ANEMIFER®
PharmaScience Indústria Farmacêutica S.A
SOLUÇÃO ORAL (GOTAS)
sulfato ferroso heptaidratado 125 mg/mL
(equivalente a 25 mg/mL de ferro elementar)
I – IDENTIFICAÇÃO DO MEDICAMENTO
Anemifer®
sulfato ferroso heptaidratado
APRESENTAÇÃO
Solução oral (gotas) de 125 mg/mL de sulfato ferroso heptaidratado (25 mg/mL de ferro elementar) em embalagem contendo frasco plástico com 30 mL.
USO ORAL
USO ADULTO E PEDIÁTRICO
| COMPOSIÇÃO | |
| Cada mL da solução oral (gotas) contém: | |
| sulfato ferroso heptaidratado ………………………………………………………………………………………………………………….. | 125 mg* |
| excipientes q.s.p. ……………………………………………………………………………………………………………………………………….. | 1 mL |
Excipientes: ácido cítrico, metilparabeno, propilparabeno, sorbitol, propilenoglicol, aroma de amora, sacarose, corante amarelo crepúsculo e água purificada.
*Equivalente a 25 mg/mL de ferro elementar.
Cada mL de Anemifer® equivale a aproximadamente 35 gotas e 1 gota equivale a aproximadamente 0,71 mg de ferro elementar.
- – INFORMAÇÕES AO PACIENTE
- PARA QUE ESTE MEDICAMENTO É INDICADO?
Anemifer® solução oral (gotas) é indicado como auxiliar no tratamento das anemias carenciais.
2. COMO ESTE MEDICAMENTO FUNCIONA?
Anemifer® solução oral (gotas) atua como antianêmico por ser um medicamento à base de sulfato ferroso heptaidratado, no qual fornece ao organismo uma suplementação de íons férricos que são necessários no tratamento das anemias carenciais por deficiência de ferro.
3. QUANDO NÃO DEVO USAR ESTE MEDICAMENTO?
O medicamento é contraindicado para pacientes com hipersensibilidade (alergia) aos sais de ferro ou a qualquer um dos componentes da fórmula, não deve ser administrado por pacientes em tratamento de anemia hemolítica, em pacientes recebendo transfusão sanguínea e em uso de ferro por via parenteral. Este medicamento não deve ser utilizado por pacientes com hepatite ou disfunção hepática, úlcera péptica; gástrica ou duodenal, hemossiderose (doença em que ocorre depósito de ferro nos tecidos devido ao seu excesso no organismo), talassemias (distúrbio sanguíneo hereditário que causa anemia) e por pacientes alcoolistas, pois há um aumento da toxicidade do ferro.
4. O QUE DEVO SABER ANTES DE USAR ESTE MEDICAMENTO?
Os sais de ferro devem ser administrados com cautela para pacientes com doenças que interferem na absorção ou armazenamento de ferro, hemoglobinopatias ou doenças gastrintestinais extensas. O sangramento do trato gastrintestinal também pode escurecer as fezes e frequentemente é acompanhado de outros sintomas: listras vermelhas nas fezes, câimbras, dores de estômago ou na região abdominal. Não administrar por períodos maiores que 6 meses e em doses acima das recomendadas.
Pacientes Idosos: Alguns pacientes idosos podem requerer uma ingestão de ferro maior que a normal, devido a sua capacidade de absorção de ferro ser diminuída pela redução de secreções gástricas (secreções do estômago). Recomenda-se o uso sob orientação médica.
Gravidez: No 1º trimestre de gestação, a ingestão de ferro necessária para o organismo é obtida através de uma dieta adequada, entretanto, no 2º e 3º trimestres, o organismo necessita de uma quantidade superior de ferro, devendo a gestante fazer uso de um suplemento de ferro para suprir a carência deste mineral no organismo, desde que observada a posologia e conforme orientação médica.
Este medicamento não deve ser utilizado por mulheres grávidas sem orientação médica ou do cirurgião-dentista.
Interações Medicamentosas:
Interação medicamento-medicamento: o uso concomitante do produto com antiácidos, com suplementos à base de cálcio e com medicamentos contendo em sua composição carbonatos, bicarbonatos, fosfatos ou oxalatos podem inteferir na absorção dos íons férricos, recomenda-se a suplementação com ferro 1 hora antes ou 2 horas após o uso desses medicamentos.
Fluoroquinolonas: o ferro presente no medicamento pode levar a redução da absorção de fluoroquinolonas, devido ao efeito quelante, para evitar essa interação, fazer a suplementação com intervalo de duas horas antes ou depois da ingestão de fluoroquinolonas.
Tetraciclinas: o ferro provoca a redução dos efeitos terapêuticos das tetraciclinas de uso oral. As doses de tetraciclinas devem ser administradas 2 horas após o uso do produto.
Vitamina C: a vitamina C aumenta a absorção de ferro medicinal em pelo menos 30%. No entanto, essa maior absorção está associada a um aumento da incidência de efeitos colaterais.
Interação medicamento-substância química: Álcool: o uso concomitante por períodos prolongados pode provocar intoxicações.
Interação medicamento -exame laboratoriais: o teste de ortoluidina com a presença de suplementos à base de ferro pode levar a um resultado falso positivo. A concentração plasmática de bilirrubina pode apresentar falsos valores elevados e a concentração plasmática de cálcio falsamente diminuídos. E o sulfato ferroso pode levar a um resultado negativo o teste de glicose oxidada. Sugere-se interromper o uso do produto alguns dias antes de realizar estes exames.
Atenção: Este medicamento contém Açúcar, portanto, deve ser usado com cautela em portadores de Diabetes.
Informe ao seu médico ou cirurgião-dentista se você está fazendo uso de algum outro medicamento.
- ONDE, COMO E POR QUANTO TEMPO POSSO GUARDAR ESTE MEDICAMENTO? Conservar em temperatura ambiente (entre 15 e 30°C). Proteger da luz e umidade.
Número de lote e datas de fabricação e validade: vide embalagem.
Não use medicamento com o prazo de validade vencido. Guarde-o em sua embalagem original. Características do medicamento: solução de cor amarela, sabor de amora e isenta de partículas estranhas.
Antes de usar, observe o aspecto do medicamento. Caso ele esteja no prazo de validade e você observe alguma mudança no aspecto, consulte o farmacêutico para saber se poderá utilizá-lo.
Todo medicamento deve ser mantido fora do alcance das crianças.
- COMO DEVO USAR ESTE MEDICAMENTO?
Ingerir Anemifer® solução oral (gotas), por via oral, uma hora antes ou duas horas após uma das principais refeições, de preferência com alimentos ou bebidas ácidas, os quais atuam diminuindo o pH estomacal facilitando a absorção do ferro. Lactentes: administrar ao lactente 2 gotas/Kg peso corporal ao dia. Não ultrapassar o limite de 21 gotas ao dia (14,91 mgde ferro elementar) ou a critério médico.
Crianças: administrar à criança 2 gotas/Kg peso corporal ao dia. Não ultrapassar o limite de 70 gotas ao dia (49,70 mg de ferro elementar) ou a critério médico.
Adultos: ingerir de 20 a 91 gotas ao dia (14,20 mg a 64,61 mg de ferro elementar) ou a critério médico.
Siga corretamente o modo de usar. Em caso de dúvidas sobre este medicamento, procure orientação do farmacêutico. Não desaparecendo os sintomas, procure orientação de seu médico ou cirurgião-dentista.
7. O QUE DEVO FAZER QUANDO EU ME ESQUECER DE USAR ESTE MEDICAMENTO?
Caso haja esquecimento da ingestão de uma dose deste medicamento, retome a posologia prescrita sem a necessidade de suplementação.
Em caso de dúvidas, procure orientação do farmacêutico ou de seu médico, ou cirurgião-dentista.
8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?
Durante o tratamento, embora raramente, podem surgir reações adversas características como diarreia, náusea, vômito, azia ou sensação de queimação no estômago, prisão de ventre e dor no abdômen. Além disso, pode ocorrer o escurecimento das fezes.
Informe ao seu médico, cirurgião-dentista ou farmacêutico o aparecimento de reações indesejáveis pelo uso do medicamento. Informe também à empresa através de seu serviço de atendimento.
- O QUE FAZER SE ALGUÉM USAR UMA QUANTIDADE MAIOR DO QUE A INDICADA DESTE MEDICAMENTO?
No caso de superdosagem procure atendimento médico imediatamente. Os sinais e sintomas de intoxicação são: diarreia algumas vezes contendo sangue, náusea severa, febre, dor estomacal e vômitos algumas vezes também com presença de sangue. O atendimento hospitalar pode ser fundamental para melhora do quadro de superdosagem, pois poderá ser feito uma dosagem da quantidade de ferro presente no sangue e determinar o melhor tratamento. Desidratação e manutenção do equilíbrio eletrolítico devem ser tratadas de modo convencional.
Em caso de uso de grande quantidade deste medicamento, procure rapidamente socorro médico, e leve a embalagem ou bula do medicamento, se possível. Ligue para 0800 722 6001, se você precisar de mais orientações.
III – DIZERES LEGAIS
Registro MS: 1.1717.0015
Farm. Resp.: Lílian C. O. Meireles – CRF/MG: 14.813
PharmaScience Indústria Farmacêutica S.A
Rua Texaco, 640 – Jardim Piemonte
CEP: 32.689-322 – Betim – MG
CNPJ: 25.773.037/0001-83 SAC 0800 037 5000
INDÚSTRIA BRASILEIRA
Siga corretamente o modo de usar, não desaparecendo os sintomas procure orientação médica. Esta bula foi aprovada pela Anvisa em 09/09/2022
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