This information is intended for use by health professionals

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)

Excipient(s) with known effect

This medicine contains:

Methyl parahydroxybenzoate (containing sulfites)

Ethyl parahydroxybenzoate (containing sulfites)

Propyl parahydroxybenzoate (containing sulfites)

Maltitol liquid (containing sorbitol and maltitol)

Benzyl alcohol

Ethanol

Sodium benzoate

Milk

For the full list of excipients, see section 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

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 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.

Excipients with specified warnings

This medicine contains sodium parahydroxybenzoates which may cause allergic reactions (possibly delayed).

This medicine contains less than 1mmol sodium (23mg) per 10ml dose, that is to say essentially 'sodium-free'.

This medicine contains 10g maltitol and 800mg of sorbitol in each 10ml dose. May have a mild laxative effect. Sorbitol is a source of fructose. Patients with rare hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

This medicine contains small amounts of ethanol (alcohol), less than 100mg per 10ml dose.

This medicine contains 5.2µg Sodium benzoate in each 10ml dose.

This medicine contains 1.3µg Benzyl alcohol per 10ml dose which may cause allergic reactions. Not to be used for more than a week in young children (less than 3 years old), unless advised by a doctor or pharmacist. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children. Doctors and pharmacists should give advice if patients are pregnant, breast-feeding or have a liver or kidney disease (as large amounts of benzyl alcohol can build-up in the body and may cause side effects (called “metabolic acidosis”).

This medicine contains sulfites which may rarely cause severe hypersensitivity reactions and bronchospasm.

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 Fertility, pregnancy and lactation

Pregnant women also need to take folic acid.

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 and should not be administered unless clearly indicated. For the remainder of the pregnancy, iron therapy may be indicated but only on the advice of a physician.

No adverse effects of ferrous fumarate have been shown in breastfed infants of treated mothers. Ferrous fumarate can be used during breast-feeding if clinically indicated.

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.

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

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.

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

Sodium Methyl Hydroxybenzoate (E219) (Containing sulfites)

Sodium Ethyl Hydroxybenzoate (E215) (Containing sulfites)

Sodium Propyl Hydroxybenzoate (Containing sulfites)

Citric Acid Monohydrate

Aluminium Magnesium Silicate (Veegum HS)

Chocolate flavour (17.42.5444) (Containing Propylene glycol (E1520), Benzyl alcohol (E1519), Ethanol, Sodium benzoate (E211), Milk)

Peppermint flavour (17.40.1951) (Containing Propylene glycol (E1520), Benzyl alcohol (E1519))

Liquid Maltitol (Containing Sorbitol (E420) and Maltitol (E965))

Purified water

6.2 Incompatibilities

None stated

6.3 Shelf life

24 months from the date of manufacture.

Use within one month of first opening.

6.4 Special precautions for storage

Store in a cool place.

Keep out of the sight and reach of children.

6.5 Nature and contents of container

100ml amber glass sirop bottle with a child resistant closure with a low density polyethylene plug

300ml amber glass sirop bottle with a child resistant closure with EPE/Saranex liner.

6.6 Special precautions for disposal and other handling

Not applicable

7. Marketing authorisation holder

Thornton & Ross Limited

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

8. Marketing authorisation number(s)

PL 00240/0106

9. Date of first authorisation/renewal of the authorisation

08/06/2002

10. Date of revision of the text

20/12/2019