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Iron Jelloids

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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    )

Nicotinamide    )

Ascorbic Acid    )

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