Zirtek 10 mg film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Cetirizine hydrochloride

Disponibil de la:

UCB (Pharma) Ireland Limited

Codul ATC:

R06AE; R06AE07

INN (nume internaţional):

Cetirizine hydrochloride

Dozare:

10 milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

Product not subject to medical prescription

Zonă Terapeutică:

Piperazine derivatives; cetirizine

Statutul autorizaţiei:

Marketed

Data de autorizare:

1988-08-08

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIRTEK 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 Zirtek is and what it is used for
2.
What you need to know before you take Zirtek
3.
How to take Zirtek
4.
Possible side effects
5.
How to store Zirtek
6.
Contents of the pack and other information
1.
WHAT ZIRTEK IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zirtek.
Zirtek is an antiallergic medication.
In adults and children aged 6 years and above, Zirtek 10 mg
film-coated tablets are indicated
-
for the relief of nasal and ocular symptoms of seasonal and perennial
allergic rhinitis.
-
for the relief of urticaria.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZIRTEK
DO NOT TAKE ZIRTEK
-
if you have a severe kidney disease requiring dialysis;
-
if you are allergic to cetirizine dihydrochloride, to any of the other
ingredients (listed in
section 6), to hydroxyzine or to piperazine derivatives (closely
related active ingredients of
other medicines).
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zirtek.
If you are a patient with renal insufficiency, please ask your doctor
for advice; if necessary, you will
take a lower dose. The new dose will be determined by your doctor.
If you have problems passing urine (like spinal cord problems or
prostate or bladder problems), please
ask your doctor for advice.
If you are an epileptic patient or a patient at risk of convulsions,
you should ask your docto

Caracteristicilor produsului

Health Products Regulatory Authority
02 October 2023
CRN00DGKH
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zirtek 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg cetirizine dihydrochloride.
Excipients with known effect: one film-coated tablet contains 66.40 mg
lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
White, oblong, film-coated tablet, with breakline and Y-Y logo.
The tablet can be divided into 2 equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cetirizine dihydrochloride 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
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 cases no alternative treatment can
be used, the dosing intervals must be individualized
according to renal function. Refer to the following table and adjust
the dose as indicated.
Dosing adjustments for adult patients with impaired renal function
Group
Estimated Glomerular Filtration Rate (eGFR) (ml/min)
Dosage and frequency
Normal renal function
>90
10 mg once daily
Mildly decreased renal function
60 - < 90
10 mg once daily
Moderately decreased renal function
30 – < 60
5 mg once daily
Severely decreased renal function
15 - <30 not requiring dialysis treatment
5 mg once every 2 days
End-stage renal disease
<15 requiring dialysis treatment
Contraindicated
_Hepatic impairment_
Health Products Regulatory Authority
02 October