Sodium feredetate (iron 27.5mg5ml) oral solution sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium feredetate

Available from:

iron 27.5mg/5ml

ATC code:

B03AB03

INN (International Name):

Sodium feredetate

Dosage:

5.5mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010101; GTIN: 5060090470270

Patient Information leaflet

SODIUM FEREDETATE
190MG/5ML ORAL SOLUTION
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.
500ML
SODIUM FEREDETATE
190MG/5ML ORAL SOLUTION
500ML
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.
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

Summary of Product characteristics

OBJECT 1
SODIUM FEREDETATE 190MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 12-May-2017 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Sodium Feredetate 190mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml dose contains Sodium Feredetate 190mg (equivalent to 27.5mg
of elemental iron/5ml)
Also contains the following excipients with known effect
Ponceau 4R lake (E124)
Methyl hydroxybenzoate
(E218)
Propyl hydroxybenzoate
(E216)
Sorbitol liquid (E420)
Ethanol
0.08mg/5ml
5.0mg/5ml
1.0mg/5ml
1500mg/5ml
0.014ml/5ml
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution.
Red coloured liquid.
4. Clinical particulars
4.1 Therapeutic indications
Iron deficiency anaemia, notably in paediatrics.
In pregnancy when other forms of oral iron may not be well tolerated.
Anaemias secondary to rheumatoid arthritis.
4.2 Posology and method of administration
For oral administration:
Treatment:
Children:
Treatment of iron-deficiency anaemia in all paediatric age groups is
3-6 mg/kg (max 200 mg) of
elemental iron daily given in 2-3 divided doses.
Adults: 5ml increasing gradually to 10ml three times daily.
Elderly (over 65 years): As for adults.
Prophylaxis:
Babies of low birth weight who are solely breast-fed:
A daily dose of 5 mg of elemental iron as prophylactic iron
supplementation for babies of low birth
weight who are solely breast-fed is recommended. Higher doses up to 2
mg/kg of elemental iron per day
might be needed to cover the needs of growing exclusively breastfed
infants. Supplementation is started
4-6 weeks after birth and continued until mixed feeding is
established.
Other children (elemental iron per day):
Age 6 - 24 months: 12.5 mg
Age 2 - 5 years: 20-30 mg
Age 6 - 11 years: 30 – 60 mg
Adolescents: 60 mg
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Iron preparations are contraindicated in patients with
haemochromatosis and haemosiderosis.
Iron is contrain