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SYTRON 27.5MG IRON PER 5 ML ORAL SOLUTION

Active substance(s): SODIUM FEREDETATE / SODIUM FEREDETATE

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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 the past.

are currently having iron injections.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sytron:

if you have haemolytic anaemia

if you have an iron storage or absorption disease

if you have gastrointestinal disease




if a child has been taking Sytron for a long
time or at high doses as this can lead to toxic
accumulation in the body
if you are having tests on your stools as iron
preparations colour the faeces black and can
interfere with test results

Other medicines and Sytron
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following:

dimercaprol (for metal poisoning)

iron-containing medicines or tonics

chloramphenicol, fluoroquinolones or tetracyclines
(to treat infections)

penicillamine (for rheumatoid arthritis)

methyldopa (for high blood pressure)

mycophenolate (to prevent organ transplant rejection)

levodopa, carbidopa or entacapone
(for Parkinson’s disease)

bisphosphonates (for osteoporosis)

thyroxine (for thyroid problems)

trientine (for Wilson’s Disease)

cholestyramine (for high cholesterol)

proton-pump-inhibitors e.g. omeprazole
(for stomach ulcers)

bicarbonates, carbonates, calcium, magnesium,
zinc and other mineral supplements (indigestion
and antacid remedies)
Sytron with food and drink
Tea, coffee, eggs, milk, ascorbic acid (vitamin c) and
citric acid, may interfere with Sytron.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or planning to have a baby, ask your doctor
for advice before taking this medicine.
Driving and using machines
Sytron is not expected to have an effect on your ability
to drive or operate machinery.
Sytron contains:
• Methyl hydroxybenzoate (E218), propyl
hydroxybenzoate (E216), ponceau 4R (E124) –
which may cause allergic reactions (possibly
delayed).

Sorbitol – if you have been told by your doctor
that you have an intolerance to some sugars,
contact your doctor before taking this medicinal
product.

Ethanol – this medicinal product contains small
amounts of ethanol (alcohol), less than 100 mg in
the maximum dose of 10 ml.

Sodium – this medicinal product contains
approximately 1.04 mmol (24.00 mg) sodium in the
maximum dose of 10 ml (2 x 5 ml spoonfuls), and
should be taken into consideration by patients on a
controlled sodium diet. However, if you are taking
smaller doses e.g. 1 x 5 ml spoonful at a time or
less then it contains less than 1 mmol (23 mg)
sodium per dose and is essentially sodium free.

3. How to take Sytron
The liquid is to be taken by mouth. Always take this
medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Take the following doses as given in the table below:
Age
Dose
Treatment of anaemia:
Adults
1 or 2 x 5 ml spoonfuls 3 times
a day
Elderly
1 or 2 x 5 ml spoonfuls
(over 65 years)
3 times a day
Children
Depends on weight – 3 to
6 mg/kg (max 200mg) of
elemental iron* as given by
your healthcare professional
in 2-3 divided doses
Prevention of anaemia:
5 mg of elemental iron*
Babies of low-birth
weight who are solely (0.9 ml given in a 1ml syringe)
daily as given by your
breast-fed
healthcare professional.
A higher dose – depending
on weight – up to 2 mg/kg of
elemental iron* daily as given
by your healthcare professional
may be required for exclusively
breast-fed babies.
Babies (6 to 24 months) 1 x 2.5ml spoonful daily
Children (2 to 5 years) 1 x 5ml spoonful daily
Children (6 to 11 years) 1 - 2 x 5ml spoonfuls daily
Adolescents
2 x 5ml spoonfuls daily
*Elemental iron is iron your body can absorb.
If you take more Sytron than you should
If you accidentally take too much Sytron or give too
much to a child, tell your doctor immediately or contact
your hospital. Take this leaflet, the container and any
remaining Sytron with you, if you can.
An overdose may cause:
• sickness (this may have some blood in it) or make
you feel sick

stomach pains

diarrhoea

blood in your stools

tiredness

cold and sweaty skin

fast heart beat

high blood sugar

high blood acidity (metabolic acidosis).
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
If you forget to take Sytron
If you forget to take a dose, take the next dose at the
usual time. Do not take a double dose to make up for a
forgotten dose.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Allergic reactions: e.g. itchy skin rash, swelling of
the face, lips, tongue or throat, or difficulty breathing
or swallowing.

If you experience any of the above, stop taking this
medicine and see a doctor immediately.
You may feel sick or have mild diarrhoea in the early
stages of treatment. These effects should quickly
disappear if you stop taking Sytron for a short time.
When treatment is restarted, a lower dose of your
medicine should be taken.
If your doctor tells you to take Sytron at doses higher
than is stated in this leaflet, you may experience
mild diarrhoea.
Reporting of side effects
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 the 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. How to store Sytron
Keep this medicine out of the sight and reach of
children.
The product should be stored below 30°C.
Do not use this medicine after the expiry date which
is stated on the label after EXP. Once opened the
product should be used within 3 months (there is a
space on the label to record the date it was first opened).
If the product shows any signs of deterioration
please return it to your pharmacist.
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 protect the environment.

6. Contents of the pack and other
information
What Sytron contains
The active substance is: sodium feredetate trihydrate
(also known as sodium iron edetate) 207.5 mg/5 ml
(equivalent to 27.5 mg/5 ml of elemental iron).
The other ingredients are: methyl hydroxybenzoate
(E218), propyl hydroxybenzoate (E216), citric acid
monohydrate, saccharin sodium, glycerol, sorbitol,
ethanol, ponceau 4R (E124), black cherry flavouring,
water (please see end of section 2: “Sytron contains” for
important information about some of the ingredients).
What Sytron looks like and contents of the pack
Sytron is a red, sugar free, cherry-flavoured liquid
supplied in amber coloured glass bottles containing
125 ml, 500 ml or 2250 ml of oral solution (not all pack
sizes may be marketed).
Marketing Authorisation Holder
Archimedes Pharma UK Limited,
Galabank Business Park, Galashiels,
TD1 1QH, United Kingdom.
Manufacturer
Laleham Health and Beauty Limited,
Fairfield, Bradshaw Lane, Greenhalgh, Kirkham,
Preston, Lancashire, PR4 3JA, United Kingdom.
The leaflet was last revised: 05/2017
LFT-SYT-GB-005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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