Ferrous Gluconate 300mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FERROUS GLUCONATE

Available from:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC code:

B03AA03

INN (International Name):

FERROUS GLUCONATE 300 mg

Pharmaceutical form:

TABLET

Composition:

FERROUS GLUCONATE 300 mg

Prescription type:

OTC

Therapeutic area:

ANTIANEMIC PREPARATIONS

Authorization status:

Authorised

Authorization date:

2019-06-19

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FERROUS GLUCONATE TABLETS 300MG
Ferrous Gluconate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, or pharmacist or
nurse.
•
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 or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Ferrous Gluconate Tablets are and what they are used for
2.
What you need to know before you take Gluconate Tablets
3.
How to take Gluconate Tablets
4.
Possible side effects
5.
How to store Gluconate Tablets
6.
Contents of the pack and other information
1.
WHAT FERROUS GLUCONATE 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.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE FERROUS GLUCONATE TABLETS
DO NOT TAKE FERROUS GLUCONATE 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)
•
you suffer from iron storage haemosiderosis or absorption
(haemoglobinuria)
•
if you have a type of anaemia not caused by a lack of 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 (i

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ferrous Gluconate Tablets 300 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg Ferrous Gluconate.
Excipients with known effect: each tablet contains 2.659mg Sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Red, sugar coated, deep convex tablets.
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
Posology
_Adults and the elderly _
Prophylactic: 2 tablets daily.
Therapeutic: 4-6 tablets daily in divided doses.
_Paedriatic population_
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.
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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 patients with
haemolyt