The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/13/896/001.
GRANUPAS 4 g gastro-resistant granules
1. What GRANUPAS is and what it is used for
2. What you need to know before you take GRANUPAS
3. How to take GRANUPAS
4. Possible side effects
5. How to store GRANUPAS
6. Contents of the pack and other information
GRANUPAS contains para-aminosalicylic acid which is used in adults and children aged 28 days and older to treat resistant tuberculosis in combination with other medicines, in cases of resistance or intolerability with other treatments.
If you are not sure, talk to your doctor or pharmacist before taking GRANUPAS.
Talk to your doctor or pharmacist before taking GRANUPAS
Use of GRANUPAS is not recommended in newborn babies (under 28 days of age).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important to tell your doctor if you are taking any of the following:
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 is not recommended during pregnancy and should only be used if advised by your physician.
Do not breastfeed whilst taking GRANUPAS. This is because small amounts of the medicine can pass into mother’s milk.
GRANUPAS is unlikely to affect your ability to drive any vehicle and use machines. In case it does, please report it to your doctor or pharmacist.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults is 1 sachet three times a day, with a schedule of 1 sachet every 8 hours. Your physician may need to start with a lower dose to prevent possible side effects. Do not take more than 3 sachets per day. Treatment is usually given for two years (24 months).
The dose in infants, children and adolescents will be calculated by your doctor based on the patient’s body weight. The recommended total dose per day is 150 mg for each kg of body weight. This daily amount is divided into two doses spread out through the day.
Speak to a doctor or pharmacist.
Do not take a double dose to make up for a forgotten dose. Wait until the next dose is due, then take your normal dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 must be attentive to any sign of allergic reaction (for example skin eruption, itchy red spots on the skin, itching, rash, watery or itchy eyes or stuffy nose) or hepatitis (for example fever, fatigue, dark urine, pale stool, abdominal pain, yellow skin and eyes). If you experience any of these symptoms, you must contact to your doctor immediately.
Common side effects (may affect more than 1 in 100 people):
Uncommon side effects (may affect more than 1 in 1,000 people):
Rare side effects (may affect more than 1 in 10,000 people):
(*) in subjects also infected with HIV thyroid gland problems and specifically underactive thyroid or low levels of thyroid hormones, are a very common side effect that may affect more than 1 in 10 people. Regular monitoring of the thyroid function is indicated for all people living with HIV.
Very rare side effects (may affect less than 1 in 10,000 people):
Not known side effects (frequency cannot be estimated from the available data):
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 refers to the last day of the month.
Do not store above 25°C. The sachets can be stored below 25°C up to 24 hours after opening.
Do not use this medicine if you notice the sachets are swollen or if the granules are dark brown or purple.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is para-aminosalicylic acid.
Each sachet of gastro-resistant granules contains 4 g of para-aminosalicylic acid.
The other ingredients are silica, colloidal hydrated, dibutyl sebacate, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 per cent, hypromellose, cellulose, microcrystalline, talc.
This medicine is presented as light brown gastro-resistant granules in sachets.
Each box contains 30 sachets. A calibrated measuring spoon is provided.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 11/2019
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
There are also links to other websites about rare diseases and treatments.