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 140mg/5ml Syrup contains 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 140mg/5ml Syrup is used to prevent or treat iron deficiency anaemia. The prevention of iron deficiency during pregnancy usually requires a combination of iron and folic acid.
E FERROUS FUMARATE 140MG/5ML SYRUP Do not take Ferrous Fumarate 140mg/5ml Syrup if:
This medicine also contains Sucrose and Glucose Liquid. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Also, it May be harmful to the teeth.
FERROUS FUMARATE 140MG/5ML SYRUP Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It is important to take your medicine at the right time. The label will tell you how much to take and how often. The recommended dose is: Adults and the elderly: The usual dose to prevent Iron deficiency anaemia is one spoonful (5ml) twice a day. Use in children For children and premature infants, your doctor will decide the dose, according to the age and weight of the child and infant. Your doctor will advise you on how long you should take the medicine, which is normally not more than six months. It is usually stopped three months after the anaemia has been corrected. If you have to go to another doctor or to the hospital tell them you are taking Ferrous Fumarate 140mg/5ml Syrup. If you take more Ferrous Fumarate 140mg/5ml Syrup than you should: Contact your nearest hospital casualty department or doctor immediately. Take any remaining medicine and this leaflet with you so that the medical staff know exactly what you have taken. Your medicine is very dangerous if too much is taken by young children and care should be taken to keep the medicine safely out of the reach of children. If you forget to take your Ferrous Fumarate 140mg/5ml Syrup: Do not take a double dose to make up for a forgotten dose. Take your dose as soon as you remember. Then go on as before. If it is almost time for the next dose, then do not take the missed dose at all. If you stop taking Ferrous Fumarate 140mg/5ml Syrup: If you are having no problems with Ferrous Fumarate 140mg/5ml Syrup, do not stop taking it until your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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
Other side effects may include:
FERROUS FUMARATE 140MG/5ML SYRUP Important warning: contains iron. Keep this medicine out of the sight and reach of children, as overdose may be fatal. Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light. Shake the bottle before use. Replace the cap after taking your dose. If you have any of your medicine left after finishing your treatment, return it to your pharmacist. Do not use this medicine if the bottle is damaged or after the Expiry Date which is stated on the bottle after 'Exp'. 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. REMEMBER This medicine is for YOU. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.
The active substance is ferrous fumarate. Each 5 ml spoonful contains 140mg ferrous fumarate(approximately 45mg elemental iron). Ferrous fumarate is an iron compound. The other ingredients are nipastat, methyl cellulose, glucose liquid, sucrose, lecithin vegetable , elderberry flavour, sodium metabisulphite (E223) and purified water.
Nipastat contains methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate, butyl hydroxybenzoate and isobutyl hydroxybenzoate. What Ferrous Fumarate 140mg/5ml Syrup looks like and contents of pack Ferrous Fumarate 140mg/5ml Syrup is a smooth brown suspension which separates on standing with an elderberry smell. It is packed in amber glass bottles containing 200ml suspension. Marketing authorisation holder Mercury Pharmaceuticals Ltd., Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom Manufacturer:
Kleva Pharmaceuticals S.A., Parnithos Ave. 189, Acharnai Attiki, 13675, Greece. This leaflet was last revised in August 2023.
Ferrous fumarate 140mg/5ml Syrup comes as oral solution containing 140mg / 5ml. 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 140mg/5ml Syrup is ferrous fumarate.
This leaflet reproduces the patient information leaflet approved for Ferrous fumarate 140mg/5ml Syrup, 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.
For prophylaxis during pregnancy, a combination of iron and folic acid is usually recommended.
Posology
Each 5 ml of Fersamal syrup contains 140 mg Ferrous Fumarate which approximates to 45 mg of elemental iron – section 2 SmPC.
Prevention of iron deficiency:
Adults and elderly:
Fersamal syrup one 5 ml spoonful twice a day.
Paediatric population
6-24 months of age: 12.5mg/day
2-5 years of age: 20-30mg/day
6-11 years of age: 30-60mg/day
Older children: 60mg/day
Premature infants: 5mg elemental iron per day. Iron supplementation in premature infants is only recommended in those of low birth weight who are solely breast fed. Higher doses up to 2mg/kg of elemental iron per day might be needed to cover the needs of growing exclusively breastfed infants. Supplementation should be commenced 4-6 weeks after birth and continued until mixed feeding is established.
Treatment of iron deficiency:
Adults and elderly:
Fersamal syrup two 5 ml spoonfuls twice a day
Paediatric population:
Full term infants and children: 3 to 6 mg elemental iron/Kg/day given in 2 to 3 divided doses. Total daily dose should not exceed 180 mg elemental iron.
Administration to infants and children should take place under medical advice.
Medical advice should be sought if symptoms do not improve after four weeks of use of this product as these symptoms may reflect an underlying disease process.
Method of administration: Oral
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Known hypersensitivity to any of the ingredients of the product. Paroxysmal nocturnal haemoglobinuria. Haemosiderosis, haemochromatosis. Active peptic ulcer. Repeated blood transfusions. Regional enteritis and ulcerative colitis. Must not be used in anaemias other than those due to iron deficiency.
Some post-gastrectomy patients show poor absorption of iron. Care is required when treating patients with iron deficiency anaemia who have treated or controlled peptic ulceration.
Duration of treatment of uncomplicated iron deficiency anaemia should not usually exceed 6 months (3 months after reversal of the anaemia has been achieved).
Because anaemia due to combined iron and Vitamin B12 or folate deficiencies may be microcytic in type, patients with microcytic anaemia resistant to treatment with iron alone should be screened for Vitamin B12 or folate deficiency.
Paediatric population
Fersamal syrup should be kept out of the reach of children.
Long-term treatment with Fersamal syrup may increase the risk of dental caries. Adequate dental hygiene must be maintained. Since Fersamal syrup contains sugar, care must be exercised when using in patients with diabetes mellitus.
Fersamal Syrup contains:
Glucose: Patients with rare Glucose galactose malabsorption should not take this medicine.
Sucrose: Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
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 Fersamal 140mg/5ml 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 can be used during pregnancy if clinically indicated.
Breastfeeding
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:
Not known: frequency cannot be estimated from the available data
Gastrointestinal disorders:
The commonest side effects relate to gastrointestinal irritation (nausea, epigastric pain, constipation or diarrhoea). In the event of these ADRs, it may be helpful to reduce the dose or switch to an alternative iron salt.
Darkening of stools, black discoloration of the teeth and allergic reactions (due to metabisulphite in the syrup vehicle) may also occur.
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, website: 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.
Serum Iron
Severity
< 3 mg/L (55 micromol/L)
Mild toxicity
3-5 mg/L (55-90 micromol/L)
Moderate toxicity
> 5 mg/L (90 micromol/L)
Severe toxicity
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, monitor 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 140mg/5ml Syrup. 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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