Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ferrous Sulfate Tablets 200mg
⚠ This medicine appears to have been discontinued
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 Dried ferrous sulfate bp may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for The name of your medicine is Ferrous sulfate 200 mg film-coated tablets. These tablets contain iron, a mineral essential in the production of red blood cells. Ferrous sulfate tablets are used to treat anaemia caused by lack of iron in the diet or loss of iron from the body.
What you need to know before you take it
e Ferrous sulfate tablets Do not take Ferrous sulfate tablets:
- if you are allergic to ferrous sulfate or any of the other ingredients of this medicine (listed in section 6)
- if you notice blood in your urine (Paroxysmal nocturnal haemoglobinuria)
- if you suffer from iron storage disease, where the body contains more iron than it should (conditions such as haemosiderosis, haemochromatosis)
- if you suffer from an active stomach ulcer (peptic ulcer)
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if you suffer from inflammation which causes abdominal pain or diarrhoea (ulcerative colitis) or any other inflammatory condition of the bowels (regional enteritis) if you have had repeated blood transfusion If you suffer from haemolytic anaemia (anaemia due to destruction of red blood cells) if you are already being treated with iron supplements.
Warnings and precautions Talk to your doctor or pharmacist before taking Ferrous sulfate tablets:
- if you have had a gastrectomy (operation to remove all or part of the stomach)
- if you have a history of stomach ulcer
- if you suffer from diabetes
- if you have suffered from inflammatory bowel disease
- if you suffer from diverticular disease (where pouches form in the bowel wall)
- if you suffer from iron overload
- if you suffer from intestinal strictures (abnormal narrowing of the bowel often caused by inflammation)
- if you have co-existing deficiency of vitamin B12 or folic acid since combined deficiency produces microcytic blood film
- if you have difficulties swallowing. Due to the risk of mouth ulceration and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth but swallowed whole with water. If you cannot follow this instruction or have difficulty swallowing, please contact your doctor. If you accidentally choke on a tablet, please contact your doctor as soon as possible. This is because there is a risk of ulcers and narrowing of the bronchus occurring if the tablet enters the airways. This may result in persistent coughing, coughing up blood and/or feeling out of breath, even if the choking happened days to months before these symptoms occurred. Therefore you need to be urgently assessed to make sure that the tablet doesn't damage your airways. Children and adolescents Ferrous sulfate tablets are not recommended for use in children and adolescents. Other medicines and Ferrous sulfate tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription The following medicines can affect or be affected by treatment with Ferrous sulfate tablets:
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medicines used to treat indigestion (antacids and mineral supplements e.g. calcium, magnesium, bicarbonates, carbonates, oxalates and phosphates). It is important not to take this medicine for two hours before or after taking Ferrous sulfate tablets. medicines used to treat bacterial infections (antibiotics e.g. tetracyclines, quinolones, and chloramphenicol). It is important not to take this medicine for two hours before or after taking Ferrous sulfate tablets. zinc supplements penicillamine used to treat rheumatoid disease trientine used in Wilson's disease, a disorder where your body stores too much copper. It is important not to take this medicine for two hours before or after taking Ferrous sulfate tablets. medicines used to treat bone problems e.g. bisphosphonates. It is important not to take this medicine for two hours before or after taking Ferrous sulfate tablets. medicines used to treat Parkinsonism (e.g. co-careldopa, entacapone and levodopa) levothyroxine used to treat under-active thyroid glands. It is important not to take this medicine for two hours before or after taking Ferrous sulfate tablets. methyldopa used to treat high blood pressure colestyramine used to treat high blood cholesterol and itching caused by liver disease dimercaprol used to treat metal poisoning mycophenolate mofetil used to suppress the immune system and stop organ rejection after transplant.
Ferrous sulfate tablets with food and drink Do not take this medicine with tea, eggs or milk as they reduce its absorption in the stomach. Pregnancy, breast-feeding and fertility 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 this medicine if your doctor has specifically recommended it. For the remainder of the pregnancy Ferrous sulfate tablets can be taken to prevent iron deficiency. Ask your doctor or pharmacist before taking any medicine. Driving and using machines This medicine does not affect your ability to drive a car or operate machinery. Ferrous sulfate tablets contains sodium and aspartame
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This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say it is essentially 'sodium-free'. This medicine contains 0.08 mg aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
How to take it
Ferrous sulfate 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. Swallow the tablet whole with water. Do not suck, chew or keep the tablet in your mouth. Adults and Elderly: Prevention of Iron-deficiency Anaemia: One tablet daily. Treatment of Iron-deficiency Anaemia: One tablet two to three times daily • •
Take Ferrous sulfate tablets by mouth Ferrous sulfate tablets should not be taken with tea, milk or eggs
Treatment should not last more than three months after anaemia is controlled. If you take more Ferrous sulfate tablets than you should If you take more Ferrous sulfate tablets than you should, contact your doctor or go to the nearest hospital casualty department immediately. Take this leaflet with you so your doctor will know what you have taken. Symptoms of overdose include abdominal pain, nausea, vomiting and vomiting blood (haematemesis). If you forget to take Ferrous sulfate tablets If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Do not take a double dose to make up for a 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.
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Serious side effects: As can happen with any medicine; a few people may develop an allergic reaction. If you experience any of the following, seek medical help immediately:
- rash, itching, or difficulty breathing. Other side effects: Other side effects that have been reported are:
- upset stomach
- stomach pain
- feeling or being sick
- diarrhoea
- constipation
- darkening of stools
- loss of appetite. Irritation and ulceration of the gullet can occur if the tablets become stuck, so take with water. If you take this medicine for longer than you should, you are at increased risk of tooth decay and infections. Not known (frequency cannot be estimated from the available data) Mouth ulceration (in case of incorrect use, when tablets are chewed, sucked or left in the mouth). All patients, but especially elderly patients and patients with difficulties swallowing may also be at risk of ulceration of the throat or the esophagus (the tube that connects your mouth with your stomach). If the tablet enters the airways, there may be a risk of ulceration of the bronchus (the major air passages of the lungs), resulting in bronchial narrowing. If you experience any side effects or feel that the medicine is affecting you badly, tell your doctor or pharmacist immediately. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible
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 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.
How to store it
Ferrous sulfate tablets • •
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Keep this medicine out of the sight and reach of children. Keep tightly closed, do not store above 25 °C.
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Do not use this medicine after the expiry date which is stated on the outer packaging 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.
Contents of the pack and other information
What Ferrous sulfate 200 mg film-coated tablets contain:
- The active ingredient is dried ferrous sulfate 200 mg (equivalent to 65 mg Ferrous Iron (Fe II)).
- The other ingredients are microcrystalline cellulose (E460(i)), pregelatinised starch, crospovidone, colloidal anhydrous silica, magnesium stearate (E572), polyvinyl alcohol (E1203), talc (E553B), titanium dioxide (E171), glycerol monocaprylocaprate (E471), sodium lauryl sulfate (E487), macrogol (PEG) polyvinyl alcohol graftcopolymer (E1209), aspartame (E951). What Ferrous sulfate 200 mg film-coated tablets look like and content of the pack:
- Ferrous sulfate 200 mg film-coated tablets are white round biconvex coated tablets, plain on both sides.
- The tablets are available in packs of 14, 15, 21, 28, 42, 50, 56, 70, 84, 100, 250, 500 or 1000 tablets and in blister strips of 14, 15, 21, 28, 42, 56, 70, 84 and 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132JH Hoofddorp The Netherlands Manufacturer Terapia S.A. 124 Fabricii street 400632 Cluj Napoca Romania This leaflet was last revised in June 2020. PL 31750/0113
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Frequently asked questions about Ferrous Sulfate Tablets 200mg
How do I take Ferrous Sulfate Tablets 200mg?
Ferrous Sulfate Tablets 200mg comes as tablet containing 200mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ferrous Sulfate Tablets 200mg?
The active substance in Ferrous Sulfate Tablets 200mg is dried ferrous sulfate bp.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ferrous Sulfate Tablets 200mg, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ferrous Sulfate Tablets 200mg without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: dried ferrous sulfate bp
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Iron-deficiency anaemia.
4.2. Posology and method of administration
Posology:
Adults:
Prophylactic dose: one tablet daily.
Therapeutic dose: one tablet 2-3 times daily.
Elderly: as above.
Paediatric population: This presentation is not recommended for children.
Method of administration
For oral administration
The tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.
Tablets should be taken before meals or during meals, depending on gastrointestinal tolerance.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Paroxysmal nocturnal haemoglobinuria.
Haemosiderosis and haemochromatoisis.
Active peptic ulcer.
Repeated blood transfusions.
Regional enteritis and ulcerative colitis.
Haemolytic anaemia.
Oral and parenteral iron preparations should not be used concomitantly.
4.4. Special warnings and precautions for use
Some post-gastrectomy patients show poor absorption of iron.
Caution is advised when prescribing iron preparations to individuals with history of peptic ulcer, and inflammatory bowel disease, including regional enteritis and ulcerative colitis. Care should be taken in patients with intestinal strictures or diverticulae. Duration of treatment should generally not exceed 3 months after correction of anaemia.
Dental caries is a definite risk following long-term treatment with this product.
Due to the risk of mouth ulcerations and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.
Patients suffering from iron overload are particularly susceptible to infection. Treatment of iron overload should be with caution.
Co-existing deficiency of vitamin B12 or folic acid should be ruled out since combined deficiency produces microcytic blood film.
Aspiration of iron sulfate tablets can cause necrosis of the bronchial mucosa which may result in coughing, haemoptysis, bronchostenosis and/or pulmonary infection (even if aspiration happened days to months before these symptoms occurred). Elderly patients and patients who have difficulties swallowing should only be treated with iron sulfate tablets after a careful evaluation of the individual patient's risk of aspiration. Alternative formulations should be considered. Patients should seek medical attention in case of suspected aspiration.
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.
4.5. Interaction with other medicinal products and other forms of interaction
Antibacterials: Iron and tetracyclines reduce the absorption of each other when administered concomitantly. Administration of iron preparations and tetracyclines should be separated by 2 to 3 hours.
Iron may reduce the absorption of quinolones. Administration of iron preparations and quinolones should be separated by at least 2 hours.
The absorption of ciprofloxacin, levofloxacin, norfloxacin and ofloxacin may be reduced by oral iron.
Chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Antacids and mineral supplements: Compounds containing calcium, magnesium (including antacids and mineral supplements), bicarbonates, carbonates, oxalates or phosphates may impair the absorption of iron. Administration of iron preparations with such compounds should be separated by at least 2 hours.
Bisphosphonates: The absorption of bisphosphonates is reduced when taken concurrently with iron preparations. Administration should be separated by at least 2 hours.
Colestyramine: Absorption of iron is impaired by colestyramine.
Dimercaprol: Concomitant administration of oral iron preparations and dimercaprol should be avoided.
Dopaminergics: Oral iron preparations may reduce the absorption of dopaminergics such as co-careldopa, entacapone and levodopa.
Food Products: Absorption of iron is impaired by tea, eggs or milk.
Methyldopa: Oral iron preparations may antagonise the antihypertensive effect of methyldopa.
Mycophenolate mofetil: Oral iron preparations significantly reduce the absorption of mycophenolate mofetil.
Penicillamine: Oral iron preparations can reduce the absorption of penicillamine. Also the absorption of iron is impaired by penicillamine.
Thyroid hormone: Ferrous sulphate reduces the absorption of levothyroxine and so should be taken at least 2 hours apart.
Trientine: the absorption of oral iron preparations is reduced by trientine. Administration should be separated by at least 2 hours.
Zinc: Iron preparations and zinc preparations can reduce the absorption of each other.
4.6. Fertility, pregnancy and lactation
Pregnancy
Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of iron during the first trimester however requires evidence of iron deficiency. Prophylaxis of iron deficiency during the remainder of pregnancy is justified.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Immune system disorders:
Allergic reactions have been reported
Gastro-intestinal disorders : abdominal pain, nausea and vomiting (these are usually dose related), constipation, diarrhoea and dark stools.
Contact irritation can occur with ferrous sulphate tablets resulting in erosion or ulceration, particularly if they become lodged in the upper gastrointestinal tract.
Gastro-intestinal, including discomfort and anorexia.
Post-marketing: The following ADR has been reported during post-marketing surveillance. The frequency of this reaction is considered not known (cannot be estimated from the available data).
Gastro-intestinal disorders: mouth ulceration*
*in the context of incorrect administration, when the tablets are chewed, sucked or kept in mouth. Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions, of bronchial necrosis or bronchial stenosis (see section 4.4), in case of false route.
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.
4.9. Overdose
Symptoms:
Acute iron overdosage can be divided into four stages. In the first phase, which occurs up to 6 hours after oral ingestion, gastrointestinal toxicity, notably vomiting and diarrhoea, predominates. Other effects may include cardiovascular disorders such as hypotension and tachycardia, metabolic changes including acidosis and hyperglycaemia, and CNS depression ranging from lethargy to coma. Patients with only mild to moderate poisoning do not generally pass this first phase. The second phase may occur at 6-24 hours after ingestion and is characterised by a temporary remission or clinical stabilisation. In the third phase gastrointestinal toxicity recurs together with shock, metabolic acidosis, convulsions, coma, hepatic necrosis and jaundice, hypoglycaemia, coagulation disorders, oliguria or renal failure, and pulmonary oedema. The fourth phase may occur several weeks after ingestion and is characterised by gastrointestinal obstruction and possibly late hepatic damage.
Overdosage of ferrous salts is particularly dangerous to young children.
Management:
Treatment consists of gastric lavage followed by the introduction of 5 g desferrioxamine into the stomach. Serum iron levels should be monitored and in severe cases i.v. desferrioxamine should be given together with supportive and symptomatic measures as required. Gastric lavage with 5% sodium bicarbonate and saline cathartics (e.g. sodium sulfate 30 g for adults); milk and eggs with 5 g bismuth carbonate every hour as demulcents. Blood or plasma transfusion for shock, oxygen for respiratory embarrassment. Chelating agents (e.g. disodium calcium edetate) may be tried (500 mg/500 ml by continuous iv infusion). Dimercaprol should not be used since it forms a toxic complex with iron. Desferrioxamine is a specific iron chelating agent and severe acute poisoning in infants should always be treated with desferrioxamine at a dose of 90 mg/kg im followed by 15 mg/kg per hour i.v. until the serum iron is within the plasma binding capacity.
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Ask anything about Ferrous Sulfate Tablets 200mg. 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.