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SELENASE 100 MICROGRAMS ORAL SOLUTION (50 MICROGRAMS/ML)

Active substance(s): SODIUM SELENITE PENTAHYDRATE

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biosyn Arzneimittel GmbH
Schorndorfer Strasse 32, 70734 Fellbach, Germany
PACKAGE LEAFLET: INFORMATION FOR THE USER
selenase® 100 micrograms, oral solution (50 micrograms/ml)
100 microgram selenium per 2 ml oral solution

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. BEFORE YOU USE SELENASE® ORAL SOLUTION
Do not use selenase® oral solution
– if you are allergic (hypersensitive) to sodium selenite pentahydrate
or any of the other ingredients of selenase® oral solution.
– if you have a selenosis (selenium poisoning).

selenase® 500 micrograms, oral solution (50 micrograms/ml)
500 microgram selenium per 10 ml oral solution

Take special care with selenase® oral solution
There are no special warnings or precautions for the use of selenase®
oral solution.

Active substance: Sodium selenite pentahydrate

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.

Read all of this leaflet carefully before you start using this
medicine.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
– If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist
In this leaflet:
1. What selenase® oral solution is and what it is used for
2. Before you use selenase® oral solution
3. How to use selenase® oral solution
4. Possible side effects
5. How to store selenase® oral solution
6. Further information

It must be ensured that the solution is not mixed or taken at the same
time with reducing substances (e.g. vitamin C).
selenase® oral solution and vitamin C should be administered at an
interval of 4 hours.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy:
There are no data from the use of selenase® oral solution in pregnant
women. No adverse effect of sodium selenite on the pregnancy or the
unborn child is expected, provided that it is used in case of proven
selenium deficiency.
Breast-feeding:
Selenium is excreted into the breast milk. But doses correcting
selenium deficiency in breast-feeding women are not expected to
exert adverse effects on the breast-feeded infant.

1. WHAT SELENASE® ORAL SOLUTION IS AND WHAT IT IS
USED FOR

Driving and using machines
There is no effect on the ability to drive and use machines.

selenase® 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.

3. HOW TO USE SELENASE® ORAL SOLUTION
Always use medicinal products exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.

selenase® oral solution is for single use only.
The usual daily dose is:
100 – 200 micrograms selenium (equivalent to 1 to 2 ampoules
selenase® 100 micrograms, oral solution or 2 – 4 ml selenase® 500
micrograms, oral solution).
If the results from a blood test show that more selenium is required
your doctor can increase the dose up to 500 micrograms selenium
(equivalent to 5 ampoules selenase® 100 micrograms, oral solution or
1 drinking bottle selenase® 500 micrograms, oral solution).
Method of administration:
selenase® oral solution is indicated for self-medication.
selenase® 100 micrograms, oral solution:
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 content of the ampoule into the mouth.
selenase® 500 micrograms, oral solution:
You have to make the drinking bottle ready for use before first use.
Picture 1:
Picture 1
Picture 2
Picture 3
Turn the screw cap first clockwise
down in order to open the drinking
bottle with the integrated spike of the
screw cap.
Picture 2:
Then turn off the screw cap
anti-clockwise.
Picture 3:
If you should take 500 micrograms
selenium place the complete contents in the mouth. If your doctor has
prescribed you a dose less than 500 micrograms selenium remove
the required dose in milliliter by carefully squeezing of the drinking
bottle into the enclosed measuring cup with milliliter graduation. Then
close the drinking bottle firmly.
Hold the liquid in the mouth for about 30 to 60 seconds before
swallowing.
Duration of treatment:
Samples of your blood will be taken from time to time and used to
determine the levels of selenium in your blood in order to monitor the
success of your treatment. As soon as your selenium levels will be
normal your treatment with selenase® oral solution will be finished.

( see reverse )

There is no time limit to the administration of selenase® oral solution in
a supplementary dose (100 micrograms selenium per day is
equivalent to 1 ampoule).
Dosage in children
If you are a child your doctor will prescribe you a dose of 2 µg/kg
body weight per day at therapy onset and a maintenance dose of
1 µg/kg body weight per day.
For measuring your children’s dose of less than 1 ml oral solution
place approximately 5 ml oral solution in the measuring cup and draw
up the needed volume with the enclosed pipette. For example if you
have a 1-year-old child with 10 kg body weight the maintenance dose
is 10 µg/kg corresponding to 0.2 ml oral solution.
Samples of your blood will be taken from time to time and used to
determine the levels of selenium in your blood in order to monitor the
success of your treatment.
In the table below you can find the maximum daily doses for children
for a longer time:
Age (years)
Tolerable Upper Intake Level (µg selenium/day)
1-3
60
4-6
90
7-10
130
11-14
200
15-17
250
Dosage in patients with renal or hepatic impairment:
Your doctor will not prescribe a different dose if you have renal or
hepatic impairment.
If you use more selenase® oral solution than you should
If you use more selenase® oral solution than you should the following
symptoms may occur:
• acute (short-term): odour of garlic on the breath, tiredness, nausea,
diarrhoea and abdominal pain or
• chronic (long-term) what can affect the growth of nails and hair and
may lead to peripheral polyneuropathy (a disorder of a nerve or nervous
pathway that may be associated with numbness or tingling).
If you forget to use selenase® oral solution
Do not use a double dose to make up for a forgotten dose.
If you stop using selenase® oral solution
There are no special instructions, if you stop using selenase® oral solution.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
®

Like all medicines, selenase oral solution can cause side effects,
although not everybody gets them.
If selenase® oral solution is given as directed, unwanted effects, so called
side effects, have not been reported. However, if you are given too
much, the symptoms listed in the above section may be experienced.
If any side effects occur or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE SELENASE® ORAL SOLUTION
Keep out of the reach and sight of children.
Do not store selenase® oral solution above 25 °C.
– selenase® 100 micrograms, oral solution:
Use selenase® 100 micrograms, oral solution immediately after
opening the ampoules.
– selenase® 500 micrograms, oral solution:
Use selenase® 500 micrograms, oral solution immediately after
opening of the drinking bottle.
Do not use this medicine if the ampoule or the drinking bottle is
damaged or if the solution is cloudy.
Discard any unused contents.
Do not use selenase® oral solution after the expiry date which is
stated on the label on the ampoule or the drinking bottle and on the
carton after “EXP”. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What selenase® oral solution contains
The active substance is:
Sodium selenite pentahydrate
The other ingredients are:
Sodium chloride, hydrochloric acid, water for injections
– selenase® 100 micrograms, oral solution:
Each ampoule of 2 ml oral solution contains 100 micrograms
selenium in the form of 332 micrograms sodium selenite pentahydrate, corresponding to 50 micrograms/ml.

– selenase® 500 micrograms, oral solution:
Each drinking bottle of 10 ml oral solution contains 500
micrograms selenium in the form of 1,665 micrograms sodium
selenite pentahydrate, corresponding to 50 micrograms/ml.
What selenase® oral solution looks like and contents of the pack
What selenase® oral solution looks like:
selenase® oral solution is a clear and colourless solution.
Contents of the pack:
– selenase® 100 micrograms, oral solution:
Ampoules each containing 2 ml of oral solution are made of plastic
(LDPE)
Pack sizes: 10, 20, 50, 60, 90 and 100.
– selenase® 500 micrograms, oral solution:
Drinking bottles of plastic (LDPE) with polypropylene screw cap
each containing 10 ml of oral solution, a measuring cup and a
dosing pipette.
Pack sizes: 10, 20 and 50.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
biosyn Arzneimittel GmbH
Schorndorfer Strasse 32, 70734 Fellbach, Germany
Distributed by:
Baxter Healthcare Limited
Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
This medicinal product is authorised in the Member States of
the EEA under the following names:
NL: selenase® drank 100 µg, drank 50 µg/ml
selenase® drank 500 µg, drank 50 µg/ml
HU: selesyn® 100 µg/2 ml, belsöleges oldat
selesyn® 500 µg/10 ml, belsöleges oldat
IE: selesyn® 100 micrograms/2 ml, oral solution (50 micrograms/ml)
selesyn® 500 micrograms/10 ml, oral solution (50 micrograms/ml)
IT: selesyn® 100 mcg soluzione orale
selesyn® 500 mcg soluzione orale
PT: selenase® solução oral 100 microgramas
selenase® solução oral 500 microgramas
SK: selenase® perorálny roztok 100 µg, perorálny roztok 50 µg/ml
selenase® perorálny roztok 500 µg, perorálny roztok 50 µg/ml
UK: selenase® 100 micrograms, oral solution (50 micrograms/ml)
selenase® 500 micrograms, oral solution (50 micrograms/ml)
This leaflet was last approved in 01/2013.
Druck-Nr. Tx-21407

( Datum: January 2013 )

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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