SEBUMSELEN SHAMPOO

Introduction

Package Leaflet: Information for the User

SEBUMSELEN Shampoo

Selenium Sulfide / Benzalkonium Chloride

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 15 days.

Contents of the Package Leaflet

1. What SEBUMSELEN shampoo is and what it is used for
2. What you need to know before using SEBUMSELEN shampoo
3. How to use SEBUMSELEN shampoo
4. Possible side effects
5. Storage of SEBUMSELEN shampoo
6. Package contents and additional information

1. What is SEBUMSELEN shampoo and what is it used for

It belongs to a group of medications called medicinal shampoos. Its active ingredients help reduce excessive scaling of the scalp and have antimicrobial properties.

It is indicated for the symptomatic treatment of seborrheic dermatitis (eruption with inflammation and scaling) and dandruff.

SEBUMSELEN shampoo is indicated for adults and adolescents from 14 years of age.

2. What you need to know before using SEBUMSELEN shampoo

Do not use SEBUMSELEN shampoo

• If you are allergic to selenium sulfide, benzalkonium chloride, or any of the other components of this medication (listed in section 6).
• On damaged, inflamed, or exudative skin areas (that release fluid) or on extensive areas.
• In children (see the section Children and Adolescentsin this section, below).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use SEBUMSELEN shampoo.

For topical use, exclusively on the scalp.

• Avoid contact with the eyes. If this medication accidentally comes into contact with the eyes, they should be rinsed with clean, warm water.
• Avoid contact with mucous membranes.
• If this medication is used before or after a hair clarifying treatment, dye, or permanent wave, it should be rinsed thoroughly with warm water for at least 5 minutes after application.
• Some components of this medication may cause side effects if applied to wounded skin.

Children and Adolescents

This medication is not indicated for children under 14 years of age, as its safety and efficacy have not been established in this age group.

Using SEBUMSELEN shampoo with other medications

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

The simultaneous use of this medication with some soaps (anionic) may cause it to become inactive, so it should not be mixed with other products.

Pregnancy, Breastfeeding, and Fertility

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

Treatment with SEBUMSELEN shampoo is not recommended if you are pregnant.

In case of necessity, SEBUMSELEN shampoo may be used if you are breastfeeding a baby, weighing the benefits against the potential risks.

Driving and Using Machines

Not applicable.

SEBUMSELEN shampoo contains benzalkonium chloride

This medication may be irritating and cause skin reactions because it contains benzalkonium chloride.

3. How to use SEBUMSELEN shampoo

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your pharmacist. In case of doubt, ask your doctor or pharmacist.

For topical use, exclusively on the scalp.

It is recommended to apply SEBUMSELEN shampoo to the scalp 2 times a week for 2 weeks, then reduce to 1 time a week, and finally to 1 time a month.

• Apply a sufficient amount of SEBUMSELEN shampoo to the hair, which has been moistened with warm water.
• Gently massage the scalp to produce abundant foam and maintain the foam for 2-3 minutes.
• Rinse thoroughly.
• The operation can be repeated and rinsed thoroughly with water.

Always use the lowest effective dose.

If symptoms do not improve after 15 days of treatment, the treatment should be discontinued and a doctor consulted.

The administration of this product is subject to the appearance of symptoms. As the symptoms disappear, this medication should be suspended.

Use in Children and Adolescents

Do not use this shampoo in children under 14 years of age (see section 2).

If you use more SEBUMSELEN shampoo than you should

SEBUMSELEN shampoo is for topical use only, exclusively on the hair. Excessive application or prolonged use of the product does not lead to faster or better results and may cause contact dermatitis and skin irritation. If this occurs, the treatment should be discontinued. Application to wounded skin can produce adverse effects not only in the application area but also through absorption into the body.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicology Information Service, Telephone: 91 5620420, indicating the medication and the amount ingested.

If you forget to use SEBUMSELEN shampoo

Do not apply a double dose to make up for forgotten doses.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During the period of use of the active ingredients of this medication, the following side effects have been described, whose frequency cannot be estimated from the available data:

Sensitization of the scalp; if it appears, the treatment should be discontinued.

Skin irritation, diffuse hair loss (alopecia), hair discoloration, or hyperpigmentation of the scalp, which is usually due to insufficient rinsing of the product, greasiness of the hair and scalp, moderate scaling.

Conjunctivitis in the eyes, if the medication comes into contact with the eyes.

Transient nausea may occur due to the smell of selenium sulfide.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of SEBUMSELEN shampoo

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of SEBUMSELEN shampoo

• The active ingredients are Selenium Sulfide and Benzalkonium Chloride. Each gram of shampoo contains 25 mg of selenium sulfide (2.5%) and 3 mg of benzalkonium chloride (0.3%).
• The other components are: magnesium stearate, bentonite, Texapon C.S. (sodium lauryl sulfate), Coperlan 100, PC-8009 fragrance, and purified water.

Appearance of the Product and Package Contents

SEBUMSELEN is a homogeneous shampoo with an orange-brown color.

It is available in a bottle containing 20 or 70 g of shampoo.

Marketing Authorization Holder

Marketing Authorization Holder

Laboratorios ERN, S.A.

Perú, 228. 08020

Barcelona, Spain

Manufacturer

• Braun Medical S.A.

Huelma, 5. Poligono Industrial Los Olivares.

Jaén, Spain

Date of the Last Revision of this Package Leaflet: August 2013.

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