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FERROUS GLUCONATE Coated tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Ferrous Gluconate 300mg Tablets.

Qualitative and quantitative composition

Each tablet contains 300mg ferrous gluconate. Excipients with known effect: contains sucrose and ponceau 4R red (E124). For a full list of excipients, see section 6.1.

Pharmaceutical form

Coated tablet. Appearance: Red, circular, biconvex, sugar-coated tablet.

Therapeutic indications

Ferrous Gluconate 300mg Tablets are indicated for the prevention and treatment of iron deficiency states.

Posology and method of administration

Adults and the elderly <u>Prophylactic:</u> 2 tablets daily. <u>Therapeutic:</u> 4-6 tablets daily in divided doses. Children (aged 6-12 years) <u>Prophylactic:</u> 1 or 2 tablets daily. <u>Therapeutic: ...

Contraindications

Hypersensitivity to the active ingredient ferrous gluconate or to any of the excipients listed in section 6.1. Iron preparations are contra-indicated in patients with haemochromatosis, iron storage or ...

Special warnings and precautions for use

Large doses may have irritant/corrosive effect on gastro-intestinal mucosa which can lead to necrosis and perforation. Ferrous Gluconate should be used with caution in patients with haemolytic anaemia. ...

Interaction with other medicinal products and other forms of interaction

Iron and possibly other heavy metals are chelated with concurrent oral administration of acetohydroxamic acid resulting in reduced intestinal absorption of both drugs. <u>Antacids and mineral supplements: ...

Pregnancy and lactation

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of iron during the first trimester requires definite evidence of iron deficiency. There is no ...

Effects on ability to drive and use machines

None known.

Undesirable effects

Gastro-intestinal disorders have been reported with large doses of Iron including gastro-intestinal discomfort, epigastric pain, anorexia, nausea, heartburn, vomiting, constipation, and diarrhoea. These ...

Overdose

Large amounts of Ferrous gluconate are toxic, but in adults rarely prove fatal. In children between 1 and 2 years of age as little as 1 to 2 g of iron can cause death. Symptoms Iron poisoning is commonest ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antianemic preparations ATC code: B03AA03 Iron is an essential constituent of the body, being necessary for haemoglobin formation and for the oxidative processes of living tissues. ...

Pharmacokinetic properties

After acidification and partial digestion of food in the stomach its content of iron is presented to the intestinal mucosa as either inorganic or heme iron. These fractions are taken up by the absorptive ...

Preclinical safety data

Not available.

List of excipients

Sodium starch glycollate Stearic acid Colloidal anhydrous silica <u>Sugar-coat excipients:</u> Sucrose Polyvinylacetate phthalate Stearic acid Talc Calcium carbonate Acacia Titanium dioxide(E171) Ponceau ...

Incompatibilities

None known.

Shelf life

3 years.

Special precautions for storage

Do not store above 25°C. Keep the container tightly closed. Store in theoriginal container.

Nature and contents of container

Polypropylene tubes with high-density/low-density polyethylene caps and a silica gel desiccant. A low-density polyethylene bag contains the leaflet in the pot. Pack sizes: 28, 100, 250,500, 1000 and 5000 ...

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland

Marketing authorization number(s)

PL 30464/0026

Date of first authorization / renewal of the authorization

Date of first authorisation: 07/08/1979 Date of last renewal: 21/09/2006

Date of revision of the text

18 June 2018

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