BIOSELENIUM 25 mg/ml CUTANEOUS SUSPENSION

Introduction

Package Leaflet: Information for the User

Bioselenium 25 mg/ml Cutaneous Suspension

Selenium Sulfide

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 7 days.

Contents of the Package Leaflet

1. What is Bioselenium and what is it used for
2. What you need to know before starting to use Bioselenium
3. How to use Bioselenium
4. Possible side effects
5. Storage of Bioselenium
6. Package Contents and Additional Information

1. What is Bioselenium and what is it used for

Bioselenium is a suspension for use on the skin or scalp that contains selenium sulfide as the active ingredient, which acts against bacteria and fungi (antifungal).

It is indicated for the symptomatic treatment of common dandruff and inflamed, flaky skin (seborrheic dermatitis) of the skin and scalp.

Bioselenium is indicated for adults and adolescents over 14 years of age.

2. What you need to know before starting to use Bioselenium

Do not use Bioselenium:

• if you are allergic to selenium sulfide or any of the other components of this medication (listed in section 6).
• if the application area is wounded, inflamed, or secreting fluid.
• on large areas of skin.
• for female intimate hygiene.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Bioselenium.

• This medication is for external use only (cutaneous). Do not ingest.
• Avoid contact with the eyes, as it may be irritating. If this medication comes into contact with the eyes accidentally, rinse them with clean, lukewarm water.
• Avoid contact with other mucous membranes. Also, rinse the hands that have applied the product.
• Do not use if the area to be treated has wounds, inflammation, or suppurating blisters, and in this case, consult your doctor before using this medication.
• The active ingredient of this medication, if applied to damaged skin, could be absorbed and cause toxicity (causing tremors, sweating, lower abdominal pain, etc.). In this case, treatment should be discontinued, and the symptoms may disappear within 10 days.

Children and Adolescents

Do not use Bioselenium in children under 14 years of age, as safety and efficacy have not been established in children.

Using Bioselenium with Other Medications

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

Do not use Bioselenium with other anti-seborrheic preparations without consulting your doctor.

Pregnancy, Breastfeeding, and Fertility

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

Bioselenium should only be used during pregnancy if the potential benefit outweighs the potential risk to the fetus.

If necessary, you can use Bioselenium while breastfeeding a baby.

Driving and Using Machines

This medication does not affect your ability to drive or operate machinery.

Bioselenium contains sodium lauryl sulfate, benzyl alcohol, and sodium benzoate (E-211):

• This medication contains 70 mg of sodium lauryl sulfate per ml. Sodium lauryl sulfate may cause local skin reactions (such as itching or burning sensation) or increase skin reactions caused by other medications when applied to the same area.
• This medication contains 10 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause moderate local irritation.
• This medication contains 0.32 mg of sodium benzoate (E-211) per ml. Sodium benzoate may cause local irritation.

3. How to Use Bioselenium

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

External use (cutaneous).

The recommended dose is:

Adults:

One or two coffee spoonfuls of the suspension twice a week for the first 15 days and then one to four times a month, depending on the response.

Instructions for Correct Administration of the Medication

1- Shake the Bioselenium bottle well and pour the equivalent of one or two coffee spoonfuls into the palm of your hand and apply to the area to be treated, massaging gently, adding a little warm water, which accelerates the formation of foam and disperses the medication better.

2- Leave Bioselenium on for 2 or 3 minutes.

3- Rinse with plenty of water until the medication is completely removed.

The operation can be repeated immediately.

If your symptoms worsen or persist after one week, consult your doctor.

Use in Children and Adolescents

Do not use in children under 14 years of age.

If You Use More Bioselenium Than You Should

Given the route of administration, overdose is not expected. Although accidental ingestion of large quantities is unlikely due to its bad taste, if it occurs, you may notice loss of appetite, vomiting, and anemia.

In case of accidental ingestion, consult your doctor or pharmacist immediately or go to a Medical Center, or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the product and the amount ingested.

Treatment may consist of stomach emptying by aspiration and washing with a saline purgative.

If You Forget to Use Bioselenium

Do not use a double dose to make up for forgotten doses. Apply Bioselenium when you remember and continue with the established frequency.

If You Interrupt Treatment with Bioselenium

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.

If the medication comes into contact with the eyes, it may be irritating and cause conjunctivitis.

Irritation may occur on the skin, so it is essential to rinse the hair thoroughly until the medication is completely removed. It can cause unusual greasiness in the hair and diffuse hair loss. In rare cases, it can pigment the hair (usually due to not rinsing well) and may cause transient nausea (due to the odor of the active ingredient). Sensitization may also occur.

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: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Bioselenium

No special storage conditions are required.

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

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 Bioselenium 25 mg/ml Cutaneous Suspension

• The active ingredient is Selenium Sulfide. Each ml contains 25 mg of Selenium Sulfide (2.5%).
• The other components (excipients) are: benzyl alcohol, lactic acid, cocamidopropyl betaine, povidone, methylcellulose, sodium lauryl sulfate, magnesium aluminum silicate, lavender perfume, sodium carbonate, sodium benzoate, and purified water.

Appearance of the Product and Package Contents

This medication is presented as a cutaneous suspension.

Each bottle (plastic) contains 100 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Uriach Consumer Healthcare, S.L.

Av. Generalitat 163-167

08174 Sant Cugat del Vallès

(Barcelona, Spain)

Manufacturer:

Feltor, S.A.

Roques Blanques, 3-5

Pol. Ind. Molí de les Planes

08470 Sant Celoni

(Barcelona, Spain)

Date of the Last Revision of this Package Leaflet:02/2015.

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