Pyrazinamide 500mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Pyrazinamide

Tilgjengelig fra:

Macleods Pharma UK Ltd

ATC-kode:

J04AK01

INN (International Name):

Pyrazinamide

Dosering :

500mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 05010900; GTIN: 18901463146481

Informasjon til brukeren

2.
What you need to know before you take
Pyrazinamide tablets
3.
How to take Pyrazinamide tablets
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
PYRAZINAMIDE
PYRAZINAMIDE 500 MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
1.
What Pyrazinamide tablets are and what
they are used for
-
If you have any further questions, ask
your doctor or pharmacist.
-
Keep this leaflet. You may need to read
it again.
-
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.
-
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.
WHAT IS IN THIS LEAFLET
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:
Ÿ
if you are allergic to pyrazinamide or
any of the other ingredients of this
medicine (listed in section 6 );
Ÿ
if you are breast-feeding;
Ÿ
if you have liver disease;
Ÿ
if you have gouty arthritis (arthritis
associated with inflammation of the
joints);
Ÿ
if you have an abnormally high
concentration of uric acid in your blood;
Ÿ
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
Ÿ
if you are or think you may be pregnant;
Ÿ
if you have kidney problems;
Ÿ
if you have a hist

Preparatomtale

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 standard 6
month regimen