Galfer Syrup

1. Name Of The Medicinal Product

Galfer Syrup

2. Qualitative And Quantitative Composition

Active Ingredient:

Ferrous Fumarate 140mg/5ml*

(*Equivalent to 45mg of elemental iron).

For excipients, see 6.1

3. Pharmaceutical Form

Oral solution.

A viscous brown coloured liquid with a peppermint/chocolate odour.

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

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.

4.4 Special Warnings And Precautions For Use

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.

The label will state:

“Important warning: Contains iron. Keep out of the reach and sight 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

Iron and tetracyclines reduce the absorption of each other. Iron reduces absorption of zinc, and absorption of oral iron is reduced by zinc.

Iron reduces the absorption of penicillamine, fluoroquinolones, levodopa, carbidopa, entacapone, bisphosphonates, mycophenolate and levothyroxine.

Absorption of iron is reduced with calcium, magnesium and other mineral supplements, bicarbonates, carbonates, zinc and trientine and impaired by antacids, cholestyramine, tea, eggs or milk, but may be increased by ascorbic or citric acid.

Chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.

Reduced hypotensive effect of methyldopa.

4.6 Pregnancy And Lactation

Galfer Syrup is suitable for use during pregnancy and lactation. However, administration of drugs during the first trimester of pregnancy requires careful assessment of potential risks versus benefits to be gained.

4.7 Effects On Ability To Drive And Use Machines

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

4.8 Undesirable Effects

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.

4.9 Overdose

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.

Gastric lavage should be considered only within 1 hour of a life-threatening amount being ingested within 1 hour, if the airway can be protected adequately. Desferrioxamine mesilate (5 to 10 g in 50 to 100 ml of water) may be given by mouth, or by stomach tube, to chelate any iron left in the stomach and prevent further absorption following gastric lavage, as activated charcoal is ineffective. To eliminate iron already absorbed, desferrioxamine mesilate should be given intramuscularly, or if the patient is hypotensive or in shock, intravenously by slow infusion. The dose and route of parenteral administration should be adjusted according to the severity of the poisoning.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Nipasept Sodium

Citric Acid Monohydrate

Aluminium Magnesium Silicate (Veegum HS)

Chocolate flavour (17.42.5444)

Peppermint flavour (17.40.1951)

Liquid Maltitol

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months from the date of manufacture.

6.4 Special Precautions For Storage

Store in a cool place.

Keep out of reach of children.

6.5 Nature And Contents Of Container

Amber glass bottles with polypropylene caps.

Pack sizes: 100 and 300ml.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Thornton & Ross Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH.

8. Marketing Authorisation Number(S)

PL: 00240/0106

9. Date Of First Authorisation/Renewal Of The Authorisation

8 June 2002

10. Date Of Revision Of The Text

04/02/2010

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable