Ferrous sulfate 200mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Ferrous sulfate dried

Saatavilla:

Sandoz Ltd

ATC-koodi:

B03AA07

INN (Kansainvälinen yleisnimi):

Ferrous sulfate dried

Annos:

200mg

Lääkemuoto:

Oral tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 09010101; GTIN: 5050650006025 5050650006032

Pakkausseloste

ferrous su-
lfate #200
mg tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
FERROUS SULFATE TABLETS 200 MG
ferrous sulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take/use this medicine exactly as described in this leaflet or
as your doctor or pharmacist has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact a doctor if your symptoms worsen or do not improve.
•
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.
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
Ferrous Sulfate tablets belong to a group of medicines called iron
supplements. These medicines work by replacing
body iron. Iron is a mineral that the body needs to produce red blood
cells. When the body does not get enough
iron, it cannot produce the number of normal red blood cells needed to
keep you in good health. This condition is
called irondeficiency anaemia.
Ferrous Sulfate tablets are used for the prevention and treatment of
iron-deficiency anaemia.
DO NOT TAKE Ferrous Sulfate Tablets and tell your doctor if you:
•
are ALLERGIC to the active substance, iron salts, or any of the other
ingredients of this medicine (listed in section 6).
•
are receiving repeated BLOOD TRANSFUSIONS.
•
are receiving IRON INTRAVENOUSLY.
•
have a disorder in which there is EXCESSIVE ABSORPTION and STORAGE of
IRON such as haemochromatosis.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST before taking Ferrous Sulfate
tablets if you have:
• HAEMOLYTIC ANAEMIA
• a BLOOD disease (haemoglobinopathy)
• an IRON STORAGE or ABS

Valmisteyhteenveto

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