Ferrous Gluconate 300mg Tablets Bp
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Patient information leaflet
FERROUS GLUCONATE 300MG TABLETS BP
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 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 Tablets
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 300mg Tablets contains the active substance Ferrous Gluconate
• Ferrous Gluconate belongs to a group of drugs called antianaemic preparations (used to treat iron deficiency anaemia)
• Ferrous Gluconate is a form of iron. Iron has an important role in the oxygen-carrying pigment, haemoglobin. It is involved in the formation of myoglobin, a pigment which stores oxygen in muscles for use during exercise
• Ferrous Gluconate is used for the prevention and treatment of iron deficiency in adults and children aged 6 years and above
2. What you need to know before you take Ferrous Gluconate
Do not take Ferrous Gluconate if you:
• have previously suffered an allergic reaction to a medicine containing iron or any of the other ingredients in this medicine (listed in section 6)
• suffer from any blood disorder
• are pregnant or planning to become pregnant
• have too much build-up of iron in the body (haemochromatosis or haemosiderosis)
• receive regular blood transfusions or iron by injection
• have active peptic ulcer, regional enteritis or ulcerative colitis
Ferrous Gluconate Tablets should not be used in
the treatment of anaemia other than that due to
iron deficiency
Warnings and precautions
Talk to your doctor or pharmacist before taking
Ferrous Gluconate if you:
• suffer from any serious disease affecting the stomach or intestines
• suffer from breakdown of red blood cells (haemolytic anaemia). Before starting treatment it is important to exclude any underlying causes of anaemia
• have an iron absorption disorder
• have strictures or diverticulae (intestinal narrowing/bulges which may be accompanied by inflammation or infection)
• are elderly as there is an increased risk of unwanted effects
• have been told by your doctor that you have intolerance to some sugars
The colouring agent E124 can cause allergic-type reactions including asthma. Allergy is more common in people who are allergic to aspirin.
Other medicines and Ferrous Gluconate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including:
• antacids (used to treat indigestion): magnesium trisilicate reduces absorption of oral iron. Other medicines containing bicarbonates, carbonates, oxalates or phosphates also reduces iron absorption
• antibacterials (used to treat bacterial infections): tetracylines reduce absorption of oral iron (and vice versa). Absorption of ciprofloxacin, levofloxacin, norfloxacin and ofloxacin (fluoroquinolones) is reduced by oral iron
• antihypertensives (used in the treatment of high blood pressure): reduced hypotensive effect of methyldopa
• bisphosphonates (used in the treatment of bone diseases e.g. osteoporosis): reduced absorption
• dopaminergics (used in the treatment of Parkinson’s disease): absorption of entacapone, carbidopa and levodopa may be reduced
• mycophenolate, a drug given after an organ transplant
• penicillamine (used in the treatment of rheumatoid arthritis): reduced absorption of penicillamine
• trientine (used in the treatment of Wilson’s disease): reduced absorption of ferrous gluconate
• vitamin E or calcium, aluminium and zinc salts (essential mineral): reduced absorption of oral iron (and vice versa)
• proton pump inhibitors: used to treat stomach ulcers e.g. omeprazole
• neomycin, oral chloramphenicol (medicines use to treat bacterial infections)
• dimercaprol (used in the treatment of heavy metal poisoning)
• cholestyramine (used to reduce blood cholesterol and control diarrhoea)
• acetohydroxamic acid, levothyroxine, eltrombopag: reduced absorption of these medicines
Ferrous Gluconate with food and drink
If you drink tea, coffee, milk or eat eggs while taking Ferrous Gluconate tablets, the absorption of iron may be decreased by the body.
Pregnancy and breast feeding
Ferrous Gluconate Tablets may be administered in pregnancy or during lactation when there is a risk of iron deficiency. If you are pregnant or
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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
There are no known effects on your ability to drive or use machines.
Ferrous Gluconate contains 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
3. How to take Ferrous Gluconate
Always take this medicine exactly 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.
• Swallow the tablets with water
• Take the tablets about one hour before meals
Dosage:
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 one tablet three times a day
Children less than 6 years of age:
• Ferrous Gluconate tablets are NOT recommended for children under 6 years of age
If you take more Ferrous Gluconate than you should
If you or anyone else has taken too many tablets at the same time contact your nearest hospital casualty department or your doctor IMMEDIATELY. Signs and symptoms of an iron overdose include stomach pain, diarrhoea, being sick and collapse.
If you forget to take Ferrous Gluconate
If you forget to take a dose leave that dose and take the next dose when it is due.
DO NOT take a double dose to make up for the forgotten dose.
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.
If any of the following occur STOP TAKING the tablets and IMMEDIATELY contact your doctor:
• allergic reaction (e.g. rash, itching, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing), haemorrhage/blood loss (symptoms may include being in a 'state of shock')
• severe diarrhoea, prolonged constipation
• vomiting blood (haematemesis)
Other side effects include:
Gastro-intestinal discomfort, anorexia, nausea, vomiting, heartburn, abdominal pain, pain in upper part of abdomen (epigastric pain), diarrhoea and constipation, dark colouration of stools.
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.
5. How to store Ferrous Gluconate
Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month
• Do not store above 250C. Keep the container tightly closed. Store in the original container
• The tablets are sensitive to moisture and light
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ferrous Gluconate Tablets contain
• The active substance is 300mg Ferrous Gluconate equivalent to 35mg Ferrous iron.
• The other ingredients are sodium starch glycolate, stearic acid, colloidal anhydrous silica, sucrose, talc, calcium carbonate, acacia, polyvinyl acetate, phthalate, ethyl acetate, yellow carnauba wax, white beeswax, shellac and the colours titanium dioxide (E171) and ponceau 4R (E124).
See end of section 2 for further information on Ponceau 4R Red (E124) and Sucrose.
What Ferrous Gluconate Tablets look like and the contents of the pack
Ferrous Gluconate tablets are red, circular, biconvex, sugar coated tablets Pack size: 7, 14, 28, 56, 84, 100, 250, 500, 1000 and 5000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Pharmvit Ltd. 177 Bilton Road, Perivale, Greenford, Middlesex, UB6 7HQ.
Telephone: 02089975444 Fax: 02089975433
To request a copy of this leaflet in large print or audio format, please contact the licence holder at the address (or telephone, fax) above
PL 04556 / 0038
Reference No: 00380716/03
This leaflet was last revised in July 2016
