Zirtek 10 mg/ml Oral Drops, Solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
02-10-2023
Summary of Product characteristics
(SPC)
02-10-2023
Active ingredient:
Cetirizine dihydrochloride
Available from:
UCB (Pharma) Ireland Limited
ATC code:
R06AE; R06AE07
INN (International Name):
Cetirizine dihydrochloride
Dosage:
10 milligram(s)/millilitre
Pharmaceutical form:
Oral drops, solution
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Piperazine derivatives; cetirizine
Authorization status:
Not marketed
Authorization date:
2009-08-28
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIRTEK 10 MG/ML ORAL DROPS, SOLUTION
Cetirizine dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 do 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 paediatric patients aged 2 years and above, Zirtek 10
mg/ml oral drops, solution 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
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 any 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,
y
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Summary of Product characteristics
Health Products Regulatory Authority
02 October 2023
CRN00DGKH
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zirtek 10 mg/ml Oral Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral drops, solution contains 10 mg cetirizine
dihydrochloride, one drop of solution contains 0.5 mg cetirizine
dihydrochloride
Excipients with known effect:
- one ml of solution contains 1.35 mg methylparahydroxybenzoate (E
218)
- one ml of solution contains 0.15 mg propylparahydroxybenzoate (E
216)
- one ml of solution contains 350 mg propylene glycol (E 1520)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral drops, solution
Clear and colorless liquid with slightly sweet taste and a bitter
flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cetirizine dihydrochloride 10 mg/ml oral drops, solution is indicated
in adults and paediatric patients 2 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 (20 drops).
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 eliminated
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 req
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