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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

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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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Introduction

Package Leaflet: Information for the Patient

GRANUPAS 4 g Gastro-Resistant Granules

Para-aminosalicylic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What is GRANUPAS and what is it used for
  1. What you need to know before you take GRANUPAS
  2. How to take GRANUPAS
  1. Possible side effects
  2. Storage of GRANUPAS
  3. Contents of the pack and other information

1. What is GRANUPAS and what is it used for

GRANUPAS contains para-aminosalicylic acid which is used in adults and in children from 28 days of age or older to treat resistant tuberculosis, in combination with other medicines, in cases of resistance or intolerance to other treatments.

Doctor consultation

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2. What you need to know before you take GRANUPAS

Do not take GRANUPAS

  • if you are allergic to para-aminosalicylic acid or any of the other ingredients of this medicine (listed in section 6).
  • if you have severe kidney disease.

If you are not sure, consult your doctor or pharmacist before taking GRANUPAS.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting treatment with GRANUPAS

  • if you have liver problems or mild or moderate kidney disease
  • if you have a stomach ulcer
  • if you are infected with HIV

Children

GRANUPAS is not recommended for use in newborn babies (less than 28 days old).

Other medicines and GRANUPAS

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important that you tell your doctor if you are taking any of the following medicines:

  • Anti-tuberculosis medicines or ethionamide (other treatments for tuberculosis)
  • Vitamin B12
  • Digoxin (for heart disease)
  • Diphenhydramine (for allergic reactions)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

GRANUPAS should not be taken during pregnancy and should only be used if your doctor considers it essential. Do not breast-feed while taking GRANUPAS, as small amounts of this medicine may pass into breast milk.

Driving and using machines

GRANUPAS is unlikely to affect your ability to drive or use machines. If this happens, tell your doctor or pharmacist.

3. How to take GRANUPAS

Medicine questions

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Follow exactly the administration instructions of this medicine given by your doctor.

In case of doubt, ask your doctor or pharmacist.

Adults

The recommended dose for adults is 1 sachet, 3 times a day, with a schedule of 1 sachet every 8 hours. Your doctor may need to start treatment with a lower dose to avoid possible side effects.

Do not take more than 3 sachets per day. The treatment is usually given for two years (24 months).

  • Empty the contents of the sachet into a glass of tomato or orange juice.
  • Drink it immediately.
  • If some granules remain in the glass, add a little more juice and drink it immediately.

Use in infants, children and adolescents

The doctor will calculate the dose for infants, children and adolescents based on the patient's body weight. The recommended total daily dose is 150 mg per kg of body weight. This daily amount is divided into two doses distributed throughout the day.

  • Use the measuring spoon provided with the medicine to measure the dose.
  • To measure the dose:
    1. The lines on the measuring spoon indicate the amount (in milligrams of para-aminosalicylic acid). Take the correct amount that your doctor has prescribed.
    1. Put the granules directly into the measuring spoon.
      1. Gently tap the measuring spoon on a table to level the granules horizontally and fill it more if necessary.
    • Sprinkle the granules over apple puree or yoghurt.
    • Have your child eat it immediately.

    Use of this medicine

    • Do not crush or chew the granules. Swallow the granules whole. It is important that you do not dissolve, crush or chew the granules, as they may not be absorbed correctly and may cause stomach pain or bleeding.
    • Do not use the sachet if it is swollen or the granules have lost their original light brown color.
    • You may see granules in the stool; this is normal.

    If you take more GRANUPAS than you should

    Consult your doctor or pharmacist.

    If you forget to take a dose of GRANUPAS

    Do not take a double dose to make up for forgotten doses. Wait until the next dose is due and take the usual dose.

    If you have any other questions on how to use this medicine, ask your doctor or pharmacist.

    4. Possible side effects

    Like all medicines, this medicine can cause side effects, although not everybody gets them.

    During the first 3 months of your treatment with GRANUPAS, you should pay attention to any signs of an allergic reaction (such as rash, red spots on the skin that itch, itching, hives, watery eyes, itchy eyes or nasal congestion) or hepatitis (such as fever, fatigue, dark urine, very light stools, abdominal pain, yellow skin and eyes). If you experience any of these symptoms, you should consult your doctor immediately.

    Common side effects (occurring in more than 1 patient in 100):

    • dizziness,
    • stomach pain (abdominal pain),
    • vomiting,
    • nausea,
    • hiccups,
    • diarrhea,
    • soft stools,
    • redness of the skin or rash,
    • alteration of gait or balance.

    Uncommon side effects (occurring in more than 1 patient in 1,000):

    • loss of appetite (anorexia)

    Rare side effects (occurring in more than 1 patient in 10,000):

    • thyroid problems*,
    • decreased ability to absorb nutrients from food,
    • ulcer, intestinal bleeding,
    • yellowing of the skin or eyes (jaundice),
    • metallic taste,
    • itchy rash.
    • In people also infected with HIV, thyroid problems, in particular insufficient thyroid activity or low levels of thyroid hormones, are a very common side effect that may affect more than 1 in 10 people. Periodic monitoring of thyroid function is recommended for all people with HIV.

    Very rare side effects (occurring in less than 1 patient in 10,000):

    • reduction in the number of blood platelets,
    • red spots on the skin,
    • reduction in the number of white blood cells,
    • reduction in the number of red blood cells,
    • reduction in the ability of red blood cells to release oxygen,
    • low blood sugar levels,
    • tendon pain, headache,
    • visual disturbances, nerve damage to hands and feet,
    • dizziness,
    • crystals in the urine.
    • prolonged bleeding time,
    • liver cell destruction,
    • high enzyme levels,
    • weight loss,

    Side effects of unknown frequency (cannot be estimated from the available data)

    • hepatitis

    Reporting of side effects

    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

    5. Storage of GRANUPAS

    Keep this medicine out of the sight and reach of children.

    Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry date is the last day of the month stated.

    Do not store above 25°C. Once opened, the sachets can be stored below 25°C for up to 24 hours.

    Do not use this medicine if you notice that the sachets are swollen or the granules are dark brown or purple in color

    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

    6. Contents of the pack and other information

    Composition of GRANUPAS

    The active substance is para-aminosalicylic acid.

    Each sachet of gastro-resistant granules contains 4 g of para-aminosalicylic acid.

    The other ingredients are colloidal silicon dioxide, dibutyl sebacate, methacrylic acid copolymer (1:1) dispersion 30%, hypromellose, microcrystalline cellulose, talc.

    Appearance and packaging of the product

    This medicine is presented as a light brown gastro-resistant granule in sachets.

    Each carton contains 30 sachets. A measuring spoon is provided.

    Marketing authorisation holder

    Eurocept International BV

    Trapgans 5

    1244 RL Ankeveen

    The Netherlands

    Manufacturer

    Lucane Pharma

    172 rue de Charonne

    75011 Paris

    France

    Eurocept International BV

    Trapgans 5

    1244 RL Ankeveen

    The Netherlands

    You can request more information about this medicine from the local representative of the marketing authorisation holder:

    Belgium/Belgique/Belgien

    Lithuania

    Lucane Pharma

    FrostPharma AB

    Tel: + 33 153 868 750

    Tel: +46 775 86 80 02

    [email protected]

    [email protected]

    Bulgaria

    Luxembourg/Luxemburg

    Lucane Pharma

    Lucane Pharma

    Tel: + 33 153 868 750

    Tel: + 33 153 868 750

    [email protected]

    [email protected]

    Czech Republic

    Hungary

    Lucane Pharma

    Lucane Pharma

    Tel: + 33 153 868 750

    Tel: + 33 153 868 750

    [email protected]

    [email protected]

    Denmark

    Malta

    FrostPharma AB

    Lucane Pharma

    Tel: +45 808 20 101

    Tel: + 33 153 868 750

    [email protected]

    [email protected]

    Germany

    Netherlands

    Lucane Pharma

    Eurocept International BV

    Tel: + 33 153 868 750

    Tel: +31 35 528 39 57

    [email protected]

    [email protected]

    Estonia

    Norway

    FrostPharma AB

    FrostPharma AB

    Tel: +46 775 86 80 02

    Tel: +47 815 03 175

    [email protected]

    [email protected]

    Greece

    Austria

    Lucane Pharma

    Lucane Pharma

    Tel: + 33 153 868 750

    Tel: + 33 153 868 750

    [email protected]

    [email protected]

    Spain

    Poland

    Lucane Pharma

    Lucane Pharma

    Tel: + 33 153 868 750

    Tel: + 33 153 868 750

    [email protected]

    [email protected]

    France

    Portugal

    Lucane Pharma

    Overpharma

    Tel: + 33 153 868 750

    Tel: +351 214 307 760

    [email protected]

    [email protected]

    Croatia

    Romania

    Lucane Pharma

    Lucane Pharma

    Tel: + 33 153 868 750

    Tel: + 33 153 868 750

    [email protected]

    [email protected]

    Ireland

    Slovenia

    Lucane Pharma

    Lucane Pharma

    Tel: + 33 153 868 750

    Tel: + 33 153 868 750

    [email protected]

    [email protected]

    Iceland

    Slovakia

    FrostPharma AB

    Lucane Pharma

    Tel: +46 775 86 80 02

    Tel: + 33 153 868 750

    [email protected]

    [email protected]

    Italy

    Finland

    Lucane Pharma

    FrostPharma AB

    Tel: + 33 153 868 750

    Tel: +35 875 32 51 209

    [email protected]

    [email protected]

    Cyprus

    Sweden

    Lucane Pharma

    FrostPharma AB

    Tel: + 33 153 868 750

    Tel: +46 775 86 80 02

    [email protected]

    [email protected]

    Latvia

    United Kingdom

    FrostPharma AB

    Lucane Pharma

    Tel: +46 775 86 80 02

    Tel: + 33 153 868 750

    [email protected]

    [email protected]

    Date of last revision of this leaflet:

    Other sources of information

    Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

    There are also links to other websites on rare diseases and orphan medicines.

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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Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
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Gastroenterology – Digestive health:
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  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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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.

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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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Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

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If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

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Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

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Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

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  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
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  • Anaemia, including iron deficiency and related conditions.
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During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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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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