Clobex 500 micrograms/g shampoo

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Clobex 500 micrograms/g shampoo

clobetasol propionate

Read the entire leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Clobex Shampoo is and what it is used for

Clobex shampoo contains the active substance called clobetasol propionate; it belongs to a group of medicines known as corticosteroids (or steroids). "Topical" means that it should be applied only to the surface of the skin. Topical steroids reduce redness, itching, and inflammation associated with skin disorders.

Scalp psoriasis is caused by excessively rapid production of skin cells on your scalp. Clobex shampoo is used to treat moderate 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.

2. What you need to know before using Clobex shampoo

Do not use Clobex shampoo

• If you are allergic to clobetasol propionate or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, inform your doctor before starting treatment.
• If you have bacterial, viral, fungal, or parasitic skin infections, such as herpes, chickenpox, shingles (herpes zoster), impetigo (a type of facial rash), ringworm, athlete’s foot, oral thrush, cutaneous tuberculosis, or a skin disease caused by syphilis.
• If you have ulcerated (weeping) 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 clouding of the eye's lens).

Warnings and precautions

Talk to your doctor or pharmacist before using Clobex shampoo if:

• You are using other oral/topical medications containing corticosteroids or medicines intended to suppress your immune system (e.g., for autoimmune diseases or after an organ transplant). Combining Clobex shampoo with these medicines may lead to serious infections.

Take special care with Clobex shampoo

• Clobex shampoo should only be used on the scalp. Do not use it as a daily shampoo or on other parts of the body. 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 treated area (e.g., do not use a shower cap), as this may increase absorption of the active ingredient through the skin and affect other parts of the body.
• While using Clobex shampoo, avoid contact with the face, eyelids, armpits (underarms), eroded skin (cracked skin), or genital areas. Rinse immediately with water if the product spreads to areas outside the scalp.
• If Clobex shampoo gets into your eye(s), thoroughly rinse the affected eye(s) with water. If irritation persists, consult your doctor.
• If you do not notice improvement in your scalp psoriasis, contact your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• Consult your doctor or pharmacist if you develop new bone pain or worsening of pre-existing bone symptoms during treatment with Clobex shampoo, especially if you have been using Clobex shampoo for a prolonged or repeated period.

Children and adolescents

• If this medicine has been prescribed for a child or adolescent under 18 years of age, weekly consultation with your doctor is required before continuing treatment.

Using Clobex shampoo with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Pregnancy and breastfeeding

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

Driving and using machines

Clobex shampoo has no or negligible effect on the ability to drive or operate machinery.

Clobex shampoo contains ethanol

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

3. How to use Clobex shampoo

Follow exactly the instructions for administration of this medicine given 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), sufficient to cover the entire scalp.

Unless otherwise directed by your doctor, wash your hands and apply Clobex shampoo directly to your dry scalp once daily, taking care to cover it thoroughly, and massage it into the affected areas. Avoid using large amounts of Clobex shampoo; use only enough to cover your dry scalp. Wash your hands thoroughly after application. Leave the product on the scalp for 15 minutes, without covering it, to allow it to take effect, then add water, rinse it off, and dry your hair as usual. You may use your regular shampoo if you need additional shampoo to wash your hair. Do not apply more Clobex shampoo to your hair.

Your doctor will inform you how long you need to use Clobex shampoo to control your scalp psoriasis. Treatment should not last longer than 4 weeks. However, if your scalp psoriasis improves significantly before the end of treatment, please consult your doctor. Conversely, if no improvement is observed at the end of treatment, please inform your doctor. This treatment requires careful monitoring; you must 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 instruct you to use Clobex shampoo again in the future after a treatment-free period.

Use in children and adolescents

If the medicine has been prescribed for a child or adolescent between the ages of 2 and 18 years, the instructions given by the doctor must be followed. You should visit your doctor weekly 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 on the scalp only. Do not swallow it. If accidentally ingested, small quantities 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 as directed by your doctor. If you have missed several doses, inform your doctor.

If you stop using Clobex shampoo

If you stop treatment with Clobex shampoo, consult your doctor. It may occur that your psoriasis worsens after stopping Clobex shampoo, especially if it has been used for a long period of time. Inform your doctor if you notice a worsening of your scalp psoriasis.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Clobex shampoo may cause the following adverse effects.

Common: may affect up to 1 in 10 people:

• Skin burning sensation.
• 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 over large areas or for prolonged periods.
• Stinging or burning in the eyes.
• Eye irritation.
• Eye tightness sensation.
• Glaucoma.
• Hypersensitivity.
• Headache.
• Skin pain.
• Skin discomfort.
• Itching.
• Acne.
• Skin edema.
• Telangiectasias (blood vessels under the surface of the skin may become more visible).
• Worsening of psoriasis.
• Hair loss.
• Dry skin.
• Hives.
• Skin atrophy (thinning of the skin).
• Skin irritation.
• Skin tightness.
• Allergic contact dermatitis.
• Erythema.
• Rash.

Not known: frequency cannot be estimated from available data:

• Blurred vision.

• Irritation, itching, hives, visible small blood vessels, or thinning of the skin 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 treated areas, do not use Clobex shampoo until these symptoms have disappeared.

• If your condition worsens during treatment (this is more likely if Clobex shampoo is used for longer than recommended), or if you experience swelling of the eyelids, face, or lips, which may indicate an allergic reaction to the product or 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 longer than 15 minutes may:

• cause the skin to become thinner and therefore more easily damaged.

• 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 over a long period of time may occasionally cause pustular eruptions (large pimples), changes in hair growth, and changes in skin pigmentation. Striae (stretch marks) and purpura (bruising) may also occur.
  • If you have rosacea (facial erythema associated with skin redness and possible development of papulopustules), applying Clobex shampoo to the face may worsen your skin condition.
  • Applying Clobex shampoo to the face may induce perioral dermatitis (a rash with red patches around the mouth).
  • Applying Clobex shampoo to the skin may cause skin thinning; therefore, it should never be used on the face or on other skin areas apart from the scalp.
  • To avoid interaction with hair dyes, such as changes in hair color, Clobex shampoo must be thoroughly rinsed off.
  • If you experience any unusual discomfort that you cannot explain, inform your doctor as soon as possible.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clobex shampoo

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

Do not use this medicine after the expiry date stated on the carton and on the bottle following EXP. The expiry date refers to the last day of the month indicated.

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

Discard the bottle 6 months after first opening.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clobex shampoo

The active substance is clobetasol propionate.

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

The other components 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 liquid, thick, slightly transparent shampoo with an alcoholic odor and appears colorless to pale yellow.

Clobex shampoo is available by prescription only from your doctor and is supplied in white high-density polyethylene (HDPE) plastic bottles of 60 ml or 125 ml with press-on polypropylene caps. The 30 ml white high-density polyethylene (HDPE) plastic bottles are fitted with polypropylene screw caps. The bottles contain 30 ml, 60 ml, or 125 ml of shampoo (Not all pack sizes may be 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 medicinal product is authorized in the European Economic Area (EEA) Member States 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 most recent revision of this leaflet: November 2024

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