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Ferrous Gluconate 300mg Tablets

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CP.FGL300T.V1P1 PATIENT INFORMATION LEAFLET

CP.FGL300T.V1P1 PATIENT INFORMATION LEAFLET


FERROUS GLUCONATE 300mg TABLETS

Please read this leaflet carefully before you start to take this medicine. It contains important information for you. This medicine is available without prescription; however, you still need to take Ferrous Gluconate 300mg Tablets carefully.

*    Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist.

*    This medicine is for your use only. Do not pass it on to others. It may harm them.

*    If any of the side effects get serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET

1.    What your medicine is and what it is used for

2.    Before you take your medicine

3.    How to take your medicine

4.    Possible side effects

5.    How to store your medicine

6.    Further information

1WHAT YOUR MEDICINE IS AND . WHAT IT IS USED FOR


2 BEFORE YOU TAKE YOUR . MEDICINE


Ferrous Gluconate is 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.

DO NOT take Ferrous Gluconate 300mg Tablets if you:

•    previously suffered an allergic reaction to a medicine containing iron or any of the other ingredients in this medicine

•    have a build up of too much iron in the body (haemochromatosis or haemosiderosis)

•    suffer from breakdown of red blood cells (haemiolytic anaemia)

•    receive regular blood transfusions or iron by injection

•    suffer from any serious disease affecting the intestines

Take special care with this medicine if you:

•    are elderly as there is an increased risk of unwanted effects

•    have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

If any of the conditions listed above apply to you please talk to your doctor or pharmacist.

If you drink tea, coffee or milk or eat eggs at the same time as taking Ferrous Gluconate Tablets, your body may absorb less of the iron contained in the tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

You must tell your doctor or pharmacist if you are taking any of the medicines listed below:

•    tetracyclines (medicines used to treat bacterial infections)

•    antibiotics (used to treat bacterial infections, e.g. flouroquinolones, chloramphenicol, neomycin)

•    zinc salts

•    penicillamine (used in the treatment of rheumatoid arthritis)

•    magnesium trisilicate or antacids (used to treat indigestion)

•    trientine (used in the treatment of Wilson’s disease)

•    cholestyramine, used to reduce blood cholesterol and control diarrhoea

•    levodopa, carbidopa and entacapone (used in the treatment of Parkinson’s disease)

•    thyroxine, a thyroid hormone

•    bisphosphonates (used in the treatment of bone diseases e.g. osteoporosis)

•    aminopterin (a cytotoxic drug used in the treatment of certain types of cancers)

•    methyldopa (used in the treatment of high blood pressure)

•    mycophenolate, a drug given after an organ transplant

•    drugs to control epilepsy

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

•    dimercaprol (used in the treatment of heavy metal poisoning)

Pregnancy and breast-feeding

Ferrous Gluconate Tablets may be taken during pregnancy and while breast-feeding if you are at risk of developing iron deficiency anaemia.

Driving and using machines

No effects of Ferrous Gluconate 300mg Tablets are known.

Important information about some of the ingredients of Ferrous Gluconate Tablets

Ferrous Gluconate Tablets contain ponceau 4R Red (E124) and sucrose.

•    Ponceau 4R Red (E124): may cause allergic reactions.

•    Sucrose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


Other less serious side effects include:

•    nausea

•    vomiting

•    heartburn

•    abdominal pain

•    diarrhoea

•    constipation

•    dark coloration of stools

If any of the side effects become serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


S. HOW TO STORE YOUR MEDICINE


3 . HOW TO TAKE YOUR MEDICINE


Take this medicine as instructed on the packing and in this leaflet. You should check with your doctor or pharmacist if you are unsure. Do not take more than the recommended dose.

•    Swallow the tablets with water.

•    Take the tablets about 1 hour before meals.

Adults (including the elderly) and children over 12 years

•    For the prevention of iron deficiency: take two tablets daily.

•    For the treatment of iron deficiency: take four to six tablets daily in divided doses.

Children (aged 6-12 years)

•    For the prevention of iron deficiency: take one or two tablets daily.

•    For the treatment of iron deficiency: take three tablets daily in divided doses.

Children less than 6 years of age

Ferrous Gluconate Tablets are NOT recommended for children under 6 years of age.

Overdose: If you take more of your medicine than you should

If you, or anyone else, has taken too many tablets, contact your doctor or nearest casualty department IMMEDIATELY.

If you forget to take your medicine

If you forget to take a dose leave out that dose and take the next dose when it is due. DO NOT take a double dose to make up for the forgotten dose. Signs and symptoms of an iron overdose include stomach pain, diarrhoea, being sick and collapse.


Do not take Ferrous Gluconate Tablets after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 25°C. Store in the original container. Keep the container tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.


6. FURTHER INFORMATION


. POSSIBLE SIDE EFFECTS


Like all medicines, Ferrous Gluconate can have side effects.

STOP taking Ferrous Gluconate Tablets and contact your doctor immediately if you experience:

• an allergic reaction


What Ferrous Gluconate Tablets contain

Active substance: Each tablet contains 300mg ferrous gluconate equivalent to 35mg ferrous iron.

Other ingredients: sodium starch glycollate, stearic acid, colloidal anhydrous silica, sucrose, talc, calcium carbonate, acacia, polyvinylacetate phthalate, yellow carnauba wax, white beeswax, shellac, titanium dioxide (E171) and ponceau 4R Red (E124).

What Ferrous Gluconate Tablets look like and the contents of the pack

Ferrous Gluconate 300mg Tablets are red, circular, biconvex, sugar coated tablets. Ferrous Gluconate 300mg Tablets come in pots containing 28, 100, 250, 500, 1000 and 5000 tablets or blister packs containing 28 tablets. Not all pack types or sizes may be marketed.

Marketing Authorisation Holder

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.

Distributor

Kent Pharmaceuticals Limited,

Repton Road, Measham, DE12 7DT, U.K.

PL 30464/0026

This leaflet was last revised in May 2011.


CP.FGL.300T.V1P1