Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ferrous fumarate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR Ferrous Fumarate Tablets contain a form of iron called ferrous fumarate. Iron is usually found in foods and is necessary for the normal development of red blood cells. A lack of iron affects the development of the red blood cells and causes iron deficiency anaemia. Ferrous Fumarate Tablets are used to prevent or treat iron deficiency anaemia.
E FERROUS FUMARATE TABLETS Do not take Ferrous Fumarate Tablets if
Warnings and precautions Talk to your doctor or pharmacist before taking Ferrous Fumarate Tablets if:
This medicine contains less than 1 mmol sodium (23 mg) per dosage, that is to say essentially 'sodium-free'.
FERROUS FUMARATE 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. The recommended dose: The recommended dose is one tablet a day. Occasionally it may be increased to one tablet twice a day. To help you to remember to take your medicine, select the tablet(s) for the appropriate day of the week marked on the strips. Swallow the tablets with a glass of water. Taking Ferrous Fumarate Tablets with meals may help to relieve any stomach related side effects. Your doctor will advise you on how long you should take the tablets. Normally this will be for 3
All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately. Not known: frequency cannot be estimated from the available data
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
FERROUS FUMARATE TABLETS Keep this medicine out of the sight & reach of children, as overdose may be fatal. Do not use this medicine after the expiry date which is stated on the carton and blister after "Exp". The expiry date refers to the last day of that month. Store below 25°C. Store in the original package in order to protect from light. Do not use your medicine if the pack is damaged. Disposal of the product: 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 to protect the environment. REMEMBER This medicine is for YOU. Never give it to anyone else. It may harm them, even if their signs of illness are the same as yours.
What Ferrous Fumarate tablets contain: The active substance is ferrous fumarate. Each tablet contains 322 mg ferrous fumarate (equivalent to approximately 100 mg ferrous iron). Ferrous fumarate is an iron compound.
The other ingredients are maize starch, sodium lauryl sulfate, gelatin and liquid paraffin. The film coating of the tablets contains hypromellose, acetylated monoglyceride, hydroxypropyl cellulose, titanium dioxide (E171), talc, iron oxide yellow (E172) and iron oxide red (E172). What Ferrous Fumarate Tablets look like and contents of the pack Each film coated tablet is brown ochre in colour and engraved FE on one face and 322 on the other. Ferrous Fumarate Tablets are usually available in cartons containing two blister strips of 14 tablets, therefore 28 tablets altogether. However, pots of 1000 tablets may also be available. Not all pack sizes may be marketed. Marketing Authorisation Holder Mercury Pharma Group Ltd., Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom Manufacturer: Lusomedicamenta S.A.Sociedade Técnica, Farmaceutica 2730 055 Barcarena, Portugal This leaflet was last revised in January 2024.
Ferrous Fumarate 322mg Tablets comes as tablet containing 322mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Ferrous Fumarate 322mg Tablets is ferrous fumarate.
This leaflet reproduces the patient information leaflet approved for Ferrous Fumarate 322mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Prophylaxis and treatment of iron deficiency states.
Posology
Adults and the elderly: One tablet daily (the foil enclosing the tablet is printed with days of the week in sequence).
In severe or refractory iron deficiency, one tablet may be given twice a day.
Paediatric population: Ferrous Fumarate tablets are not intended for the treatment of children.
Method of administration:
Oral
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Paroxysmal nocturnal haemoglobinuria, haemosiderosis, haemochromatosis, active peptic ulcer, repeated blood transfusions, regional enteritis, and ulcerative colitis. Ferasday tablets must not be used in anaemias other than those due to iron deficiency.
Some post gastrectomy patients show poor absorption of iron. Care is needed when treating patients with iron deficiency anaemia in patients with treated or controlled peptic ulceration. Duration of treatment of uncomplicated iron deficiency anaemia should not usually exceed 6 months (or 3 months after reversal of the anaemia has been achieved).
Since anaemia due to combined iron and vitamin B12 or folate deficiencies may be microcytic in type, patients with microytic anaemia resistant to therapy with iron alone should be screened for vitamin B12 or folate deficiency.
Paediatric Population
Ferrous Fumarate tablets should be kept out of the sight and reach of children.
The label will state:
Important Warning: Contains Iron.
Keep out of the sight and reach of children, as overdose may be fatal.
This will appear on the front of the pack within a rectangle, in which there is no other information.
This medicine contains less than 1 mmol sodium (23 mg) per dosage, that is to say essentially 'sodium-free'.
Iron reduces the absorption of penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine) (give at least 2 hours apart), moxifloxacin, mycophenolate, norfloxacin, ofloxacin, zinc. Absorption of both iron and antibiotic may be reduced if Ferrous Fumarate tablet is given with tetracycline. Absorption of oral iron is reduced by calcium salts, Magnesium salts (as magnesium trisilicate), Trientine.
Chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis. Some inhibition of iron absorption may occur if it is taken with cholestyramine, tea, eggs or milk.
Avoid concomitant use of iron with dimercaprol.
Oral iron antagonises hypotensive effect of methyldopa.
Pregnancy
Ferrous fumarate tablets can be used during pregnancy if clinically indicated.
Breast-feeding
No adverse effects of ferrous fumarate have been shown in breastfed infants of treated mothers. Ferrous fumarate tablets can be used during breast-feeding if clinically indicated.
Not relevant
The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention:
Rare (≥1/10 000 to <1/1 000):
Immune system disorders:
• Allergic reactions.
Not known: frequency cannot be estimated from the available data
Gastrointestinal disorders:
• Gastro-intestinal irritation and darkening of stools can occur with iron salts. Nausea and epigastric pain are dose-related but the relationship between dose and altered bowel habit (constipation or diarrhoea) is less clear. Oral iron, particularly modified-release preparations, can exacerbate diarrhoea in patients with inflammatory bowel disease; care is also needed in patients with intestinal strictures and diverticular disease.
• Iron preparations taken orally can be constipating, particularly in older patients and occasionally lead to faecal impaction.
• If side-effects occur, the dose may be reduced; alternatively, another iron salt may be used but an improvement in tolerance may simply be a result of a lower content of elemental iron.
Paediatric population
Iron preparations are a common cause of accidental overdose in children
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms:
Ingestion of 20 mg/kg elemental iron is potentially toxic and 200-250 mg/kg is potentially fatal. No single method of assessment is entirely satisfactory - clinical features as well as laboratory analysis must be taken into account. The serum iron taken at about 4 hours after ingestion is the best laboratory measure of severity.
Early signs and symptoms include nausea, vomiting, abdominal pain and diarrhoea. The vomit and stools may be grey or black. In mild cases early features improve but in more serious cases there may be evidence of hypoperfusion (cool peripheries and hypotension), metabolic acidosis and systemic toxicity. In serious cases there can be recurrence of vomiting and gastrointestinal bleeding, 12 hours after ingestion. Shock can result from hypovolaemia or direct cardiotoxicity.Evidence of hepatocellular necrosis appears at this stage with jaundice, bleeding, hypoglycaemia, encephalopathy and positive anion gap metabolic acidosis. Poor tissue perfusion may lead to renal failure. Rarely, gastric scarring causing stricture or pyloric stenosis (alone or in combination) may lead to partial or complete bowel obstruction 2-5 weeks after ingestion.
Management:
Supportive and symptomatic measures include ensuring a clear airway, monitoring of cardiac rhythm, BP and urine output, establishing IV access and administering sufficient fluids to ensure adequate hydration. Consider whole bowel irrigation. If metabolic acidosis persists despite correction of hypoxia and adequate fluid resuscitation, an initial dose of 50 mmol sodium bicarbonate may be given and repeated as necessary, for adults guided by arterial blood gas monitoring (aim for a pH of 7.4). Consider the use of desferrioxamine, if the patient is symptomatic (other than nausea), serum iron concentration is between 3-5 mg/L (55-90 micromol/L) and still rising. Haemodialysis does not remove iron effectively but should be considered on a supportive basis for acute renal failure as this will facilitate removal of the iron-desferrioxamine complex.
Ask anything about Ferrous Fumarate 322mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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