국가: 몰타
언어: 영어
출처: Medicines Authority
FERROUS GLUCONATE
Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta
B03AA03
FERROUS GLUCONATE 300 mg
TABLET
FERROUS GLUCONATE 300 mg
OTC
ANTIANEMIC PREPARATIONS
Authorised
2019-06-19
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FERROUS GLUCONATE TABLETS 300MG Ferrous Gluconate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, or pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Ferrous Gluconate Tablets are and what they are used for 2. What you need to know before you take Gluconate Tablets 3. How to take Gluconate Tablets 4. Possible side effects 5. How to store Gluconate Tablets 6. Contents of the pack and other information 1. WHAT FERROUS GLUCONATE 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERROUS GLUCONATE TABLETS DO NOT TAKE FERROUS GLUCONATE 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) • you suffer from iron storage haemosiderosis or absorption (haemoglobinuria) • if you have a type of anaemia not caused by a lack of 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 (i 전체 문서 읽기
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ferrous Gluconate Tablets 300 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg Ferrous Gluconate. Excipients with known effect: each tablet contains 2.659mg Sucrose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Red, sugar coated, deep convex tablets. 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 Posology _Adults and the elderly _ Prophylactic: 2 tablets daily. Therapeutic: 4-6 tablets daily in divided doses. _Paedriatic population_ 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. Page 2 of 9 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 patients with haemolyt 전체 문서 읽기