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SODIUM FEREDETATE 190MG/5ML ORAL SOLUTION

Active substance(s): SODIUM FEREDETATE

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Sodium Feredetate

Sodium
Feredetate
190mg/5ml Oral Solution
#190 mg / #5 ml
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.

POM PL 41830/0037
PL Holder:
NRIM Limited
Unit 15Moorcroft
Harlington Road
Hillingdon
UB8 3HD UK

POM PL 41830/0037
PL Holder:
NRIM Limited
Unit 15Moorcroft
Harlington Road
Hillingdon
UB8 3HD UK

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

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

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.

Other medicines and Sodium Feredetate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Driving and using machines
Sodium Feredetate is not expected to have an effect on your ability to drive or operate machinery.

This includes any medicines you buy without a prescription, including iron-containing 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

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.
- 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.

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.
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.

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The name of your medicine is Sodium Feredetate 190 mg/5 ml Oral Solution (called Sodium Feredetate
throughout this leaflet).

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.

- Adolescents
o 2 x 5 ml spoonful daily.
*Elemental iron is iron your body can absorb.
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.

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 glass bottles with a child
resistant cap containing 500ml of oral solution.
Marketing Authorisation Holder and Manufacturer
NRIM Limited, Unit 15 Moorcroft, Harlington Road, Hillingdon, UB8 3HD, United Kingdom.
This leaflet was last revised in 07/2015.

NRIM

Client: NRIM

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.

Version: 1

(equivalent to 27.5 mg of elemental iron/5ml)

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.

SODIUM FEREDETATE
190 MG/5 ML ORAL SOLUTION

Strength: 125ml

1. WHAT SODIUM FEREDETATE IS AND WHAT IT IS USED FOR

Date: 6.7.15

PACKAGE LEAFLET: INFORMATION FOR THE USER

Product: Sodium Feredetate 190mg/5ml
Oral Solution 500ml

PL Number:

41830/0037

500ml Solution

020 8203 5976
020 8203 2357
info@artacreative.co.uk
www.artacreative.co.uk

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.

Arta Creative Solutions Ltd
Suite 1, Interlinks House
81c Church Road
London, NW4 4DP

Sodium Feredetate
#190 mg / #5 ml
Oral Solution

190mg/5ml Oral Solution

Fonts: Vectora Light & Vectora Bold

Sodium Feredetate

Colours: ■ Pantone 647 ■ Pantone 254
■ Black

Size: 143mm x 105mm

500ml Solution

t
f
e
w

41830/0037

020 8203 5976
020 8203 2357
info@artacreative.co.uk
www.artacreative.co.uk

Version: 1

Strength: 125ml

Arta Creative Solutions Ltd
Suite 1, Interlinks House
81c Church Road
London, NW4 4DP

Date: 6.7.15

Product: Sodium Feredetate 190mg/5ml
Oral Solution Braille

PL Number:

Fonts: SD Pharma Braille UK

Colours: N/A

Size: 143mm x 105mm

Sodium Feredetate
#190 mg / #5 ml
Oral Solution

Client: NRIM

Sodium Feredetate
#190 mg / #5 ml
Oral Solution

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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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