FERROUS SULFATE TABLETS Coated tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Ferrous Sulfate Tablets 200mg.
Qualitative and quantitative composition
Each tablet contains: ferrous sulfate 200mg equivalent to 65 mg ferrous iron. For the full list of excipients, see section 6.1.
Pharmaceutical form
Coated tablets.
Therapeutic indications
Iron-deficiency anaemia.
Posology and method of administration
Adults Prophylactic dose: one tablet daily. Therapeutic dose: one tablet 2-3 times daily. Elderly The usual adult dose can be administered (see section 4.4). Children 6-12 years Treatment: Children weighing ...
Contraindications
Hypersensitivity to any ingredients in the formulation; patients receiving repeated blood transfusions; concomitant parenteral iron; haemochromatosis and other iron overload syndromes.
Special warnings and precautions for use
Administer with caution in patients with haemolytic anaemia, haemoglobinopathies, iron storage or iron absorption diseases, existing gastrointestinal disease. The label will state: Important warning: Contains ...
Interaction with other medicinal products and other forms of interaction
Concurrent administration with tetracyclines may impair absorption of both agents. The absorption of ciprofloxacin, norfloxacin and ofloxacin and bisphosphonates is reduced by oral iron. Cholestyramine ...
Pregnancy and lactation
Ferrous salts are recommended for use in pregnancy and lactation, and no contraindications to such are known.
Effects on ability to drive and use machines
None known.
Undesirable effects
Although iron preparations are best absorbed on an empty stomach, they may be taken after food to reduce gastrointestinal side-effects. Large doses may produce gastro-intestinal irritation, nausea, vomiting, ...
Overdose
Acute iron overdosage can be divided into four stages. In the first phase, which occurs up to 6 hours after oral ingestion, gastrointestinal toxicity, notably vomiting and diarrhoea, predominates. Other ...
Pharmacodynamic properties
ATC CODE: B03AA07 Ferrous sulfate is used in the treatment of iron deficiency anaemias. Iron preparations have no intrinsic therapeutic activity except as a nutrient source: their use without evidence ...
Pharmacokinetic properties
Iron is irregularly and incompletely absorbed from the gastrointestinal tract, the main sites of absorption being the duodenum and the jejunum. Absorption is aided by the acid secretion of the stomach ...
Preclinical safety data
Not applicable.
List of excipients
<u>Core:</u> Stearic acid EP Magnesium stearate EP Sodium lauryl sulfate EP Microcrystalline cellulose EP Croscarmellose sodium EP <u>Coating:</u> Opaglos HSE Titanium dioxide EP Sucrose EP Calcium carbonate ...
Incompatibilities
None known.
Shelf life
36 months.
Special precautions for storage
Store in a cool dry place.
Nature and contents of container
Tamper evident containers made of polypropylene or polyethylene, with polyethylene closures. Pack sizes: 28, 50, 100, 250, 500 and 1,000.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
Marketing authorization number(s)
PL 04416/0216
Date of first authorization / renewal of the authorization
12 January 1993
Date of revision of the text
13/12/2018
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