Ferrous gluconate 300mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ferrous gluconate

Available from:

Arrow Generics Ltd

ATC code:

B03AA03

INN (International Name):

Ferrous gluconate

Dosage:

300mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010101; GTIN: 5060034830924

Patient Information leaflet

PATIENT INFORMATION LEAFLET
FERROUS GLUCONATE 300MG TABLETS
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.
• YOU MUST TALK TO A DOCTOR IF YOU DO NOT FEEL BETTER OR IF YOU FEEL
WORSE. WHAT IS IN THIS LEAFLET
1. What Ferrous Gluconate 300mg Tablets are and what they are used for
2. What you need to know before you take Ferrous Gluconate 300mg
Tablets
3. How to take Ferrous Gluconate 300mg Tablets
4. Possible side effects
5. How to store Ferrous Gluconate 300mg Tablets
6. Contents of the pack and other information
PRODUCT:
PLEASE SIGN
PL HOLDER: _
_____________________________
PRINTER: _
________________________________
PACKING SITE:
____________________________
PROOF NO & DATE
Proof for submission to MHRA
Colours
CUSTOMER: SP
DESIGNER: MAT (AWG)
PRODUCT: Ferrous Gluconate 300mg Tablets
ITEM CODE: CP.FGL.300T.SP.V3P1
PROOF NO AND DATE: 2 19/02/2018
REVISION:
ARTWORK FOR SUBMISSION
Supersedes: CP.FGL.300T.SP.V2P3
Pantone Blue
280 C
DIMENSIONS: 146mm x 350mm
CP.FGL.300T.SP.V3P1
1.
2. 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 YO

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ferrous Gluconate 300 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg of Ferrous Gluconate.
Excipients of known effect: Each tablet also contains 168.2 mg of
Sucrose and
2.7 mg of Liquid glucose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
A dark-red, smooth, polished tablet with a slight odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ferrous Gluconate 300 mg Tablets is indicated for the prevention and
treatment of iron deficiency states.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Adults and the elderly:
Prophylactic:
2 tablets daily.
Therapeutic:
4 to 6 tablets daily in divided doses.
Children (aged 6-l2 years):
Prophylactic: 1 or 2 tablets daily
Therapeutic: 3 tablets daily in divided doses
These tablets are best taken about one hour before meals.
METHOD OF ADMINISTRATION:
The route of administration for Ferrous Gluconate 300 mg 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 shou