Patient leaflet - Sodium Feredetate 190 mg / 5 ml oral solution
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SODIUM
FEREDETATE
Do not take Sodium Feredetate
if you are allergic to sodium feredetate (also known as sodium iron
edetate) or any of the ingredients of this medicine (listed in section 6).
- if you have a history of sensitivity to iron-containing preparations.
if you have a disorder in which there is excessive absorption and storage
of (iron haemochromatosis or haemosiderosis).
- if you have repeated blood transfusions or have had them in the past.
- if you 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 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.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist 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 parahydroxybenzoate (E218)., propyl parahydroxybenzoate
(E216). These ingredients may cause allergic reactions (possibly delayed).
- Ponceau 4R (E124). This ingredient may cause allergic reactions.
Sorbitol. This medicine contains 1050 mg per 5 ml of solution which is
equivalent to 210 mg per ml of solution. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Ethanol (alcohol). This medicine contains 11 mg of alcohol (ethanol) in
each 5 ml of solution which is equivalent to 2.2 mg per ml of solution. The amount in 5ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine.
Information on Sodium content
Sodium. This medicine contains less than 1 mmol sodium (23 mg) per
dose, that is to say essentially ‘sodium-free’.
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.
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
PACKAGE LEAFLET: INFORMATION FOR THE USER SODIUM FEREDETATE
190 MG/5 ML ORAL SOLUTION (equivalent to 27.5 mg of elemental iron/5 ml)
190mg/
5ml
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, Dashwood House,
69 Old Broad Street, London, EC2M 1QS, United Kingdom
PL 12762/0537 POM
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.
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.
Sodium Feredetate #190mg/5ml Oral Solution
Sodium Feredetate #190mg/5ml Oral Solution
Sodium Feredetate #190mg/5ml Oral Solution
E2246 AW-LL-0000005 (v0.2)
E2246 AW-LL-0000005 (v0.2)
and technical approval needs to be taken, from the CMO, before Implementation.
Dimension: 143 x 105 mm Commodity No.: E2246
Version No.: AW-LL-0000005
(v0.2)
Product Description: Sodium Ferede-tate 190mg/5ml Oral Solution - 500 ml
Component: LL
Product Code: 103802
Country: UK
Vendor Name: Dales
Revision Date: 10-Jan-2024 Revised by:
Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd, Dashwood House,
69 Old Broad Street, London, EC2M 1QS, United Kingdom
PL 12762/0537 POM
- 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.
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 or or search for MHRA Yellow Card in the Google Play or Apple App Store.
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. 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 parahydroxybenzoate (E218), propyl parahydroxybenzoate (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
Mercury Pharmaceuticals Ltd,
Dashwood House, 69 Old Broad Street,
London, EC2M 1QS,
United Kingdom
Manufacturer
Dales Pharmaceuticals Limited, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, United Kingdom
This leaflet was last revised in January 2024.
AW-LL-0000005 (v0.2)
E2246