Ferrous Gluconate Tablets Bp 300mg
Package Leaflet: Information for the user FERROUS GLUCONATE 300 mg 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 possible side effects 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.
What is in this leaflet
1. What Ferrous Gluconate Tablets 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 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 300 mg Tablets. 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 300 mg 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);
• Suffer from iron storage (haemosiderosis) or absorption (haemoglobinuria);
• Have anaemia not caused by Iron deficiency;
• Receive regular blood transfusions or iron by IV infusion (drip);
• Have an ulcer of the stomach or small intestine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ferrous Gluconate Tablets if you:
• Are having tests for occult (hidden) blood in the stools this medicine can colour faeces black;
• Are elderly as there is an increased risk of unwanted effects;
• Suffer from breakdown of red blood cells (haemolytic anaemia);
• Also have deficiency of vitamin b12 or folic acid;
• Have diabetes as these tablets contain sugar;
• Have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product;
• Have a history of stomach ulcers;
• Suffer from inflammatory bowel disease;
• Have intestinal strictures or suffer from diverticular disease;
• Have had an operation to remove all or part of the stomach (gastrectomy).
After correction of iron deficiency, duration of treatment should generally not exceed 3
months. Long term use of this product may cause tooth decay and infections.
If any of the conditions listed above apply to you please talk to your doctor or pharmacist.
Other medicines and Ferrous Gluconate Tablets
Tell your doctor or pharmacist if you are taking or have recently taken or might take 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:
• Antibiotics (used to treat bacterial infections), e.g. tetracyclines, flouroquinolones, chloramphenicol,or neomycin). Do not take these medicines for two hours before and after taking Ferrous Gluconate Tablets;
• Zinc salts;
• Penicillamine (used in the treatment of rheumatoid arthritis);
• Antacids (used to treat indigestion) and mineral supplements e.g. calcium, magnesium, bicarbonates, carbonates, oxalates, or phosphates. Do not take these medicines for two hours before and after taking Ferrous Gluconate Tablets;
• Trientine (used to treat conditions of too much copper in the body e.g. Wilson’s disease). Do not take these medicines for two hours before and after taking Ferrous Gluconate Tablets;
• Cholestyramine, used to reduce blood cholesterol and control diarrhoea;
• Levodopa, carbidopa, co-careldopa and entacapone (used in the treatment of Parkinson’s disease);
• Thyroxine, a thyroid hormone. Do not take these medicines for two hours before and after taking Ferrous Gluconate Tablets;
• Bisphosphonates (used in the treatment of bone diseases e.g. osteoporosis). Do not take these medicines for two hours before and after taking Ferrous Gluconate Tablets;
• Methyldopa (used in the treatment of high blood pressure);
• Mycophenolate, a drug given after an organ transplant;
• 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 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
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.
During the first 12 weeks of pregnancy only take Ferrous Gluconate Tablets if your doctor has specifically recommended it. This medicine may be taken during pregnancy and while breastfeeding if you are at risk of developing iron deficiency anaemia.
Driving and using machines
No effects of Ferrous Gluconate Tablets are known.
Ferrous Gluconate Tablets contains Glucose and 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 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)
• 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.
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 have taken too much Ferrous Gluconate you may experience nausea, vomiting, abdominal pain, diarrhoea, high blood pressure, changes in metabolism, coma, seizures, and liver problems.
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.
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.
Symptoms include: swelling of the hands, feet, ankles, face, lips or throat, problems with breathing skin rash, itching or hives
Other serious side effects include:
• Nausea;
• Vomiting;
• Heartburn;
• Abdominal pain;
• Diarrhoea;
• Constipation;
• Lack or loss of appetite;
• Dark coloration of stools.
Contact irritation can occur with ferrous gluconate tablets resulting in erosion or ulceration, particularly if they become lodged in the upper gastrointestinal tract (oesophagus, stomach and duodenum).
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 Tablets
- Keep this medicine out of the sight and reach of children.
- Keep the container 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.
6. Contents of the pack and other information
What Ferrous Gluconate Tablets contain
Active substance: Each tablet contains 300 mg of Ferrous Gluconate.
Other ingredients: Maize Starch, Magnesium Stearate, Stearic Acid, Orange Shellac, French Chalk for Tablets, sucrose, Glucose liquid, Opalux AS 4910 red, Opaglos 6000.
What Ferrous Gluconate Tablets look like and the contents of the pack
Ferrous Gluconate 300 mg Tablets are dark-red, smooth, polished tablets with slight odour Ferrous Gluconate Tablets come in the bottles of 1000 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 300 mg Tablets: PL 17907/0170
This leaflet is last revised in July 2016
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.