Ironorm Syrup
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ironorm Syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains: -
Iron and Ammonium Citrate BP'73 250.00 mg
Thiamine Hydrochloride BP 0.50 mg
Pyridoxine Hydrochloride BP 0.125 mg
Calcium Pantothenate USP 0.125 mg
Calcium Glycerophosphate BPC'63 10.75 mg
Sodium Glycerophosphate BPC'49 21.25 mg
Potassium Glycerophosphate BPC'63 1.75 mg
Manganese Glycerophosphate BPC'49 1.00 mg
3. PHARMACEUTICAL FORM
Oral Syrup
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
As a supplement of Iron, Vitamins B and minerals in situations of special dietary need. Not suitable for correction of deficiency status.
4.2 Posology and method of administration
Oral
Adults: One 5ml spoonful daily Children: Not recommended
4.3 Contraindications
• Hypersensitivity to any of the ingredients.
• Haemosiderosis and haemoglobinopathies.
• Haemolytic anaemias.
• Unexplained anaemia.
• Renal failure.
4.4 Special warnings and special precautions for use
Administration of Ironorm Syrup may mask signs of occult blood loss.
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 Interactions with other medicinal products and other forms of interaction
Iron and tetracyclines interfere with absorption of each other.
Absorption of iron is impaired by penicillamine, antacids, cholestyramine, tea, eggs or milk.
Chloramphenicol delays plasma clearance of iron, incorporation of iron into red blood cells by interfering with erythropoiesis.
The efficacy of L-Dopa is reduced by pyridoxine.
4.6 Pregnancy and lactation
Not recommended for use during the first trimester. Safe after the first trimester only when taken in recommended doses and if no other iron or calcium supplements are taken concurrently. Safe during lactation when used in recommended doses.
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
Constipation, diarrhoea, dark stools, nausea and gastric irritation. Allergic reactions may occasionally occur..
4.9 Overdose
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 and signs include abdominal pain, diarrhoea and vomiting (haematemesis is a possibility) within 1-2 hours, followed by cardiovascular collapse and coma in some patients. Recovery follows this phase and in some patients this continues. In others, deterioration occurs after about 15 hours characterised by diffuse vascular congestion, pulmonary oedema, convulsions, hypothermia, renal failure, shock, metabolic acidosis, coagulopathy and/or hypoglycaemia.
Treatment consists of supportive and symptomatic measures. Vomiting should be induced if patient presents early and gastric lavage should be considered using a solution of desferrioxamine. Parenteral injection of 2g desferrioxamine should be given IV or IM and 5g of desferrioxamine in 50 - 100ml of fluid may also be left in the stomach.
Recovery may be complicated by long term effects such as hepatic necrosis, toxic encephalitis and CNS damage and pyloric stenosis.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
A supplement of iron, Vitamin B complex, and minerals in cases of special dietary need.
5.2 Pharmacokinetic properties
The absorption of iron salts from the gastro-intestinal tract varies widely with individuals. Unabsorbed iron will blacken the faeces. Peak plasma levels are usually reached in about 2 hours.
Vitamins of the B-complex are absorbed from the gastro intestinal tract and widely distributed in body tissues. Little is stored in the body and quantities in excess of body requirements are excreted in the urine.
The mineral salts of glycerophosphoric acid are readily absorbed from the gastro intestinal tract.
5.3 Preclinical safety data
None stated.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerin, Glycerophosphoric Acid, Dilute Hydrochloric Acid, Hydroxybenzoates (Methyl, Ethyl, Propyl and Butyl), Propylene Glycol, Flavouring (Orange Essence and Morella Cherry Essence), Sucrose, Caramel (E150), Potassium Sorbate and Water
6.2 Incompatibilities
Not Known
6.3 Shelf life
36 Months
6.4 Special precautions for storage
Store in a cool place.
6.5 Nature and contents of container
Glass bottle containing 150ml of Ironorm Syrup
6.6
Instructions for use/handling
None stated.
7 MARKETING AUTHORISATION HOLDER
Wallace Manufacturing Chemists Ltd.
Wallace House 51-53 Stert Street Abingdon
Oxfordshire OX14 3JF United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00400/5017R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/01/2005
10 DATE OF REVISION OF THE TEXT
17/04/2009