Ironorm Capsules
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Ironorm Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains: Ferrous Sulphate Exsicc. BP 195 mg, Folic Acid BP
1.7 mg, Thiamine Hydrochloride BP (Vit B1) 1 mg Riboflavine (Vit B2) 2 mg Ascorbic Acid BP (Vit C)15 mg Nicotinamide BP 10 mg
Also contains: Vegetable Oil, Fat Mix, Lecithin, Coat, Gelatin, Glycerin, Sorbitol Solution, Potassium Sorbate, Black Iron Oxide, Carmine Red, Yellow Iron Oxide, Titanium Dioxide
3. PHARMACEUTICAL FORM
Soft Gelatin Capsules
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The treatment of iron and vitamin deficiency states.
4.2 Posology and method of administration
One capsule to be taken by mouth three times a day with meals.
4.3 Contraindications
None in recommended dosage.
4.4
Special warnings and precautions for use
Use with caution in the presence of Haemochromatosis, Haemolytic Anaemias and Haemoglobinopathies.
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.
4.6 Pregnancy and lactation
As with all medicines, Ironorm preparations should only be administered where potential benefit exceeding any risk has been demonstrated, especially during the first trimester of pregnancy.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Anorexia, nausea, vomiting, gastrointestinal discomfort, constipation, diarrhoea, dark stools and allergic reactions.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard
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. Serum iron levels should be monitored.
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, convulsion, hypothermia, renal failure, shock, metabolic acidosis, coagulopathy and/or hypoglycaemia. Treatment consists of supportive and symptomatic measures. Vomiting should be induced if the patient presents early and gastric lavage should be considered using a solution of desferrioxamine. Parenteral injection of 2gm desferrioxamine should be given IV or IM and 5gm 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
Iron and Multivitamins.
Multivitamin Supplement.
5.2 Pharmacokinetic properties
Soft gelatine capsule complies with BP disintegration test and all actives are bioavailable.
5.3 Preclinical safety data
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Vegetable Oil, Fat Mix, Lecithin, Coat, Gelatin, Glycerin, Sorbitol Solution, Potassium Sorbate, Black Iron Oxide, Carmine Red, Yellow Iron Oxide, Titanium Dioxide
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Keep in a cool, dry place.
6.5 Nature and contents of container
Glass vials of 25 capsules. Glass jars of 100 capsules
6.6 Instructions for use, handling and disposal
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 0400/5016R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1 May 1972
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DATE OF REVISION OF THE TEXT
06/07/2015