Rulofer N

This product is indicated in the prophylaxis and treatment of iron deficiency anaemia.

For oral administration:

a) Prevention of iron deficiency:

Adults, the elderly and children over 12 years:

Two 5ml spoonfuls (10ml) taken once daily.

Children (under 12 years):

Full term infants and young children: 0.5ml/kg/day administered in 2 - 3 divided doses daily. The maximum total daily dose should not exceed 20ml (180mg elemental iron).

Premature infants: 0.5ml/day in infants weighing up to 3kgs.

Iron supplementation in premature infants is only recommended in those of low birth weight who are solely breast fed, and in these cases, supplementation should be commenced 4-6 weeks after birth and continued until mixed feeding is established.

b) Treatment of iron deficiency:

Adults, the elderly and children over 12 years:

Two 5ml spoonfuls (10ml) taken once or twice daily.

Children (under 12 years):

Full term infants and young children: 0.5ml/kg/day administered in 2 - 3 divided doses daily. The maximum total daily dose should not exceed 20ml (180mg 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.

Known hypersensitivity to the product or ingredients.

Haemosiderosis, haemochromatosis, haemoglobinopathies, inflammatory bowel disease, intestinal strictures and diverticulae, active peptic ulcer, repeated blood transfusions, regional enteritis and ulcerative colitis and anaemias not produced by iron deficiency unless iron deficiency is also present.

Concomitant use with parenteral iron.

Concomitant use with dimercaprol.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Iron preparations colour the faeces black, which may interfere with tests used for detection of occult blood in the stools. Oral liquid preparations containing iron salts may blacken the teeth. To help prevent this, the mouth may be rinsed with water after use to minimise exposure.

Prolonged or excessive use in children without medical supervision may lead to toxic accumulation.

Some post-gastrectomy patients have poor absorption of iron.

Caution is advised when prescribing iron preparations to individuals with a history of peptic ulcers.

Duration of treatment should generally not exceed 3 months after correction of the anaemia has been achieved. Patients with microcytic anaemia resistant to therapy with iron alone should be screened for vitamin B₁₂ or foliate deficiency, since anaemia due to combined deficiencies may be microcytic in type.

Iron deficiency in male patients warrants careful investigation to determine its cause.

May cause allergic reactions (possibly delayed).

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.

Rulofer N Syrup does not affect the ability to drive or operate machinery.

Oral liquid preparations containing iron salts may blacken the teeth. To help prevent this, the mouth may be rinsed with water after use to minimise exposure.

Anorexia, nausea, vomiting, gastro-intestinal discomfort, constipation, diarrhoea, darkening of the stools and allergic reactions occur rarely. Gastro-intestinal side effects may be reduced by taking the syrup after food or by beginning with a small dose and increasing gradually. Iron preparations can be particularly constipating in older patients and occasionally lead to faecal impaction. Iron preparations can also exacerbate diarrhoea in patients with inflammatory bowel disease; care should be taken with patients who have intestinal strictures or diverticular disease.

Haemosiderosis may occur as a result of excessive or mistaken therapy.

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.

All those who have recently ingested more than 20mg/kg should be referred to hospital.

In the first phase of acute iron overdosage, which occurs up to 6 hours after oral ingestion, gastrointestinal toxicity, notably nausea, vomiting, abdominal pain and diarrhoea, predominates. Haematemesis and rectal bleeding may also occur. 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 progress past this phase.

The second phase may occur at 6 to 24 hours after ingestion and is characterised by a temporary remission or clinical stabilisation.

In the third phase, which occurs between 12 and 48 hours after ingestion, gastrointestinal toxicity recurs together with shock, metabolic acidosis, convulsions, coma, hepatic necrosis and jaundice, hypoglycaemia, coagulation disorders, oliguria or renal failure, and pulmonary oedema. Patients may also experience severe lethargy and myocardial dysfunction.

The fourth phase may occur several weeks after ingestion and is characterised by gastrointestinal obstruction and possibly late hepatic damage.

Treatment:

The following steps are recommended to minimise or prevent further absorption of the medication. Gastric lavage should be considered only within 1 hour of a life-threatening amount being ingested, if the airway can be protected adequately.

Children:

1. Administer an emetic such as syrup of ipecac.

2. Emesis should be followed by gastric lavage with desferrioxamine solution (2 g/l). This should then be followed by the installation of desferrioxamine 5 g in 50-100 ml water, to be retained in the stomach. Inducing diarrhoea in children may be dangerous and should not be undertaken in young children. Keep the patient under constant surveillance to detect possible aspiration of vomitus - maintain suction apparatus and standby emergency oxygen in case of need.

3. Severe poisoning:

In the presence of shock and/or coma with high serum iron levels (serum iron > 90 µmol/l) immediate supportive measure plus IV infusion of desferrioxamine should be instituted. Desferrioxamine 1 5 mg/kg body weight should be administered every hour by slow IV infusion to a maximum 80 mg/kg/24 hours.

Warning:

Hypotension may occur if the infusion rate is too rapid.

4. Less severe poisoning:

IM desferrioxamine 1 g 4-6-hourly is recommended.

5. Serum iron levels should be monitored throughout.

Adults:

1. Administer an emetic.

2.Gastric lavage may be necessary to remove drug already released into the stomach. This should be undertaken using a desferrioxamine solution (2 g/l).

Desferrioxamine 5 g in 50-100 ml water should be introduced into the stomach following gastric emptying. Keep the patients under constant surveillance to detect possible aspiration of vomitus; maintain suction apparatus and standby emergency oxygen in case of need.

3. A drink of mannitol or sorbitol should be given to induce small bowel emptying.

4. Severe poisoning.

In the presence of shock and/or coma with high serum iron levels (> 142 µmol/l) immediate supportive measures plus IV infusion of desferrioxamine should be instituted. The recommended dose of desferrioxamine is 5 mg/kg/h by a slow IV infusion up to a maximum of 80 mg/kg/24 hours.

Warning:

Hypotension may occur if the infusion rate is too rapid.

5. Less severe poisoning:

IM desferrioxamine 50 mg/kg up to a maximum dose of 4 g should be given.

6. Serum iron levels should be monitored throughout.

B03A A02 - Iron bivalent, oral preparations

Elemental iron in the ferrous form is effective as prophylaxis against iron deficiency and as replacement therapy in mild to moderate iron deficiency anaemia. Good serum rise and haemoglobin response are obtained. Gastro-intestinal disturbance is low as ferrous fumarate has low irritant characteristics.

Iron is irregularly and incompletely absorbed from the gastro-intestinal tract, the main sites of absorption being the duodenum and jejunum. Absorption is aided by the acid secretions of the stomach or dietary acids, and is more readily effected when the iron is in the ferrous state. Absorption is also increased in conditions of iron deficiency or in the fasting state but is decreased if body stores are overloaded.

None stated

None stated

Not applicable