FERROUS FUMARATE Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Fersamal 322mg tablets. Ferrous Fumarate 322mg Film-Coated Tablets.
Qualitative and quantitative composition
Each tablet contains 322.0mg Ferrous Fumarate BP (equivalent to approximately 100 mg ferrous iron). For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated Tablets. Each film coated tablet is brown ochre in colour and engraved FE on one face and 322 on the other.
Therapeutic indications
Prophylaxis and treatment of iron deficiency states.
Posology and method of administration
Posology Adults and the elderly One tablet daily (the foil enclosing the tablet is printed with days of the week in sequence). In severe or refractory iron deficiency, one tablet may be given twice a day. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Paroxysmal nocturnal haemoglobinuria, haemosiderosis, haemochromatosis, active peptic ulcer, repeated blood transfusions, ...
Special warnings and precautions for use
Some post gastrectomy patients show poor absorption of iron. Care is needed when treating patients with iron deficiency anaemia in patients with treated or controlled peptic ulceration. Duration of treatment ...
Interaction with other medicinal products and other forms of interaction
Iron reduces the absorption of penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine) (give at least 2 hours apart), moxifloxacin, mycophenolate, norfloxacin, ...
Pregnancy and lactation
Pregnancy Ferrous fumarate tablets can be used during pregnancy if clinically indicated. Breast-feeding No adverse effects of ferrous fumarate have been shown in breastfed infants of treated mothers. Ferrous ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: Not known: frequency cannot be estimated from the available data ...
Overdose
Symptoms Ingestion of 20 mg/kg elemental iron is potentially toxic and 200-250 mg/kg is potentially fatal. No single method of assessment is entirely satisfactory clinical features as well as laboratory ...
Pharmacodynamic properties
Pharmacotherapeutic group: Iron bivalent, oral preparations ATC code: B03AA02 Iron is an essential constituent of the body, and is necessary for haemoglobin formation and the oxidative processes of living ...
Pharmacokinetic properties
Absorption Once in the stomach, the acid conditions of the gastric contents cause the dissociation of ferrous fumerate and ferrous ions are liberated. These ions are absorbed through the proximal portion ...
Preclinical safety data
No further data.
List of excipients
Tablet core: Maize Starch BP Sodium Lauryl Sulphate BP Gelatin BP Paraffin Liquid BP Film coating: Acetylated Monoglyceride Opadry20A270006 Opadry20A270006 contains: Hypromellose Iron Oxide Yellow Titanium ...
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
Protect from light. Store below 25°C.
Nature and contents of container
Cartons containing two blister packs of 14 tablets, prepared from White 250/60 micron PVC/PVDC film and printed 30 micron hard-tempered aluminium foil. 28 tablets in each carton or dispensing pack of 1000 ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Mercury Pharma Group Ltd, Capital House, 85 King William Street, London, EC4N 7BL, UK
Marketing authorization number(s)
PL 10972/0041
Date of first authorization / renewal of the authorization
07/01/2009
Date of revision of the text
09/10/2019
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