4 g enterogranulate
para-aminosalicylic acid
1. What GRANUPAS is and what it is used for
GRANUPAS contains para-aminosalicylic acid, which is given to adults and children from at least 28 days of age to treat resistant tuberculosis in combination with other medicines, in case of resistance or intolerance to other treatments.
2. What you need to know before taking GRANUPAS
Do not take GRANUPAS
- you are allergic to para-aminosalicylic acid or any of the other ingredients of this medicine (listed in section 6)
- you have severe kidney disease.
If you are not sure, talk to your doctor or pharmacist before taking GRANUPAS.
Warnings and cautions
Talk to your doctor or pharmacist before taking GRANUPAS
- if you have liver problems or mild or moderate kidney disease
- if you have stomach ulcers
- if you are infected with HIV
Children
The use of GRANUPAS is not recommended for newborns (under 28 days of age).
Other medicines and GRANUPAS
Tell your doctor or pharmacist if you 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 for tuberculosis or ethionamide (other treatments for tuberculosis )
- Vitamin B12
- Digoxin (for heart disease)
- Diphenylhydramine (for allergic reactions)
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 you get the go-ahead from your doctor. Do not breastfeed while taking GRANUPAS. The reason is that small amounts of the drug can pass over to breast milk.
Driving and using machines
GRANUPAS is unlikely to affect the ability to drive or use machines. If it does, it should be reported to a doctor or pharmacist.
3. How to take GRANUPAS
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Adults
The recommended dose for adults is 1 sachet three times a day; 1 sachet every 8 hours. Your doctor may need to start treatment with a lower dose to prevent any side effects.
Do not take more than 3 sachets each day. The treatment is usually given for two years (24 months).
- Add the contents of the sachet to a glass of tomato or orange juice.
- Drink it immediately.
- If any granules remain in the glass, add more juice and drink it immediately.
Use for infants, children, and adolescents
The dose in infants, children, and adolescents is calculated by the doctor based on the patient’s body weight. The recommended total dose per day is 150 mg per kg body weight. This daily amount is divided into two doses that are spread out during the day.
- Use the spoon that comes with the medicine to measure dose one.
- To measure the dose:
- The lines on the spoons show the amount (in milligrams of para-aminosalicylic acid). Take the correct amount according to the doctor’s instructions.
- Add granules directly to the spoon.
- Tap the spoons once against a table so that the granules are horizontal and continue to refill if necessary.
- Sprinkle granules one over apple puree or yogurt.
- Make sure your child eats it immediately.
Taking this medicine
- Granules should not be crushed or chewed. Swallow granules whole. It is important that you do not dissolve, crush or chew granules one as it is possible that they will not be absorbed properly and can cause stomach pain or bleeding.
- Do not use the sachet if it is swollen or granular and has lost its light brown color.
- You may see granules in the stool, which is normal.
If you take more GRANUPAS than you should
Talk to a doctor or pharmacist.
If you forget to take the dose of GRANUPAS
Do not take a double dose to make up for a forgotten dose. Wait until it is time for the next dose, and then take your normal dose.
If you have any further questions on the use of this product, 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 must be aware of all signs of allergic reactions (eg skin rash, red itchy spots on the skin, itching, rash, watery or itchy eyes or stuffy nose) or hepatitis (t. eg fever, fatigue, dark urine, light stools, abdominal pain, yellowish skin, and yellowish eyes). Contact your doctor immediately if you experience any of these symptoms.
Common side effects are (may affect more than 1 in 100 people:
- feeling unsteady,
- abdominal pain (stomach pain),
- vomiting,
- nausea,
- weather voltage,
- diarrhea
- soft stools,
- redness or rash,
- disturbance in the aisle and balance.
Less common side effects are (may affect more than 1 in 1000 people):
- loss of appetite
Rare side effects are (may affect more than 1 in 10,000 people):
- thyroid problems *,
- impaired absorption of nutrients from food,
- gastric ulcer ,
- gastric haemorrhage,
- yellowing of the skin or eyes (jaundice),
- metallic taste,
- itchy rash.
(*) in patients who are also infected with HIV, thyroid problems, especially underactive thyroid gland or low levels of thyroid hormone, are a very common side effect that can affect more than 1 in 10 people. Regular monitoring of thyroid function is indicated for people living with HIV.
Very rare side effects are (may affect less than 1 in 10,000 people):
- decreased platelet count ,
- red spots on the skin,
- decreased white blood cell count ,
- decreased number of red blood cells ,
- decreased ability of blood cells to release oxygen,
- low blood sugar levels,
- pain in tendons,
- headache,
- visual aberrations,
- nerve damage in hands and feet,
- dizziness,
- crystals in the urine,
- prolonged bleeding time,
- degradation of liver cells,
- elevated liver enzymes,
- weight loss.
Not known side effects are (can not be estimated from the available data):
- hepatitis
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store 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 expiration date is the last day of the month.
Do not store above 25 ° C. The sachets can be stored below 25 ° C for up to 24 hours after opening.
Do not use this medicine if you notice that the sachets are swollen or if the granules are dark brown or purple.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is para-aminosalicylic acid.
Each sachet of enterogranulate contains 4 g of para-aminosalicylic acid.
The other ingredients are colloidal silicon dioxide, dibutyl sebacate, methacrylic acid – ethyl acrylate copolymer (1: 1) dispersion 30 percent, hypromellose, microcrystalline cellulose, talc.
What the medicine looks like and contents of the pack
This medicine is available as light brown enterogranules in sachets.
Each box contains 30 sachets. A calibrated measuring spoon is included.
Marketing Authorisation Holder
Eurocept International BV
Trapgans 5
1244 RL Ankeveen
Netherlands
Manufacturer
Lucane Pharma
172 rue de Charonne
75011 Paris
France
Contact the representative of the marketing authorization holder to find out more about this medicine:
FrostPharma AB
Tel: +46 775 86 80 02
info@frostpharma.com