CP.FGL.300T.V2P1

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.

•    Ask your pharmacist if you need more information or advice.

•    If you get any side effects talk to your doctor or pharmacist. This includes any

•    side affects 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

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.    Further information

WHAT FERROUS GLUCONATE 1    300mg TABLETS ARE AND WHAT

" THEY ARE USED FOR

-errous Gluconate 300mg I ablets 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.

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, especially

•    antibiotics (used to treat b acterial infections), eg. tetracyclines

•    Penicillins,flouroquinolones, chloramphenicol or neomycin

•    zinc salts

•    penicillamine (used in the treatment of rheumatoid arthritis)

•    magnesium trisilicate or antacids (used to treat indigestion)

Driving and using machines

No effects of Ferrous Gluconate 300mg Tablets are known.

Important information about some of the ingredients of Ferrous Gluconate 300mg Tablets

Ferrous Gluconate 300mg 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    •    heartburn

•    vomiting    •    abdominal pain

_{•    diarrhoea}    •    dark coloration of stools

•    constipation    •    Lack or loss of appetite

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. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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.

3

HOW TO TAKE FERROUS GLUCONATE 300mg TABLETS

Always take this medicine as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not take more than the recommended dose.

•    Take the tablets about 1 hour before meals With water

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)

5,

HOW TO STORE FERROUS GLUCONATE 300mg TABLETS

Do not take Ferrous Gluconate 300mg 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 SIGHT AND REACH 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

Dimensions: 146mm x 280mm

Pantone Blue 280 C

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 (listed in section 6)

•    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 Ferrous Gluconate 300mg Tablets 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.

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)

If you drink large amouts of tea, coffee or milk or eat egs at the same time as taking Ferrous Gluconate, your body may absorb less of the iron contained in the tablets which can reduce the effects of Ferrous gluconate. If you are worried that you are not getting the full effect of Ferrous Gluconate, speak to your doctor Pregnancy, breast feeding and fertility Ferrous Gluconate 300mg Tablets may be taken during pregnancy and while breastfeeding if you are at risk of developing iron deficiency anaemia.

Children less than 6 years of age

Ferrous Gluconate 300mg Tablets are NOT recommended for children under 6 years of age.

If you take more Ferrous Gluconate 300mg Tablets than you should

If you, or anyone else, has taken too many tablets, contact your doctor or nearest casualty department IMMEDIATELY.If you have taken too much Ferrous Gluconate you may experiance nausea, vomiting, abdominal pain, diarrhoea, high blood pressure, changes in metabolism, coma seizure and liver problems If you forget to take Ferrous Gluconate 300mg Tablets

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._

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Ferrous Gluconate 300mg Tablets can have side effects. STOP taking Ferrous Gluconate 300mg Tablets and contact your doctor immediately if you experience:

• an allergic reaction. symptoms include swelling of the hands, feet, ankles, face, lips or throat, problems with breating, skin rash, itching or hives

What Ferrous Gluconate 300mg 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, polyvinyl acetate phthalate, 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 August 2014.

CP.FGL.300T.V2P1