Pyrazinamide Tablets 500mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PYRAZINAMIDE

Available from:

Macleods Pharma UK Ltd Wynyard Park House, Wynyard Avenue, Wynyard, Billingham TS22 5TB , United Kingdom

ATC code:

J04AK01

INN (International Name):

PYRAZINAMIDE 500 mg

Pharmaceutical form:

TABLET

Composition:

PYRAZINAMIDE 500 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOBACTERIALS

Authorization status:

Withdrawn

Authorization date:

2018-11-20

Patient Information leaflet

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1
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4
PACKAGE LEAFLET: INFORMATION FOR THE USER
PYRAZINAMIDE 500 MG TABLETS
PYRAZINAMIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Pyrazinamide tablets are and what they are used for
2.
What you need to know before you take Pyrazinamide tablets
3.
How to take Pyrazinamide tablets
4.
Possible side effects
5.
How to store Pyrazinamide tablets
6.
Contents of the pack and other information
1.
WHAT PYRAZINAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Pyrazinamide tablets contain pyrazinamide, which is an antituberculous
agent. Pyrazinamide tablets
are used for treating tuberculosis, commonly called ‘TB’. These
products work by killing a particular
type of bacteria which causes tuberculosis. Pyrazinamide tablets are
always given in combination with
other antituberculous agents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYRAZINAMIDE TABLETS
DO NOT TAKE PYRAZINAMIDE TABLETS:
•
if you are allergic to pyrazinamide or any of the other ingredients of
this medicine (listed in
section 6 );
•
if you are breast-feeding;
•
if you have liver disease;
•
if you have gouty arthritis (arthritis associated with inflammation of
the joints);
•
if you have an abnormally high concentration of uric acid in your
blood;
•
if you have a condition that results in a high level of porphyrin in
your urine and extreme
sensitivity to light.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Pyrazinamide tablets
•
if you are or think you may be pregnant;
•
if you have kidney problem

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pyrazinamide 500 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of pyrazinamide Ph. Eur.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Round, white to off white uncoated, scored tablets with notches,
debossed ‘F’ above the score
and ‘43’ below the score and plain on other side. Diameter of 12.0
± 0.2 mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
‘Pyrazinamide’ is indicated in patients with active tuberculosis
caused by
_Mycobacterium _
_tuberculosis_
. ‘Pyrazinamide’ is not active against the atypical mycobacteria.
‘Pyrazinamide’
should only be given in combination with other antituberculous agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dosage for standard unsupervised 2-month treatment:
_Adults_
: Under 50kg bodyweight: maximum of 3 tablets or 1.5g daily. Patients
≥ 50kg and over
bodyweight: maximum of 4 tablets or 2g daily.
_Children: _
35mg/kg daily.
Recommended dosage for intermittent supervised 2-month treatment:
_Adults_
: Under 50kg bodyweight: maximum of 4 tablets or 2g 3 times a week.
Patients ≥ 50kg and over bodyweight: maximum of 5 tablets or 2.5g 3
times a week.
_Children: _
50mg/kg 3 times a week.
‘Pyrazinamide’ should be administered with at least one other
effective antituberculous drug.
The use of ‘Pyrazinamide’ in combination therapy does not modify
the accepted dosages of
other antituberculous agents.
_Use in elderly_
: The general considerations outlined above should also apply to
elderly patients.
_Immunocompromised patients_
: Multi-resistant
_M. tuberculosis _
may be present in
immunocompromised patients. The organism should always be cultured to
confirm its type and
drug sensitivity. Confirmed
_M. Tuberculosis _
infection sensitive to first-line drugs should be
treated with a stand