Source: European Medicines Agency (EU) Revision Year: 2017
Iron deficiency.
Niferex is indicated in adults and children from 6 years (min. 20 kg BW).
For all ages, body weights and dosing groups the posology should be adjusted to suit the patient’s needs and the response of the clinical variables (e.g. haemoglobin, ferritin and transferrin) should be monitored.
A daily dose of 5mg Fe2+/kg BW should not be exceeded (see section 4.9).
| Bodyweight (kg) | Capsules per intake | Frequency of intake | Total Fe2+ dose (mg) |
|---|---|---|---|
| ≥20 | 1 | 1 time daily | 100 |
In adolescents from age 15 years and adults the following dosage is recommended at the beginning of therapy in cases of pronounced iron deficiency:
| Bodyweight (kg) | Capsules per intake | Frequency of intake | Total Fe2+ dose (mg) |
|---|---|---|---|
| 50 - ˂60 | 1 | 2 times daily | 200 |
| ≥60 | 1 | 2-3 times daily | 200-300 |
No clinical data on the need to adjust the dosage in elderly patients are available (see section 4.4).
No clinical data on the need to adjust the dosage in patients with impaired renal or hepatic function are available (see section 4.4).
Niferex is contraindicated in children aged less than 6 years (see section 4.3).
Children from 6 years (min 20 kg BW) can be given 1 capsule daily.
For further dosages see table.
The capsules should be taken without chewing and with sufficient water. The capsules are to be taken at sufficient intervals from meals (for instance, on an empty stomach in the morning or between two principal meals), because absorption can be reduced by ingredients of food. The duration of therapy is determined according to the laboratory follow-up study results.
If swallowing of the capsule proves difficult or is not desirable, the capsule content can also be taken without the capsule body. Therefore the patient cautiously draws the capsule body over a spoon, in which the granules are gathered. After the granules have been taken from the spoon, the patient should drink sufficient water.
The treatment should be continued until normal values have been obtained. The treatment can be continued as long as necessary to replenish the body iron stores. Treatment duration varies depending on the severity of the deficiency, but generally about 10 to 20 weeks treatment is required, or longer in case of persisting underlying pathology. Treatment duration in prevention of iron deficiency varies depending on the situation (pregnancy, blood donation, chronic haemodialysis and planned autologous transfusion).
Symptoms of intoxication may appear after dosages as 20 mg Fe2+/kg BW or more. The appearance of serious toxic effects must be anticipated for dosages from 60 mg Fe2+/kg BW and more. Intoxications by dosages of 200 to 400 mg Fe2+/kg BW result in death when left untreated.
A total dose as small as 400 mg Fe2+ may lead to life-threatening states in infants.
Iron poisoning can show several phases. During the first phase, about 30 minutes to 5 hours following oral administration, symptoms such as restlessness, stomachache, nausea, vomiting and diarrhoea are observed. The faeces show a tarry coloration, the vomit can contain blood. Shock, metabolic changes such as too much acid in the body and coma can develop. This is often followed by a phase of apparent recovery that may last up to 24 hours. Then diarrhoea, shock and acidosis reappear. Death can occur after convulsions, Cheyne-Stokes breathing, coma and pulmonary oedema.
Gastric lavage or causing vomiting may be considered shortly after overdose. A specific antidote is desferrioxamine (Desferal).
For detailed information please see corresponding information of the manufacturer.
5 years.
Do not store above 25°C.
Blister of paper/aluminium composite film with a polypropylene (PP) white opaque foil with 30, 50, 90 and 500x1 gastro-resistant capsules.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
