Sytron oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium feredetate

Available from:

Kyowa Kirin International UK NewCo Ltd

ATC code:

B03AB03

INN (International Name):

Sodium feredetate

Dosage:

5.5mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010101; GTIN: 5027229000012

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SYTRON
®
27.5 MG IRON PER 5 ML ORAL SOLUTION
Sodium feredetate trihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist 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. 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.
WHAT IS IN THIS LEAFLET:
1.
What Sytron is and what it is used for
2.
What you need to know before you take Sytron
3.
How to take Sytron
4.
Possible side effects
5.
How to store Sytron
6.
Contents of the pack and other information
1.
WHAT SYTRON IS AND WHAT IT IS USED FOR
Sytron is an oral solution for adults, children and babies to treat
iron deficiency anaemia caused by too
little iron in the body. The form of iron used in this product means
that it is less likely to cause
stomach upsets than other iron-containing medicines, and will not
discolour teeth. It is taken by:
•
People with iron deficiency anaemia (especially children)
•
Pregnant women when other forms of oral iron may not be well tolerated
•
People who have become anaemic as a result of having rheumatoid
arthritis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SYTRON
DO NOT TAKE SYTRON IF YOU:
•
are
ALLERGIC
to sodium feredetate trihydrate or any of the other ingredients of
this medicine
(listed in section 6, please also see end of section 2: ”Sytron
contains” for important information
about some of the ingredients).
•
have a history of
SENSITIVITY TO IRON
-containing preparations.
•
have a disorder in which there is
EXCESSIVE ABSORPTION
and
STORAGE
of
IRON
such as
haemochromatosis or haemosiderosis.
•
have repeated
BLOOD TRANSFUSIONS
or have had them in

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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
(E218), 1 mg
of Propyl Hydroxybenzoate (E216), 11.4 mg of sodium, 1400 mg of
sorbitol,
0.015 ml of ethanol and 0.35 mg of Ponceau 4R (E124) - please refer to
section 4.4
for further details.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution
Clear, red syrup, free of particles
4
CLINICAL PARTICULARS
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 arthritis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment:
ADULTS AND THE ELDERLY
(OVER 65 YEARS):
5ml increasing gradually to 10ml three times daily.
PAEDIATRIC POPULATION:
Treatment of iron-deficiency anaemia in all paediatric age groups is
3-6 mg/kg
(max 200 mg) of elemental iron daily given in 2-3 divided doses.
Prophylaxis:
BABIES OF LOW BIRTH
WEIGHT WHO ARE SOLELY
BREAST-FED:
A daily dose of 5 mg of elemental iron as prophylactic iron
supplementation for babies of low birth weight who are solely
breast-fed
is recommended. Higher doses up to 2 mg/kg of elemental iron per day
might be needed to cover the needs of growing exclusively breastfed
infants. Supplementation is started 4-6 weeks after birth and
continued
until mixed feeding is established.
OTHER CHILDREN
(ELEMENTAL IRON PER
DAY):
Age 6 - 24 months: 12.5 mg
Age 2 - 5 years: 20-30 mg
Age 6 - 11 years: 30 – 60 mg
Adolescents: 60 mg
Method of administration
Oral
For instructions on dilution of the medicinal product before
administration, see
section 6.6.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substa