Maltofer Fol

Hauptinformation

  • Handelsname:
  • Maltofer Fol Kautabletten
  • Darreichungsform:
  • Kautabletten
  • Zusammensetzung:
  • Eisen(III) 100 mg als Eisen-oxidum polymaltosatum, Säure-Säure 0,35 mg, arom.: vanillinum, natrii cyclamas und andere, excipiens pro compresso.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Maltofer Fol Kautabletten
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Eisenmangel und erhöhter Folsäurebedarf während Schwangerschaft und Stillzeit

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 46538
  • Berechtigungsdatum:
  • 20-06-1985
  • Letzte Änderung:
  • 24-10-2018

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Patienteninformation

Maltofer® Fol Kautabletten

Vifor (International) AG

Was sind Maltofer Fol Kautabletten und wann werden sie angewendet?

Maltofer Fol Kautabletten sind ein Kombinationspräparat das Eisen und Folsäure enthält. Sie werden

angewendet zur Behandlung und Vorbeugung des Eisenmangels mit erhöhtem Folsäurebedarf

während der Schwangerschaft und Stillzeit.

Eisen ist ein unentbehrlicher Baustein des roten Blutfarbstoffes, des roten Muskelfarbstoffes und der

eisenhaltigen Enzyme. Folsäure ist ein für die Entwicklung des ungeborenen Kindes wichtiges

Vitamin. Ein Mangel an Folsäure in den ersten Wochen der Schwangerschaft kann zu Missbildungen

beim Kind führen.

Was sollte dazu beachtet werden?

Bevor Sie mit der Einnahme von Maltofer Fol Kautabletten beginnen, sollte der Gehalt des Blutes an

Eisen und Blutfarbstoff (Hämoglobin) vom Arzt bzw. der Ärztin durch geeignete Untersuchungen

abgeklärt worden sein. Wenn die Symptome nicht durch Eisenmangel bedingt sind, sind Maltofer Fol

Kautabletten nicht wirksam.

Ihr Arzt bzw. Ihre Ärztin möchte durch regelmässige Untersuchungen die Fortschritte Ihrer

Behandlung feststellen und vielleicht auch Blutuntersuchungen vornehmen. Das ist normal und sollte

Sie nicht weiter beunruhigen. Wenn sich Ihre Beschwerden innerhalb von 3 Wochen nicht bessern,

suchen Sie Ihren Arzt bzw. Ihre Ärztin auf.

Wann dürfen Maltofer Fol Kautabletten nicht angewendet werden?

·Bei bekannter Überempfindlichkeit (Allergie) oder Unverträglichkeit gegenüber den Wirkstoffen

Eisen(III)-hydroxid Polymaltose Komplex und Folsäure oder einem der Hilfsstoffe (siehe «Was ist in

Maltofer Fol Kautabletten enthalten?»)

·Bei Eisenüberschuss im Körper (z.B. bedingt durch selten vorkommende Eisenspeicherkrankheiten,

welche zu Eisenablagerungen in den Geweben führen)

·Bei sogenannten Eisenverwertungsstörungen (wenn die Blutarmut z.B. auf einer mangelhaften

Verwertung des Eisens beruht)

·Bei Blutarmut, die nicht auf einem Eisenmangel beruht (z.B. bedingt durch erhöhten

Hämoglobinabbau oder Mangel an Vitamin B12).

Wann ist bei der Einnahme von Maltofer Fol Kautabletten Vorsicht geboten?

Informieren Sie vor der Einnahme von Maltofer Fol Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder

Apothekerin, wenn Sie folgendes haben:

·Eine Infektion oder einen Tumor.

·Einen Mangel an Vitamin B12. Die in Maltofer Fol enthaltene Folsäure kann einen Mangel an

Vitamin B12 maskieren.

Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie mit einem

der folgenden Arzneimittel behandelt werden:

·Injizierbare Eisenpräparate. Solche Eisenpräparate sollten nicht gleichzeitig mit Maltofer Fol

angewendet werden.

·Arzneimittel zur Behandlung von Epilepsie, insbesondere Phenytoin.

·Chloramphenicol, ein Arzneimittel zur Behandlung von bakteriellen Infektionen. Ihr Arzt oder Ihre

Ärztin wird Sie sorgfältig überwachen, wenn sie beide Arzneimittel einnehmen.

Informieren Sie auch Ihren Arzt bzw. Ärztin, wenn Sie Bluttransfusionen erhalten haben, denn dann

besteht ein Risiko einer Eisenüberladung bei zusätzlicher Eisengabe.

Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie:

·An anderen Krankheiten leiden

·Allergien haben

·Andere Arzneimittel (auch selbstgekaufte!) einnehmen oder äusserlich anwenden.

Dürfen Maltofer Fol Kautabletten während einer Schwangerschaft oder in der Stillzeit eingenommen

werden?

Wenn Sie schwanger sind, es werden möchten oder stillen, dürfen Sie Maltofer Fol nur nach

Rücksprache mit Ihrem Arzt bzw. Ihrer Ärztin einnehmen.

Wie verwenden Sie Maltofer Fol Kautabletten?

Maltofer Fol Kautabletten können gekaut oder ganz geschluckt werden und sollen während oder

direkt nach dem Essen eingenommen werden.

Zur Vorbeugung und Behandlung eines Eisenmangels und zur Behandlung eines Eisenmangel ohne

Anämie (latenten Eisenmangels) sowie zur Abdeckung eines erhöhten Folsäurebedarfs:

1 mal täglich 1 Kautablette.

Zur Behandlung eines Eisenmangels mit Anämie (manifesten Eisenmangels)sowie zur Abdeckung

eines erhöhten Folsäurebedarfs:

2-3 mal täglich 1 Kautablette.

Wenn die Bluttestwerte für Hämoglobin wieder normal sind, wird die Behandlung mit 1 Kautablette

täglich bis zum Ende der Schwangerschaft fortgesetzt, um den erhöhten Eisenbedarf zu decken und

die Eisenspeicher aufzufüllen.

Die Dosierung und die Behandlungsdauer sind abhängig vom Ausmass des Eisenmangels. Über die

genaue Behandlungsdauer entscheidet in jedem Fall der Arzt bzw. die Ärztin.

Wenn Sie mehr Maltofer Fol eingenommen haben als sie sollten, so sprechen Sie mit ihrem Arzt

oder Apotheker, bzw. mit Ihrer Ärztin oder Apothekerin. Eine zu hohe Dosis Folsäure könnte

Befindlichkeitsstörungen, Veränderungen im Schlafmuster, Reizbarkeit und Hyperaktivität, Übelkeit,

Bauchaufblähungen und Flatulenz verursachen.

Wenn Sie vergessen haben Maltofer Fol einzunehmen, nehmen Sie einfach die nächste Dosis zur

gewohnten Zeit. Nehmen Sie keine doppelte Dosis, um die vergessene Dosis zu kompensieren.

Halten Sie sich an die in dieser Packungsbeilage angegebene oder vom Arzt oder der Ärztin

verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel wirke zu schwach oder zu stark, so

sprechen Sie mit Ihrem Arzt oder Apotheker, bzw. mit Ihrer Ärztin oder Apothekerin.

Welche Nebenwirkungen können Maltofer Fol Kautabletten haben?

Folgende Nebenwirkungen können bei der Einnahme von Maltofer Fol Kautabletten auftreten:

Eine sehr häufige Nebenwirkung ist eine Stuhlverfärbung bedingt durch die Eisenausscheidung,

diese ist aber harmlos. Andere häufige Nebenwirkungen sind Durchfall, Übelkeit und Magen-Darm-

Beschwerden.

Gelegentlich kommt es zu Erbrechen, Verstopfung, Bauchschmerzen, Zahnverfärbung oder

Kopfschmerzen sowie zu lokalen Hautreaktionen (Juckreiz, Ausschlag).

Diese Nebenwirkungen sind meist harmlos und vorübergehend.

Sehr selten kann es zu allergischer Reaktionen kommen. Es kann sich z.B. um Hautreaktionen,

Schwellungen (Ödeme) oder Atemnot handeln. In solchen Fällen sollten Sie das Arzneimittel nicht

mehr einnehmen und den Arzt aufsuchen.

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder

Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

Was ist ferner zu beachten?

Arzneimittel nicht in Reichweite von Kindern aufbewahren.

Das Arzneimittel darf nur bis zu dem auf der Packung mit «EXP» bezeichnetem Datum verwendet

werden.

Bei Raumtemperatur (15-25°C) lagern.

Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese

Personen verfügen über die ausführliche Fachinformation.

Was ist in Maltofer Fol Kautabletten enthalten?

1 Maltofer Fol Kautablette enthält 100 mg Eisen in Form von Eisen(III)-hydroxid Polymaltose

Komplex und 0.35 mg Folsäure, Cyclamat, Vanillin, Aroma und weitere Hilfsstoffe.

Zulassungsnummer

46538 (Swissmedic).

Wo erhalten Sie Maltofer Fol Kautabletten? Welche Packungen sind erhältlich?

Maltofer Fol Kautabletten erhalten Sie in Apotheken ohne ärztliche Verschreibung.

In Packungen zu 30 oder 100 Kautabletten.

Zulassungsinhaberin

Vifor (International) AG, 9001 St. Gallen.

Diese Packungsbeilage wurde im April 2015 letztmals durch die Arzneimittelbehörde (Swissmedic)

geprüft.

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France - Agence Nationale du Médicament Vétérinaire

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FDA - U.S. Food and Drug Administration

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21-9-2018

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Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

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Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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Europe - EFSA - European Food Safety Authority Publications

19-6-2018

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FDA - U.S. Food and Drug Administration

29-5-2018

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Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

29-5-2018

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Statistische Auswertung

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Europe - EMA - European Medicines Agency

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

6-8-2018

Scientific guideline:  ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide rec...

Europe - EMA - European Medicines Agency

27-7-2018

Scientific guideline:  Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version, draft: consultation open

Scientific guideline: Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version, draft: consultation open

The guideline is an annex to the VICH parent stability guideline, stability testing of new veterinary drug substances and medicinal products (VICH GL3 (R)), and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the regions in the climatic zones III and IV.

Europe - EMA - European Medicines Agency

8-3-2018

Human coagulation factor VIII

Human coagulation factor VIII

Human coagulation factor VIII (Active substance: Human coagulation factor VIII) - Corrigendum - Commission Decision (2017)7630 of Thu, 08 Mar 2018

Europe -DG Health and Food Safety