Iron Jelloids
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Iron jelloids.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iron jelloids contain:-
BP 60.12mg
USP 0.17mg
EP 0.29 mg
EP 1.67 mg
EP 4.17 mg
Ferrous Fumarate Thiamine Mononitrate Riboflavine Nicotinamide Ascorbic Acid
3 PHARMACEUTICAL FORM
Tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Prevention of deficiency states of Iron, B Vitamins and Vitamin C.
4.2 Posology and method of administration
Swallow whole with a drink during or after meals.
Adults and Children aged 12 years and over
Two tablets twice daily unless otherwise recommended by a doctor.
Not to be given to children under 12 years of age except on medical advice. The Elderly
The normal adult dose may be taken.
Method of Administration
Oral.
4.3 Contraindications
The product is contra-indicated for Anaemia other than iron deficiency anaemia. Known hypersensitivity to any of ingredients.
4.4 Special warnings and precautions for use
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.
Keep out of the reach of children If symptoms persist, consult your doctor
While a course of Iron Jelloids is being taken the stools may become dark or black in colour. This normal when an iron preparation is used and not a cause for concern.
4.5 Interaction with other medicinal products and other forms of interaction
Absorption of iron is decreased in the presence of antacids. it is decreased also in the presence of tetracyclines with the converse also true.
4.6 Pregnancy and lactation
The product is not contra-indicated during pregnancy and lactation. However, as with all medicines during this period, caution should be exercised.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Iron may cause mild gastrointestinal upsets. Continued administration, particularly in the elderly may cause constipation.
4.9 Overdose
Initial symptoms of iron overdosage includes nausea, vomiting, diarrhoea, abdominal pain, hasmatemesis, rectal bleeding, lethargy and circulatory collapse.
Hyperglycaemia and Metabolic Acidosis may also occur in severe cases. After a latent phase, relapse may occur, manifested by hypotension, coma, liver necrosis and renal failure.
Treatment:
In Children - Administer an emetic (Syrup of Ipecac), followed by Gastric Lavage with Desferrioxamine Solution (2G/L), followed by instillation of Desferrioxamine 5G in 50-100ml water into the stomach. In severe poisoning 15mg/kg of Desferrioxamine should be give by slow intra-venous infusion to a maximum of 80mg/kg/24 hours, together with supportive measures. In less severe poisoning intramuscular Desferrioxamine 1G, 4-6 hourly is recommended. Serum iron levels should be monitored throughout.
In adults - Administer an emetic. Gastric Lavage with Desferrioxamine solution (2G/L) may be necessary, followed by Desferrioxamine 5G in 50-100ml water instilled into the stomach. A drink of Mannitol or Sorbitol should be given to induce bowel emptying. In severe poisoning 15mg/kg of Desferrioxamine should be give by slow intra-venous infusion to a maximum of 50mg/kg/24 hours. In less severe poisoning intra-muscular Deuferrioxamine 50mg/kg up to a maximum dose of 4G should be given. Serum iron levels should be monitored throughout.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Ferrous Fumarate provides an easily absorbable source of iron.
Provide essential B & C Vitamins
Thiamine mononitrate ) Riboflavine )
5.2 Pharmacokinetic properties
Ferrous Fumarate is irregularly and incompletely absorbed from the gastrointestinal tract, and is eliminated in the faeces. Absorption is increased in conditions of iron deficiency.
Thiamine Mononitrate, Riboflavine, Nicotinamide and Ascorbic Acid are well absorbed from the gastrointestinal tract and are widely distributed in the body tissues, that in excess of the bodies requirements are excreted in the urine.
5.3 Preclinical safety data
Not stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose EP
Calcium Carbonate EP
Talc EP
Gum Sandarac Substitute HSE
Powdered Acacia EP
Titanium Dioxide (1171) EP
Opalux Black Dye AS 8100 (E153) HSE Special Wax WG 10765 HSE
Calcium Phosphate EP
Starch EP
Icing Sugar HSE
Magnesium Stearate EP
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store at or below 25 °C.
6.5 Nature and contents of container
a) Opaque blister strips made of 250 polyvinyl chloride (PVC) with a 20 p Aluminium Foil Backing, packed in printed cartons containing 60 or 150 tablets.
b) Cylindrical white (HDPE) bottles with a laminate membrane neck seal and a polypropylene screw cap, fitted with a polyester wad, containing 60 or 150 tablets.
C) Cylindrical white polyethylene (HDPE) bottle with a white polyethylene child-resistant tamper-evident lined closure. The bottle is fitted with a polyether wad and contains 100 tablets.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0059
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18th January 1995.
10 DATE OF REVISION OF THE TEXT
05/03/2011