País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Ferrous sulfate heptahydrate 30 mg/mL
Viatris Limited
Ferrous sulfate heptahydrate 30 mg/mL
30 mg/mL
Oral solution
Active: Ferrous sulfate heptahydrate 30 mg/mL Excipient: Citric acid Glycerol Lemon flavour 101805 Lemon flavour MC002252 Pineapple flavour FN-15402 Purified water Sodium benzoate Sodium bisulfite Sorbitol Strawberry Flavour FN-20072 Sucrose
Bottle, plastic, amber,metric,round,PETE bottle, 250 mL
Pharmacy only
Pharmacy only
Dr Paul Lohmann GmbH KG
Iron deficiency anaemia.
Package - Contents - Shelf Life: Bottle, plastic, amber,metric,round,PETE bottle - 250 mL - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, amber, round, PETE bottle with polypropylene child proof cap - 500 mL - 36 months from date of manufacture stored at or below 25°C
2003-08-11
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION FERODAN _FERROUS SULFATE HEPTAHYDRATE ORAL SOLUTION 30 MG/ML_ _(EQUIVALENT TO 6 MG/ML ELEMENTAL IRON)_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking FERODAN. This leaflet answers some common questions about FERODAN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking FERODAN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FERODAN IS TAKEN FOR FERODAN is taken to prevent or treat iron deficiency anaemia. You should only take iron on advice from your doctor or pharmacist. FERODAN contains the active ingredient ferrous sulfate which is a form of iron. Iron is usually found in foods and is necessary for the normal development of red blood cells. A lack of iron affects the development of the red blood cells and causes iron deficiency anaemia. Your doctor or pharmacist may have advised you to take FERODAN for another reason. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY YOU WERE ADVISED TO TAKE THIS MEDICINE. This medicine is available only from your pharmacy. BEFORE YOU TAKE FERODAN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE FERODAN IF YOU HAVE AN ALLERGY TO: • any medicine containing iron (ferrous sulfate) • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE FERODAN IF: • you have haemochromatosis (a disorder in which there is too much iron in your blood) • you are receiving repeated blood transfusions • you are receiving iron intravenously • you Llegiu el document complet
Page 1 of 7 NEW ZEALAND DATA SHEET FERODAN 1. PRODUCT NAME FERODAN, 30 mg/mL, oral solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL oral solution contains 30 mg of ferrous sulfate heptahydrate (equivalent to 6 mg elemental iron). Excipients with known effects: sucrose, sodium benzoate, sodium bisulfite and sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM FERODAN is a syrupy liquid with a fruity odour. The colour of FERODAN may vary from bluish green to very light yellow to gold. Colour variations within this range will not affect the effectiveness of the product. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Iron deficiency anaemia _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSE Children 0-2 years: Use only on medical advice. Children 2-6 years: Up to 5 mL daily (in three divided doses), for example, 2 mL in the morning, 1 mL at lunchtime and 2 mL at night. Children 6-12 years: 5 – 20 mL daily (in three divided doses), for example, 5 mL three times daily. Adults and children 12 years and over: 15 – 30 mL daily (in three divided doses), for example, 5-10 mL three times daily. METHOD OF ADMINISTRATION Shake well before use. The absorption of FERODAN is optimised when taken on an empty stomach (one hour before meals or three hours after a meal). Certain food, drinks and medicine can affect iron absorption (see section 4.5) Treatment should not be extended beyond 3 months without review. Page 2 of 7 _4.3_ _CONTRAINDICATIONS_ • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Paroxysmal nocturnal haemoglobinuria • Haemosiderosis and haemochromatosis • Active peptic ulcer • Patients receiving repeated blood transfusions • Regional enteritis and ulcerative colitis • Haemolytic anaemia • Oral and parenteral iron preparations should not be used concomitantly. _4.4_ _SPECIAL WARNINGS AND PRECAUTIONS FOR USE_ Some post-gastrectomy patients show poor absorption of iron. Administer with caution in patients Llegiu el document complet