Selesyn 500 micrograms/10 ml, oral solution (50 micrograms/ml)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Selenium

Available from:

biosyn Arzneimittel GmbH

ATC code:

A12CE; A12CE02

INN (International Name):

Selenium

Dosage:

500 microgram(s)

Pharmaceutical form:

Oral solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Selenium; sodium selenite

Authorization status:

Not marketed

Authorization date:

2006-05-26

Patient Information leaflet

biosyn Arzneimittel GmbH
Schorndorfer Strasse 32, 70734 Fellbach, Germany
PACKAGE LEAFLET: INFORMATION FOR THE USER
selesyn
®
100 micrograms/2 ml, oral solution (50 micrograms/ml)
100 microgram selenium per 2 ml oral solution
selesyn
®
500 micrograms/10 ml, oral solution (50 micrograms/ml)
500 microgram selenium per 10 ml oral solution
Active substance: Sodium selenite pentahydrate
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist
or nurse.
– This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
– If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What selesyn
®
oral solution is and what it is used for
2. What you need to know before you use selesyn
®
oral solution
3. How to use selesyn
®
oral solution
4. Possible side effects
5. How to store selesyn
®
oral solution
6. Contents of the pack and other information
1. WHAT SELESYN
®
ORAL SOLUTION IS AND WHAT IT IS
USED FOR
selesyn
®
oral solution is a medicinal product which belongs to the
group of the mineral supplements. Sodium selenite pentahydrate, the
active substance in your oral solution, provides a source of selenium,
which is an essential trace element in nutrition to ensure that your
metabolism functions efficiently.
Your doctor will have recommended this medicine because tests to
measure the selenium levels in your blood have shown that you have
a selenium deficiency, which cannot be corrected by selenium intake
from food sources.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SELESYN
®
ORAL SOLUTION
Do not use selesyn
®
oral solution
–
if you are allergic to sodium selenite pentahydrate or any of the
other ingredients of this medi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Selesyn 500 micrograms/10 ml, oral solution (50 micrograms/ml)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each drinking bottle of 10 ml oral solution contains 500 micrograms
selenium in the form of 1.665 mg sodium selenite
pentahydrate (Na
2
SeO
3
.
5 H
2
O), corresponding to 50 µg/ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Proven selenium deficiency that cannot be offset from food sources.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Daily dose
100–200 micrograms selenium (equivalent to 1-2 ampoules). If more
selenium is necessary to reach the normal blood
level, this dose can be increased to 500 micrograms selenium
(equivalent to 5 ampoules = 5 x 100 micrograms or 1
drinking bottle = 500 micrograms, respectively).
Method of administration
Detach a single-dose ampoule from the remainder of the strip of
ampoules and open the oral ampoule by twisting the
top. Squeeze out the whole of the contents of the ampoule into the
mouth.
In the case of the drinking bottles:
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Picture 1:
Before use the drinking bottle has to be made ready for use. For
opening the screw cap is first turned clockwise down
in order to open