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SYTRON

Active substance(s): SODIUM FEREDETATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SYTRON®
Sodium feredetate liquid 190 mg/5 ml (equivalent to 27.5 mg of iron/5 ml)
Read all of this leaflet carefully before you start
taking this medicine.
– Please keep this leaflet. You may need to read it
again.
– If you have any further questions, ask your doctor
or pharmacist.
– This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
– If you suffer from any side effect that gets serious,
or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Sytron is and what it is used for
2. Before you take Sytron
3. How to take Sytron
4. Possible side effects
5. How to store Sytron
6. Further information

1. WHAT SYTRON IS AND WHAT IT IS
USED FOR
Sytron is an oral solution for treating anaemia caused
by too little iron in the body (iron deficiency anaemia).
The form of iron used in this product means that it is
less likely to cause stomach upsets than other ironcontaining medicines, and will not discolour teeth. It is
taken by:
• pregnant women when other forms of oral iron may
not be well tolerated
• children and adults who have become anaemic as a
result of having rheumatoid arthritis.

2. BEFORE YOU TAKE SYTRON
DO NOT TAKE Sytron if you:
• are allergic to any of the ingredients in the product
(see end of section 2: Important information about
some of the ingredients and section 6: Further
information).
• 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.
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

Taking other medicines
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicine
obtained without a prescription.
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)
• tea, coffee, eggs, milk, ascorbic acid (vitamin c)
and citric acid, these may interfere with Sytron
Pregnancy and breast-feeding
Tell your doctor before taking Sytron if you are
pregnant, planning to become pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking
any medicines.
Driving and using machines
Sytron is not expected to have an effect on your ability
to drive or operate machinery.
Important information about some of the ingredients
of Sytron
This product contains the following:
• Methyl hydroxybenzoate (E218), propyl
hydroxybenzoate (E216), ponceau 4R (E124) which may cause allergic reactions.
• Sorbitol - consult your doctor before taking this
medicinal product if you have an intolerance to
some sugars.
• Ethanol (alcohol) - Sytron contains less than
100 mg of ethanol per 5 ml.

3. HOW TO TAKE SYTRON
The liquid is to be taken by mouth. Always take Sytron
exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Take the following doses as given in the table:

Age
Treatment of anaemia:
Adults
Elderly (over 65 years)
Children

Prevention of anaemia:
Babies of low birthweight who are solely
breast-fed

Babies (6 to 24 months)
Children (2 to 5 years)
Children (6 to 11 years)
Adolescents

Dose
1 or 2 x 5 ml spoonfuls
3 times a day
1 or 2 x 5 ml spoonfuls
3 times a day
Depends on weight 3 to 6 mg/kg (max.
200 mg) of elemental
iron* as given by your
healthcare professional in
2-3 divided doses
5 mg of elemental iron*
(0.9 ml given in a 1 ml
syringe) daily as given
by your 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.
1 x 2.5 ml spoonful daily
1 x 5 ml spoonful daily
1 - 2 x 5 ml spoonfuls
daily
2 x 5 ml 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, Sytron 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.
If any of these side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor.
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 out of the sight and reach of children.
The product should be stored below 30°C.
Do not use Sytron after the expiry date printed on the
label. 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.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

6. FURTHER INFORMATION
What Sytron contains
The active substance is: sodium feredetate (also known
as sodium iron edetate) 190 mg/5 ml.
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 (see end of section 2: Important information
about some of the ingredients of Sytron).
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
either 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 & Beauty Limited
Fairfield, Bradshaw Lane, Greenhalgh, Kirkham,
Preston, Lancashire, PR4 3JA, United Kingdom
® Sytron is a registered trade mark.
PL 12406/0005
The leaflet was last revised: 04/2015.
LFT-SYT-GB-003



Yellowdot Design Artwork Technical Specifications


DESCRIPTION: Sytron UK PIL
PRODUCT No.: LFT-SYT-GB-003

INTERNAL CODE No.:

Cutterguide ref.:

VERSION No.: 1

DATE: 25/03/2015

YELLOWDOT REF: 12501

REASON FOR CHANGE: Update the Manufacturers name/address
(BS 17/03/2015)






SIZE: 210mm high x 148mm wide
COLOURS: Black
TEXT SIZE: 8pt
LEADING: 8.25pt (2.9mm)
FONTS: Times New Roman

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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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