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IRONORM SYRUP

Active substance(s): CALCIUM GLYCEROPHOSPHATE / CALCIUM PANTOTHENATE / FERRIC AMMONIUM CITRATE / MANGANESE GLYCEROPHOSPHATE / NICOTINAMIDE / POTASSIUM GLYCEROPHOSPHATE / PYRIDOXINE HYDROCHLORIDE / RIBOFLAVINE / SODIUM GLYCEROPHOSPHATE / THIAMINE HYDROCHLORIDE

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Transcript
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
Thiamine Hydrochloride BP
Riboflavine BP
Pyridoxine Hydrochloride BP
Nicotinamide BP
Calcium Pantothenate USP
Calcium Glycerophosphate BPC'63
Sodium Glycerophosphate BPC'49
Potassium Glycerophosphate BPC'63
Manganese Glycerophosphate BPC'49

3.

250.00 mg
0.50 mg
0.25 mg
0.125 mg
3.75 mg
0.125 mg
10.75 mg
21.25 mg
1.75 mg
1.00 mg

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






4.4

Hypersensitivity to any of the ingredients.
Haemosiderosis and haemoglobinopathies.
Haemolytic anaemias.
Unexplained anaemia.
Renal failure.

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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