SYTRON Oral solution (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Sytron 27.5 mg iron per 5 ml Oral Solution.

2. Qualitative and quantitative composition

Each 5 ml of oral solution contains 207.5 mg of sodium feredetate trihydrate equivalent to 27.5 mg of iron. Excipients with known effect: Each 5 ml of Sytron solution contains: 5 mg of Methyl hydroxybenzoate ...

3. Pharmaceutical form

Oral solution. Clear, red syrup, free of particles.

4.1. Therapeutic indications

Sytron is indicated in adults, children and infants for iron deficiency anaemia: Notably in paediatrics; In pregnancy when other forms of oral iron may not be well tolerated; In anaemias secondary to rheumatoid ...

4.2. Posology and method of administration

Posology Treatment Adults and the elderly (over 65 years) 5 ml increasing gradually to 10 ml three times daily. Paediatric population Treatment of iron-deficiency anaemia in all paediatric age groups is ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Iron preparations are contraindicated in patients with haemochromatosis and haemosiderosis. Iron is contraindicated ...

4.4. Special warnings and precautions for use

Care should be taken in patients with haemolytic anaemia, iron-storage or iron-absorption diseases or existing gastrointestinal diseases. Iron preparations colour the faeces black, which may interfere ...

4.5. Interaction with other medicinal products and other forms of interaction

Avoid concomitant administration of oral iron with dimercaprol (formation of toxic compounds). Iron reduces the absorption of penicillamine, mycophenolate, fluoroquinolones, levodopa, carbidopa, thyroxine ...

4.6. Pregnancy and lactation

Administration of drugs during the first trimester of pregnancy requires careful assessment of potential risks versus benefits to be gained. No adverse events associated with Sytron administration during ...

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Adverse reactions reported as possibly associated to Sytron are presented in the following table by MedDRA System Organ Class (SOC), Preferred Term and frequency. The following frequency categories are ...

4.9. Overdose

Initial symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis may occur. ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Iron preparations ATC code: B03A After absorption, elemental iron is available for haemoglobin regeneration and reversal of anaemia associated with iron-deficient ...

5.2. Pharmacokinetic properties

Sodium feredetate is not an iron salt as it contains iron in an un-ionised form. In this compound the iron is insulated or sequestered with the sodium salt of ethylenediamine tetra-acetic acid (EDTA) to ...

5.3. Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6.1. List of excipients

Methyl hydroxybenzoate (E218) Propyl hydroxybenzoate (E216) Citric acid monohydrate Saccharin sodium Glycerol Sorbitol solution Ethanol 96% Black cherry flavour Ponceau 4R (E124) Potable water

6.2. Incompatibilities

None known.

6.3. Shelf life

Unopened: 36 months. Opened: 3 months from date of opening. If this product has been diluted with water use within 14 days of preparation.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Sytron is supplied in round amber glass bottles with a CRC cap. Each bottle contains either 125ml or 500ml or 2250ml of Sytron. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Water is the recommended diluent for this product.

7. Marketing authorization holder

Kyowa Kirin Limited, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

8. Marketing authorization number(s)

PL 16508/0059

9. Date of first authorization / renewal of the authorization

13 October 1993/18 February 2004

10. Date of revision of the text

30/07/2021

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