Zirtek 1 mg/ml oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cetirizine dihydrochloride

Available from:

IMED Healthcare Ltd.

ATC code:

R06AE; R06AE07

INN (International Name):

Cetirizine dihydrochloride

Pharmaceutical form:

Oral solution

Therapeutic area:

Piperazine derivatives; cetirizine

Authorization status:

Marketed

Authorization date:

2023-08-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE
USER
ZIRTEK 1 MG/ML ORAL SOLUTION
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 any possible side
effects not listed in this leaflet. See section 4.
-
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 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 2 years and above, Zirtek 1 mg/ml oral
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 or any of the other
ingredients of this medicine
(listed in section 6), to hydroxyzine or to any piperazine derivatives
(closely related active
ingredients of other medicines).
WARNINGS 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 p

Summary of Product characteristics

Health Products Regulatory Authority
25 August 2023
CRN00DP02
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zirtek 1 mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1 mg cetirizine dihydrochloride.
Excipients with known effect:

one ml of solution contains 450 mg sorbitol (solution at 70 %, non
crystallizing)

one ml of solution contains 1.35 mg methylparahydroxybenzoate

one ml of solution contains 0.15 mg propylparahydroxybenzoate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution
_Product imported from Spain:_
Clear and colorless liquid with slightly sweet taste and a banana
flavour
4 CLINICAL PARTICULARS
As per PA0891/008/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0891/008/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sorbitol solution at 70% (non crystallizing) (E420)
Glycerol
Propylene glycol (E1520)
Sodium saccharin
Methyl parahydroxybenzoate (E218)
Propyl parahydroxyhenzoate (E216)
Banana flavour 54.330/A (Firmenich)
Sodium acetate
Glacial acetic acid
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
25 August 2023
CRN00DP02
Page 2 of 2
After first opening: 3 months
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass bottle containing volumes of 200 ml, closed with a white
polypropylene "child-proof" cap.
A 5 ml measuring spoon with a line at 2.5 ml is provided with the
bottle.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd,
Unit 625 Kilshane Avenue,
Northwest Business Park,
Ballycoolin,