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SODIUM FEREDETATE 190MG/5ML ORAL SOLUTION

Active substance(s): SODIUM FEREDETATE / SODIUM FEREDETATE

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500ml
Sodium
Feredetate
Sodium Feredetate
190mg/5ml Oral Solution
#190mg/5ml Oral
Solution
Each 5ml dose contains Sodium Feredetate 190mg
(equivalent to 27.5mg of elemental iron/5ml)
Also contains sorbitol (E420), methyl hydroxybenzoate
(E218), propyl hydroxybenzoate (E216), ponceau 4R
lake (E124) and ethanol.
For oral administration. Read the package leaflet before
use.
Keep out of the sight and reach of children.
Important warning: Contains iron. Keep out of the
sight and reach of children, as overdose may be fatal.
Store in the original package in order to protect from
light. Use with in three months of opening.
Use as directed by your physician.

Sodium Feredetate
#190mg/5ml Oral
Solution

Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd,
Capital House,
85 King William Street,
London EC4N 7BL, UK
PL 12762/0537

190mg/
5ml

AMS Component No.:
Proof Number:
Revision Date:
Product Description:

Component:
Product Code:
Country:
Vendor Name:
CRF(s):
Revised by:

LL-102785-01

2
05-Jun-2017
Sodium
Feredetate
190mg/5ml Oral
Solution - 500 ml
LLET
103802
UK
Dales
PR 9473
ADD

POM

LL-102785-01
E2246

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref.:
Print Colours:
Non-Print Colours:
Min. Font Size:

143 x 105 mm
E2246
N/A
N/A
312 C , 471 C &
Black
Cutter & Braille
8 pt

PAGE 1 OF 1

500ml
Sodium
Feredetate
Sodium Feredetate
190mg/5ml Oral Solution
#190mg/5ml Oral
Solution
Each 5ml dose contains Sodium Feredetate 190mg
(equivalent to 27.5mg of elemental iron/5ml)
Also contains sorbitol (E420), methyl hydroxybenzoate
(E218), propyl hydroxybenzoate (E216), ponceau 4R
lake (E124) and ethanol.
For oral administration. Read the package leaflet before
use.
Keep out of the sight and reach of children.
Important warning: Contains iron. Keep out of the
sight and reach of children, as overdose may be fatal.
Store in the original package in order to protect from
light. Use with in three months of opening.
Use as directed by your physician.

Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd,
Capital House,
85 King William Street,
London EC4N 7BL, UK
PL 12762/0537

POM

LL-102785-01
E2246

190mg/
5ml

PACKAGE LEAFLET: INFORMATION FOR THE USER

SODIUM FEREDETATE
190 MG/5 ML ORAL SOLUTION
(equivalent to 27.5 mg of elemental iron/5 ml)

What is in this leaflet
1. What Sodium Feredetate is and what it is used for
2. What you need to know before you take Sodium Feredetate
3. How to take Sodium Feredetate
4. Possible side effects
5. How to store Sodium Feredetate
6. Contents of the pack and other information
1. WHAT SODIUM FEREDETATE IS AND WHAT IT IS USED FOR
The name of your medicine is Sodium Feredetate 190 mg/5 ml Oral Solution
(called Sodium Feredetate throughout this leaflet).
Sodium Feredetate is used to treat 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 iron-containing
medicines, and will not discolour teeth.
It is to be 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.

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist. See section 4.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SODIUM
FEREDETATE
Do NOT take Sodium Feredetate and tell your doctor if you:

• are allergic to sodium feredetate (also known as sodium iron edetate) or
any of the ingredients of this medicine (listed in section 2 and 6)
• have a history of sensitivity to iron-containing preparations
• have a disorder in which there is excessive absorption and storage of
(iron 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 using Sodium Feredetate:
- 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 Sodium feredetate 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 Sodium Feredetate
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
This includes any medicines you buy without a prescription, including ironcontaining medicines or tonics. This is because Sodium Feredetate can
affect the way in which some other medicines work. Also some medicines

can affect the way Sodium Feredetate works.
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 Sodium feredetate.
Pregnancy and breast-feeding
If you are pregnant, planning to have a baby or breast-feeding, ask your
doctor for advice before taking this medicine.
Driving and using machines
Sodium Feredetate is not expected to have an effect on your ability to drive

or operate machinery.
Sodium Feredetate contains:
- methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216).
These ingredients may cause allergic reactions (possibly delayed)
- ponceau 4R (E124). This ingredient may cause allergic reactions
- 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. Sorbitol may also cause mild laxative effects
- ethanol (alcohol). Sodium Feredetate contains small amounts of ethanol
less than 100 mg per 5 ml
- sodium. Sodium Feredetate contains approximately 11.51 mg of sodium
per 5 ml dose. Take this into account if you are on a controlled sodium diet.

-

3. HOW TO TAKE SODIUM FEREDETATE
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Method of administration
The oral solution is to be taken by mouth.
The recommended dose is:
Treatment of anaemia
- Adults (including elderly older than 65 years):
o 1 or 2 x 5 ml spoonful 3 times a day.

If you take more Sodium Feredetate than you should
If you accidentally take too much Sodium Feredetate or give too much to a
child, tell your doctor or contact your hospital immediately. Take this leaflet,
the container and any remaining oral solution with you.
An overdose may cause:
- you to feel sick (nausea)
- you to be sick (vomiting, which may contain blood)
- 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 forget to take Sodium Feredetate
If you forget a dose, take it as soon as you remember. However, if it is nearly
time for the next dose, skip the missed dose. Do NOT take a double dose to
make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

5. HOW TO STORE SODIUM FEREDETATE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the bottle
label after EXP. The expiry date refers to the last day of the month.
Do not use Sodium Feredetate after the bottle has been opened for more
than 3 months.
Store in the original package in order to protect from light.
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 Sodium Feredetate 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 (E420), ethanol, ponceau 4R (E124), black cherry flavouring
and water.
What Sodium Feredetate looks like and contents of the pack
Sodium feredetate is a red coloured liquid. It is supplied in amber-coloured

Children:
o 3 to 6 mg of elemental iron per 1 kg of body weight
o The maximum daily dose is 200 mg of elemental iron* (36.3 ml of
Sodium Feredetate), divided into 2 or 3 daily doses
o To be given by a healthcare professional only.
Prevention of anaemia
- Babies of low birth-weight who are solely breast-fed:
o 5 mg of elemental iron* (0.9 ml of Sodium Feredetate given in a 1 ml
syringe) daily.
o Depending on the body weight, a higher dose (up to 2 mg per 1 kg of
body weight) of elemental iron* daily may be required for exclusively
breast-fed babies.
o To be given by a healthcare professional only.
- Babies (6 to 24 months):
o 1 x 2.5 ml spoonful daily.
- Children (2 to 5 years):
o 1 x 5 ml spoonful daily.
- Children (6 to 11 years):
o 1 - 2 x 5 ml spoonful daily.
- Adolescents
o 2 x 5 ml spoonful daily.
*Elemental iron is iron your body can absorb.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Sodium Feredetate can cause side effects, although not
everybody gets them.
You may feel sick (nausea) or have mild diarrhoea in the early stages of
treatment. These effects should quickly disappear if you stop taking Sodium
Feredetate for a short time.
When treatment is restarted, a lower dose of your medicine should be taken.
If you are not sure what your dose should be, talk to your doctor.
If your doctor tells you to take Sodium Feredetate at doses higher than is
stated in this leaflet, you may experience mild diarrhoea.
If you experience any of the following side effects, STOP taking Sodium
Feredetate and see a doctor or go to a hospital IMMEDIATELY:
- allergic reactions – symptoms may include itchy skin rash, swelling of the
face, lips, tongue or throat, or difficulty breathing or swallowing.
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.

glass bottles with a child resistant cap containing 500ml of oral solution.
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd,
Capital House,
85 King William Street,
London EC4N 7BL, UK
Manufacturer
Dales Pharmaceuticals Limited, Snaygill Industrial Estate, Keighley Road,
Skipton, North Yorkshire, BD23 2RW, United Kingdom
This leaflet was last revised in June 2017.
LL-102785-01
E2246

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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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