Source: European Medicines Agency (EU) Revision Year: 2017
Administration of iron intravenously concomitantly with oral administration of iron may induce hypotension or even collapse due to the fast release of iron due to saturation of transferrin. The combination is not recommended.
Orally administered iron salts inhibit the absorption and the enterohepatic circulation of doxycycline. The combination should be avoided.
Iron inhibits the absorption of a many medicinal products by chelation. The interval between the administration of Niferex and the medicinal products mentioned below should therefore be as long as possible.
When iron salts are coadministered with fluoroquinolones, the absorption of the latter is significantely impaired. The absorption of norfloxacin, levofloxacin, ciprofloxacin, gatifloxacin and ofloxacin is inhibited by iron between 30 and 90%. Fluoroquinolones should be administered at least 2 h before or at least 4 h after Niferex.
When ferrous sulphate was given at the same time, or 1 h or 2 h before the methyldopa, the bioavailability of methyldopa was reduced 83%, 55% and 42% respectively. The interval between the administrations of these compounds should be as long as possible.
When coadministered the absorption of thyroxine is inhibited by iron, which can affect the result of the treatment. The interval between the administrations of the compounds should be at least two hours.
When iron is coadministered orally with tetracycline (e.g. doxycycline), both the absorption of iron and the absorption of the tetracyclines are inhibited. The interval between the administration of Niferex and tetracyclines other than doxycycline should be at least three hours.
The absorption of penicillamine is reduced, as it may form chelates with iron. Penicillamine should be administered at least 2 h before Niferex.
Medicinal products containing iron form complexes with Bisphosphonates in vitro. When iron salts are coadministered with Bisphosphonates, the absorption of Bisphosphonates may be impaired. The time-interval between the administration of these medicinal products should be at least two hours.
The simultaneous administration of iron sulphate and levodopa to healthy volunteers reduces the bioavailability of levodopa by 50%. The bioavailability of carbidopa is also reduced (75%). The interval between the administrations of these compounds should be as long as possible.
Concomitant administration of iron salts with non-steroidal anti-inflammatory agents may intensify the irritant effect on the gastrointestinal mucosa.
Antacids containing oxides, hydroxides or salts of magnesium, aluminium and calcium chelate iron salts. The interval between the administrations of these two compound groups should therefore be as long as possible, the minimum time is two hours between the administrations of the antacid and iron.
The concomitant use of iron and calcium decreases the absorption of iron. Niferex should be taken apart from calcium-containing food and beverages.
Bioavailability of Niferex could be reduced by iron complexing agents (such as phosphates, phytates and oxalates) contained in vegetable food and constituents of milk, coffee and tea. The interval between the administration of these compounds should be at least two hours.
Administration of ferrous (II)-glycine-sulphate complex may lead to a false positive blood stool test.
Treatment with ferrous glycine sulphate containing vitamin C can potentially result in false negative guaiac-based test results. When iron is administered orally, a dark coloration of the faeces, not resulting from occult gastrointestinal haemorrhage, may occur.
No known risks.
There are no fertility data available from the use of ferrous(II)-glycine-sulphate complex in human.
Niferex has no or negligible influence on the ability to drive and use machines.
Undesirable effects frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000) very rare (<1/10000), not known (cannot be estimated from the available data.
During administration of Ferrous glycine sulphate the following undesirable effects may be observed:
Common: Abdominal discomfort, heartburn, vomiting, diarrhoea, nausea, constipation, and dark coloured faeces.
Rare: Tooth discoloration (see also section 4.4 Special warnings and special precautions for use).
Not known: Abdominal pain and abdominal pain upper, gastrointestinal haemorrhage, tongue discolouration, oral mucosal discolouration.
Rare: Hypersensitivity reactions of the skin, e.g. exanthema, rash and urticaria.
Not known: Anaphylactic reaction
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Not applicable.
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