Selenase 500 micrograms, oral solution (50 micrograms/ml)

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
• You must talk to a doctor if you do not feel better or if you feel worse.

1. What Selenase^® oral solution is and what it is used for
2. What you need to know 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. Contents of the pack and other information

• if you are allergic to sodium selenite pentahydrate or any of the other ingredients of this medicine (listed in section 6).
• if you have a selenosis (selenium poisoning).

There are no special warnings or precautions for the use of Selenase^® oral solution.

Talk to your doctor, pharmacist or nurse before using Selenase^® oral solution.

Tell your doctor or pharmacist if you are taking/ using, have recently taken/ used or might take/ use any other medicines.

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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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.

Fertility:

There are no data available regarding the effect on fertility.

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

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 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

Your doctor will not prescribe a different dose if you have renal or hepatic impairment.

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 use.

Picture 1:

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.

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).

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).

Do not use a double dose to make up for a forgotten dose.

There are no special instructions, if you stop using Selenase^® oral solution.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

By reporting side effects you can help provide more information on the safety of this medicine.

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 333 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:

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:

Manufacturer:

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 microgramm, belsöleges oldat (oral solution)

selesyn 500 microgramm, belsöleges oldat (oral solution)

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)