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• leaflet MAH GENERIC_PL 20416-0073

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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

•    vomiting (being sick).

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.

Do not be concerned by this list of side effects, you may not get any of them. If any of the effects get serious, or if you notice any other unusual or unexpected symptoms please tell your doctor or pharmacist.

5. HOW TO STORE FERROUS GLUCONATE TABLETS

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN. These tablets could harm them. An overdose could be fatal. Do not store above 25-C. Store in the container provided 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 If you have any medicines that are out of date, return them to your pharmacist for safe disposal.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 carnaubawax. What Ferrous Gluconate Tablets look like:

The tablets are round, red, sugar coated tablets. Each pack contains 28 tablets.

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 OYZ, UK.

Date leaflet revised: December 2010.

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

PATIENT INFORMATION LEAFLET

FERROUS GLUCONATE TABLETS 300mg

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 300mg 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 lake 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 have a type of anaemia which is not due to a lack of iron

•    you have hepatitis (inflammation of the liver)

•    you suffer from alcoholism.

Check with your doctor before taking these tablets if:

•    you receive repeated blood transfusions

•    you have an iron absorption disorder

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

•    you have a gastrointestinal disease

•    you have been told by your doctor that you have an intolerance to some sugars as these tablets

•    dimercaprol (used to treat heavy metal poisoning)

•    levodopa 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 antibiotics ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin and nalidixic acid

•    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

•    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.