SANOFI-AVENTIS FARMACÊUTICA LTDA.
Esta bula é continuamente atualizada. Favor proceder a sua leitura antes de utilizar o
medicamento.

COLTRAX
tiocolchicosídeo

FORMAS FARMACÊUTICAS E APRESENTAÇÕES
Comprimidos ­ embalagens contendo 12 e 20 comprimidos.

USO ADULTO
COMPOSIÇÃO
Comprimidos:
Cada comprimido contém:
tiocolchicosídeo……………………..4 mg
excipientes q.s.p……………………1 comprimido
(amido de milho, gelatina, lactose, estearato de magnésio, talco e açúcar)

INFORMAÇÃO AO PACIENTE
Ação esperada do medicamento: COLTRAX é um derivado sulfuroso de um glicósido
natural de colchicina, atuando como relaxante muscular em casos de contratura muscular e
torcicolo.
Cuidados de armazenamento: em sua embalagem original, COLTRAX deve ser
armazenado em temperatura ambiente (entre 15 e 30) e protegido da luz.
Prazo de validade: 24 meses a partir da data de fabricação. Ao adquirir o medicamento
confira sempre o prazo de validade impresso na embalagem externa do produto. Nunca use
medicamento com prazo de validade vencido, pois pode ser prejudicial à sua saúde.
Gravidez e lactação: Estudos conduzidos em animais mostraram toxicidade reprodutiva.
Existem dados clínicos insuficientes para avaliar a segurança do uso na gravidez. Deste
modo o riso potencial para o enbrião e feto é deconhecido. Por conseqüência,
tiocolchicosídeo é contra-indicado na gravidez.
Como ocorre a passagem de COLTRAX ao leite materno, é contra-indicado o seu uso
durante a lactação.
12/07/07


Informe seu médico a ocorrência de gravidez na vigência do tratamento e após seu término.
Informar ao médico se esta amamentando.
Cuidados de administração: Siga a orientação do seu médico, respeitando sempre os
horários, as doses e a duração do tratamento. Redução da dose pode ser necessária em caso
de ocorrência de diarréia.

Ingestão concomitante com outras substâncias: Não foram relatadas interações com
outras substâncias.
Interrupção do tratamento: Não interromper o tratamento sem o conhecimento do seu
médico.
Reações adversas: Informe ao seu médico o aparecimento de reações desagradáveis, tais
como: reações alérgicas cutâneas e reações anafiláticas (prurido, urticária e angioedema).
Podem ocorrer sonolência e reações gastrintestinais tais como diarréia, gastralgia, náusea e
vômito, com o uso de COLTRAX.

TODO MEDICAMENTO DEVE SER MANTIDO FORA DO ALCANCE DAS
CRIANÇAS.
Contra-indicações e Precauções: COLTRAX é contra-indicado em pacientes que
apresentam hipersensibilidade ao tiocolchicosídeo ou a qualquer componente da fórmula.
COLTRAX não deve ser utilizado durante a gravidez e amamentação.
Devido à presença de lactose no COLTRAX, pacientes com problemas hereditários de
intolerância a galactose, deficiência de -galactosidase ou mal-absorção glucose-galactose
não devem tomar este medicamento.
Devido à presença de sacarose, pacientes com problemas hereditários de intolerância a
frutose não devem tomar este medicamento.
COLTRAX pode desencadear crises convulsivas em pacientes com epilepsia ou naqueles
com risco de crises epiléticas (vide Reações Adversas).
Informe seu médico sobre qualquer medicamento que esteja usando, antes do início, ou
durante o tratamento.
Atenção diabéticos: contém açúcar (sacarose 2,8 mg/comprimido).
NÃO TOME REMÉDIO SEM O CONHECIMENTO DO SEU MÉDICO. PODE SER
PERIGOSO PARA A SAÚDE.

12/07/07


INFORMAÇÃO TÉCNICA
Farmacodinâmica

O tiocolchicosídeo é um derivado sulfuroso de um glicósido natural de colchicina. Atua
farmacologicamente como miorrelaxante, tanto em seres humanos como em animais.
O tiocolchicosídeo promove uma atenuação ou supressão considerável da contração de
origem central: na hipertonia espástica, diminui a resistência passiva do músculo estriado e
reduz ou suprime o aparecimento da contratura residual.
A sua ação miorrelaxante manifesta-se igualmente sobre os músculos viscerais
(notavelmente sobre o útero).
O tiocolchicosídeo está desprovido de qualquer efeito curarizante. Atua por meio do
sistema nervoso central e não por uma paralisia da placa motriz.
Estudos realizados em 1980 evidenciaram uma afinidade seletiva do tipo agonista do
tiocolchicosídeo por receptores do GABA, assim como propriedades agonistas
glicinérgicas.
Por outro lado, o tiocolchicosídeo não altera a motilidade voluntária, não provoca paralisia
e evita, deste modo, todo risco respiratório.
Finalmente, COLTRAX não influi no sistema cardiovascular.
Farmacocinética
Após administração oral em indivíduo sadio, o pico plasmático é atingido em 50 minutos,
em média, e a meia-vida de eliminação é da ordem de 4 horas e 30 minutos.
Após administração intramuscular em indivíduo sadio, o pico plasmático é atingido em 30
minutos, em média, e a meia-vida de eliminação é da ordem de 4 horas e 15 minutos.
Parte do tiocolchicosídeo é eliminado na forma inalterada por via renal (“clearance” renal
médio de 70 mL/ min) e parte por via extra-renal (“clearance” extra-renal médio de 200
mL/ min).

INDICAÇÕES
Tratamento das contraturas musculares e torcicolo.
CONTRA-INDICAÇÕES
COLTRAX é contra-indicado aos pacientes que apresentam hipersensibilidade ao
tiocolchicosídeo ou a qualquer outro componente da fórmula, gravidez e lactação.

PRECAUÇÕES E ADVERTÊNCIAS
Deve-se reduzir a posologia de COLTRAX caso seja evidenciada diarréia no paciente.

12/07/07


COLTRAX pode desencadear crises convulsivas em pacientes com epilepsia ou
naqueles pacientes com risco de crises epiléticas.

Devido a presença de lactose, pacientes com raros problemas hereditários de
intolerância a lactose, deficiência na lactase ou malabsorção glicose-lactose não devem
tomar este medicamento.

Devido a presença de sacarose, pacientes com problemas raros hereditários de
intolerância a frutose não devem tomar este medicamento.

Atenção diabéticos: contém açúcar (sacarose 2,8 mg/comprimido).

COLTRAX não é recomendado para uso em crianças abaixo de 15 anos.

Deve-se reduzir a posologia de COLTRAX caso seja evidenciada diarréia no paciente.

Uso na Gravidez e Lactação:
Estudos conduzidos em animais mostraram toxicidade reprodutiva. Existem dados
clínicos insuficientes para avaliar a segurança do uso na gravidez. Deste modo o riso
potencial para o enbrião e feto é deconhecido. Por conseqüência, tiocolchicosídeo é
contra-indicado na gravidez.
Como ocorre a passagem de COLTRAX ao leite materno, é contra-indicado o seu uso
durante a lactação.

Efeitos na habilidade de dirigir ou operar máquinas:
Não existem dados disponíveis no efeito de dirigir veículos e operar máquinas. Estudos
clínicos concluíram que tiocolchicosídeo não tem efeito no desempenho psicomotor.
Entretanto, poucos casos de sonolência têm sido relatados, isto deve ser levado em
consideração quando dirigir veículos ou operar máquinas.

INTERAÇÕES MEDICAMENTOSAS
Não há relato até o momento.

REAÇÕES ADVERSAS
Doenças do sistema imune:
Reações anafiláticas, tais como pruridos, urticária, edema angioneurótico.

Doenças da pele e tecido subcutâneo:
Reações alérgicas na pele

Doenças do sistema nervoso:
Sonolência

12/07/07


Doenças gastrintestinais:
Diarréia
Gastralgia,
Náusea
Vômitos

POSOLOGIA E ADMINISTRAÇÃO
A posologia inicial é 16 mg ou 4 comprimidos, por via oral distribuído ao longo do dia ou
conforme orientação médica.
Tratamentos agudos ou exacerbações agudas: a dose diária pode ser progressivamente
aumentada de uma semi-dose (8 mg) durante 2 dias, até o dobro ou, excepcionalmente, ao
triplo da dose inicial.
Tratamento crônico: a posologia pode ser reduzida reduzindo-se a dose diária de
comprimidos.
Fisioterapia: deve-se levar em consideração o tempo de latência necessário à obtenção do
efeito miorrelaxante de 1 a 2 horas, com a administração oral.
Deve-se reduzir a posologia de COLTRAX caso seja evidenciada diarréia no paciente.
SUPERDOSAGEM
Nenhum sintoma específico de sobredosagem foi relatado em pacientes tratados com
tiocolchicosídeo. Se ocorrer sobredosagem, supervisão médica e medidas sintomáticas de
suporte são recomendadas.

IDOSOS
Não há advertências e recomendações especiais sobre o uso adequado desse medicamento
por pacientes idosos.
SIGA CORRETAMENTE O MODO DE USAR. NÃO DESAPARECENDO OS
SINTOMAS, PROCURE ORIENTAÇÃO MÉDICA.
MS 1.1300.0988
Farm. Resp.: Antonia A. Oliveira
CRF-SP 5.854
Sanofi-Aventis Farmacêutica Ltda.
Rua Conde Domingos Papais, 413
Suzano – São Paulo
12/07/07


CEP: 08613-010
C.N.P.J. 02.685.377/0008-23
Indústria Brasileira
IB 050406 B
Fabricado sob licença e segundo fórmula original de
Les Laboratoires Roussel Diamant – Paris
Atendimento ao Consumidor 0800-703-0014
www.sanofi-aventis.com.br
Nº Lote, Data de Fabricação: Vide cartucho
12/07/07


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