BioSelenium 25 mg/ml cutaneous suspension
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Bioselenium 25 mg/ml Cutaneous Suspension
Selenium sulfide
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 7 days.
Contents of the leaflet
- What Bioselenium is and what it is used for
- What you need to know before using Bioselenium
- How to use Bioselenium
- Possible side effects
- How to store Bioselenium
- Contents of the pack and other information
1. What Bioselenium is and what it is used for
Bioselenium is a topical suspension for use on the skin or scalp, containing selenium sulfide as the active substance, which acts against bacteria and fungi (antifungal).
It is indicated for the symptomatic treatment of common dandruff and an inflammatory, scaly rash (seborrheic dermatitis) of the skin and scalp.
Bioselenium is indicated in adults and adolescents over 14 years of age.
2. What you need to know before using Bioselenium
Do not use Bioselenium:
- if you are allergic to selenium sulfide or any of the other ingredients of this medicine (listed in section 6).
- if the area to be treated is injured, inflamed, or weeping.
- on large areas of skin.
- for female intimate hygiene.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Bioselenium.
- This medicine is for topical (external) use only. Do not ingest.
- Avoid contact with the eyes, as it may be irritating. If this medicine accidentally comes into contact with the eyes, rinse them thoroughly 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; in such cases, consult your doctor before using this medicine.
- The active ingredient in this medicine, if applied to damaged skin, could be absorbed and cause toxicity (causing tremors, sweating, lower abdominal pain, etc.). In such cases, treatment must be discontinued and symptoms may resolve within about 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.
Use of Bioselenium with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Do not use Bioselenium together with other antiseborrheic preparations without consulting your doctor.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Bioselenium should only be used during pregnancy if the potential benefit outweighs the potential risk to the fetus.
If necessary, Bioselenium may be used while breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Bioselenium contains sodium lauryl sulfate, benzyl alcohol, and sodium benzoate (E-211):
- This medicine 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 medicines when applied to the same area.
- This medicine contains 10 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions and may cause moderate local irritation.
- This medicine contains 0.32 mg of sodium benzoate (E-211) per ml. Sodium benzoate may cause local irritation.
3. How to use Bioselenium
Follow exactly the instructions for administering the medicine provided in this leaflet or those given by your pharmacist. If in doubt, consult your doctor or pharmacist.
For topical use (external use only).
The recommended dose is:
Adults:
One or two coffee teaspoons of the suspension twice a week during the first fifteen days, then once to four times per month, depending on response.
Instructions for correct administration of the medicine
1- Shake the Bioselenium bottle well and pour into the palm of your hand an amount equivalent to one or two coffee teaspoons; apply to the affected area with a gentle massage, adding a little warm water to accelerate foam formation and ensure better dispersion of the medicine.
2- Leave Bioselenium in contact with the skin for 2 or 3 minutes.
3- Rinse thoroughly with plenty of water until all traces of the medicine are completely removed.
The procedure may be repeated immediately afterwards.
If 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
Due to the route of administration, poisoning from overdose is not expected. Although accidental ingestion of large amounts is unlikely because of its unpleasant taste, if it occurs, you may experience anorexia (loss of appetite), vomiting, and anemia.
In case of accidental ingestion, consult your doctor or pharmacist immediately, go to a Medical Center, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the product and the amount ingested.
Treatment may include gastric emptying by aspiration and cleansing with a saline laxative.
If you forget to use Bioselenium
Do not use a double dose to make up for missed doses. Apply Bioselenium as soon as you remember, then continue with the established frequency.
If you stop using Bioselenium
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 may produce adverse effects, although not everyone will experience them.
If the medicine comes into contact with the ocular mucosa, it may be irritating and cause conjunctivitis.
Skin irritation may occur; therefore, the hair should be thoroughly rinsed to completely remove the medicine. Unusual oiliness of the hair and diffuse hair loss may occur. On rare occasions, hair pigmentation (usually due to inadequate rinsing) and transient nausea (due to the odor of the active substance) may occur. Sensitization may also appear.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bioselenium
No special storage conditions are required.
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 packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Return unused containers and unwanted medicines to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bioselenium 25 mg/ml cutaneous suspension
- The active substance 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 fragrance, sodium carbonate, sodium benzoate and purified water.
Appearance of the medicinal product and contents of the pack
This medicine is presented as a cutaneous suspension.
Each plastic bottle 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 most recent revision of this leaflet: 02/2015.
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.