Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ferrous gluconate
Kent Pharma (UK) Ltd
B03AA03
Ferrous gluconate
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09010101; GTIN: 5015201005896 5015201007623
Colours CUSTOMER: SP DESIGNER: ABC (AWG) PRODUCT: Ferrous Gluconate 300mg Tablets ITEM CODE: CP.FGL.300T.SP.V6P1 PROOF NO AND DATE: 1 11/10/2022 REVISION: MAH address update ARTWORK FOR SUBMISSION Supersedes: CP.FGL.300T.SP.V5P1 Pantone Blue 280 C DIMENSIONS: 146mm x 350mm CP.FGL.300T.SP.V6P1 2. 3. 4. 5. 6. WHAT FERROUS GLUCONATE 300MG TABLETS ARE AND WHAT THEY ARE USED FOR Ferrous Gluconate 300mg Tablets are used for the treatment and prevention of iron deficiency. Ferrous Gluconate is a form of iron. Iron is necessary for the production of haemoglobin (protein in red blood cells), which carries oxygen around the body. Iron is involved in the formation of myoglobin, a pigment that stores oxygen in muscles for use during exercise. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERROUS GLUCONATE 300MG TABLETS DO NOT TAKE FERROUS GLUCONATE 300MG TABLETS: • if you are allergic (hypersensitive) to ferrous gluconate, medicines containing iron or any of the other ingredients in this medicine (See section 6) • if you have a build up of too much iron in the body (haemochromatosis) • if you suffer from iron storage (haemosiderosis) or absorption (haemoglobinuria) • if you have anaemia not caused by Iron deficiency • if you receive regular blood transfusions or iron by IV infusion (drip) • if you have an ulcer of the stomach or small intestine • if you have hepatitis (inflammation of the liver) • if you suffer from alcoholism WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Ferrous Gluconate 300mg Tablets: • if you are having tests for occult (hidden) blood in the stools, this medicine can colour faeces black • if you are elderly as there is an increased risk of unwanted effects • if you suffer from breakdown of red blood cells (haemolytic anaemia) • if you also have deficiency of vitamin B12 or folic acid • if you have diabetes as these tablets contain sugar • if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ferrous Gluconate 300mg Tablets 2 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. 3 PHARMACEUTICAL FORM Coated tablet. Appearance: Red, circular, biconvex, sugar-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ferrous Gluconate 300mg Tablets are indicated for the prevention and treatment of iron deficiency states. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND THE ELDERLY _Prophylactic_: 2 tablets daily. _Therapeutic_: 4-6 tablets daily in divided doses. CHILDREN (AGED 6-12 YEARS) _Prophylactic: _1 or 2 tablets daily. _Therapeutic: _3 tablets daily in divided doses. Ferrous Gluconate 300mg Tablets are best taken about one hour before meals. _ _ _ _ _Method of administration _ The route of administration for Ferrous Gluconate 300mg tablets is oral. 4.3 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 absorption diseases such as and haemosiderosis or haemoglobinuria. Iron is contraindicated in patients receiving repeated blood transfusions, or in patients receiving parenteral iron therapy or to patients with anaemias not produced by iron deficiency (some conditions, such as thalassemia may cause excess storage of iron). Alcoholism and hepatitis. Iron preparations are contraindicated in active peptic ulcer, regional enteritis and ulcerative colitis. Ferrous Gluconate Tablets should not be used in patients with anaemia not produced by iron deficiency unless iron deficiency is also present. 4.4 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 pati Citiți documentul complet