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Ferrous Gluconate 300mg Tablets

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Package Leaflet: Information for the user

FERROUS GLUCONATE 300mg TABLETS BP

Read this leaflet carefully before you start to 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 possible side effects not listed in this leaflet.

•    You must talk to a doctor if you do not feel better

What is in this leaflet

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

2.    What you need to know 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.    Contents of the pack and other information

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

The name of your medicine is Ferrous Gluconate 300mg Tablets BP. The active substance present is Ferrous Gluconate. Ferrous Gluconate Tablets 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.

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

DO NOT take Ferrous Gluconate 300mg Tablets if you:

• are allergic to Ferrous Gluconate Tablets or medicine containing iron or any of the other ingredients of 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

Warnings and precautions

•    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.

Other medicines and Ferrous Gluconate Tablets

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)

Ferrous Gluconate Tablets with food, drink and alcohol

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.

Pregnancy and breast-feeding and fertility

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No effects of Ferrous Gluconate Tablets are known.

Ferrous Gluconate Tablets contains Ponceau 4R 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.

3. How to take Ferrous Gluconate Tablets

Always take this medicine exactly 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.

•    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.

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

4. Possible Side Effects

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

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

•    an allergic reaction

Other serious side effects include:

•    nausea

•    vomiting

•    heartburn

•    abdominal pain

•    diarrhoea

•    constipation

•    dark coloration of stools

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Ferrous Gluconate Tablets

Keep this medicine out of the sight and reach of children.

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

Do not use this medicine after the expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ferrous Gluconate Tablets contain

Active substance: Each tablet contains 300mg of Ferrous Gluconate

Other ingredients: Core: Sodium starch glycollate Type A, stearic acid, colloidal

anhydrous silica.

Sugar Coating: Sucrose, purified talc, calcium carbonate, acacia, titanium dioxide E171, Industrial Methylated Spirit, Ponceau 4R, Opaglos 6000.

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

Ferrous Gluconate 300mg Tablets are red, circular biconvex, sugar-coated, printed with APS and 1701

Ferrous Gluconate Tablets come in the bottles of 100, 250, 500, 1000 and 5000 packs. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Name and address: Bristol Laboratories Limited,

Unit-3, Canalside,

Northbridge Road, Berkhamsted,

Hertfordshire, HP4 1EG,

United Kingdom.

Telephone:    0044 (0) 1442 200922

Fax:    0044 (0) 1442 873717

Email:    info@bristol-labs.co.uk

Ferrous Gluconate 300mg Tablets BP: PL 17907/0347

This leaflet is last revised in December 2012

To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.