NIFEREX Gastro-resistant capsule, hard (2017)
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Περιεχόμενα
Name of the medicinal product
Niferex 100 mg gastro-resistant capsules, hard.
Qualitative and quantitative composition
<u>1 capsule contains:</u> Ferrous (II) glycine-sulphate complex 567.7 mg (equivalent to 100 mg Fe2+). For a full list of excipients, see section 6.1.
Pharmaceutical form
Gastro-resistant capsule, hard. Capsule cap: chocolate brown. Capsule body: orange. Capsule content: grey-brownish pellets.
Therapeutic indications
Iron deficiency. Niferex is indicated in adults and children from 6 years (min. 20 kg BW).
Posology and method of administration
Posology For all ages, body weights and dosing groups the posology should be adjusted to suit the patients needs and the response of the clinical variables (e.g. haemoglobin, ferritin and transferrin) ...
Contraindications
Esophageal stricture. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Repeated blood transfusion. Haemochromatosis, chronic haemolysis with signs of iron accumulation, ...
Special warnings and precautions for use
Patients with existing gastrointestinal disease such as inflammatory bowel disease, intestinal stricture, diverticulae, gastritis, stomach and intestinal ulcers should be treated carefully with Ferrous(II)-glycine-sulphate ...
Interaction with other medicinal products and other forms of interaction
The following combinations should be avoided Intravenous administration of iron salts Administration of iron intravenously concomitantly with oral administration of iron may induce hypotension or even ...
Fertility, pregnancy and lactation
Pregnancy and lactation No known risks. Fertility There are no fertility data available from the use of ferrous(II)-glycine-sulphate complex in human.
Effects on ability to drive and use machines
Niferex has no or negligible influence on the ability to drive and use machines.
Undesirable effects
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 ...
Overdose
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: anti-anemic ATC code: B03AA01 Iron is essential for transport of oxygen (e.g. haemoglobin) and for energy transfer in the body. The content of iron in the body is about 50 mg ...
Pharmacokinetic properties
Absorption Niferex, hard capsules contain gastro-resistant granules. The capsule shell dissolves in the stomach and the acid-resistant coated pellets reach subsequently, and in small amounts, the duodenum ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
List of excipients
Ascorbic acid Cellulose microcrystalline Hhypromellose Hydroxypropylcellulose Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (Eudragit L30 D-55) (contains methacrylic acid-ethyl acrylate ...
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
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.
Special precautions for disposal and other handling
No special requirements.
Date of first authorization / renewal of the authorization
1999-08-27/2009-08-27
Date of revision of the text
2017-03-10
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