Ferrous fumarate 210mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ferrous fumarate

Available from:

Phoenix Healthcare Distribution Ltd

ATC code:

B03AA02

INN (International Name):

Ferrous fumarate

Dosage:

210mg

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

PATIENT INFORMATION LEAFLET
FERROUS FUMARATE 210MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
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. Do not pass it
on to others. It may harm them, even if
their symptoms are the same as yours. If any of the side effects
become serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Ferrous Fumarate 210mg Tablets. It will
be referred to as Ferrous Fumarate Tablets
for ease hereafter.
IN THIS LEAFLET:
1.
What Ferrous Fumarate Tablets are and what they are used for
2.
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.
Further 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 a reduction in the number of red blood
cells found in the body (iron deficiency anaemia).
Ferrous Fumarate Tablets are used to prevent or treat iron deficiency
anaemia. The prevention of iron deficiency
during pregnancy usually requires a combination of iron and folic
acid.
2. BEFORE YOU TAKE FERROUS FUMARATE TABLETS
DO NOT TAKE FERROUS FUMARATE TABLETS IF:
•
You know that you are allergic to ferrous fumarate or any of the other
ingredients (see section 6 of this leaflet),
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
have incre

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fersamal 210mg tablets
Ferrous fumarate 210mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 210mg ferrous fumarate BP
3
PHARMACEUTICAL FORM
Tablet
Light brown biconvex tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis and treatment of iron deficiency states.
For prophylaxis during pregnancy, a combination of iron and folic acid
is
usually recommended.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND THE ELDERLY:
Iron deficiency anaemia - 1 tablet two to three
times a day; prophylaxis - 1 tablet once or twice
a day.
CHILDREN:
Not
recommended,
suggest
use
of
Fersamal
syrup.
METHOD OF ADMINISTRATION: Oral
The tablets are easy to swallow but may also be crushed or chewed
being
almost tasteless.
Rationale:
Taking
into
account
the
content
of
elemental
iron
and
the
referenced
recommended daily dose of the same in deficiency states and for
prophylaxis,
the Fersamal dosing is in need of revision.
Each Fersamal tablet contains 210mg ferrous fumarate which
approximates to
65-70mg
of
elemental
iron-
reference:
(1)
Goodman
&
Gilman’s
The
pharmacological Basis of Therapeutics, 10th Edition, page no. 1499 (2)
BNF
RECOMMENDED DOSES:
(a)
Iron Deficiency anaemia: 100 to 200mg elemental iron per day-
[reference
1) BNF (2) G&G]. This equates to Fersamal 1 tablet two or three times
a
day.
(b)
Prophylaxis: Ferrous sulphate 200mg once or twice a day (reference
BNF)
i.e. 60 to 120mg elemental iron per day. This equates to Fersamal 1
tablet
once or twice daily.
4.3
CONTRAINDICATIONS
Known hypersensitivity to any of the ingredients of the product.
Paroxysmal
nocturnal haemoglobinuria. Haemosiderosis, haemochromatosis. Active
peptic
ulcer. Repeated blood transfusions. Regional enteritis and ulcerative
colitis.
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
required
when treating patient