ZISTA

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cetirizine hydrochloride 10mg;  ;  

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Cetirizine hydrochloride 10 mg

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Cetirizine hydrochloride 10mg     Excipient: Hypromellose Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Pregelatinised maize starch Purified talc   Titanium dioxide

Prescription type:

Pharmacy only

Manufactured by:

Glochem Industries Limited

Therapeutic indications:

For the relief of: · Nasal and ocular symptoms of seasonal and perennial allergic rhinitis · Symptoms of urticaria and insect bites

Product summary:

Package - Contents - Shelf Life: Blister pack, Clear PVC/Aluminium blister pack - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC/Aluminium blister pack - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC/Aluminium blister pack (dispensing only) - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2013-11-18

Summary of Product characteristics

Version 1.1
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Zista, 10 mg, tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg cetirizine hydrochloride.
Excipient with known effect:
lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to off white capsule shaped film coated tablets with breakline
on one side and ‘10’ embossed
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cetirizine is indicated for the relief of symptoms associated with
seasonal allergic rhinitis (hay fever)
and perennial allergic rhinitis. Symptoms treated effectively include
sneezing, rhinorrhea, post-nasal
discharge, nasal pruritus, ocular pruritus and tearing.
Cetirizine is also indicated for the treatment of:
•
allergic conjunctivitis;
•
insect bites and the uncomplicated skin manifestations of chronic
idiopathic urticaria. It
significantly reduces the occurrence, severity and duration of hives
and markedly reduces
pruritus.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended initial dose of cetirizine is 5 to 10 mg depending on
symptom severity, given as a
single daily dose with or without food. The time of administration may
be varied to suit individual
patient needs. If sufficient response is not obtained, the dose may be
increased to the maximum
recommended daily dose of 20 mg.
_Paediatric population _
CHILDREN AGED 6-12 YEARS
Same dose as for adults given as a single or divided dose.
CHILDREN AGED 2-6 YEARS
The recommended dose of cetirizine is 5 mg (half a tablet) once daily.
_Special populations _
USE IN ELDERLY
Data does not suggest that the dose needs to be reduced in elderly
subjects provided that the renal
function is normal.
RENAL IMPAIRMENT
The dosing intervals must be individualised according to renal
function.
Version 1.1
2
Refer to the following table and adjust the dose as indicated. To use
this dosing table, an estimate of
the patient’s creatinine clearance (CLcr) in mL/min is needed. The
CLcr (mL/min) may be estimat