FERROUS GLUCONATE 300 MG TABLETS BP - patient leaflet, side effects, dosage

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 have anaemia not caused by iron deficiency
• You are having regular blood transfusions or iron by injection or infusion.
• You have hepatitis (inflammation of the liver)
• You suffer from alcoholism

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 sugar
• 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 (gastrectomy)

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.

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. Do not take these medicines for 2 hours after taking Ferrous Gluconate 300mg Tablets.
• ‘Quinolone’ antibiotics such as flouroquinolones, ciprofloxacin, norfloxacin, ofloxacin and levofloxacin
• Medicines containing zinc and aluminium
• Medicines for bone problems called ‘biphosphonates’ such as disodium etidronate or pamidronate.

Do not take these medicines for 2 hours after taking Ferrous Gluconate 300mg Tablets.

Antacids – for indigestion or heartburn 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. Do not take these medicines for 2 hours after taking Ferrous Gluconate 300mg Tablets.
• Penicillamine for treating rheumatoid arthritis
• Levodopa, co-careldopa, 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 300mg Tablets
• Mycophenolate – a drug given after an organ transplant
• Methyldopa – for high blood pressure
• Dimercaprol – used in the treatment of heavy metal poisoning
• Vitamin E
• Acetohydroxamic acid – used in the treatment of bladder infections
• Eltrombopag or Nalidixic acid

Ferrous Gluconate 300mg Tablets with food and drink

If you drink large amounts of tea, coffee, milk or milk products or eat eggs and whole grain breads and cereals 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

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 300mg Tablets if your doctor has specifically recommended it. This medicine may be taken during pregnancy and while breast-feeding 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 azo colours El22, El24 and sucrose

The colours Carmoisine (El22) and Ponceau 4R red (El24) can cause allergic type reactions. 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 aged 6 to 12 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 (including vomiting blood), abdominal pain, bleeding from the bottom, diarrhoea, low blood pressure, lack of energy, changes in metabolism, coma, seizures and liver problems. An overdose in children can be fatal.

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
• Haemorrhage/blood loss (symptoms may include being in a ‚state of shock‘, vomiting blood)
• Circulatory failure/collapse (symptoms may include chest pain, breathlessness or dizziness)
• Vomiting blood (haematemesis)
• Severe diarrhoea

High doses in some people may have an effect on the lining of the stomach or gut, which may become narrower or perforated. Symptoms of this are stomach pain and bloody stools.

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: or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 equivalen35mg of ferrous iron
• The other ingredients are maize starch, talc, shellac, sucrose and the colours titanium

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, Unit 2A, Olympic Way, Sefton Business Park, Liverpool L301RD, UK