Zinamide 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pyrazinamide

Available from:

Genus Pharmaceuticals Ltd

ATC code:

J04AK01

INN (International Name):

Pyrazinamide

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010900; GTIN: 5030451003874

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZINAMIDE TABLETS 500MG
(PYRAZINAMIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
- 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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If any of the side-effects get serious, or if you notice any
side-effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Zinamide Tablets 500mg are and what they are used for
2. Before you take Zinamide Tablets 500mg
3.
How to take Zinamide Tablets 500mg
4.
Possible side-effects
5.
How to store Zinamide Tablets 500mg
6.
Further information
1.
WHAT ZINAMIDE TABLETS 500MG ARE AND WHAT THEY ARE USED FOR
Zinamide Tablets 500mg contain pyrazinamide, which is an
antituberculous agent. Zinamide Tablets
500mg are used for treating tuberculosis, commonly called ‘TB’.
These products work by killing a
particular type of bacteria which causes tuberculosis. Zinamide
Tablets are always given in
combination with other antituberculous agents.
2.
BEFORE YOU TAKE ZINAMIDE TABLETS 500MG
DO NOT TAKE ZINAMIDE TABLETS 500MG IF YOU:
•
are allergic (hypersensitive) to pyrazinamide or any of the other
ingredients of Zinamide Tablets
500mg (see section 6 – Further information for details)
•
are breast-feeding
•
have liver disease
•
have gouty arthritis (arthritis associated with inflammation of the
joints)
•
have an abnormally high concentration of uric acid in your blood
•
have a condition that results in a high level of porphyrin in your
urine and extreme sensitivity
to light.
TAKE SPECIAL CARE WITH ZINAMIDE TABLETS 500MG IF YOU:
•
are or think you may be pregnant
• have kidney problems
• have a history of gout (inflammation of the joints)
• have diabetes
• suffer from lactose intolerance
•
have received the oral typhoid vaccination, since Zinamide may stop

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zinamide Tablets 500mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of ‘Zinamide’ contains 500 mg of pyrazinamide Ph Eur.
Excipients with known effect
Each tablet of ‘Zinamide’ contains 150.6 mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White tablets, with one side scored and marked ‘GP 504’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
‘Zinamide’
is
indicated
in
patients
with
active
tuberculosis
caused
by
_Mycobacterium tuberculosis_. ‘Zinamide’ is not active against the
atypical
mycobacteria. ‘Zinamide’ should only be given in combination with
other
antituberculous agents.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Recommended dosage for standard unsupervised 2-month treatment:
_Adults_: Under 50kg bodyweight: maximum of 3 tablets or 1.5g daily.
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.
50kg and over bodyweight: maximum of 5 tablets or 2.5g 3 times a week.
_Children:_ 50mg/kg 3 times a week.
Zinamide’ should be administered with at least one other effective
antituberculous drug. The use of ‘Zinamide’ in combination therapy
does not
modify the accepted dosages of other antituberculous agents.
_Use in the 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;
after completing treatment, patients should be closely monitored. The
regimen
may need to be modified if infection is caused by resistant organisms
and
specialist advice is needed.
In