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title: TEST PURPOSES ONLY - Dovato 50 mg/300 mg comprimidos recubiertos con película

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Prospecto: información para el paciente Dovato 50 mg/300 mg comprimidos recubiertos con película dolutegravir/lamivudina Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.
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Contenido del prospecto
  1. Qué es Dovato y para qué se utiliza
  2. Qué necesita saber antes de empezar a tomar Dovato
  3. Cómo tomar Dovato
  4. Posibles efectos adversos
  5. Conservación de Dovato
  6. Contenido del envase e información adicional
" } }, { "title" : "1. What Dovato 50 mg/300 mg comprimidos recubiertos con película is and what it is used for", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "1. What Dovato 50 mg/300 mg comprimidos recubiertos con película is and what it is used for" }, "text" : { "status" : "additional", "div" : "
1. Qué es Dovato y para qué se utiliza Dovato es un medicamento que contiene dos principios activos usados para tratar la infección por el virus de la inmunodeficiencia humana (VIH): dolutegravir y lamivudina. Dolutegravir pertenece al grupo de medicamentos antirretrovirales llamados inhibidores de la integrasa (INI) y lamivudina pertenece a un grupo de medicamentos antirretrovirales denominados inhibidores de la transcriptasa inversa análogos de nucleósido (ITIAN).
" } }, { "title" : "2. What you need to know before you take Dovato 50 mg/300 mg comprimidos recubiertos con película", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "2. What you need to know before you take Dovato 50 mg/300 mg comprimidos recubiertos con película" }, "text" : { "status" : "additional", "div" : "

No tome Dovato

? Si cree que algo de esto le aplica, consulte a su médico.

Advertencias y precauciones Algunas personas que toman Dovato u otros tratamientos combinados frente al VIH tienen un mayor riesgo de desarrollar efectos adversos graves que otras. Usted necesita saber que hay un mayor riesgo:

? Consulte a su médico antes de empezar a tomar Dovato si le aplica alguna de estas condiciones. Puede necesitar pruebas adicionales, incluyendo análisis de sangre, mientras toma este medicamento. Para más información, ver sección 4.

Reacciones alérgicas

Dovato contiene dolutegravir. Dolutegravir puede producir una reacción alérgica grave conocida como reacción de hipersensibilidad. Usted necesita saber a qué signos y síntomas importantes debe estar atento mientras esté tomando Dovato.

? Lea la información “Reacciones alérgicas” en la sección 4 de este prospecto.

Esté atento a los síntomas importantes

Algunas personas que toman medicamentos para la infección por el VIH desarrollan otros trastornos, que pueden ser graves. Estos incluyen:

Usted necesita saber a qué signos y síntomas importantes debe estar atento mientras esté tomando Dovato.

? Lea la información sobre “Otros posibles efectos adversos” en la sección 4 de este prospecto.

Niños

Este medicamento no está indicado en niños menores de 12 años, porque no ha sido estudiado en estos pacientes.

Otros medicamentos y Dovato Informe a su médico si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento.

No tome Dovato con el siguiente medicamento:

Algunos medicamentos pueden afectar al funcionamiento de Dovato o aumentar la probabilidad de sufrir efectos adversos. Dovato también puede afectar al funcionamiento de algunos otros medicamentos.

Informe a su médico si está tomando alguno de los siguientes medicamentos:

? Informe a su médico o farmacéutico si está tomando alguno de estos medicamentos. Su médico puede decidir ajustar su dosis o que usted necesite chequeos adicionales.

Embarazo

Si está embarazada, cree que podría estar embarazada o tiene intención de quedarse embarazada:

? Consulte a su médico sobre los riegos y beneficios de tomar Dovato.

Tomar Dovato en el momento de quedarse embarazada o durante las primeras seis semanas de embarazo puede aumentar el riesgo de un defecto de nacimiento, denominado defecto del tubo neural, como la espina bífida (malformación de la médula espinal).

Si existe la posibilidad de quedarse embarazada mientras está tomando Dovato:

? Consulte a su médico y valore si existe la necesidad de utilizar un método anticonceptivo, como preservativos o anticonceptivos orales.

Informe a su médico de inmediato si se queda embarazada o tiene intención de quedarse embarazada. Su médico revisará su tratamiento. No interrumpa el tratamiento con Dovato sin consultar a su médico, ya que esto podría dañarles a usted y a su hijo.

Lactancia

No se recomienda que las mujeres que conviven con el VIH den el pecho porque la infección por VIH puede transmitirse al bebé a través de la leche materna.

Una pequeña cantidad de los componentes de Dovato también pueden pasar a la leche materna.

Si está dando el pecho o piensa en dar el pecho, debe consultar con su médico lo antes posible.

Conducción y uso de máquinas Dovato puede hacer que se sienta mareado y puede tener otros efectos adversos que reduzcan su atención.

? No conduzca ni maneje maquinaria, a menos que esté seguro que no está afectado.
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3. Cómo tomar Dovato

Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. En caso de duda, consulte de nuevo a su médico o farmacéutico.

Trague el comprimido con un poco de líquido. Dovato se puede tomar con o sin alimentos.

" } }, { "title" : "4. Possible side effects", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "4. Possible side effects" }, "text" : { "status" : "additional", "div" : "

4. Posibles efectos adversos

Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran, por lo que es muy importante que le comente a su médico cualquier cambio en su estado de salud.

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5. Conservación de Dovato

Mantener este medicamento fuera de la vista y del alcance de los niños

No utilice este medicamento después de la fecha de caducidad que aparece en la caja y el frasco después de CAD. La fecha de caducidad es el último día del mes que se indica.

Este medicamento no requiere ninguna condición especial de conservación.

Los medicamentos no se deben tirar por los desagües ni a la basura. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma, ayudará a proteger el medio ambiente.

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6. Contenido del envase e información adicional Composición de Dovato
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MolecularWeights

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Structures

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Names

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*(4R,12.ALPHA.S)-N-((2,4-DIFLUOROPHENYL)METHYL)-7-HYDROXY-4-METHYL-6,8-DIOXO-3,4,6,8,12,12.ALPHA.-HEXAHYDRO-2H-PYRIDO(1',2':4,5)PYRAZINO(2,1-.BETA.)(1,3)OXAZINE-9-CARBOXAMIDEChemical Name (#x)
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Profile: SubstanceDefinition (ePI)

identifier: id:\u00a02T8Q726O95\u00a0(use:\u00a0OFFICIAL)

version: 1

status: Active (PublicationStatus#active)

manufacturer: See above (Organization/man-173fde4cb6b1018cb7ec8ab708d3961c)

MolecularWeights

-TypeAmount
*exact ()229.26

Structures

-MolecularFormula
*C8H11N303S

Names

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*(-)-1-((2R,5S)-2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)CYTOSINEChemical Name (#x)
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Profile: AdministrableProductDefinition (ePI)

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status: active

formOf: See above (MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e)

administrableDoseForm: tablet (rmswi#200000002152)

unitOfPresentation: tablet (rmswi#200000002152)

producedFrom: See above (ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f)

routeOfAdministration

code: Oral use (rmswi#100000073619)

TargetSpecies

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Profile: RegulatedAuthorization (ePI)

identifier: id:\u00a0EU/1/19/1370/001\u00a0(use:\u00a0OFFICIAL)

subject: See above (MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e)

type: Marketing Authorisation (rmswi#100000072062)

status: Active (PublicationStatus#active)

statusDate: 2019-07-01 13:28:17+0000

holder: See above (Organization/mah-31ff1af739c7dcf77386a86f8dd83d29)

regulator: See above (Organization/mra-7c9b97127f73ff3605a10eb1c2cc24d1)

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Resource Organization "man-173fde4cb6b1018cb7ec8ab708d3961c"

Profile: Organization (ePI)

identifier: id:\u00a0ORG-100004538\u00a0(use:\u00a0OFFICIAL)

active: true

type: Manufacturer (rmswi#220000000033)

name: GLAXO WELLCOME, S.A.

Contacts

-Address
*Avda. Extremadura 3, 09400 Aranda De Duero Aranda De Duero ES(WORK)
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Generated Narrative: Organization

Resource Organization "mah-31ff1af739c7dcf77386a86f8dd83d29"

Profile: Organization (ePI)

identifier: id:\u00a0ORG-100012958\u00a0(use:\u00a0OFFICIAL)

active: true

type: Marketing authorisation holder (rmswi#220000000034)

name: ViiV Healthcare BV

Contacts

-Address
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Generated Narrative: Organization

Resource Organization "mra-7c9b97127f73ff3605a10eb1c2cc24d1"

Profile: Organization (ePI)

identifier: id:\u00a0ORG-100013412\u00a0(use:\u00a0OFFICIAL)

active: true

type: Medicines Regulatory Authority (rmswi#220000000032)

name: European Medicines Agency

Contacts

-Address
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Generated Narrative: PackagedProductDefinition

Resource PackagedProductDefinition "ppd-23f4e5c6d9ca952c3ffb3940859a26f8"

Profile: PackagedProductDefinition (ePI)

identifier: id:\u00a0EU/1/19/1370/001\u00a0(use:\u00a0OFFICIAL)

name: 50 mg/300 mg film-coated tablets

type: Chemical Medicinal Prodcut (rmswi#100000155527)

packageFor: See above (MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e)

status: Active (PublicationStatus#active)

statusDate: 2012-02-07 13:28:17+0000

containedItemQuantity: 30 {tablets} (Details: UCUM code {tablets} = '{tablets}')

manufacturer: See above (Organization/man-173fde4cb6b1018cb7ec8ab708d3961c)

packaging

type: Box (rmswi#100000073498)

quantity: 1

material: Cardboard (rmswi#200000003529)

packaging

identifier: id:\u00a0654321

type: Child-resistant closure (rmswi#100000073504)

quantity: 1

material: Cardboard (rmswi#200000003529)

containedItem

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Generated Narrative: MedicinalProductDefinition

Resource MedicinalProductDefinition "mp16598f252d07b4784b82ba43cf9e847e"

Profile: MedicinalProductDefinition (ePI)

identifier: id:\u00a0EU/1/19/1370/001, id:\u00a00x073AF2E5B92AE19E8B67635AFFB3D6CA

type: Medicinal Product (Medicinal Product Type#MedicinalProduct)

domain: Human use (Medicinal Product Domain#Human)

status: active (PublicationStatus#active)

legalStatusOfSupply: Medicinal product subject to medical prescription (rmswi#100000072084)

name

productName: Dovato 50 mg/300 mg film-coated tablets

type: Full name (220000000000#220000000001)

part

part: Dovato

type: Invented name part (220000000000#220000000002)

part

part: dolutegravir/lamivudine

type: Scientific name part (220000000000#220000000003)

part

part: 50 mg/300 mg

type: Strength part (220000000000#220000000004)

part

part: film-coated tablets

type: Pharmaceutical dose form part (220000000000#220000000005)

Usages

-CountryJurisdictionLanguage
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Resource ManufacturedItemDefinition "mid-49178f16170ee8a6bc2a4361c1748d5f"

Profile: ManufacturedItemDefinition (ePI)

identifier: id:\u00a0EU/1/19/1370/001\u00a0(use:\u00a0OFFICIAL)

status: active

manufacturedDoseForm: Film-coated tablet (#100000073665)

unitOfPresentation: Tablet (rmswi#200000002152)

manufacturer: See above (Organization/man-173fde4cb6b1018cb7ec8ab708d3961c)

" }, "identifier" : [{ "use" : "official", "system" : "https://spor.ema.europa.eu/pmswi", "value" : "EU/1/19/1370/001" }], "status" : "active", "manufacturedDoseForm" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000073665", "display" : "Film-coated tablet" }] }, "unitOfPresentation" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi", "code" : "200000002152", "display" : "Tablet" }] }, "manufacturer" : [{ "reference" : "Organization/man-173fde4cb6b1018cb7ec8ab708d3961c" }] } }] }