Ferrous gluconate 300mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Vara einkenni Vara einkenni (SPC)
05-05-2023

Virkt innihaldsefni:

Ferrous gluconate

Fáanlegur frá:

Strides Pharma UK Ltd

ATC númer:

B03AA03

INN (Alþjóðlegt nafn):

Ferrous gluconate

Skammtar:

300mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 09010101; GTIN: 5031676004349 5031676001324

Upplýsingar fylgiseðill

                                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
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 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
defici
                                
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                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ferrous Gluconate Tablets BP 300 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg of the active substance ferrous gluconate
Excipient(s) with known effect
Sucrose
Certolake ponceau 4R
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet
Red, circular, biconvex sugar-coated tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Ferrous
gluconate
tablets
300
mg
are
indicated
for
the
prevention
and
treatment of iron deficiency states.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS
Prophylactic:
2 tablets daily
Therapeutic:
4-6 tablets daily in divided doses
CHILDREN (6-12 YEARS)
Prophylactic:
1 or 2 tablets daily
Therapeutic:
3 tablets daily in divided doses
Ferrous Gluconate is not recommended in children under 6 years.
Ferrous gluconate tablets are best taken about 1 hour before meals.
Method of administration
The route of administration for ferrous gluconate tablets is oral.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Iron preparations are contraindicated 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 glu
                                
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