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Ferrous Gluconate Tablets Bp 300mg

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Document: leaflet MAH GENERIC_PL 20416-0073 change

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* FERROUS GLUCONATE Tablets 300mg


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Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet, you may need to read it again.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.


IN THIS LEAFLET:

1.    What Ferrous Gluconate Tablets are and what they are used for

2.    Before you take Ferrous Gluconate Tablets

3.    How to take Ferrous Gluconate Tablets

4.    Possible side effects

5.    How to store Ferrous Gluconate Tablets

6.    Further information

1.    WHAT FERROUS GLUCONATE TABLETS ARE AND WHAT THEY ARE USED FOR

Ferrous Gluconate Tablets contain ferrous gluconate 300 mg as the active ingredient which is an iron supplement.

This medicine is used to prevent or treat anaemia due to a lack of iron caused by a number of conditions, including pregnancy. It is also used to treat anaemia caused when there is not enough iron in the diet or when the iron in the diet is poorly absorbed.

2.    BEFORE YOU TAKE FERROUS GLUCONATE TABLETS Do not take these tablets if:

•    you are allergic to ferrous gluconate,other iron preparations or any of the other ingredients in these tablets (see Section 6). (An allergic reaction may be recognised as shortness of breath, blocked nose, rash, itching, swollen face or lips)

•    you suffer from haemochromotosis (a disease which causes the body to absorb and store too much iron)

•    you suffer from haemosiderosis (an increase in the amount of iron stored in body tissues)

•    you suffer from breakdown of red blood cells (haemolytic anaemia)

•    you have a hereditary disorder resulting in abnormal haemoglobin e.g. sickle-cell disease and thalassemia

•    you have a type of anaemia which is not due to a lack of iron

•    you receive repeated blood transfusions or iron by injection

•    you suffer from any serious disease affecting the intestines or you have an ulcer

•    you have hepatitis (inflammation of the liver)

•    you suffer from alcoholism.

Check with your doctor before taking these tablets if:

•    you have an iron absorption disorder

•    you have a gastrointestinal disease

•    you are elderly.

Taking other medicines

Tell your doctor or pharmacist if you are taking other medicines including any that you can buy without a prescription. This is particularly important if you are taking:

•    trientine (used to treat Wilson’s disease)

•    acetohydroxamic acid (used to treat bladder infections)

•    dimercaprol (used to treat heavy metal poisoning)

•    levodopa, carbidopa or entacapone (used to treat Parkinson's disease)

•    bisphosphonates (e.g. etridonate, clodronate used to treat osteoporosis)

•    methyldopa (used to treat high blood pressure)

•    mycophenolate (used to prevent organ rejection after a transplant)

•    the antiobiotics ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, neomycin, nalidixic acid or oral chloramphenicol

•    levothyroxine (used as hormone replacement for thyroid problems). Ferrous gluconate tablets should be taken 2 hours after levothyroxine

•    eltrombopag (used to treat low blood platelet counts). Ferrous gluconate tablets should be taken 4 hours after eltrombopag

•    antacids containing carbonates or magnesium trisilicate, and other medicines containing bicarbonates, carbonates, oxalates or phosphates. Ferrous gluconate tablets should not be taken 1 hour before or 2 hours after taking these medicines

•    penicillamine (used to treat rheumatoid arthritis). These tablets should not be taken within 2 hours of taking penicillamine

•    tetracycline antibiotics (e.g. minocycline, oxytetracycline). Ferrous gluconate tablets should be taken 3 hours before or 2 hours after these medicines

•    colestyramine (used to reduce blood cholesterol)

•    proton pump inhibitors e.g. omeprazole (used to treat stomach ulcers)

•    vitamin E or calcium, aluminium and zinc salts.

Coffee, tea, eggs, milk products and whole grain breads and cereals may slow down the absorption of iron.

Other special warnings:

Pregnancy and breast-feeding:

Although ferrous gluconate may be taken, you should check with your doctor before taking if you are pregnant or breast-feeding.

Important information about some of the ingredients

The tablet colouring contains sunset yellow FCF aluminium lake (E110), carmoisine dioxide lake (E122) and ponceau 4R (E124) which may cause allergic reactions.

This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, check with your doctor before taking this medicine.



3.    HOW TO TAKE FERROUS GLUCONATE TABLETS

Swallow the tablets whole with a drink of water, preferably 1 hour before meals.

The following doses are the usual doses. Doctors may sometimes prescribe different doses.

Always follow the doctor’s instructions. If you are not sure of the number of tablets to take or how often to take them, ask your doctor or pharmacist.

Dose:

Adults and the elderly:

For prevention of anaemia: Take two tablets daily

For treatment of anaemia: Take four to six tablets daily in divided doses.

Children (aged 6-12 years):

For prevention of anaemia: Take one or two tablets daily.

For treatment of anaemia: Take three tablets daily in divided doses.

If you have taken too many tablets:

Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified. An overdose in children could be fatal.

If you forget to take a dose:

If you forget to take a dose of this medicine, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the usual time.

DO NOT TAKE TWO DOSES AT THE SAME TIME.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Ferrous Gluconate Tablets can cause side-effects, although not everybody gets them.

If any of the following occur STOP TAKING the tablets IMMEDIATELY and contact your doctor:

*    severe diarrhoea

*    vomiting blood

*    an allergic reaction (symptoms may include shortness of breath, blocked nose, rash, itching, swollen face or lips).

The following effects have been reported with large doses of iron:

Very common effects (that could happen to more than 1 in 10 people):

*    stomach discomfort

*    diarrhoea

*    loss of appetite

*    nausea or vomiting (feeling or being sick).

Other effects:

*    darker coloured stools than usual.

Continuous use may cause constipation.

High doses in some people may have an effect on the lining of the stomach or gut, which may become narrower. Symptoms of this are stomach pain and bloody stools.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE FERROUS GLUCONATE TABLETS

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN. These tablets could harm them. An overdose could be fatal.

Do not store above 25°C. Store in the container provided or in the original package and keep the blister in the outer carton to protect from light and moisture.

Do not take the tablets if the expiry date on the pack has passed.

If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6.    FURTHER INFORMATION

Ingredients:

Ferrous Gluconate Tablets 300mg contain 300mg of ferrous gluconate as the active ingredient. The other ingredients are: maize starch, alginic acid, colloidal anhydrous silica, water, magnesium stearate, shellac, purified talc, heavy kaolin, titanium dioxide, sucrose, ponceau 4R (E124), carmoisine dioxide lake (E122), sunset yellow FCF aluminium lake (E110), povidone, sodium benzoate (E211), beeswax and carnauba wax.

What Ferrous Gluconate Tablets look like:

The tablets are round, red, sugar coated tablets. The tablets are available in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90,100,112, 250, 500 and 1000 tablets. (Not all pack sizes may be marketed).

Who makes this medicine and holds the product licence:

The Product Licence Holder is Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED and the Manufacturer is Surepharm Services Ltd., Bretby, Burton upon Trent, Staffs, DE15 0YZ, UK.

Date leaflet revised: May 2013.

If you would like this leaflet in a different format, please contact the licence holder at the above address.


Base Point Size: 8.5pt


DIMENSIONS: 148 x 297mm Folded size 37x148mm

(If you have particular folding spac please provide)


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