Fersaday 322mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ferrous fumarate

Available from:

Advanz Pharma

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; GTIN: 5021691140016

Patient Information leaflet

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.
Fersaday 322mg Tablets was previously known as Fersaday 100mg Tablets.
The product has
been renamed to reflect the amount of ferrous fumarate instead of
elemental iron content.
The name of your medicine is Fersaday 322mg Tablets. It will be
referred to as Fersaday Tablets
for ease hereafter.
WHAT IS IN THIS LEAFLET
1. What Fersaday Tablets are and what they are used for
2. What you need to know before you take Fersaday Tablets
3. How to take Fersaday Tablets
4. Possible side effects
5. How to store Fersaday Tablets
6. Contents of the pack and other information
1. WHAT FERSADAY TABLETS ARE AND WHAT THEY ARE USED FOR
Fersaday 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.
Fersaday Tablets are used to prevent or treat iron deficiency anaemia.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERSADAY TABLETS
DO NOT TAKE FERSADAY 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 have incre

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