This information is intended for use by health professionals

1. Name of the medicinal product

FERROUS SULFATE TABLETS BP 200mg

2. Qualitative and quantitative composition

Each tablet contains 200mg Dried Ferrous Sulfate PhEur equivalent to 65mg elemental iron.

Excipients with known effect:

This product also contains glucose, sucrose and lactose.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Sugar-coated tablet.

White, circular, biconvex sugar-coated tablets.

4. Clinical particulars
4.1 Therapeutic indications

For the prevention and treatment of iron-deficiency anaemias.

4.2 Posology and method of administration

Posology

Each 200mg ferrous sulfate tablet is equivalent to 65mg of ferrous iron.

Adults:

Treatment: 130-195mg ferrous iron (2-3 tablets) daily in divided doses.

Prophylaxis: 65mg ferrous iron (1 tablet) daily.

Elderly:

The usual adult dose can be administered (see section 4.4).

Children 6-12 years:

Treatment: Children weighing over 22kg – one tablet daily.

Children weighing over 44kg – one tablet twice daily.

Children weighing over 66kg – one tablet three times daily.

Children under 6 years or weighing less than 22kg: Not recommended.

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 haemochromatosis.

• Active peptic ulcer.

• Patients receiving 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.

Administer with caution in patients with haemoglobinopathies, iron-storage or iron-absorption diseases, existing gastrointestinal disease.

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.

These tablets contain sugar and should be administered with care to patients with diabetes.

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.

Patients with rare heriditary problems of galactose intolerance or fructose intolerance, total lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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.

The absorption of ciprofloxacin, levofloxacin, norfloxacin and ofloxacin may be reduced by oral iron.

Quinolones: Iron may reduce the absorption of quinolones. Administration of iron preparations and quinolones should be separated by at least 2 hours.

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.

Cholestyramine: Absorption of iron is impaired by cholestyramine.

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. Absorption of iron salts is enhanced by ascorbic acid and meat.

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).

Gastrointestinal disorders:

Mouth ulceration*

*in the context of incorrect administration, when the tablets are chewed, sucked or kept in the mouth. Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions or 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 5g desferrioxamine into the stomach. Serum iron levels should be monitored and in severe cases iv desferrioxamine should be given together with supportive and symptomatic measures as required. Gastric lavage with 5% sodium bicarbonate and saline cathartics (eg sodium sulfate 30g for adults); milk and eggs with 5g bismuth carbonate every hour as demulcents. Blood or plasma transfusion for shock, oxygen for respiratory embarrassment.Chelating agents (eg disodium calcium edetate) may be tried (500mg/500ml 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 90mg/kg im followed by 15mg/kg per hour iv until the serum iron is within the plasma binding capacity.

5. Pharmacological properties
5.1 Pharmacodynamic properties

ATC CODE: B03A A07

Ferrous sulfate is used in the treatment of iron deficiency anaemias.

Iron preparations have no intrinsic therapeutic activity except as a nutrient source: their use without evidence of iron deficiency, or reasonable expectation of its occurrence, is to be deprecated. Iron, in excess, is toxic and haemochromatosis may result from chronic injection of iron preparations used as tonics, especially in individuals with undiagnosed blood disorders. Patients with chronic anaemia are particularly at risk from iron storage disease. Recently a severe iron overload myopathy has been described in patients given prophylactic iron indiscriminately while receiving haemodialysis. Genetic factors probably contribute to the risk of iron overload.

It should be clear that although iron deficiency is readily treated, its detection does not constitute a complete diagnosis. Every effort should be made to determine why the patient has entered a state of negative iron balance. Attention should be given to hidden sources of haemorrhage (which may indicate serious urinary or gastrointestinal conditions) and also the possibility of malabsorption of iron caused by latent disease of the small intestine.

5.2 Pharmacokinetic properties

Iron is irregularly and incompletely absorbed from the gastrointestinal tract, the main sites of absorption being the duodenum and jejunum. Absorption is aided by the acid secretion of the stomach or by dietary acids and is more readily effected when the iron is in the ferrous state or is part of the haem complex (haem-iron). Absorption is also increased in conditions of iron deficiency or in the fasting state but is decreased if the body stores are overloaded. Only about 5-15% of the iron ingested in food is normally absorbed.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical particulars
6.1 List of excipients

The tablet core contains:

Spray dried liquid glucose

Stearic acid

Magnesium stearate

Microcrystalline cellulose (101) (E460)

Lactose granules containing lactose

Maize starch

Pregelatinised maize starch

The coating contains:

Purified talc (E553)

Acacia (E414)

Gelatin

Sucrose

Titanium dioxide (E171)

The tablets may also contain:

Yellow carnauba wax

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life

Two years from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

6.4 Special precautions for storage

Store below 25°C in a dry place.

6.5 Nature and contents of container

Child-resistant blister pack: (i) 250µm white rigid PVC (ii) 9µm soft aluminium / 35g/m2 glassine paper. Compliant with BS8404.

Pack size: 28, 30, 60.

PE tablet container with a child-resistant PP closure. Compliant with ISO8317.

Pack size: 30, 60, 100.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

Accord-UK Ltd

(Trading style: Accord)

Whiddon Valley

Barnstaple

Devon

EX32 8NS

8. Marketing authorisation number(s)

PL 0142/6422 R

9. Date of first authorisation/renewal of the authorisation

July 1990 (Renewed February 1999)

10. Date of revision of the text

31/10/2019