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Ferrous Gluconate Tablets Bp 300mg

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Document: leaflet MAH GENERIC_PL 13606-0038 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

FERROUS GLUCONATE TABLETS BP 300MG

{Ferrous Gluconate}

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, or pharmacist or nurse.

•    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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Ferrous Gluconate is and what it is used for

2.    What you need to know before you take Ferrous Gluconate

3.    How to take Ferrous Gluconate

4.    Possible side effects

5.    How to store Ferrous Gluconate

6.    Contents of the pack and other information

1.    What Ferrous Gluconate is and what it is used for

Ferrous Gluconate is used as a preventative and for the treatment of patients who do not have enough iron in their blood and so require a supplement.

2.    What you need to know before you take Ferrous Gluconate

Do not take Ferrous Gluconate and tell your doctor if you:

•    Are allergic (hypersensitive) to ferrous gluconate or any of the other ingredients of these tablets (listed in section 6)

•    Suffer from blood contitions such as:

o Haemochromatosis (too much iron in your blood)

o Anaemia (not enough haemoglobin in your red blood cells)

o Iron storage (haemosiderosis) or absorption (Haemoglobinopathies diseases)

•    Suffer from inflammatory bowel disease

•    Suffer from peptic ulcers

•    Regularly receive blood transfusions

•    Are receiving iron by IV infusion (drip).

Warnings and precautions

Talk to your doctor, or pharmacist or nurse before taking Ferrous Gluconate:

If you are having tests for occult (hidden) blood in the stools as Ferrous Gluconate can colour faeces black.

If you are elderly as there is an increased risk of unwanted effects.

Other medicines and Ferrous Gluconate

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:

•    Tetracyclines (used to treat bacterial infections)

•    Other antibiotics such as fluoroquinolones, chloramphenicol, neomycin

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

•    Mycophenolate a drug given after organ transplant.

•    Trientine (to treat conditions of too much copper in the body)

•    Levodopa, Carbidopa, Entacapone (to treat Parkinson's disease)

•    Methyldopa (to treat high blood pressure)

•    Biphosphonates (to treat Osteoporosis)

•    Zinc salts

•    Magnesium trisilicate or antacids (to treat indigestion)

•    Calcium supplements or calcium contating products

•    Dimercaprol which is used to treat metal poisoning

•    Colestyramine used to lower cholesterol (fat) levels in the body

•    Levothyroxine which is used to treat and underactive thyroid.

Ferrous Gluconate with food and drink

Large amouts of tea and coffee may affect the absorption of ferrous gluconate in the body, 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 or pharmacist.

Pregnancy and breast-feeding

Ferrous Gluconate may be safetly taken by pregnant and nursing mothers.

Ferrous Gluconate contains Sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    How to take Ferrous Gluconate

Always take Ferrous Gluconate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Ferrous Gluconate Tablets are best taken about 1 hour before meals.

The usual dose is:

Adults and the elderly

Prevention: 1 to 2 tablets daily Treatment: 4-6 tablets daily in divided doses.

Children (6-12 years)

Prevention: 1 to 2 tablets daily Treatment: 3 tablets daily in divided doses.

If you take more Ferrous Gluconate than you should

An overdose of this medicine may be dangerous. If you or someone else has taken too many tablets, tell your doctor or go to the the nearest casualty department immediately. If you have taken too much Ferrous Gluconate you may experience vomiting, diarrhoea, high blood pressure, changes in metabolism, coma, seizures, and liver problems.

If you forget to take Ferrous Gluconate

Take your medicine as soon as you remember. If it is almost time for your next dose, wait until that is due, then continue as normal. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Ferrous Gluconate

You should contact your doctor before you stop taking Ferrous Gluconate, it may be dangerous to stop taking your tablets.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The occurrence of possible side effects may be related to the dose.

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

•    An allergic reaction with symptoms such as sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash, reddening of the skin or itching (especially affecting your whole body).

Other side effects include:

•    Nausea

•    Vomiting

•    Blackening of the stools

•    Stomach pain

•    Altered bowel habit

•    Lack of appetite.

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

Keep out of the sight and reach of children.

Do not use Ferrous Gluconate after the expiry date stated on the carton.

The expiry date refers to the last day of that month.

Store below 25°C in a dry place.

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.    Contents of the pack and further information

What Ferrous Gluconate contains

The active substance is Ferrous Gluconate.

The other ingredients are Sodium starch glycollate, Stearic adic, Colloidal silicon dioxide, Sucrose, Opaseal, Talc,

Calcium carbonate, Acacia, Titanium dioxide, Certolake ponceau 4R, Opaglos 6000P.

What Ferrous Gluconate looks like and contents of the pack

Ferrous Gluconate are red, circular and biconvex sugar coated tablets.

Polypropylene tubes with low-density polyethylene caps.

Pack sizes of 28, 250, 500, 1000, 5000 tablets.

Blister packs with white PVC contained in cardboard cartons.

Pack sizes of 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Co-Pharma Ltd Unit 4 Metro Centre,

Tolpits Lane,

Watford,

Hertfordshire,

WD18 9SS

Manufacturer

Surepharm Services Ltd Bretby,

Burton upon Trent,

Staffs,

DE15 0YZ

This leaflet was last revised 06/2015.