Ferrous sulfate 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ferrous sulfate dried

Available from:

Accord-UK Ltd

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: 5012617010315 5012617009470 5012617016706

Patient Information leaflet

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Ferrous Sulphate, Tablets, 200mg,
28s, 100s - UK
148x210 (Reel Fed)
51010524
Leaflet for Blisters
1131
RH
01-02-2022
approved for print/date
PROOF ROUND
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Approval
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T. Hull
08.02.2022
14.02.2022
T. Hull
148x210
8pt
Accord Barnstaple
n/a
FERROUS SULFATE 200MG TABLETS PIL - UK
Black
Profile
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German GTIN 14
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FERROUS SULFATE 200MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take 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.
• 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.
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 A

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ferrous Sulfate Tablets BP 200mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg Dried Ferrous Sulfate PhEur equivalent to
65mg
elemental iron.
Excipients with known effect:
This product also contains glucose, sucrose and lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Sugar-coated tablet.
White, circular, biconvex sugar-coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prevention and treatment of iron-deficiency anaemias.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Each 200mg ferrous sulfate tablet is equivalent to 65mg of ferrous
iron.
_ _
_Adults:_ Treatment: 130-195mg ferrous iron (2-3 tablets) daily in
divided
doses.
_ _
_ _
_ _Prophylaxis: 65mg ferrous iron (1 tablet) daily.
_Elderly: _The usual adult dose can be administered (see section 4.4).
_Children 6-12 years: _
Treatment: Children weighing over 22kg – one tablet daily.
Children weighing over 44kg – one tablet twice daily.
Children weighing over 66kg – one tablet three times daily.
_Children under 6 years or weighing less than 22kg: _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 the active substance or to any of the excipients
listed
in section 6.1.
•
Paroxysmal nocturnal haemoglobinuria.
•
Haemosiderosis and haemochromatosis.
•
Active peptic ulcer.
•
Patients receiving repeated blood transfusions.
•
Regional enteritis and ulcerative colitis.
•
Haemolytic anaemia
•
Oral and parenteral iron preparations should not be used
concomitantly.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Some post-gastrectomy patients show poor absorption of iron.
Administer with caution in patients with haemoglobinopathies,
iron-storage or
iron-absorpt