Galfer FA Capsules

Capsules

The prophylaxis of iron and folic acid deficiencies during pregnancy.

For oral administration.

Contra-indicated in patients with megaloblastic anaemia due to vitamin B₁₂ deficiency and in patients with a known hypersensitivity to the product or its ingredients. Not intended for the prevention or treatment of anaemia in men, non-pregnant women or children.

Use in patients with haemosiderosis, haemochromatosis and haemoglobinopathies.

Use in patients anaemias other than those due to iron deficiency.

Use in patients with inflammatory bowel disease, including regional enteritis and ulcerative colitis, intestinal strictures and diverticulae.

Concomitant use with parenteral iron.

Use in patients with active peptic ulcer.

Use in patients who require repeated blood transfusion.

Galfer FA is intended only for the prevention of iron and folic acid deficiencies in pregnancy; the dose of folic acid provided is inadequate for the treatment of megaloblastic anaemias. The development of anaemia despite prophylaxis with Galfer FA requires further investigation and appropriate therapy.

Iron preparations colour the faeces black, which may interfere with tests used for detection of occult blood in the stools.

The label will state:

“Important warning: Contains iron. Keep out of 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.

Iron chelates with concomitantly administered tetracyclines, and absorption of both agents may be impaired. Absorption of iron may be reduced in the presence of antacids.

Reduced iron absorption with calcium supplements, zinc and trientine.

The hypotensive effect of methyldopa is reduced.

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

Serum levels of anticonvulsant drugs may be reduced by the co-administration of folate.

Galfer FA is suitable for use during pregnancy.

Does not affect ability to drive and to use machinery.

Side effects may include nausea, diarrhoea, constipation and other gastro-intestinal disturbances.

Rarely, folic acid may cause allergic reactions.

Iron overdosage is an acute emergency requiring urgent medical attention. An acute intake of 75mg/kg of elemental iron is considered extremely dangerous in young children.

Symptoms:

Initial symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycemia and metabolic acidosis may occur. However, if overdosage is suspected, treatment should be implemented immediately. In severe cases, after a latent phase, relapse may occur after 24-48 hours manifested by hypotension, coma, hypothermia, hepatocellular necrosis, renal failure, pulmonary oedema, diffuse vascular congestion, coagulopathy and/or convulsions. In many cases, full recovery may be complicated by long-term effects such as hepatic necrosis, toxic encephalitis, CNS damage and pyloric stenosis.

Treatment:

The following steps are recommended to minimise or prevent further absorption of the medication.

Children:

1. Administer an emetic such as syrup of ipecac.

2. Emesis should be followed by gastric lavage with desferrioxamine solution (2g/l). This should then be followed by the installation of desferroxamine 5g in 50 – 100ml 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 >90umol/l) immediate supportive measure plus IV infusion of desferrioxamine should be instituted. Desferrioxamine 1 5mg/kg body weight should be administered every hour by slow IV infusion to a maximum 80mg/kg/24 hours.

Warning:

Hypotension may occur if the infusion rate is too rapid.

4. Less severe poisoning: i.m desferroxamine 1g 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 (2g/l).

Desferrioxamine 5g in 50-100ml 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. In the presence of shock and/or coma with high serum iron levels (>142umol/l) immediate supportive measures plus IV infusion of desferrioxamine should be instituted.

The recommended dose of desferrioxamine is 5mg/kg/h by a slow IV infusion up to a maximum of 80mg/kg/24 hours.

Warning:

Hypotension may occur if the infusion rate is too rapid.

5. Less severe poisoning:

i.m. deferrioxamine 50mg/kg up to a maximum dose of 4g should be given.

6. Serum iron levels should be monitored throughout.

A daily dose 100mg of iron and 200-500 micrograms of folic acid is recommended for the prevention of iron and folic acid deficiencies during pregnancy. Galfer FA contains 305mg ferrous fumarate, equivalent to 100mg of elemental iron, and 350 micrograms of folic acid, and thus one capsule daily provides a suitable prophylactic dose.

Folic acid is rapidly absorbed, mainly from the proximal part of the small intestine. Iron is irregularly and incompletely absorbed from the gastro-intestinal tract, the main site 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 affected 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.

Not applicable.

Microcrystalline Cellulose BP

Capsule Shell Constituents:

Quinoline Yellow (E104)

Erythrosine (E127) Pharm Fr

Indigotine (E132) Pharm Fr

Titanium Dioxide (E171) Pharm Fr

Gelatin Ph Eur

None stated.

Store in a cool place.

Keep container tightly closed.

Keep out of reach of children.

Cylindrical polypropylene containers with polyethylene snap-close caps.

Pack sizes: 100 and 250 capsules.

Child resistant vial complying with British Standard (BSI 5321).

Pack size: 30 capsules.

PVdC/Aluminium foil blisters.

Pack size: 28 capsules.

Not applicable.

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

PL 00240/0105

31 May 2003

08/01/2007

Not Applicable

Not Applicable