Selesyn

PACKAGE LEAFLET: INFORMATION FOR THE USER

selesyn 100 micrograms oral solution (50 micrograms/ml)

100 micrograms of selenium per 2 ml of oral solution
selesyn 500 micrograms oral solution (50 micrograms/ml)
500 micrograms of selenium per 10 ml of oral solution
Active substance: Sodium selenite pentahydrate
Please 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What selesyn oral solution is and what it is used for
2. What you need to know before using 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 belonging to the group of mineral supplements.
Sodium selenite pentahydrate, the active substance in the oral solution, provides a source of selenium, an
essential trace element in nutrition, which enables the body's metabolism to function efficiently.
Your doctor has prescribed this medicine because blood tests measuring your selenium levels have revealed a deficiency of this element, which cannot be corrected by taking selenium from normal dietary sources.

2. WHAT YOU SHOULD KNOW BEFORE USING SELESYN ORAL SOLUTION

Do not use selesyn oral solution

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

Warnings and precautions
There are no specific warnings or precautions for the use of selesyn oral solution.
Other medicines and selesyn oral solution
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Care should be taken not to mix or take the solution simultaneously with reducing agents (e.g. vitamin C).
Selesyn oral solution and vitamin C should be administered at least 4 hours apart.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy:
There are no data available on the use of selesyn oral solution in pregnant women.
Undesirable effects of sodium selenite on pregnancy or the fetus are not expected, provided it is used in cases of proven selenium deficiency.
Breastfeeding:
Selenium is excreted in breast milk. However, doses administered to correct selenium deficiency in breastfeeding women are not expected to cause undesirable effects in the breastfed infant.
Fertility
There are no data available on the effect on fertility.
Driving and using machines
This medicine does not impair the ability to drive or use machinery.

3. HOW TO USE SELESYN ORAL SOLUTION

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Selesyn oral solution is for single use only.

Recommended dose:
100 – 200 micrograms of selenium (equivalent to 1 or 2 vials of Selesyn 100 mcg oral solution,
or 2 – 4 ml of Selesyn 500 mcg oral solution).

If blood test results indicate the need for a higher intake of selenium, your doctor may increase the dose up to 500 micrograms of selenium (equivalent to 5 vials of Selesyn 100 mcg oral solution, or 1 drinkable bottle of Selesyn 500 mcg oral solution).

Use in children and adolescents
In children, the doctor will prescribe an initial dose of 2 µg/kg body weight per day, and a maintenance dose of 1 µg/kg body weight per day.
To measure a dose smaller than 1 ml of oral solution for a child, pour approximately 5 ml of oral solution into the provided measuring cup and draw up the required volume using the supplied pipette. For example, for a 1-year-old child weighing 10 kg, the maintenance dose is 10 µg, equivalent to 0.2 ml of oral solution.
Regular blood tests will be performed to monitor selenium levels in the blood and assess treatment efficacy.

The following table shows the maximum daily doses for children when administered over prolonged periods:

| Age (years) | Maximum Tolerable Intake Level (µg selenium/day) |
|-------------|--------------------------------------------------|
| 1–3 | 60 |
| 4–6 | 90 |
| 7–10 | 130 |
| 11–14 | 200 |
| 15–17 | 250 |

Dosing in patients with impaired renal or hepatic function
Your doctor will not prescribe a different dose if you suffer from kidney or liver disorders.

Method of administration:
Selesyn oral solution is intended for self-administration.

Selenase 100 micrograms, oral solution
Detach a single-dose vial from the strip and open it by twisting the cap. Squeeze the entire contents directly into the mouth. For drinkable bottles, unscrew the screw cap and pour the contents directly into the mouth.

Selenase 500 micrograms, oral solution
Before use, the drinkable bottle must be prepared for use.

Figure 1:
To open the bottle, first rotate the screw cap clockwise while pressing downwards, to open the bottle using the integrated tip of the cap.
Figure 2:
Then rotate the cap counterclockwise.
Figure 3:
If 500 micrograms of selenium are to be taken, pour the entire contents of the bottle into the mouth. If your doctor has prescribed a dose lower than 500 micrograms of selenium, carefully squeeze the bottle to pour the required dose in millilitres into the provided graduated measuring cup. Then close the bottle tightly.
Hold the liquid in the mouth for approximately 30–60 seconds before swallowing.

Duration of treatment:
Periodic blood tests will be performed to monitor selenium levels and assess treatment response. Treatment with Selesyn oral solution will be discontinued as soon as selenium levels return to normal.
There is no restriction on administering Selesyn oral solution at the supplemental dose (100 micrograms of selenium per day, equivalent to 1 vial).

If you use more Selesyn oral solution than you should
If you use more Selesyn oral solution than prescribed, the following symptoms may occur:

• Acute (short-term): garlic-like breath odour, fatigue, nausea, diarrhoea, and abdominal pain; or
• Chronic (long-term): possible effects on nail and hair growth, and potential development of peripheral polyneuropathy (a nerve disorder that may cause numbness or tingling).

If you forget to use Selesyn oral solution
Do not take a double dose to make up for the missed dose.

If you stop using Selesyn oral solution
There are no special instructions regarding discontinuation of treatment with Selesyn oral solution.
If you have any doubts about the use of Selesyn oral solution, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
When used correctly, Selesyn oral solution has not been associated with any reported side effects,
i.e. adverse reactions. However, if taken in excessive amounts, the medicine may cause the symptoms
listed above.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report adverse reactions directly through the national reporting system at the following address:
http://www.agenziafarmaco.gov.it/it/responsabili
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. HOW TO STORE SELESYN ORAL SOLUTION

Keep this medicine out of the sight and reach of children.
Do not store selesyn oral solution at temperatures above 25°C.

• selesyn 100 micrograms, oral solution Use selesyn 100 micrograms, oral solution immediately after opening the ampoule.
• selesyn 500 micrograms, oral solution Use selesyn 500 micrograms, oral solution immediately after opening the oral bottle.

Do not use this medicine if the ampoule or the oral bottle is damaged or if the solution is cloudy.
Discard any unused contents.
Do not use this medicine after the expiry date stated on the label applied to the ampoule or oral bottle and on the carton after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What selesyn oral solution contains
The active substance is:
Sodium selenite pentahydrate
The other components are:
Sodium chloride, hydrochloric acid, water for injections

• selesyn 100 mcg oral solution: Each 2 ml vial of oral solution contains 100 micrograms of selenium in the form of 333 micrograms of sodium selenite pentahydrate, corresponding to 50 micrograms/ml.
• selesyn 500 mcg oral solution: Each 10 ml oral solution bottle for oral use contains 500 micrograms of selenium in the form of 1.665 micrograms of sodium selenite pentahydrate, corresponding to 50 micrograms/ml.

Description of the appearance of selesyn oral solution and contents of the package
Description of the appearance of selesyn oral solution: selesyn oral solution is a clear, colourless solution.

Contents of the package:

• selesyn 100 micrograms oral solution: Plastic vials (LDPE), each containing 2 ml of oral solution. Pack sizes: 10, 20, 50, 60, 90 and 100 vials.
• selesyn 500 micrograms oral solution: Oral solution bottles made of plastic (LDPE) with screw cap made of polypropylene, each containing 10 ml of oral solution, one measuring spoon and one dosing pipette. Pack sizes: 10, 20 and 50 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
biosyn Arzneimittel GmbH
Schorndorfer Strasse 32
70734 Fellbach
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
NL: selenase drank 100 µg, drank 50 µg/ml
selenase drank 500 µg, drank 50 µg/ml
HU: selesyn 100 mikrogramm, belsöleges oldat
selesyn 500 mikrogramm, 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)

PACKAGE LEAFLET: INFORMATION FOR THE USER

selesyn 100 micrograms injectable solution (50 micrograms/ml)

100 micrograms of selenium in each 2 ml of injectable solution
selesyn 500 micrograms injectable solution (50 micrograms/ml)
500 micrograms of selenium in each 10 ml of injectable solution
Active substance: Sodium selenite pentahydrate
Please read this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if their symptoms are similar to yours, as it could be harmful.
• If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What selesyn injectable solution is and what it is used for
2. Before using selesyn injectable solution
3. How to use selesyn injectable solution
4. Possible side effects
5. How to store selesyn injectable solution
6. Further information

1. WHAT SELESYN INJECTABLE SOLUTION IS AND WHAT IT IS USED FOR

Selesyn Injectable Solution is a medicinal product belonging to the group of mineral supplements.
Sodium selenite pentahydrate, the active substance of the injectable solution, provides a source of selenium,
an essential trace element in nutrition, which enables metabolism to function efficiently.
Your doctor has prescribed this medicine because blood tests measuring your selenium levels have revealed
a deficiency of this element, which cannot be corrected by taking selenium from normal dietary sources.

2. BEFORE USING SELESYN INJECTABLE SOLUTION

Do not use Selesyn Injectable Solution

• if you are allergic (hypersensitive) to sodium selenite pentahydrate or to any of the excipients of Selesyn injectable solution.
• if you have selenosis (selenium poisoning).

Take special care with Selesyn Injectable Solution
There are no specific warnings or precautions for the use of Selesyn injectable solution.

Taking Selesyn Injectable Solution with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those obtained without a prescription.
Care must be taken not to mix the solution with reducing substances (e.g. vitamin C).

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy:
There are no data available on the use of Selesyn injectable solution in pregnant women.
No adverse effects of sodium selenite on pregnancy or the fetus are expected, provided it is used in cases of proven selenium deficiency.
Breastfeeding:
Selenium is excreted in breast milk. However, the administered doses used to correct selenium deficiency in breastfeeding women are not expected to cause adverse effects in the infant.

Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.

Important information about some excipients of Selesyn Injectable Solution
Selesyn injectable solution contains less than 1 mmol of sodium (23 mg) per ml and is therefore essentially “sodium-free”.

3. HOW TO USE SELESYN INJECTABLE SOLUTION

Always use selesyn injectable solution exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Selesyn injectable solution is for single use only.
The usual daily dose is:
100 – 200 micrograms of selenium (equivalent to 1 or 2 vials of selesyn 100 mcg injectable solution, or 2 – 4 ml of selesyn 500 mcg injectable solution).
If blood test results indicate the need for a higher amount of selenium, your doctor may increase the dose up to 500 micrograms of selenium (equivalent to 5 vials of selesyn 100 mcg injectable solution, or 1 vial of selesyn 500 mcg injectable solution).
Method of administration:
Selesyn injectable solution will be administered to you exclusively by a nurse or doctor.
Selesyn injectable solution is given as an intramuscular injection (into the muscle) or intravenous injection (into a vein).
Duration of treatment:
Blood samples will be taken periodically to determine selenium levels in the blood and monitor the effectiveness of treatment. Treatment with selesyn injectable solution will be discontinued as soon as selenium levels return to normal.
Dosage in children:
In children, the doctor will prescribe an initial dose of 2 µg/kg body weight per day, followed by a maintenance dose of 1 µg/kg body weight per day. Blood samples will be taken periodically to determine selenium levels in the blood and monitor the effectiveness of treatment.
The following table shows the maximum daily doses for children when administered over prolonged periods:
Age (years) Maximum tolerable intake level (µg selenium/day)
1-3 60
4-6 90
7-10 130
11-14 200
15-17 250
Dosage in patients with impaired renal or hepatic function:
Your doctor will not prescribe a different dose if you have kidney or liver disorders.
If you use more selesyn injectable solution than you should
If you use more selesyn injectable solution than prescribed, the following symptoms may occur:

• Acute (short-term): garlic odor on the breath, fatigue, nausea, diarrhea, and abdominal pain; or
• Chronic (long-term): possible effects on nail and hair growth, and potential development of peripheral polyneuropathy (a nerve disorder that may be associated with numbness or tingling).
  If you forget to use selesyn injectable solution
  Do not use a double dose to make up for the missed injection.
  If you stop using selesyn injectable solution
  There are no special instructions regarding interruption of treatment with selesyn injectable solution.
  If you have any doubts about the use of selesyn injectable solution, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Selesyn injectable solution may cause adverse reactions, although not
everyone experiences them.
Frequency not known (cannot be estimated from the available data):
after intramuscular administration, you may experience pain at the site where the nurse or
doctor administered Selesyn injectable solution.
However, if taken in excessive amounts, the medicine may cause the symptoms listed above.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your
doctor or pharmacist. You may also report adverse reactions directly via the national
reporting system at the following address:
http://www.agenziafarmaco.gov.it/it/responsabili
By reporting adverse reactions, you can help provide more information on the safety of
this medicine.

5. HOW TO STORE SELESYN INJECTABLE SOLUTION

Keep Selesyn injectable solution out of the reach and sight of children.
The nurse or doctor will administer this medicine immediately after opening the vials or bottles.
The nurse or doctor will not administer this medicine if the vial or bottle is damaged or if the solution is cloudy.
This medicine does not require any special storage conditions.
Do not use Selesyn injectable solution after the expiry date stated on the label affixed to the glass vial or bottle and on the carton after "exp.". The expiry date refers to the last day of the month.

6. OTHER INFORMATION

What selesyn injectable solution contains
The active substance is:
Sodium selenite pentahydrate

The excipients are:
Sodium chloride, hydrochloric acid, water for injections

• selesyn 100 micrograms injectable solution: Each 2 ml vial of injectable solution contains 100 micrograms of selenium in the form of 333 micrograms of sodium selenite pentahydrate, corresponding to 50 micrograms/ml.
• selesyn 500 micrograms injectable solution: Each 10 ml vial of injectable solution contains 500 micrograms of selenium in the form of 1,665 micrograms of sodium selenite pentahydrate, corresponding to 50 micrograms/ml.

Description of the appearance of selesyn injectable solution and contents of the pack
Description of the appearance of selesyn injectable solution
selesyn injectable solution is a clear, colourless solution.

Contents of the pack:

• selesyn 100 micrograms injectable solution: glass vials, each containing 2 ml of injectable solution. Pack sizes: 5, 10 and 50 vials.
• selesyn 500 micrograms injectable solution: glass vials, each containing 10 ml of injectable solution, made of transparent glass closed with blue metallic chlorobutyl rubber stoppers and aluminium caps with natural-coloured PP discs, or closed with grey bromobutyl rubber stoppers and aluminium caps with grey PP discs. Pack sizes: 2 and 10 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
biosyn Arzneimittel GmbH
Schorndorfer Strasse 32
70734 Fellbach
Germany

This medicinal product is authorised in the European Economic Area Member States under the following names:
NL: selenase oplossing voor injectie 100 µg, oplossing voor injectie 50 µg/ml
selenase oplossing voor injectie 500 µg, oplossing voor injectie 50 µg/ml
CZ: selenase injekční roztok 500 µg, injekční roztok 50 µg/ml
HU: selesyn 100 mikrogramm, oldatos injekció
selesyn 500 mikrogramm, oldatos injekció
IE: selesyn 100 micrograms/2 ml, solution for injection (50 micrograms/ml)
selesyn 500 micrograms/10 ml, solution for injection (50 micrograms/ml)
IT: selesyn 100 mcg soluzione iniettabile
selesyn 500 mcg soluzione iniettabile
PT: selenase solução injectável 100 microgramas
selenase solução injectável 500 microgramas
SK: selenase injekčný roztok 100 µg, injekčný roztok 50 µg/ml
selenase injekčný roztok 500 µg, injekčný roztok 50 µg/ml
UK: selenase 100 micrograms, solution for injection (50 micrograms/ml)
selenase 500 micrograms, solution for injection (50 micrograms/ml)

This Patient Information Leaflet was last approved in 11/2023.

Additional information for healthcare professionals administering the medicine
When preparing an infusion solution using selesyn injectable solution as a supplement, ensure that the pH does not fall below 7.0 and that the solution is not mixed with reducing agents (e.g. vitamin C), as this may cause precipitation of elemental selenium. For safety reasons, it is recommended to avoid non-specific precipitation after mixing infusion solutions with selesyn injectable solution.
Elemental selenium is insoluble in aqueous media and has no bioavailability.

When selesyn injectable solution is administered as a supplement to infusion solutions for total parenteral nutrition, a daily dose of 100 micrograms of selenium should be ensured (1 vial of selesyn 100 mcg injectable solution). There are no predefined intervals to be observed for the possible administration of a supplementary dose of selesyn injectable solution (100 micrograms of selenium per day = 1 vial of selesyn 100 mcg injectable solution).

Whole blood or serum selenium levels should be determined to monitor the effectiveness of therapy.

selesyn injectable solution may be mixed with 0.9% NaCl.

This medicinal product requires no special storage conditions.
The shelf life of selesyn injectable solution in unopened vials or vials is 4 years.
Discard any unused contents.