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GRANUPAS 4 g gastro-resistant granules

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About the medicine

How to use GRANUPAS 4 g gastro-resistant granules

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introducción

Prospecto: información para el paciente

GRANUPAS 4 g granulado gastrorresistente

ácido para-aminosalicílico

Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.

  • Conserve este prospecto, ya que puede tener que volver a leerlo.
  • Si tiene alguna duda, consulte a su médico o farmacéutico.
  • Este medicamento se le ha recetado solamente a usted y no debe dárselo a otras personas, aunque tengan los mismos síntomas, ya que puede perjudicarles.
  • Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4

Contenido del prospecto

  1. Qué es GRANUPAS y para qué se utiliza
  1. Qué necesita saber antes de empezar a tomar GRANUPAS
  2. Cómo tomar GRANUPAS
  1. Posibles efectos adversos
  2. Conservación de GRANUPAS
  3. Contenido del envase e información adicional

1. Qué es GRANUPAS y para qué se utiliza

GRANUPAS contiene ácido para-aminosalicílico que se utiliza en adultos y en niños de 28 días de edad o mayores para tratar la tuberculosis resistente, combinado con otros medicamentos, en casos de resistencia o intolerabilidad a otros tratamientos.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. Qué necesita saber antes de empezar a tomar GRANUPAS

No tome GRANUPAS

  • si es alérgico al ácido para-aminosalicílico o a alguno de los demás componentes de este medicamento (incluidos en la sección 6).
  • si padece una enfermedad renal grave.

Si no está seguro, consulte con su médico o farmacéutico antes de tomar GRANUPAS.

Advertencias y precauciones

Consulte a su médico o farmacéutico o enfermero antes de empezar a tomar GRANUPAS

  • si tiene problemas hepáticos o enfermedad renal leve o moderada
  • si padece una úlcera de estómago
  • si está infectado por el VIH

Niños

No se recomienda el uso de GRANUPAS en niños recién nacidos (menores de 28 días).

Otros medicamentos y GRANUPAS

Informe a su médico o farmacéutico si está utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento.

Es especialmente importante que informe a su médico si está utilizando alguno de los siguientes medicamentos:

  • Medicamentos antituberculosos o etionamida (otros tratamientos contra la tuberculosis)
  • Vitamina B12
  • Digoxina (para la enfermedad cardiaca)
  • Difenilhidramina (para las reacciones alérgicas)

Embarazo y lactancia

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

No se recomienda tomar GRANUPAS durante el embarazo y solo debe utilizarse si así lo indica su médico. No dé el pecho mientras toma GRANUPAS, ya que es posible que pequeñas cantidades de este medicamento pasen a la leche materna.

Conducción y uso de máquinas

Es poco probable que GRANUPAS afecte su capacidad para conducir cualquier vehículo y utilizar máquinas. En caso de que ocurra, notifíquelo a su médico o farmacéutico.

3. Cómo tomar GRANUPAS

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico.

En caso de duda, pregunte a su médico o farmacéutico.

Adultos

La dosis recomendada para adultos es de 1 sobre, 3 veces al día, con una pauta de 1 sobre cada 8 horas. Es posible que su médico deba iniciar el tratamiento con una dosis inferior para evitar posibles efectos adversos.

No tome más de 3 sobres al día. Por lo general, el tratamiento se administra durante dos años (24 meses).

  • Vacíe el contenido del sobre en un vaso de zumo de tomate o naranja.
  • Bébalo en seguida.
  • Si quedan algunos gránulos en el vaso, vierta un poco más de zumo y bébalo en seguida.

Uso en lactantes, niños y adolescentes

El médico calculará la dosis para los lactantes, los niños y los adolescentes basándose en el peso corporal del paciente. La dosis diaria total recomendada es de 150 mg por cada kg de peso corporal. Esta cantidad diaria se divide en dos dosis distribuidas a lo largo del día.

  • Use la cucharilla que viene con el medicamento para medir la dosis.
  • Para medir la dosis:
  1. Las líneas de la cucharilla indican la cantidad (en miligramos de ácido para-aminosalicílico). Tome la cantidad correcta que le ha recetado su médico.
  1. Ponga los gránulos directamente en la cucharilla.
    1. Dé un ligero golpe con la cucharilla sobre una mesa para que los gránulos se nivelen horizontalmente y llénela más si fuera necesario.
  • Espolvoree los gránulos sobre puré de manzana o yogur.
  • Haga que su hijo lo coma enseguida.

Uso de este medicamento

  • No triture ni mastique los gránulos. Trague los gránulos enteros. Es importante que no disuelva, triture o mastique los gránulos, ya que pueden no absorberse de forma correcta y causar dolor de estómago o sangrado.
  • No utilice el sobre si está hinchado o los gránulos han perdido su color marrón claro original.
  • Es posible que vea gránulos en las heces; es normal.

Si toma más GRANUPAS del que debe

Consulte a su médico o farmacéutico.

Si olvidó tomar una dosis de GRANUPAS

No tome una dosis doble para compensar las dosis olvidadas. Espere hasta el momento de tomar la dosis siguiente y tome la dosis habitual.

Si tiene cualquier otra duda sobre cómo utilizar este medicamento, pregunte a su médico o farmacéutico.

4. Posibles efectos adversos

Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

Durante los 3 primeros meses de su tratamiento con GRANUPAS, debe prestar atención a cualquier signo de reacción alérgica (por ejemplo, erupciones, manchas rojas en la piel que pican, picazón, sarpullido, ojos llorosos, picor de ojos o congestión nasal) o de hepatitis (por ejemplo, fiebre, fatiga, orina oscura, deposiciones muy claras, dolor abdominal, piel y ojos amarillos). Si experimenta alguno de estos síntomas, debe consultar de inmediato a su médico.

Efectos adversos frecuentes (observados en más de 1 paciente de cada 100):

  • vértigo,
  • dolor de estómago (dolor abdominal),
  • vómitos,
  • náuseas,
  • hinchazón,
  • diarrea,
  • heces blandas,
  • enrojecimiento de la piel o sarpullido,
  • alteración de la forma de andar o del equilibrio.

Efectos adversos poco frecuentes (observados en más de 1 paciente de cada 1 000):

  • pérdida del apetito (anorexia)

Efectos adversos raros (observados en más de 1 paciente de cada 10 000):

  • problemas de la glándula tiroides*,
  • disminución de la capacidad de absorber nutrientes de los alimentos,
  • úlcera, sangrado del intestino,
  • coloración amarillenta de la piel o los ojos (ictericia),
  • sabor metálico,
  • sarpullido con picor.
  • En personas infectadas también por el VIH, los problemas de la glándula tiroides, en concreto una actividad insuficiente de la tiroides o concentraciones bajas de hormonas tiroideas, son un efecto adverso muy frecuente que puede afectar a más de 1 de cada 10 personas. Se recomienda un control periódico de la función tiroidea a todas las personas con VIH.

Efectos adversos muy raros (observados en menos de 1 paciente de cada 10 000):

  • reducción del número de plaquetas de la sangre,
  • manchas rojas en la piel,
  • reducción del número de glóbulos blancos,
  • reducción del número de glóbulos rojos,
  • reducción de la capacidad de los glóbulos rojos para liberar oxígeno,
  • niveles bajos de azúcar en la sangre,
  • dolor de los tendones, dolor de cabeza,
  • anomalías visuales, daño a los nervios de las manos y los pies,
  • mareo,
  • cristales en la orina.
  • tiempo de sangrado prolongado,
  • destrucción de células hepáticas,
  • nivel de enzimas elevado,
  • pérdida de peso,

Efectos adversos frecuencia no conocida (no puede estimarse a partir de los datos disponibles)

  • hepatitis

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del sistema nacional de notificación incluido en el Apéndice V. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

5. Conservación de GRANUPAS

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 sobre después de CAD. La fecha de caducidad es el último día del mes que se indica.

No conservar a temperatura superior a 25 ºC. Una vez abiertos los sobres se pueden conservar por debajo de 25°C hasta 24 horas.

No utilice este medicamento si observa que los sobres están hinchados o los gránulos son de color marrón oscuro o púrpura

Los medicamentos no se deben tirar por los desagües . 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.

6. Contenido del envase e información adicional

Composición de GRANUPAS

El principio activo es el ácido para-aminosalicílico.

Cada sobre de granulado gastrointestinal contiene 4 g de ácido para-aminosalicílico.

Los demás componentes son dióxido de silicio coloidal, dibutilsebacato, copolímero de ácido metacrílico, etilacrilato (1:1) en dispersión al 30 %, hipromelosa, celulosa microcristalina, talco.

Aspecto del producto y contenido del envase

Este medicamento se presenta como un granulado gastrorresistente marrón claro en sobres.

Cada caja contiene 30 sobres. Se facilita una cucharilla de medida calibrada.

Titular de la autorización de comercialización

Eurocept International BV

Trapgans 5

1244 RL Ankeveen

los Países Bajos

Fabricante

Lucane Pharma

172 rue de Charonne

75011 París

Francia

Eurocept International BV

Trapgans 5

1244 RL Ankeveen

los Países Bajos

Pueden solicitar más información respecto a este medicamento dirigiéndose al representante local del titular de la autorización de comercialización:

België/Belgique/Belgien

Lietuva

Lucane Pharma

FrostPharma AB

Tél/Tel: + 33 153 868 750

Tel: +46 775 86 80 02

[email protected]

[email protected]

????????

Luxembourg/Luxemburg

Lucane Pharma

Lucane Pharma

Te?.: + 33 153 868 750

Tél/Tel: + 33 153 868 750

[email protected]

[email protected]

Ceská republika

Magyarország

Lucane Pharma

Lucane Pharma

Tel: + 33 153 868 750

Tel.: + 33 153 868 750

[email protected]

[email protected]

Danmark

Malta

FrostPharma AB

Lucane Pharma

Tlf: +45 808 20 101

Tel: + 33 153 868 750

[email protected]

[email protected]

Deutschland

Nederland

Lucane Pharma

Eurocept International BV

Tel: + 33 153 868 750

Tel: +31 35 528 39 57

[email protected]

[email protected]

Eesti

Norge

FrostPharma AB

FrostPharma AB

Tel: +46 775 86 80 02

Tlf: +47 815 03 175

[email protected]

[email protected]

Ελλ?δα

Österreich

Lucane Pharma

Lucane Pharma

Τηλ: + 33 153 868 750

Tel: + 33 153 868 750

[email protected]

[email protected]

España

Polska

Lucane Pharma

Lucane Pharma

Tel: + 33 153 868 750

Tel.: + 33 153 868 750

[email protected]

[email protected]

France

Portugal

Lucane Pharma

Overpharma

Tél: + 33 153 868 750

Tel: +351 214 307 760

[email protected]

[email protected]

Hrvatska

România

Lucane Pharma

Lucane Pharma

Tel: + 33 153 868 750

Tel: + 33 153 868 750

[email protected]

[email protected]

Ireland

Slovenija

Lucane Pharma

Lucane Pharma

Tel: + 33 153 868 750

Tel: + 33 153 868 750

[email protected]

[email protected]

Ísland

Slovenská republika

FrostPharma AB

Lucane Pharma

Sími: +46 775 86 80 02

Tel: + 33 153 868 750

E-mail: [email protected]

[email protected]

Italia

Suomi/Finland

Lucane Pharma

FrostPharma AB

Tel: + 33 153 868 750

Puh/Tel: +35 875 32 51 209

[email protected]

[email protected]

Κ?προς

Sverige

Lucane Pharma

FrostPharma AB

Τηλ: + 33 153 868 750

Tel: +46 775 86 80 02

[email protected]

[email protected]

Latvija

United Kingdom

FrostPharma AB

Lucane Pharma

Tel: +46 775 86 80 02

Tel: + 33 153 868 750

[email protected]

[email protected]

Fecha de la última revisión de este prospecto:

Otras fuentes de información

La información detallada de este medicamento está disponible en el sitio web de la Agencia Europea de Medicamentos: http://www.ema.europa.eu.

También existen enlaces a otras páginas web sobre enfermedades raras y medicamentos huérfanos.

Online doctors for GRANUPAS 4 g gastro-resistant granules

Discuss questions about GRANUPAS 4 g gastro-resistant granules, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Tarek Agami

General medicine 11 years exp.

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

  • Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
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Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

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Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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Nuno Tavares Lopes

Family medicine 18 years exp.

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies
  • Family medicine: hypertension, diabetes, cholesterol, chronic disease management
  • Travel medicine: pre-travel advice, vaccinations, fit-to-fly certificates, travel-related illnesses
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  • Sick leave (Baixa médica) connected to Segurança Social in Portugal
  • IMT medical certificates for driving licence exchange
Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.

Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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Анастасія Шалко

Family medicine 13 years exp.

Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

  • acute respiratory symptoms (cough, sore throat, runny nose, fever)
  • viral illnesses such as colds and seasonal infections
  • gastrointestinal complaints (nausea, diarrhoea, abdominal pain, gastroenteritis)
  • sudden changes in how a child or adult feels
  • questions about existing treatment and whether adjustments are needed
  • renewal of prescriptions when clinically appropriate

Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.She does not provide long-term management of chronic conditions, ongoing follow-up or comprehensive care plans for complex long-term illnesses. Her consultations are designed for acute symptoms, sudden concerns and situations where timely medical input is important.With clinical experience in both paediatrics and general medicine, Dr. Shalko confidently supports adults and children. Her communication style is clear, simple and reassuring, helping patients feel informed and supported throughout the consultation.

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
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Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
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  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Frequently Asked Questions

Is a prescription required for GRANUPAS 4 g gastro-resistant granules?
GRANUPAS 4 g gastro-resistant granules requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in GRANUPAS 4 g gastro-resistant granules?
The active ingredient in GRANUPAS 4 g gastro-resistant granules is 4-aminosalicylic acid. This information helps identify medicines with the same composition but different brand names.
Who manufactures GRANUPAS 4 g gastro-resistant granules?
GRANUPAS 4 g gastro-resistant granules is manufactured by Eurocept International B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of GRANUPAS 4 g gastro-resistant granules online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether GRANUPAS 4 g gastro-resistant granules is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to GRANUPAS 4 g gastro-resistant granules?
Other medicines with the same active substance (4-aminosalicylic acid) include ANSATIPIN 150 mg HARD CAPSULES, CEMIDON 60 mg/ml INJECTABLE SOLUTION, CEMIDON B6 150 MG/25 MG TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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