GRANUPAS 4 g gastro-resistant granules
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.
Show originalContents of the leaflet
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
- What is GRANUPAS and what is it used for
- What you need to know before you take GRANUPAS
- How to take GRANUPAS
- Possible side effects
- Storage of GRANUPAS
- 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.
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
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:
- The lines on the measuring spoon indicate the amount (in milligrams of para-aminosalicylic acid). Take the correct amount that your doctor has prescribed.
- Put the granules directly into the measuring spoon.
- 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.
- 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.
- dizziness,
- stomach pain (abdominal pain),
- vomiting,
- nausea,
- hiccups,
- diarrhea,
- soft stools,
- redness of the skin or rash,
- alteration of gait or balance.
- loss of appetite (anorexia)
- 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.
- 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,
- hepatitis
Use of this medicine
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):
Uncommon side effects (occurring in more than 1 patient in 1,000):
Rare side effects (occurring in more than 1 patient in 10,000):
Very rare side effects (occurring in less than 1 patient in 10,000):
Side effects of unknown frequency (cannot be estimated from the available data)
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 | |
Bulgaria | Luxembourg/Luxemburg | ||
Lucane Pharma | Lucane Pharma | ||
Tel: + 33 153 868 750 | Tel: + 33 153 868 750 | ||
Czech Republic | Hungary | |
Lucane Pharma | Lucane Pharma | |
Tel: + 33 153 868 750 | Tel: + 33 153 868 750 | |
Denmark | Malta | |
FrostPharma AB | Lucane Pharma | |
Tel: +45 808 20 101 | Tel: + 33 153 868 750 | |
Germany | Netherlands |
Lucane Pharma | Eurocept International BV |
Tel: + 33 153 868 750 | Tel: +31 35 528 39 57 |
Estonia | Norway | |
FrostPharma AB | FrostPharma AB | |
Tel: +46 775 86 80 02 | Tel: +47 815 03 175 | |
Greece | Austria | |
Lucane Pharma | Lucane Pharma | |
Tel: + 33 153 868 750 | Tel: + 33 153 868 750 | |
Spain | Poland | |
Lucane Pharma | Lucane Pharma | |
Tel: + 33 153 868 750 | Tel: + 33 153 868 750 | |
France | Portugal | ||
Lucane Pharma | Overpharma | ||
Tel: + 33 153 868 750 | Tel: +351 214 307 760 | ||
Croatia | Romania | |
Lucane Pharma | Lucane Pharma | |
Tel: + 33 153 868 750 | Tel: + 33 153 868 750 | |
Ireland | Slovenia | |
Lucane Pharma | Lucane Pharma | |
Tel: + 33 153 868 750 | Tel: + 33 153 868 750 | |
Iceland | Slovakia | ||
FrostPharma AB | Lucane Pharma | ||
Tel: +46 775 86 80 02 | Tel: + 33 153 868 750 | ||
Italy | Finland | ||
Lucane Pharma | FrostPharma AB | ||
Tel: + 33 153 868 750 | Tel: +35 875 32 51 209 | ||
Cyprus | Sweden | |
Lucane Pharma | FrostPharma AB | |
Tel: + 33 153 868 750 | Tel: +46 775 86 80 02 | |
Latvia | United Kingdom | |
FrostPharma AB | Lucane Pharma | |
Tel: +46 775 86 80 02 | Tel: + 33 153 868 750 | |
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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to GRANUPAS 4 g gastro-resistant granulesDosage form: CAPSULE, 150 mgActive substance: rifabutinManufacturer: Binesa 2002 S.L.Prescription requiredDosage form: INJECTABLE, 300 mgActive substance: isoniazidManufacturer: Chiesi España S.A.U.Prescription requiredDosage form: TABLET, 150/25 mg/mgActive substance: isoniazid, combinationsManufacturer: Chiesi España S.A.U.Prescription required
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.
Frequently Asked Questions