FrancophonIA/ELRC3.0 huggingface dataset:
English: Albert-Schweitzer-Gasse 6 A-1140 Wien Austria
Spanish: GlaxoSmithKline Pharma GmbH, Albert-Schweitzer-Gasse 6 A-1140 Wien
English: 25, 50, 100 and 200 mg tablets, 5, 25, 50, 100 and 200 mg dispersible/chewable tablets: Three years.
Spanish: Comprimidos de 25, 50, 100 y 200 mg, comprimidos dispersables/masticables de 5, 25, 50, 100 y 200 mg: Tres años.
English: 22 23 24 25 26 27 28 (2 pockets)
Spanish: 22 23 24 25 26 27 28 (2 alveolos)
English: 4.5 Interaction with other medicinal products and other forms of interaction
Spanish: 4.5 Interacción con otros medicamentos y otras formas de interacción Los estudios de interacción se han realizado sólo en adultos.
English: Monotherapy:
Spanish: Monoterapia:
English: Very common side effects These may affect more than 1 in 10 people:
Spanish: Efectos adversos muy frecuentes Estos afectan a más de 1 de cada 10 personas:
English: Monotherapy of typical absence seizures:
Spanish: Monoterapia en crisis de ausencia típica:
English: 42 tablets
Spanish: 42 comprimidos
English: 10 dispersible/chewable tablets 14 dispersible/chewable tablets 28 dispersible/chewable tablets 30 dispersible/chewable tablets 50 dispersible/chewable tablets 56 dispersible/chewable tablets
Spanish: 10 comprimidos dispersables/masticables 14 comprimidos dispersables/masticables 28 comprimidos dispersables/masticables 30 comprimidos dispersables/masticables 50 comprimidos dispersables/masticables 56 comprimidos dispersables/masticables
English: 0.3 mg/kg/day (once a day)
Spanish: 0,3 mg/kg/día (una vez al día)
English: Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom
Spanish: Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN Reino Unido
English: The impact of the modest increase in levonorgestrel clearance, and the changes in serum FSH and LH, on ovarian ovulatory activity is unknown (see section 4.4).
Spanish: Se desconoce el impacto sobre la actividad ovulatoria de este leve aumento en el aclaramiento de levonorgestrel y de los cambios en los niveles sanguíneos de FSH y LH (ver sección 4.4).
English: Table 7: Summary of results from studies investigating the efficacy of lamotrigine in the prevention of mood episodes in patients with bipolar I disorder
Spanish: Tabla 7: Resumen de los resultados de los estudios de investigación de la eficacia de lamotrigina en la prevención de trastornos del estado del ánimo en pacientes con trastorno bipolar I ‘Proporción' de pacientes sin eventos en la semana 76 Estudio SCAB2003 Bipolar I
English: In women who wish to stop taking a hormonal contraceptive that includes one week of inactive treatment ("pill-free week"), serum lamotrigine level monitoring should be conducted during week 3 of active treatment, i.e. on days 15 to 21 of the pill cycle.
Spanish: En mujeres que deseen dejar de tomar anticonceptivos hormonales cuya pauta posológica incluye una semana libre de píldora, se debe llevar a cabo una monitorización de los niveles séricos de lamotrigina durante la tercera semana de tratamiento p.ej.: en los días 15 a 21 del ciclo de la píldora.
English: • risperidone, used to treat mental health problems
Spanish: • risperidona, indicado para el tratamiento de problemas de salud mental
English: PVC/PVdC/aluminium foil blister.
Spanish: Blister PVC/PVDC/Aluminio
English: Medicinal products that significantly induce glucuronidation of lamotrigine
Spanish: Fármacos que inducen significativamente la glucuronidación de lamotrigina
English: The majority of rashes are mild and self-limiting, however serious rashes requiring hospitalisation and discontinuation of lamotrigine have also been reported.
Spanish: No obstante, también se han notificado casos de erupciones cutáneas graves que requirieron hospitalización y la discontinuación de lamotrigina.
English: arthralgia.
Spanish: artralgia.
English: Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom
Spanish: Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN Reino Unido
English: 300 mg/day 400 mg/day Maintain this dose (400 mg/day)
Spanish: 300 mg/día 400 mg/día Mantener esta dosis (400 mg/día)
English: 21 tablets
Spanish: 21 comprimidos
English: Very rare side effects These may affect up to 1 in 10,000 people:
Spanish: Efectos adversos muy raros Estos afectan hasta 1 de cada 10.000 personas:
English: Intake of folic acid when planning pregnancy and during early pregnancy may be considered.
Spanish: Se recomienda la administración de ácido fólico en mujeres que estén planeando quedarse embarazadas y en mujeres embarazadas, durante las primeras etapas del embarazo.
English: somnolence, ataxia, dizziness, headache.
Spanish: somnolencia, ataxia, vértigo, dolor de cabeza.
English: The recommended dose escalation and maintenance doses for adults of 18 years of age and above are given in the tables below.
Spanish: En las siguientes tablas se describe la escalada de dosis recomendada y la dosis de mantenimiento para adultos de 18 años de edad en adelante.
English: If any of these applies to you: Î Tell your doctor, who may decide to lower your dose, or that Lamictal is not suitable for you.
Spanish: Î Comuníqueselo al médico, quien decidirá disminuir su dosis, o determinará que Lamictal no es adecuado para usted.
English: 15 17 19 21 23 25 27 (one pocket)
Spanish: 15 17 19 21 23 25 27 (un alveolo)
English: Specialist advice should be given to women who are of childbearing potential.
Spanish: Las mujeres que estén en período fértil deben disponer del consejo de un especialista.
English: In women taking a hormonal contraceptive that includes one week of inactive treatment ("pill-free week"), serum lamotrigine level monitoring should be conducted during week 3 of active treatment, i.e. on days 15 to 21 of the pill cycle.
Spanish: En aquellas mujeres que tomen anticonceptivos hormonales cuya pauta posológica incluya una semana libre de píldora, se debe llevar a cabo una monitorización de los niveles séricos de lamotrigina durante la tercera semana de tratamiento p.ej.: en los días 15 a 21 del ciclo de la píldora.
English: 100 mg/day Maintain this dose (100 mg/day)
Spanish: 100 mg/día Mantener esta dosis (100 mg/día)
English: - high initial doses of lamotrigine and exceeding the recommended dose escalation of lamotrigine therapy (see section 4.2) - concomitant use of valproate (see section 4.2).
Spanish: - Dosis iniciales elevadas de lamotrigina que exceden la pauta de escalada de dosis recomendada (ver sección 4.2).
English: In patients receiving concomitant therapy with valproate, the appropriate treatment regimen should be used (see section 4.2).
Spanish: En pacientes que se encuentren en tratamiento concomitante con valproato, se debe utilizar el régimen de tratamiento apropiado (ver sección 4.2).
English: 25 mg/day (once a day)
Spanish: 25 mg/día (una vez al día)
English: Withdrawal of inducers of lamotrigine glucuronidation (see section 4.5), depending on original dose of lamotrigine:
Spanish: Retirada de inductores de la glucuronidación de lamotrigina (ver sección 4.5), dependiendo de la dosis original de lamotrigina:
English: Stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and NOT taking inducers of lamotrigine glucuronidation The maintenance dose of lamotrigine will in most cases need to be decreased by as much as 50% (see sections 4.4 and 4.5).
Spanish: Cese del tratamiento con anticonceptivos hormonales en pacientes que estén en tratamiento con dosis de mantenimiento de lamotrigina y NO estén tomando inductores de la glucuronidación de lamotrigina Puede ser necesario reducir la dosis de mantenimiento de lamotrigina hasta como máximo la mitad de la dosis (ver sección 4.4 y 4.5).
English: 200 mg/day - usual target dose for optimal response (once a day or two divided doses)
Spanish: 200 mg/día - dosis habitual para lograr una respuesta óptima (una vez al día o divididos en dos dosis)
English: Starter pack of 21 or 42 dispersible/chewable tablets.
Spanish: Envase de iniciación de 21 o 42 comprimidos dispersables/masticables.
English: The other side is marked with two overlapping super-ellipses at right angles.
Spanish: La otra cara muestra grabadas dos superelipses que se solapan perpendicularmente.
English: In patients receiving concomitant therapy with lopinavir/ritonavir, the appropriate treatment regimen should be used (see section 4.2).
Spanish: En pacientes que reciben terapia concomitante con lopinovir/ritonavir, se debe utilizar el régimen de tratamiento apropiado (ver sección 4.2).
English: The incidence of suicidal ideation and behaviour was evaluated in a pooled analysis of placebo-controlled clinical trials with lamotrigine involving a total of 6467 patients from a number of indications.
Spanish: En un análisis conjunto de ensayos clínicos con lamotrigina controlado con placebo donde participaron un total de 6.467 pacientes, se evaluó la incidencia de ideación y comportamiento suicida.
English: “Adults and children above 12 years {Tradename} is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome”.
Spanish: “Adultos y niños mayores de 12 años {Nombre comercial} está indicado como terapia auxiliar o en monoterapia en el tratamiento de la epilepsia, de las crisis parciales y generalizadas, incluidas las crisis tónico-clónicas y las crisis asociadas al síndrome de Lennox-Gastaut”.
English: 100 mg/day - usual target dose for optimal response (once a day or two divided doses)
Spanish: 100 mg/día - dosis habitual para lograr una respuesta óptima (una vez al día o divididos en dos dosis)
English: “Children 2 to 12 years {Tradename} is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome”.
Spanish: “Niños de 2 a 12 años {Nombre comercial} está indicado como terapia auxiliar en el tratamiento de la epilepsia, en las crisis parciales y las crisis generalizadas, incluidas las crisis tónico-clónicas y las crisis asociadas al síndrome de Lennox-Gastaut”.
English: There are reports in the literature of decreased lamotrigine levels when lamotrigine was given in combination with oxcarbazepine.
Spanish: En la bibliografía, hay notificaciones de casos en los que la administración concomitante de lamotrigina y oxcarbamazepina produjo una disminución los niveles de lamotrigina.
English: In vitro experiments indicated that the formation of lamotrigine's primary metabolite, the 2-N-glucuronide, was minimally inhibited by co-incubation with amitriptyline, bupropion, clonazepam, haloperidol or lorazepam.
Spanish: Los estudios de inhibición in vitro indican que la formación del principal metabolito de lamotrigina, el 2-Nglucurónido, se vio mínimamente afectada por la incubación conjunta con amitriptilina, bupropión,
English: Because of the risk of rash the initial dose and subsequent dose escalation should not be exceeded (see section 4.4).
Spanish: No se deben superar ni la dosis inicial ni la subsiguiente escalada de dosis debido al riesgo de que se produzca erúpción cutanea (ver sección 4.4)
English: Intervention free p-value Log rank test
Spanish: Sin intervención Valor-p ensayo Log rank
English: Major manic episode Lamotrigine Lithium Placebo Lamotrigine Lithium Placebo
Spanish: Placebo Lamotrigina Litio
English: 50 mg/day (once a day)
Spanish: 50 mg/día (una vez al día)
English: Packs of 30, 56 or 100 tablets.
Spanish: Envases de 30, 56 o 100 comprimidos
English: Medicinal products that do not significantly inhibit or induce glucuronidation of lamotrigine
Spanish: Fármacos que no inhiben ni inducen significativamente la glucuronidación de lamotrigina
English: Excipient: Each tablet contains 23.5 mg lactose.
Spanish: Excipiente: cada comprimido contiene 23,5 mg de lactosa.
English: Table 5: Adults aged 18 years and above - adjustment of lamotrigine daily dosing following the addition of other medicinal products in treatment of bipolar disorder There is no clinical experience in adjusting the lamotrigine daily dose following the addition of other medicinal products.
Spanish: Tabla 5: Adultos a partir de 18 años - ajuste de la dosis diaria de lamotrigina tras añadir otros fármacos para el tratamiento del trastorno bipolar
English: Twelve volunteers with chronic renal failure, and another six individuals undergoing hemodialysis were each given a single 100 mg dose of lamotrigine.
Spanish: Se administró una dosis única de 100 mg de lamotrigina a doce voluntarios con insuficiencia renal crónica y a otros 6 individuos sometidos a hemodiálisis.
English: Treatment Regimen
Spanish: Pauta de tratamiento
English: Starter pack of 42 dispersible/chewable tablets.
Spanish: Envase de iniciación de 42 comprimidos dispersables/masticables.
English: Medicinal products that significantly inhibit glucuronidation of lamotrigine
Spanish: Fármacos que inhiben significativamente la glucuronidación de lamotrigina
English: Children and adolescents aged 2 to 12 years - Adjunctive treatment of partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome.
Spanish: Niños y adolescentes entre 2 y 12 años - Tratamiento complementario de crisis parciales y crisis generalizadas, incluyendo crisis tónico-clónicas y crisis asociadas al síndrome de Lennox-Gastaut.
English: Nervous system disorders During monotherapy clinical trials: Very common:
Spanish: Trastornos del sistema nervioso Durante ensayos clínicos en monoterapia: Muy frecuentes:
English: Efficacy as monotherapy treatment of typical absence seizures was demonstrated.
Spanish: Se ha demostrado la eficacia de la monoterapia en las crisis de ausencia típicas.
English: Hungary GlaxoSmithKline Kft. 1124Bp.
Spanish: 1124Bp.
English: • swelling around the face (oedema) or swollen glands in the neck, armpit or groin
Spanish: • Hinchazón alrededor de la cara o inflamación de las glándulas del cuello, axilas e ingles
English: Oral use Read the package leaflet before use
Spanish: Vía oral Leer el prospecto antes de utilizar este medicamento.
English: The use of an ethinyloestradiol/levonorgestrel (30 µg/150 µg) combination increases the clearance of lamotrigine by approximately two-fold, resulting in decreased lamotrigine levels.
Spanish: La administración de una combinación de etinilestradiol/levonorgestrel (30 mcg/150 mcg) aumenta hasta aproximadamente el doble el aclaramiento de lamotrigina dando lugar a una disminución en los niveles de lamotrigina (ver sección 4.5).
English: Each pack contains blisters of 30, 56 or 100 tablets.
Spanish: Cada envase contiene blisters de 30, 56 o 100 comprimidos.
English: Free of mania p-value Log rank test
Spanish: Sin manía** Valor-p ensayo Log rank
English: Dispersible/chewable tablets:
Spanish: Comprimidos dispersables/masticables:
English: In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen as recommended for lamotrigine with concurrent valproate, should be used.
Spanish: En pacientes que toman fármacos de los que se desconoce la interacción farmacocinética con lamotrigina (ver sección 4.5), se debe utilizar la pauta de tratamiento recomendada para la administración conjunta de lamotrigina con valproato.
English: For patients with end-stage renal failure, initial doses of lamotrigine should be based on patients' concomitant medicinal products; reduced maintenance doses may be effective for patients with significant renal functional impairment (see sections 4.4 and 5.2).
Spanish: En casos de insuficiencia renal terminal, la dosis inicial de lamotrigina debe ajustarse a lo indicado en las recomendaciones posológicas, teniendo en consideración la medicación concomitante que esté tomando el paciente; puede ser eficaz reducir las dosis de mantenimiento en pacientes con insuficiencia renal significativa (ver sección 4.4 y 5.2).
English: Skin and subcutaneous tissue disorders During bipolar disorder clinical trials: Very common:
Spanish: Trastornos de la piel y tejido subcutáneo Durante ensayos clínicos en trastorno bipolar: Muy frecuentes:
English: Adults and adolescents aged 13 years and above - Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic-clonic seizures.
Spanish: Adultos y adolescentes a partir de los 13 años de edad - Tratamiento añadido o en monoterapia de las crisis parciales y las crisis generalizadas, incluidas las crisis tónico-clónicas.
English: 150 mg/day
Spanish: 150 mg/día
English: Starter pack 21 dispersible/chewable tablets, valproate add-on therapy Starter pack 42 dispersible/chewable tablets, monotherapy
Spanish: Envase de iniciación 21 comprimidos dispersables/masticables, terapia adicional con valproato Envase de iniciación 42 comprimidos dispersables/masticables, monoterapia.
English: Belgium GlaxoSmithKline s.a. Rue du Tilleul 13, B86
Spanish: GlaxoSmithKline s.a. Rue du Tilleul 13, B86 1332 Genval Belgica
English: • itchy eyes, with discharge and crusty eyelids (conjunctivitis)
Spanish: • Picor de ojos, con secreción y legañas en los párpados (conjuntivitis)
English: Withdrawal of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
Spanish: Retirada de fármacos que NO inhiben o inducen significantemente la glucuronidación de lamotrigina (ver sección 4.5):
English: nausea, vomiting.
Spanish: náuseas, vómitos.
English: PVC/aluminium foil blister.
Spanish: Blister de PVC/Aluminio
English: • skin rashes or redness
Spanish: • erupciones o enrojecimiento en la piel
English: The efficacy and safety of adjunctive therapy in partial seizures in patients aged 1 to 24 months has been evaluated in a small double-blind placebo-controlled withdrawal study.
Spanish: En un pequeño estudio de retirada, doble ciego controlado con placebo, se ha evaluado la eficacia y seguridad de la terapia añadida en crisis parciales en niños de entre 1 y 24 meses.
English: 200 − 400 mg/day (two divided doses)
Spanish: 200 - 400 mg/día (divididos en dos dosis)
English: Lamictal 200 mg tablets are marked ‘GSEE7' on one side and ‘200' on the other.
Spanish: Los comprimidos de Lamictal 200 mg muestran la leyenda“GSEE7” grabada en una cara y la leyenda “200” en la otra cara.
English: Excipient: Each tablet contains 46.9 mg lactose.
Spanish: Excipiente: cada comprimido contiene 46,9 mg de lactosa.
English: To achieve maintenance, doses may be increased by maximum of 1.2 mg/kg every one to two weeks until optimal response is achieved, with a maximum maintenance dose of 400 mg/day
Spanish: Para alcanzar las dosis de mantenimiento, éstas pueden aumentarse en un máximo de 1,2 mg/kg cada una o dos semanas hasta alcanzar la respuesta óptima, con un máximo de dosis de mantenimiento de 400 mg/día.
English: Excipient: Each tablet contains 109.0 mg lactose.
Spanish: Excipiente: cada comprimido contiene 109,0 mg de lactosa.
English: However, accumulation of the glucuronide metabolite is to be expected; caution should therefore be exercised in treating patients with renal failure.
Spanish: Sin embargo, se debe tener precaución en el tratamiento de pacientes con insuficiencia renal puesto que es esperable que se produzca la acumulación del metabolito glucurónido.
English: There is no evidence that lamotrigine causes clinically significant induction or inhibition of hepatic oxidative drug-metabolising enzymes, and interactions between lamotrigine and medicinal products metabolised by cytochrome P450 enzymes are unlikely to occur.
Spanish: No hay evidencias de que la administración de lamotrigina produzca una inducción o inhibición de las enzimas responsables del metabolismo oxidativo hepático de fármacos clínicamente significativas.
English: Withdrawal of valproate (inhibitor of lamotrigine glucuronidation - see section 4.5), depending on original dose of lamotrigine:
Spanish: Retirada de valproato (inhibidor de la glucuronidación de lamotrigina- ver sección 4.5), dependiendo de la dosis original de lamotrigina:
English: Gastrointestinal disorders During bipolar disorder clinical trials: Common:
Spanish: Trastornos gastrointestinales Durante ensayos clínicos en trastorno bipolar: Frecuentes:
English: • feeling sleepy or drowsy
Spanish: • sensación de sueño o somnolencia
English: Week 2 Week 3 onwards
Spanish: Semana 2 A partir de la Semana 3
English: Musculoskeletal and connective tissue disorders Very rare:
Spanish: Trastornos musculoesqueléticos, del tejido conjuntivo y de los huesos Muy raras:
English: Addition of valproate (inhibitor of lamotrigine glucuronidation - see section 4.5), depending on original dose of lamotrigine:
Spanish: Al añadir valproato (inhibidor de la glucuronidación de lamotrigina - ver sección 4.5), dependiendo de la dosis original de lamotrigina:
English: Lamictal Dispersible 50mg Starter-Pack add-on 50 mg Dispersible Tablet
Spanish: Lamictal Dispersible 50mg Starter-Pack add-on 50 mg Comprimidos dispersables
English: Addition of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
Spanish: Al añadir fármacos que NO inhiben o inducen significantemente la glucuronidación de lamotrigina (ver sección 4.5):
English: 6.5 Nature and contents of container 25 mg tablets:
Spanish: 6.5 Naturaleza y contenido del envase
English: To achieve maintenance, doses may be increased by maximum of 0.6 mg/kg/day every one to two weeks until optimal response is achieved
Spanish: Para alcanzar las dosis de mantenimiento, éstas pueden aumentarse en un máximo de 0,6 mg/kg/día cada una o dos semanas hasta alcanzar la respuesta óptima.
English: Each Lamictal 200 mg tablet contains 200 mg lamotrigine.
Spanish: Cada comprimido de Lamictal 200 mg contiene 200 mg de lamotrigina.
English: Excipient: Each tablet contains 93.9 mg lactose.
Spanish: Excipiente: cada comprimido contiene 93,9 mg de lactosa.
English: Monotherapy with lamotrigine OR adjunctive therapy WITHOUT valproate and WITHOUT inducers of lamotrigine glucuronidation (see section 4.5):
Spanish: Monoterapia con lamotrigina O terapia complementaria SIN valproato y SIN inductores de la glucuronidación de lamotrigina (ver sección 4.5):
English: Lamictal Dispersible 25mg Starter-Pack Mono 25 mg Dispersible Tablet
Spanish: Lamictal Dispersible 25mg Starter-Pack Mono 25 mg Comprimidos dispersables
English: 25 mg tablets:
Spanish: 25 mg comprimidos:
English: Low-substituted hydroxypropyl cellulose Aluminium magnesium silicate Sodium starch glycolate (Type A) Povidone K30
Spanish: Glicolato sódico de almidón (Tipo A) Povidona K30
English: Each pack contains blisters of 10, 14, 28, 30, 50 or 56 tablets.
Spanish: Cada envase contiene blisters de 10, 14, 28, 30, 50 o 56 comprimidos.
English: 200 mg/day 300 mg/day 400 mg/day
Spanish: 200 mg/día 300 mg/día 400 mg/día
English: 42 dispersible/chewable tablets
Spanish: 42 comprimidos dispersables/masticables
English: To achieve maintenance, doses may be increased by maximum of 0.6 mg/kg every one to two weeks until optimal response is achieved, with a maximum of maintenance dose of 200 mg/day
Spanish: Para alcanzar las dosis de mantenimiento, éstas pueden aumentarse en un máximo de 0,6 mg/kg cada una o dos semanas hasta alcanzar la respuesta óptima, con un máximo de dosis de mantenimiento de 200 mg/día.
English: Lamictal 100 mg tablets are marked ‘GSEE5' on one side and ‘100' on the other.
Spanish: Los comprimidos de Lamictal 100 mg muestran la leyenda “GSEE5” grabada en una cara y la leyenda“100” en la otra cara.
English: Starter pack 42 tablets, non-valproate add-on therapy
Spanish: Envase de iniciación 42 comprimidos, terapia adicional sin valproato.
English: • lithium, used to treat mental health problems
Spanish: • litio, indicado para el tratamiento de problemas de salud mental
English: GlaxoSmithKline Oy Piispansilta 9 A 02230 Espoo Finland
Spanish: Finlandia GlaxoSmithKline Oy Piispansilta 9 A
English: Gastrointestinal disorders During monotherapy clinical trials:
Spanish: Trastornos gastrointestinales Durante ensayos clínicos en monoterapia: Frecuentes:
English: 25 mg Tablet
Spanish: 25 mg Comprimidos