Zirtene 10 mg film-coated tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Cetirizine dihydrochloride

Tersedia dari:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Kode ATC:

R06AE; R06AE07

INN (Nama Internasional):

Cetirizine dihydrochloride

Dosis:

10 milligram(s)

Bentuk farmasi:

Film-coated tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Piperazine derivatives; cetirizine

Status otorisasi:

Marketed

Tanggal Otorisasi:

2006-06-13

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZIRTENE 10 MG FILM-COATED TABLETS
cetirizine dihydrochloride
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 Zirtene is and what it is used for
2. What you need to know before you take Zirtene
3. How to take Zirtene
4. Possible side effects
5. How to store Zirtene
6. Contents of the pack and other information
1.
WHAT ZIRTENE IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zirtene.
Zirtene is an anti-allergy medication.
In adults and children aged 6 years and above, Zirtene 10 mg
film-coated tablets are indicated:

for the relief of nasal and ocular symptoms of hay fever (seasonal
allergic rhinitis) and allergies
such as dust or pet allergies (perennial allergic rhinitis), such as
sneezing, itchy, runny and
blocked nose, red and watery eyes.

for the relief of chronic nettle rash (chronic idiopathic urticaria).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZIRTENE
DO NOT TAKE ZIRTENE

if you have a severe kidney disease and are undergoing dialysis due to
severe kidney failure
(creatine clearance below 10 ml/min);

if you are allergic to cetirizine dihydrochloride, to any of the other
ingredients of this medicine
(listed in section 6), to hydroxyzine or to piperazine derivatives
(closely related active ingredients
of other medicines).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zirtene:

if you have kidney (renal insufficiency) problems. You may need to
take a lower dose.

Karakteristik produk

Health Products Regulatory Authority
14 April 2020
CRN009LY7
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zirtene 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains10 mg cetirizine dihydrochloride.
Excipient with known effect:
Each film-coated tablet contains 74.3 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, capsule shaped, film-coated tablet with score line and marked
‘CZ’ and ‘10’ on one side and marked ‘G’ on the reverse.
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
Zirtene 10 mg film-coated tablets are indicated in adults and
paediatric patients 6 years and above:
- for the relief of nasal and ocular symptoms of seasonal and
perennial allergic rhinitis.
- for the relief of symptoms of chronic idiopathic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
10 mg once daily (1 tablet)
Special Population
_Elderly_
Data do not suggest that the dose needs to be reduced in elderly
subjects provided that the renal function is normal.
_Renal impairment_
There are no data to document the efficacy/safety ratio in patients
with renal impairment. Since cetirizine is mainly excreted via
renal route (see section 5.2), in case no alternative treatment can be
used, the dosing intervals must be individualised
according to renal function. Refer to the following table and adjust
the dose as indicated. To use this dosing table, an estimate
of the patient's creatinine clearance (CL
cr
) in ml/min is needed. The CL
cr
(ml/min) may be estimated from serum creatinine
(mg/dl) determination using the following formula:
Dosing adjustments for adult patients with impaired renal function
GROUP
CREATININE CLEARANCE (ML/MIN)
DOSAGE AND FREQUENCY
Normal
≥ 80
10 mg once daily
Mild
50 – 79
10 mg once daily
Health Products Regulatory Author