topical steroids for a long period may occasionally produce pustular eruptions (large pimples) and changes in hair growth and skin color. Stretch marks (striae) and purpura (bruises) may appear.
• 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 disease.
• Applying Clobex shampoo to the face may induce perioral dermatitis (rash in the form of red spots around the mouth).
• Applying Clobex shampoo to the skin may cause skin thinning, so it should never be used on the face or on other skin areas different from the scalp.
• To avoid interaction with hair dyes, such as changes in hair color, Clobex shampoo should be rinsed completely.
• 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. Storing Clobex shampoo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The expiry date is the last day of the month stated.

Store in the original plastic bottle to protect from light.

Discard the bottle 6 months after opening it for the first time.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clobex shampoo

The active ingredient is clobetasol propionate.

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

The other ingredients are: ethanol, coco alkyl dimethyl betaine, sodium laureth sulfate, poliquaternium-10, sodium citrate, citric acid monohydrate, and purified water.

Appearance of the product and contents of the pack

Clobex shampoo is a thick, semi-transparent liquid shampoo with an alcoholic odor and a colorless to light yellow appearance.

Clobex shampoo should be obtained with a medical prescription from your doctor and is packaged in white high-density polyethylene (HDPE) plastic bottles of 60 ml or 125 ml with polypropylene pressure caps. The 30 ml white high-density polyethylene (HDPE) plastic bottles are provided with polypropylene screw caps. The bottles contain 30 ml, 60 ml, or 125 ml of shampoo (it is possible that not all packs are marketed).

Marketing authorization holder and manufacturer:

Marketing authorization holder

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

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) under 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

Date of the last revision of this leaflet:November 2024

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