Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sodium selenite pentahydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR
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. 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. selenase® oral solution, UK
PIL (July 2024)
Page 1/7
2.
E SELENASE® ORAL SOLUTION
Do not use Selenase® oral solution
SELENASE® ORAL SOLUTION
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure. Selenase® oral solution is for single use only. selenase® oral solution, UK
PIL (July 2024)
Page 2/7
The recommended 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 10 ml (2 x 5 ml) of Selenase® 500 micrograms, oral solution). Use in children and adolescents 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 Dosage in patients with renal or hepatic impairment 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.
selenase® oral solution, UK
PIL (July 2024)
Page 3/7
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: Please remove the required dose in milliliter which your doctor has prescribed you by carefully squeezing of the drinking bottle into the enclosed measuring cup with milliliter graduation. For example if you should take 500 micrograms selenium please remove two times 5 ml (2 x 5 ml) from the drinking bottle. 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 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 medicine, ask your doctor, pharmacist or nurse. selenase® oral solution, UK
PIL (July 2024)
Page 4/7
4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine. 5.
SELENASE® ORAL SOLUTION
Keep this medicine out of the sight and reach 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 you notice the ampoule or the drinking bottle is damaged or if the solution is cloudy. Discard any unused contents. Do not use this medicine 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. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. selenase® oral solution, UK
PIL (July 2024)
Page 5/7
6.
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 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 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: Kora Corporation Ltd. t/a Kora Healthcare 20 Harcourt Street Dublin 2, D02 H364 Ireland Manufacturer: biosyn Arzneimittel GmbH Schorndorfer Strasse 32 70734 Fellbach Germany
selenase® oral solution, UK
PIL (July 2024)
Page 6/7
This medicinal product is authorised in the Member States of the EEA under the following names: NL: HU: IE: IT: PT: SK: UK:
selenase drank 100 μg, drank 50 μg/ml selenase drank 500 μg, drank 50 μg/ml selesyn 100 microgramm, belsöleges oldat (oral solution) selesyn 500 microgramm, belsöleges oldat (oral solution) selesyn 100 micrograms/2 ml, oral solution (50 micrograms/ml) selesyn 500 micrograms/10 ml, oral solution (50 micrograms/ml) selesyn 100 mcg soluzione orale selesyn 500 mcg soluzione orale selenase solução oral 100 microgramas selenase solução oral 500 microgramas selenase perorálny roztok 100 μg, perorálny roztok 50 μg/ml selenase perorálny roztok 500 μg, perorálny roztok 50 μg/ml selenase 100 micrograms, oral solution (50 micrograms/ml) selenase 500 micrograms, oral solution (50 micrograms/ml)
This leaflet was last revised in 07/2024.
selenase® oral solution, UK
PIL (July 2024)
Page 7/7
Selenase 500 micrograms, oral solution (50 micrograms/ml) comes as oral solution containing 500mcg / 50micrograms/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Selenase 500 micrograms, oral solution (50 micrograms/ml) is sodium selenite pentahydrate.
This leaflet reproduces the patient information leaflet approved for Selenase 500 micrograms, oral solution (50 micrograms/ml), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Proven selenium deficiency that cannot be offset from food sources.
Posology
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 10 ml (2 x 5 ml) of the drinking bottle = 500 micrograms, respectively).
Paediatric population
For measurement of dosage for children only selenase® 500 micrograms, oral solution (50 micrograms/ml) can be used.
2 µg/kg body weight/day at therapy onset and a maintenance dose of 1 µg/kg body weight/day.
For measuring a children's dose of less than 1 ml oral solution approximately 5 ml oral solution is placed in the measuring cup and the needed volume is drawn up with the enclosed pipette. For example for a 1-year-old child with 10 kg body weight the maintenance dose is 10 µg per day corresponding to 0.2 ml oral solution.
Selenium levels in whole blood or serum should be determined in order to monitor the success of therapy.
Maximum daily doses for children for a longer time:
Age (years)
UL (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
There is no scientific evidence on dosage adjustment in patients with renal or hepatic impairment.
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:
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 the drinking bottle with the integrated spike of the screw cap.
Picture 2:
Then the screw cap is turned off anti-clockwise.
Picture 3:
The required dose is removed by carefully squeezing of the drinking bottle into the enclosed measuring cup with milliliter graduation. Then the drinking bottle is closed firmly.
Hold the liquid in the mouth for about 30–60 seconds before swallowing.
Selenium levels in whole blood or serum should be determined in order to monitor the success of treatment.
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).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Selenosis.
None.
It must be ensured that selenase® oral solution is not administered orally at the same time as reducing substances (e.g. vitamin C), as precipitation of elemental selenium cannot be excluded (see section 6.2 "Incompatibilities").
Elemental selenium is not soluble in an aqueous medium and has no biological availability. Oral administration of selenase® oral solution and vitamin C should be given at an interval of 4 hours.
Pregnancy
There are no data from the use of selenase® in pregnant woman. Limited published data from animal studies reveal only evidence for toxicity to reproduction at maternally toxic dose.
No adverse effect of sodium selenite on the pregnancy or unborn child is expected, provided that it is used in case of proven selenium deficiency.
Breastfeeding
Selenium is excreted in breast milk. Doses correcting selenium deficiency in breast feeding woman are not expected to exert adverse effects on the suckling infant.
Fertility
There are no data available regarding the effect on fertility.
None.
None known to date when selenase® oral solution is used as directed.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Signs of an acute overdose are an odour of garlic on the breath, tiredness, nausea, diarrhoea and abdominal pain. Chronic overdose can affect growth of nails and hair and may lead to peripheral polyneuropathy.
Countermeasures include gastric lavage, forced diuresis or the administration of high doses of vitamin C. In the case of an extreme overdose (1,000–10,000 times the normal dose) an attempt should be made to eliminate the selenium by dialysis. Administration of dimercaprol is not recommended as the toxic effect of selenium is potentiated.
Ask anything about Selenase 500 micrograms, oral solution (50 micrograms/ml). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.