Modelo de Texto de Bula
Naramig® 2,5mg comprimidos

Naramig®
cloridrato de naratriptana

FORMA FARMACÊUTICA E APRESENTAÇÃO
Naramig® 2,5 mg é apresentado em embalagem contendo 4 comprimidos.
Comprimidos revestidos
USO ADULTO
COMPOSIÇÃO
Cada comprimido contém:
cloridrato de naratriptana (equivalente a 2,5mg de naratriptana base) ………………………. 2,78 mg
excipientes (celulose microcristalina, croscarmelose sódica, lactose anidra, estearato de
magnésio, metilhidroxipropil celulose, dióxido de titânio, triacetina, óxido de ferro amarelo, laca
indigotina, água purificada) q.s.p……………………………………………..1 comprimido.
INFORMAÇÕES AO PACIENTE
Ação esperada do medicamento: Naramig® é indicado para o tratamento agudo de crises de
enxaqueca, com ou sem aura.
Cuidados de armazenamento: mantenha o produto em sua embalagem original e em
temperatura ambiente (entre 15°C e 30°C).
Prazo de validade: o prazo de validade é de 36 meses, contados a partir da data de
fabricação, que se encontra impressa na embalagem externa do produto com o número de lote.
Não utilize medicamentos que estejam fora do prazo de validade, pois o efeito desejado pode
não ser obtido.
Gravidez e lactação: informe ao seu médico a ocorrência de gravidez na vigência do
tratamento ou após o seu término. Informe ao médico se você estiver amamentando.
Cuidados de administração: Naramig® deve ser utilizado somente quando houver um
diagnóstico claro de enxaqueca. Não está indicado para a profilaxia, nem para o tratamento da
dor de cabeça comum. Siga a orientação do seu médico, respeitando sempre os horários, as
doses e a duração do tratamento.
Interrupção do tratamento: não interrompa o tratamento sem o conhecimento do seu médico.
Reações adversas: informe ao seu médico o aparecimento de reações desagradáveis, como
dor, sensação de formigamento e calor, sensação de peso, pressão ou tensão no peito,
náuseas e vômitos após o uso da medicação.
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TODO MEDICAMENTO DEVE SER MANTIDO FORA DO ALCANCE DAS CRIANÇAS.
Ingestão concomitante de outras substâncias: informe ao seu médico sobre qualquer outro
medicamento que esteja usando, antes do início ou durante o tratamento. A administração
concomitante de ergotamina, derivados da ergotamina (inclusive metisergida) ou sumatriptana
não é recomendada, como ocorre com todos os medicamentos da família dos triptanos.
Contra-indicações e precauções: o uso de Naramig® é contra-indicado em pacientes com
hipersensibilidade conhecida a qualquer componente da fórmula.
Capacidade de dirigir e operar máquinas: existem dados disponíveis sugerindo que
Naramig® pode influenciar a capacidade de dirigir veículos ou operar máquinas por ocasionar
sonolência como conseqüência da enxaqueca em si. Portanto, consulte seu médico antes de
iniciar o tratamento com Naramig®.
NÃO TOME MEDICAMENTO SEM O CONHECIMENTO DE SEU MÉDICO. PODE SER
PERIGOSO PARA A SUA SAÚDE.
INFORMAÇÕES TÉCNICAS
Propriedades farmacodinâmicas
Foi demonstrado que a naratriptana é um agonista seletivo dos receptores da 5-
hidroxitriptamina (5-HT ), que mediam a contração vascular. Estes receptores são encontrados
1
principalmente em vasos sangüíneos intracranianos (cerebrais e durais). A naratriptana possui
uma alta afinidade pelos receptores 5-HT e 5-HT clonados de humanos. Supõe-se que o
1B
1D
receptor 5-HT corresponde ao receptor 5-HT vascular, que media a contração de vasos
1B
1
sangüíneos intracranianos. A naratriptana tem pouco ou nenhum efeito sobre outros subtipos
de receptores 5-HT (5-HT , 5-HT , 5-HT e 5-HT ).
2
3
4
7
Em animais, a naratriptana contrai seletivamente a circulação arterial da carótida. Esta
circulação fornece sangue aos tecidos extracranianos e intracranianos, como as meninges,
antagonizando a dilatação e/ou formação de edema nestes vasos, que é tida como o
mecanismo subjacente da enxaqueca no ser humano. Além disto, as evidências experimentais
sugerem que a naratriptana inibe a atividade nervosa do trigêmeo, contribuindo para o bloqueio
central da percepção dolorosa. Ambas ações contribuem para a ação anti-enxaqueca da
naratriptana.
Propriedades farmacocinéticas
Absorção, distribuição, metabolismo e eliminação: após a administração oral, a
naratriptana é absorvida rapidamente, com concentrações plasmáticas máximas observadas
após 2-3 horas. Após a administração de um comprimido de 2,5 mg de naratriptana, a C
é
máx
de aproximadamente 8,3 ng/mL (95% Cl: 6,5 a 10,5 ng/mL) em mulheres, e de 5,4 ng/mL (95%
Cl: 4,7 a 6,1ng/mL) em homens. A biodisponibilidade oral é de 74% em mulheres e 63% em
homens, sem diferenças na eficácia e na tolerabilidade quando em uso clínico. Portanto, não é
necessário o ajuste de dose de acordo com o sexo. O volume de distribuição da naratriptana é
de 170 L. A ligação às proteínas plasmáticas é baixa (29%). A meia-vida de eliminação média
(t ) é de 6 horas. O clearance médio, após administração intravenosa, foi de 470 mL/min em
1/2
homens, e 380 mL/min em mulheres. O clearance renal de 220 mL/min é similar em homens e
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mulheres, e é mais alto do que a taxa de filtração glomerular, sugerindo que a naratriptana
sofre secreção ativa nos túbulos renais. A excreção predominante de naratriptana ocorre
através da urina, com 50% da dose recuperada como droga inalterada e 30% como metabólitos
inativos. In vitro, a naratriptana foi metabolizada por uma ampla série de isoenzimas do
citocromo P450. Conseqüentemente, não são previstas interações metabólicas significativas
com outras drogas (Ver Interações medicamentosas).
Insuficiência renal: a excreção renal é a principal via de eliminação da naratriptana. Por isto, a
exposição a naratriptana pode estar aumentada em pacientes com doença renal. Pacientes
com insuficiência renal (clearance de creatinina 18 a 115 mL/min; n=15), semelhantes quanto
ao sexo, à idade e ao peso foram comparados com indivíduos sadios (n=8) em um estudo. Os
pacientes com insuficiência renal apresentaram um aumento de aproximadamente 80% no t ,
1/2
e uma redução de aproximadamente 50% no clearance (Ver Posologia).
Insuficiência hepática: o fígado desempenha um papel menor no clearance da naratriptana
administrada por via oral. Em um estudo com homens e mulheres com insuficiência hepática
(grau Child-Pugh A ou B; n=8), semelhantes quanto ao sexo, a idade e ao peso comparados
com indivíduos sadios que receberam naratriptana por via oral, os pacientes com insuficiência
hepática apresentaram um aumento de aproximadamente 40% no t , e uma redução de
1/2
aproximadamente 30% no clearance (Ver Posologia).
Variações de acordo com o sexo: tanto a área sob a curva (ASC) como a Cmáx foram,
aproximadamente, 35% menores em homens quando comparado às mulheres; entretanto, não
houve diferenças na eficácia e tolerabilidade durante o uso clínico. Desta forma, não é
necessário um ajuste de dose relacionado ao sexo (Ver Posologia).
Pacientes idosos: em um mesmo estudo, pacientes idosos saudáveis (n=12) mostraram um
decréscimo de 26% no clearance em relação a pacientes jovens saudáveis (n=12) (Ver
Posologia).
INDICAÇÕES TERAPÊUTICAS
Naramig® é indicado para o tratamento agudo de crises de enxaqueca, com ou sem aura.
CONTRA-INDICAÇÕES
Naramig® é contra-indicado em indivíduos com conhecida hipersensibilidade a naratriptana ou
a qualquer componente da fórmula.
Naramig® não deve ser usado por pacientes com antecedentes de infarto agudo do miocárdio
ou cardiopatia isquêmica, angina de Prinzmetal / vasoespasmo coronariano, doença vascular
periférica ou por pacientes com sintomas ou sinais compatíveis com cardiopatia isquêmica.
Naramig® não deve ser administrado em pacientes com histórico de acidente vascular cerebral
ou ataque isquêmico transitório.
Naramig® é contra-indicado em pacientes com hipertensão grave não controlada e em
pacientes com grave insuficiência hepática ou renal.
PRECAUÇÕES E ADVERTÊNCIAS
Naramig® deve ser usado somente quando há um diagnóstico claro de enxaqueca.
O produto não é indicado para o controle da enxaqueca hemiplégica, basilar ou oftalmoplégica.
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Assim como com outras terapias agudas para enxaqueca, antes de tratar pacientes sem
diagnóstico prévio de enxaqueca ou pacientes com enxaqueca com sintomas atípicos, deve-se
excluir outras condições neurológicas potencialmente graves. Estes pacientes podem estar em
risco de eventos cerebrovasculares (por exemplo, acidente vascular cerebral ou ataque
isquêmico transitório).
Assim como se aplica a outros agonistas dos receptores da 5-hidroxitriptamina (5-HT ), a
1
naratriptana não deve ser administrada em pacientes pertencentes ao grupo de risco de
doenças cardíacas, sem uma avaliação prévia de doença cardiovascular subjacente. Estes
pacientes incluem mulheres após a menopausa, homens acima de 40 anos de idade e
pacientes com fatores de risco para doenças coronarianas.
Se ocorrerem sintomas sugestivos de cardiopatia isquêmica, deve ser feita uma avaliação
adequada (veja Reações Adversas).
Síndrome serotoninérgica (incluindo estado mental alterado, instabilidade autonômica e
anormalidades neuromusculares) tem sido relatada devido ao uso concomitante de triptanos
com inibidores seletivos de recaptação da serotonina (ISRS)/ inibidores seletivos de recaptação
da serotonina e noradrenalina (ISRN). Se o tratamento com naratriptana e um ISRS/ISRN é
necessário, é recomendada uma observação apropriada do paciente (veja Interações
Medicamentosas).
A administração concomitante de ergotamina, derivados da ergotamina (inclusive metisergida)
ou qualquer triptano/agonista 5-HT1 com Naramig® não é recomendada. Entretanto, a co-
administração de naratriptana com ergotamina, diidroergotamina ou sumatriptana não resultou
em efeitos clinicamente significativos na pressão arterial, na freqüência cardíaca ou no ECG e
não afetou a farmacocinética da naratriptana.
A naratriptana possui um grupamento sulfonamídico na molécula, portanto teoricamente existe
risco em pacientes com conhecida hipersensibilidade às sulfonamidas.
Deve-se evitar exceder a dose máxima recomendada de naratriptana.
O uso excessivo de tratamentos para enxaqueca aguda foi associado a exacerbação da dor de
cabeça em pacientes suscetíveis. A interrupção do tratamento pode ser necessária.
Gravidez: a segurança do uso de naratriptana em mulheres grávidas não foi estabelecida. A
avaliação de estudos em animais não indicou nenhum efeito teratogênico direto ou quaisquer
efeitos nocivos sobre o desenvolvimento peri ou pós-natal. Como os estudos em animais nem
sempre refletem a resposta em humanos, a administração de naratriptana somente deve ser
considerada se o benefício esperado para a mãe for maior do que qualquer possível risco para
o feto.
Lactação: a naratriptana e/ou seus metabólitos são secretados no leite de ratas lactantes.
Portanto, deve haver cautela ao decidir administrar Naramig® em mulheres que estejam
amamentando.
Efeitos sobre a capacidade de dirigir e operar máquinas: o paciente deve ter cuidado ao
dirigir ou operar máquinas, pois pode ocorrer sonolência como conseqüência da enxaqueca.
INTERAÇÕES MEDICAMENTOSAS E OUTRAS FORMAS DE INTERAÇÃO
Síndrome serotoninérgica (incluindo estado mental alterado, instabilidade autonômica e
anormalidades neuromusculares) tem sido relatada devido ao tratamento concomitante de
triptanos com ISRS/ISRN (veja Precauções e Advertências).
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Não há evidências de interação farmacocinética entre a naratriptana e beta-bloqueadores,
antidepressivos tricíclicos, inibidores seletivos da recaptação da serotonina, álcool ou
alimentos. A naratriptana não inibe a enzima monoaminoxidase, portanto não são previstas
interações com os inibidores desta enzima. Além disto, o metabolismo limitado da naratriptana
e a ampla gama de isoenzimas do citocromo P450 envolvidas, sugerem que são pouco
prováveis interações medicamentosas significativas.
REAÇÕES ADVERSAS
Reações adversas são listadas abaixo por classe do sistema orgânico e freqüência. As
freqüências são definidas como: muito comum (1/10), comum (1/100 e <1/10), incomum
(1/1000 e <1/100), rara (1/10000 a <1/1000) e muito rara (<1/10000). As freqüências dos
eventos muito comuns, comuns e incomuns foram determinados a partir de estudos clínicos. A
identificação de reações adversas muito raras derivam de dados do sistema de
farmacovigilância pós-comercialização.
Estudos clínicos
Em doses terapêuticas de Naramig® a incidência de efeitos colaterais reportada em estudos
clínicos foi similar ao placebo.
Distúrbios do sistema nervoso
Comum: parestesia
(dormência).
Este sintoma é normalmente de curta duração, pode ser grave e pode afetar qualquer parte do
corpo incluindo o tórax e a garganta.
Distúrbios gastrintestinais
Comuns: náusea,
vômito.
Ocorreu em alguns pacientes, porém a relação com a naratriptana não está estabelecida.
Distúrbios músculo-esqueléticos e do tecido conjuntivo
Incomum: sensação
de
peso.
Este sintoma é normalmente de curta duração, pode ser grave e pode afetar qualquer parte do
corpo incluindo o tórax e a garganta.
Distúrbios gerais
Os seguintes sintomas são normalmente de curta duração, podem ser graves e podem afetar
qualquer parte do corpo incluindo o tórax e a garganta.
Comuns:
dor e sensação de calor.
Incomuns:
sensação de peso ou aperto.
Dados de farmacovigilância pós-comercialização
Distúrbios do sistema imune
Muito rara:
reações de hipersensibilidade, variando de hipersensibilidade cutânea a
anafilaxia.
Distúrbios cardíacos
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Muito raras:
vasoespasmo arterial coronariano, alterações eletrocardiográficas isquêmicas
transitórias, angina e infarto do miocárdio.
Distúrbios vasculares
Muito rara:
isquemia vascular periférica.
Distúrbios gastrintestinais
Muito rara: colite
isquêmica.
POSOLOGIA
Naramig® deve ser administrado preferencialmente tão logo se inicie uma crise de enxaqueca,
mas também é eficaz quando tomado algum tempo após instalação da crise. Naramig® não
deve ser usado profilaticamente. Os comprimidos devem ser ingeridos inteiros e com água.
Adultos: A dose recomendada para adultos (18-65 anos) é de um comprimido de 2,5 mg. Se
os sintomas da enxaqueca recidivarem, uma segunda dose pode ser tomada, contanto que o
intervalo entre as doses seja de no mínimo 4 horas. A dose total não deve ultrapassar dois
comprimidos de 2,5 mg em um período de 24 horas. Se um paciente não responder à primeira
dose, é pouco provável que uma segunda dose apresente benefício substancial, na mesma
crise. Naramig® pode ser administrado em crises de enxaqueca subseqüentes.
Uso em adolescentes (12 a 17 anos): a eficácia da naratriptana nesta faixa de idade ainda
não foi demonstrada e, portanto, o seu uso não é recomendado. Em um estudo clínico em
adolescentes foi observada uma resposta muito alta ao placebo.
Crianças (com menos de 12 anos): ainda não há dados disponíveis a respeito do uso de
naratriptana em crianças com menos de 12 anos de idade e, portanto, o seu uso neste grupo
de pacientes não é recomendado.
Idosos (com mais de 65 anos): a segurança e a eficácia da naratriptana em indivíduos com
mais de 65 anos de idade ainda não foram avaliadas e, portanto, o seu uso não é
recomendado. Há um decréscimo no clearance com a idade (Ver Propriedades
Farmacocinéticas).
Insuficiência renal: a dose diária máxima total em pacientes com insuficiência renal é de um
único comprimido de 2,5 mg. O uso da naratriptana é contra-indicado em pacientes com
insuficiência renal grave (clearance de creatinina < 15mL/min) (Ver Contra-indicações e
Propriedades farmacocinéticas).
Insuficiência hepática: a dose total máxima diária, em pacientes com insuficiência hepática é
de um único comprimido de 2,5 mg. O uso da naratriptana é contra-indicado em pacientes com
insuficiência hepática grave (Child-Pugh grau C) (Ver Contra-indicações e Propriedades
farmacocinéticas).
SUPERDOSAGEM
A administração de uma dose elevada (25 mg) de naratriptana em um paciente saudável do
sexo masculino elevou a pressão sangüínea em 71 mmHg, resultando em sensação de cabeça
vazia, tensão no pescoço, cansaço e perda da coordenação. A pressão sangüínea retornou
para a linha basal 8 horas após a dosagem sem outra intervenção farmacológica.
Tratamento: Se ocorrer superdosagem com naratriptana, o paciente deve ser monitorado por
pelo menos 24 horas e devem ser aplicadas as medidas de suporte habituais. Ainda não se
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Naramig® 2,5mg comprimidos

conhece o efeito da hemodiálise ou da diálise peritoneal sobre a concentração plasmática da
naratriptana.

Nº de lote, data de fabricação e data de validade: vide cartucho.

VENDA SOB PRESCRIÇÃO MÉDICA.
Fabricado por: Glaxo Operations UK Limited ­ Ware ­ Inglaterra.
Importado por:
Serviço de Atendimento ao
GlaxoSmithKline Brasil Ltda.
Consumidor
0800 701 22 33
Estrada dos Bandeirantes, 8.464 – Rio de Janeiro – RJ
Discagem Direta Gratuita
CNPJ: 33.247.743/0001-10
Indústria Brasileira
MS: 1.0107.0259
Farm. Resp.: Milton de Oliveira
CRF-RJ Nº 5522
Versão: GDS 10_IPI04
Data: 13/03/2007
BL_naramig_com_GDS10_IPI04_v6
GDS 10 IPI 04
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