Ferrous fumarate 322mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ferrous fumarate

Available from:

A A H Pharmaceuticals Ltd

ATC code:

B03AA02

INN (International Name):

Ferrous fumarate

Dosage:

322mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010101

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FERROUS FUMARATE 322MG
FILM-COATED TABLETS
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 you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in
this leaflet. See section 4.
The name of your medicine is Ferrous Fumarate 322mg Film-Coated
Tablets. It will be referred to as Ferrous
Fumarate Tablets for ease hereafter.
WHAT IS IN THIS LEAFLET
1. What Ferrous Fumarate Tablets are and what they are used for
2. What you need to know before you take Ferrous Fumarate Tablets
3. How to take Ferrous Fumarate Tablets
4. Possible side effects
5. How to store Ferrous Fumarate Tablets
6. Contents of the pack and other information
1. WHAT FERROUS FUMARATE TABLETS ARE AND WHAT THEY ARE USED FOR
Ferrous Fumarate Tablets contain a form of iron called ferrous
fumarate. Iron is usually found in foods and is
necessary for the normal development of red blood cells. A lack of
iron affects the development of the red blood cells
and causes iron deficiency anaemia.
Ferrous Fumarate Tablets are used to prevent or treat iron deficiency
anaemia.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERROUS FUMARATE TABLETS
DO NOT TAKE FERROUS FUMARATE TABLETS IF
• You are allergic to Ferrous fumarate or any of the other
ingredients of this medicine (listed in section 6), or to any
other medicine containing iron
• You have noticed blood in your urine
• You suffer from any form of anaemia, other than iron deficiency
anaemia, or from any other condition where your
body’s iron is affected (your doctor will be able to advise you)
• You have bronze markings on your skin or you have been told that
you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fersaday 322mg Tablets
Ferrous Fumarate 322mg Film-Coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 322.0mg Ferrous Fumarate BP (equivalent to
approximately 100 mg ferrous iron)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated Tablets
Each film coated tablet is brown ochre in colour and engraved ‘FE’
on
one face and ‘322’ on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis and treatment of iron deficiency states.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and the elderly: One tablet daily (the foil enclosing the
tablet is printed
with days of the week in sequence).
In severe or refractory iron deficiency, one tablet may be given twice
a day.
_Paediatric population:_ Ferrous Fumarate tablets are not intended for
the
treatment of children.
Method of administration:
Oral
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Paroxysmal nocturnal haemoglobinuria, haemosiderosis,
haemochromatosis,
active
peptic
ulcer,
repeated
blood
transfusions,
regional
enteritis,
and
ulcerative colitis. Ferasday tablets must not be used in anaemias
other than
those due to iron deficiency.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Some post gastrectomy patients show poor absorption of iron. Care is
needed when
treating patients with iron deficiency anaemia in patients with
treated or controlled
peptic ulceration. Duration of treatment of uncomplicated iron
deficiency anaemia
should not usually exceed 6 months (or 3 months after reversal of the
anaemia has
been achieved).
Since anaemia due to combined iron and vitamin B12 or folate
deficiencies may be
microcytic in type, patients with microytic anaemia resistant to
therapy with iron
alone should be screened for vitamin B12 or folate deficiency.
Paediatric Population
Ferrous Fumarate tablets should be kept out of the sight and reach of
children.
T