Ferrous sulfate 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ferrous sulfate dried

Available from:

Sun Pharmaceutical Industries Europe B.V.

ATC code:

B03AA07

INN (International Name):

Ferrous sulfate dried

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010101; GTIN: 5015525060243 5015525060274

Patient Information leaflet

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04
FERROUS SULFATE 200 MG
FILM-COATED TABLETS
FERROUS SULFATE 200 MG
FILM-COATED TABLETS
WHAT IS IN THIS LEAFLET:
1.
What Ferrous sulfate tablets are and what they are
used for
2.
What you need to know before you take Ferrous
sulfate tablets
3.
How to take Ferrous sulfate tablets
4.
Possible side effects
5.
How to store Ferrous sulfate tablets
6.
Contents of the pack and other information
1.
WHAT FERROUS SULFATE TABLETS ARE AND WHAT THEY
ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERROUS
SULFATE TABLETS
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The name of your medicine is Ferrous sulfate 200 mg
film-coated tablets. These tablets contain iron, a
mineral essential in the production of red blood cells.
Ferrous sulfate tablets are used to treat anaemia caused
by lack of iron in the diet or loss of iron from the body.
DO NOT TAKE FERROUS SULFATE TABLETS:
if you are allergic to ferrous sulfate or any of the other
ingredients of this medicine (listed in section 6)
if you notice blood in your urine (Paroxysmal
nocturnal haemoglobinuria)
if you suffer from iron storage disease, where the
body contains more iron than it should (conditions
such as haemosiderosis, haemochromatosis)
if you suffer from an active_ _stomach ulcer_ (_peptic ulcer)
if you suffer from inflammation which causes
abdominal pain or diarrhoea (ulcerative colitis) or
any other inflammatory condition of the bowels
(regional enteritis)
if you have had repeated blood transfusion
If you suffer from haemolytic anaemia (anaemia
due to destruction of red blood cells)
if you are already being treated with iron supplements.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Ferrous
sulfate tablets:
if you have had a gastrectomy (operation to
remove all or part of the stomach)
if you have a history of stomach ulcer_ _
if you suffer from diabetes
if you have suffered from inflammatory bowel disease
if you suffer from diverticular disease (where
pouches form in the bowel wall)
if you suffer from iron ove

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ferrous Sulfate Tablets 200mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: ferrous sulfate 200mg equivalent to 65 mg
ferrous iron.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Coated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Iron-deficiency anaemia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Prophylactic dose - one tablet daily.
Therapeutic dose - one tablet 2-3 times daily.
Elderly:
The usual adult dose can be administered (see section 4.4).
Children 6-12 years:
Treatment:
Children weighing > 22kg – one tablet daily.
Children weighing > 44kg – one tablet twice daily.
Children weighing > 66kg – one tablet three times daily.
A liquid preparation maybe more appropriate for children.
Children under 6 years or weighing less than 22kg:_ _
This medicine is not recommended.
Method of administration:
For oral administration.
The tablets should not be sucked, chewed or kept in the mouth, but
swallowed whole
with water.
Tablets should be taken before meals or during meals, depending on
gastrointestinal
tolerance.
4.3
CONTRAINDICATIONS
Hypersensitivity to any ingredients in the formulation; patients
receiving repeated
blood transfusions; concomitant parenteral iron; haemochromatosis and
other iron
overload syndromes.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Administer with caution in patients with haemolytic anaemia,
haemoglobinopathies, iron storage or iron absorption diseases,
existing
gastrointestinal disease.
The label will state
‘Important warning: Contains iron. Keep out of the sight and reach
of children,
as overdose may be fatal’.
This will appear on the front of the pack within a rectangle in which
there is no
other information.
Patients with rare hereditary problems of galactose intolerance or
fructose
intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption or
sucrase-isomaltase insufficiency should not take this medicinal
product.
Before starti