Ferrous gluconate 300mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Ferrous gluconate

Commercializzato da:

Kent Pharma (UK) Ltd

Codice ATC:

B03AA03

INN (Nome Internazionale):

Ferrous gluconate

Dosaggio:

300mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 09010101; GTIN: 5015201005896 5015201007623

Foglio illustrativo

Colours
CUSTOMER: SP
DESIGNER: ABC (AWG)
PRODUCT: Ferrous Gluconate 300mg Tablets
ITEM CODE: CP.FGL.300T.SP.V6P1
PROOF NO AND DATE: 1 11/10/2022
REVISION: MAH address update
ARTWORK FOR SUBMISSION
Supersedes:
CP.FGL.300T.SP.V5P1
Pantone Blue
280 C
DIMENSIONS: 146mm x 350mm
CP.FGL.300T.SP.V6P1
2.
3.
4.
5.
6. WHAT FERROUS GLUCONATE 300MG TABLETS ARE AND WHAT THEY ARE USED FOR
Ferrous Gluconate 300mg Tablets are used for
the treatment and prevention of iron deficiency.
Ferrous Gluconate is a form of iron. Iron is
necessary for the production of haemoglobin
(protein in red blood cells), which carries oxygen
around the body. Iron is involved in the
formation of myoglobin, a pigment that stores
oxygen in muscles for use during exercise. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERROUS GLUCONATE 300MG TABLETS
DO NOT TAKE FERROUS GLUCONATE 300MG
TABLETS:
• if you are allergic (hypersensitive) to
ferrous gluconate, medicines containing
iron or any of the other ingredients in this
medicine (See section 6)
• if you have a build up of too much iron in
the body (haemochromatosis)
• if you suffer from iron storage
(haemosiderosis) or absorption
(haemoglobinuria)
• if you have anaemia not caused by Iron
deficiency
• if you receive regular blood transfusions or
iron by IV infusion (drip)
• if you have an ulcer of the stomach or
small intestine
• if you have hepatitis (inflammation of the
liver)
• if you suffer from alcoholism
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Ferrous Gluconate 300mg Tablets:
• if you are having tests for occult (hidden)
blood in the stools, this medicine can
colour faeces black
• if you are elderly as there is an increased
risk of unwanted effects
• if you suffer from breakdown of red blood
cells (haemolytic anaemia)
• if you also have deficiency of vitamin B12
or folic acid
• if you have diabetes as these tablets
contain sugar
• if you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ferrous Gluconate 300mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg ferrous gluconate.
Excipients with known effect: contains sucrose and ponceau 4R red
(E124).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Coated tablet.
Appearance: Red, circular, biconvex, sugar-coated tablet.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ferrous Gluconate 300mg Tablets are indicated for the prevention and
treatment of iron deficiency states.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND THE ELDERLY
_Prophylactic_: 2 tablets daily.
_Therapeutic_: 4-6 tablets daily in divided doses.
CHILDREN (AGED 6-12 YEARS)
_Prophylactic: _1 or 2 tablets daily.
_Therapeutic: _3 tablets daily in divided doses.
Ferrous Gluconate 300mg Tablets are best taken about one hour before
meals.
_ _
_ _
_Method of administration _
The route of administration for Ferrous Gluconate 300mg tablets is
oral.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active ingredient ferrous gluconate or to any
of the excipients
listed in section 6.1.
Iron preparations are contra-indicated in patients with
haemochromatosis, iron storage
or absorption diseases such as and haemosiderosis or haemoglobinuria.
Iron is contraindicated in patients receiving repeated blood
transfusions, or in patients
receiving parenteral iron therapy or to patients with anaemias not
produced by iron
deficiency (some conditions, such as thalassemia may cause excess
storage of iron).
Alcoholism and hepatitis.
Iron preparations are contraindicated in active peptic ulcer, regional
enteritis and
ulcerative colitis.
Ferrous Gluconate Tablets should not be used in patients with anaemia
not produced
by iron deficiency unless iron deficiency is also present.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Large doses may have irritant/corrosive effect on gastro-intestinal
mucosa which can
lead to necrosis and perforation.
Ferrous Gluconate should be used with caution in pati