Package Insert: Information for the User

Bioselenium 25 mg/ml Topical Suspension

Selenium Sulfide

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

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

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 an inflammatory eruption with peeling (seborrheic dermatitis) of the skin and scalp.

Bioselenium is indicated for adults and adolescents over 14 years old.

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 injured, inflamed, or secretes liquid.
• on extensive areas of skin.
• for female genital hygiene.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Bioselenium.

• This medication is for external use only. Do not ingest.
• Avoid contact with the eyes, as it may be irritating. If this medication accidentally enters the eyes, rinse them with clean, lukewarm water.
• Avoid contact with other mucous membranes. Also, wash 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, may be absorbed and cause toxicity (causing tremors, sweating, lower abdominal pain, etc.). In this case, discontinue treatment and symptoms may disappear in about 10 days.

Children and Adolescents

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

Use of Bioselenium with other medications

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

Do not use Bioselenium with other antiseborrheic preparations without consulting a doctor.

Pregnancy, Breastfeeding, and Fertility

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

You should only use Bioselenium during pregnancy if the potential benefit outweighs the potential risk to the fetus.

In case of need, you can use Bioselenium while breastfeeding.

Driving and Operating Machines

This medication does not affect the 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 in each 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 in each 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) in each ml. Sodium benzoate may cause local irritation.

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

Skin use (external use).

The recommended dose is:

Adults:

One or two teaspoons of the suspension twice a week for the first fifteen days and afterwards one to four times a month, according to response.

Instructions for correct medication administration

1- Shake the Bioselenium bottle well and pour into the palm of the hand the equivalent of one or two teaspoons and apply to the affected area in the form of a light massage, adding a little warm water, which accelerates the formation of foam and disperses the medication better.

2- Leave Bioselenium to act for 2 or 3 minutes.

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

The operation can be repeated afterwards.

In case of aggravation or persistence of symptoms after a week, consult your doctor.

Use in children and adolescents

Do not use in children under 14 years old.

If you use more Bioselenium than you should

Given the administration route, overdose is not expected. Although accidental ingestion of large quantities is difficult 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 Toxicological Information Service, Telephone 91 562 04 20, indicating the product and the amount ingested.

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

If you forgot to use Bioselenium

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

If you interrupt the treatment with Bioselenium

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Irritation of the skin may occur, so the hair should be thoroughly washed until the medication is completely eliminated. It may cause unusual hair greasiness and diffuse hair loss. In rare cases, the hair may become pigmented (usually due to inadequate washing) and transient nausea (due to the active ingredient's odor) may occur. Sensitization may also appear.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

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

This product does not require special conditions for conservation.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bioselenium 25 mg/ml topical suspension

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

Appearance of the product and contents of the packaging

This medication is presented in the form of a topical suspension.

Each bottle (of plastic) contains 100 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Uriach Consumer Healthcare, S.L.

Av.Generalitat 163-167

08174 Sant Cugat del Vallès

(Barcelona -Spain)

Responsible for manufacturing:

Feltor, S.A.

Roques Blanques, 3-5

Pol. Ind. Molí de les Planes

08470 Sant Celoni

(Barcelona -Spain)

Date of the last review of this leaflet:02/2015.

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.