Zirtek Allergy Relief 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cetirizine dihydrochloride

Available from:

UCB (Pharma) Ireland Limited

ATC code:

R06AE; R06AE07

INN (International Name):

Cetirizine dihydrochloride

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

Oral use

Units in package:

Boxes of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100 or 100 (10x10) tablets.

Prescription type:

Product not subject to medical prescription

Manufactured by:

UCB Pharma Ireland Ltd

Therapeutic group:

Piperazine derivatives

Therapeutic area:

Piperazine derivatives; cetirizine

Therapeutic indications:

In adults and paediatric patients 6 years and above: Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.

Authorization status:

Marketed

Authorization date:

2015-03-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIRTEK ALLERGY RELIEF 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.
Always take this medicine exactly as described in this leaflet, or as
your doctor or pharmacist
have told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes side effects not
listed in this leaflet.

You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET:
1. What Zirtek Allergy Relief is and what it is used for
2. What you need to know before you take Zirtek Allergy Relief
3. How to take Zirtek Allergy Relief
4. Possible side effects
5. How to store Zirtek Allergy Relief
6. Contents of the pack and other information
1.
WHAT ZIRTEK ALLERGY RELIEF IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zirtek Allergy
Relief.
Zirtek Allergy Relief is an antiallergic medication.
In adults and children aged 6 years and above, Zirtek Allergy Relief
is 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 ALLERGY RELIEF
DO NOT TAKE ZIRTEK ALLERGY RELIEF

if you have an end-stage kidney disease (severe renal failure
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 Allergy Relief.
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 pro

Summary of Product characteristics

Health Products Regulatory Authority
27 September 2021
CRN00C916
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zirtek Allergy Relief 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 individualised
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
GFR (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
Contra-indicated
Health Products Regulatory Authority
27 September 2021
CRN00C916
Page 2 of 8
_Hepatic impa