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Ferrous Gluconate 300mg Tablets Bp

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Document: leaflet MAH GENERIC_PL 43870-0025 change

FERROUS GLUCONATE 300mg TABLETS BP


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

This medicine is available without prescription. However, you still need to take Ferrous Gluconate 300mg Tablets carefully to get the best results from it.

•    Keep this leaflet. You may need to read itagain

•    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 300mg Tablets is and what it is 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.    Contents of the pack and other information_

1. What Ferrous Gluconate 300mgTablets is and what it is used for


The name of your medicine is Ferrous Gluconate 300mgTablets. This is a form of iron. Iron is needed by your body to help carry oxygen around it and to make oxygen available to your muscles when you exercise.

Ferrous Gluconate 300mg Tablets is used to:

•    Increase levels of iron in your body when the levels are too low (treatment of iron deficiency)

•    Stop the levels of iron in your body getting too low in the future (prevention of iron deficiency)

2. What you need to know before you take Ferrous Gluconate 300mg Tablets

Do not take Ferrous Gluconate 300mg Tablets if:

•    You are allergic (hypersensitive) to Ferrous Gluconate, iron or any of the other ingredients of this medicine (listed in Section 6)

•    You have a build up of too much iron in the body (haemochromatosis)

•    You suffer from iron storage (haemosiderosis) or absorption (haemoglobinuria)

•    You are having regular blood transfusions or iron by injection or infusion.

•    You suffer from an ulcer of the stomach or small intestine

Warnings and precautions

Check with your doctor or pharmacist before taking your medicine if:

•    You are elderly as there is an increased risk of unwanted side effects

•    You suffer from breakdown of red blood cells (haemolytic anaemia)

•    If you are having tests for hidden (occult blood) in the stools as this medicine colours faeces black

•    If you have a vitamin B12 deficiency

•    If you have a folic acid deficiency

•    If you have diabetes as these tablets contain sucrose

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

•    If you have a history of stomach ulcers

•    If you suffer from inflammatory bowel disease

•    If you have intestinal strictures or diverticular disease.

•    If you have had an operation to remove all or part of the stomach.

•    After correction of Iron deficiency duration of treatment should not exceed 3 months. Long term use of this product may cause tooth decay and infections.

Ferrous Gluconate is not recommended in cases where anaemia is not caused by low iron levels

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ferrous

Gluconate 300mg Tablets.

Other medicines and Ferrous Gluconate 300mg Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Ferrous Gluconate 300mg Tablets can affect the way some other medicines work. Also some other medicines can affect the way Ferrous Gluconate 300mg Tablets work.

In particular, tell your doctor or pharmacist if you are taking any of the following:

•    Antibiotics such as minocycline, tetracycline, chloramphenicol, penicillins or neomycin

•    ‘Quinolone’ antibiotics such as flouroquinolones, ciprofloxacin, norfloxacin, ofloxacin and levofloxacin

•    Medicines containing zinc

•    Medicines for bone problems called ‘biphosphonates’ such as disodium etidronate or pamidronate

•    Antacids - for indigestion or hear t burn such as magnesium trisilicate Do not take these medicines for two hours before and after taking Ferrous Gluconate 300mg Tablets

•    Mineral supplements e.g calcium, magnesium, bicarbonates, carbonates,oxalates,phosphates

•    Trientine - for removing copper from your body

•    Penicillamine for treating rheumatoid arthritis

•    Levodopa, carbidopa and entacapone - for Parkinson’s disease

•    Cholestyramine - used to reduce blood cholesterol and control diarrhoea

•    Thyroxine - a thyroid hormone. Do not take these medicines for two hours before and after taking Ferrous Gluconate 300mgTablets

•    Mycophenolate - a drug given after an organ transplant

•    Methyldopa - for high blood pressure

•    Dimercaprol - used in the treatment of heavy metal poisoning

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

Ferrous Gluconate 300mg Tablets with food and drink

If you drink large amounts of tea, coffee or milk or eat eggs at the same time as taking Ferrous Gluconate 300mg Tablets, your body may absorb less of the iron 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

During the first 12 weeks of pregnancy only take Ferrous Gluconate 300mg Tablets if you doctor has specifically recommended it. This medicine may be taken during pregnancy if you are at risk of developing iron deficiency anaemia.

Driving and using machines

No effects of Ferrous Gluconate 300mg Tablets are known.

Ferrous Gluconate 300mg Tablets contains the colours E122 and E124 and sucrose

The colours Carmoisine (El22) and Ponceau 4R red (E124) can cause allergic type reactions including asthma. These reactions are more common in people who are allergic to aspirin.

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 300mg Tablets

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

Taking this medicine

•    Take this medicine by mouth

•    Swallow the tablets whole with a drink of water

•    Do not crush or chew the tablets

•    Take about one hour before a meal Adults and children over 12 years

•    When iron levels are too low take 4 - 6 tablets spread out through the day (1200mg -1800mg in total)

•    You can choose to take the tablets 2 at a time if that suits your daily routine better To stop iron levels getting too low in the future take 2 tablets each day (600mg in total)

Use in Children Children aged 6 to12 years

Take 1 to 3 tablets each day if iron levels are too low or to stop them getting low in the future.

Children under 6 years

These tablets are not recommended for children under 6 years. If a child under 6 years takes any of this medicine, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. Taking this medicine can be fatal for a child.

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

If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away.

Take the medicine pack with you. If you have taken too much Ferrous Gluconate you may experience 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 a forgotten dose

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. 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 breathing, skin rash, itching or hives.

Other less serious side effects include:

•    Nausea, vomiting or heartburn

•    Abdominal pain, diarrhoea or constipation

•    Dark colouration of stools

•    Lack or loss of appetite

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contact irritation can occur with Ferrous Gluconate tablets resulting in the breakdown or formation of ulcers, particularly if the tablets become stuck in the upper gastrointestinal tract (oesophagus (food pipe,stomach and large intestine)).

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 via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard. By reporting side effects you can help provide information on the safety of this medicine.

5. How to store Ferrous Gluconate 300mg Tablets


•    Keep out of the sight and reach of children

•    Do not use Ferrous Gluconate after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month

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

•    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 to protect the environment.

6. Contents of the pack and other information


What Ferrous Gluconate 300mg Tablets contains

•    The active substance is ferrous gluconate. Each tablet contains 300mg, which is equivalent to 35mg of ferrous iron

•    The other ingredients are maize starch, talc, shellac, sucrose and the colours titanium dioxide (E171), Carmoisine (E122) and Ponceau 4R red(E124)

What Ferrous Gluconate 300mg Tablets looks like and contents of the pack

The tablets are red, circular and sugar coated. Tablets are available in packs of 28 and 1000.

MA Holder: Medley Pharma Limited, Unit2A, OlympicWay, Sefton Business Park, Liverpool L301RD, UK

Leaflet last revised: November 2016    PL43870/0025    361/03