Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
iron polymaltose, Quantity: 185 mg/mL (Equivalent: iron, Qty 50 mg/mL)
Aspen Pharmacare Australia Pty Ltd
Iron polymaltose
Oral Liquid
Excipient Ingredients: sodium propyl hydroxybenzoate; sodium methyl hydroxybenzoate; purified water; sucrose; sodium hydroxide; Flavour
Oral
30 mL
(S2) Pharmacy Medicine
Treatment of iron deficiency in adults and adolescents where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate.,Prevention of iron deficiency in adults and adolescents at high risk where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate.
Visual Identification: Dark brown solution; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-11-14
1 CONSUMER MEDICINE INFORMATION MALTOFER ® TABLETS MALTOFER ® SYRUP MALTOFER ® DROPS MALTOFER ® PRODUCTS contain iron as iron polymaltose, an iron carbohydrate compound. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MALTOFER ® . It does not contain all the available information. This does not replace talking with your medical practitioner or pharmacist. All medicines have risks and benefits. Your medical practitioner or pharmacist has weighed the risks of you taking MALTOFER ® against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR MEDICAL PRACTITIONER OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT IS MALTOFER ® MALTOFER is a medicine that is used in the treatment of iron deficiency in adolescents and adults where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate. It contains iron in the form of iron polymaltose, an iron carbohydrate compound. Iron is an essential element required for the oxygen-carrying capacity of haemoglobin (the red pigment in red blood cells) and of myoglobin (the red pigment in muscle tissue). Moreover, iron plays an important role in many other vital processes in the human body. WHAT MALTOFER IS USED FOR MALTOFER ® is used for the treatment of iron deficiency in adults and adolescents where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate. MALTOFER ® is used for the prevention of iron deficiency in adults and adolescents at high risk where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate. BEFORE YOU TAKE MALTOFER ® WHEN YOU MUST NOT TAKE IT − if you are hypersensitive (allergic) to iron polymaltose or any of the other ingredients in MALTOFER ® tablets or oral liquid. Symptoms of an allergic reaction may include: • rash, itching, hives on the skin • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body Read the complete document
MALTOFER Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION MALTOFER ® (IRON POLYMALTOSE) TABLETS, SYRUP AND DROPS 1. NAME OF THE MEDICINE Iron polymaltose (AAN) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MALTOFER ® TABLETS contain 100 mg iron as iron polymaltose as the active ingredient. MALTOFER ® SYRUP, oral liquid contains 50 mg/5 mL iron as iron polymaltose as the active ingredient. The oral solution also contains methyl hydroxybenzoate, propyl hydroxybenzoate, sorbitol solution (70%) (non-crystallising), and sucrose. MALTOFER ® DROPS, oral liquid contains 50 mg/mL iron as iron polymaltose as the active ingredient. The oral liquid also contains sucrose, sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate. For the full list of excipients see Section 6.1 LIST OF EXCIPIENTS. Iron polymaltose is a polynuclear iron(III)-hydroxide core surrounded by polymaltose and has a molecular weight of about 50kD. It is stable and highly water-soluble over a broad pH range, and, unlike simple iron(III)-oxide or iron(III)-hydroxide, does not precipitate even in an alkaline environment. 3. PHARMACEUTICAL FORM MALTOFER ® TABLETS are film-coated, reddish brown, round and biconvex tablets. MALTOFER ® SYRUP, oral liquid is a dark brown solution. MALTOFER ® DROPS, oral liquid is a dark brown solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of iron deficiency in adults and adolescents where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate. MALTOFER Page 2 of 17 Prevention of iron deficiency in adults and adolescents at high risk where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate. 4.2 DOSAGE AND METHOD OF ADMINISTRATION The dosage and duration of treatment depend upon the extent of iron deficiency. The daily dose can be divided into separate doses or can be taken at once. MALTOFER ® should be taken during or immediately after a meal. Doses below 100 mg iron cannot be achieved with MALTOFER ® TABLETS. In cases where lower doses are Read the complete document