Granupas (previously Para-aminosalicylic acid Lucane)

Țară: Uniunea Europeană

Limbă: engleză

Sursă: EMA (European Medicines Agency)

Ingredient activ:

Para-aminosalicylic acid

Disponibil de la:

Eurocept International B. V.

Codul ATC:

J04AA01

INN (nume internaţional):

para-aminosalicylic acid

Grupul Terapeutică:

Antimycobacterials

Zonă Terapeutică:

Tuberculosis

Indicații terapeutice:

Granupas is indicated for use as part of an appropriate combination regimen for multi-drug resistant tuberculosis in adults and paediatric patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see section 4.4).Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Rezumat produs:

Revision: 11

Statutul autorizaţiei:

Authorised

Data de autorizare:

2014-04-07

Prospect

17
B. PACKAGE LEAFLET
18
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.
WHAT IS IN THIS LEAFLET
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
1.
WHAT GRANUPAS IS AND WHAT IT IS USED FOR
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.
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, talk to your doctor or pharmacist before taking
GRANUPAS.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking 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
Use of GRANUPAS is not recommended in newborn babies (under 28 days of
age).
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 to tell your doctor if you are taking any
of the following:
•
Antitube

Caracteristicilor produsului

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
GRANUPAS 4 g gastro-resistant granules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 4 g of para-aminosalicylic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant granules
The granules are small off white/ light brown coloured approximately
1.5 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GRANUPAS is indicated for use as part of an appropriate combination
regimen for multi-drug
resistant tuberculosis in adults and paediatric patients from 28 days
of age and older when an effective
treatment regimen cannot otherwise be composed for reasons of
resistance or tolerability.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults_
4 g (one sachet) three times per day.
The recommended schedule is 4 g every 8 hours. GRANUPAS can be taken
with food.
Maximum daily dose is 12 g. Usual duration of treatment is 24 months.
_Desensitization_
Desensitization can be accomplished by starting with 10 mg
para-aminosalicylic acid (PAS) given as
a single dose. The dosage is doubled every 2 days until reaching a
total of 1 gram after which the
dosage is divided to follow the regular schedule of administration. If
a mild temperature rise or
skin reaction develops, the increment is to be dropped back one level
or the progression held for one
cycle. Reactions are rare after a total dosage of 1.5 g.
_Paediatric population_
The optimal dose regimen in children is uncertain. Limited
pharmacokinetic data suggest no
substantial difference between adults and children.
For infants, children and adolescents the dosage will be adapted to
the patient’s weight at 150 mg/kg
per day, divided in two intakes. A dosing spoon is provided to measure
small doses below 4 g
for young children.
The safety and efficacy of para-aminosalicylic acid in neonates have
not been established. No da