Zirtek 1 mg/ml oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cetirizine dihydrochloride

Available from:

Lexon Pharmaceuticals (Ireland) Limited

ATC code:

R06AE; R06AE07

INN (International Name):

Cetirizine dihydrochloride

Pharmaceutical form:

Oral solution

Therapeutic area:

Piperazine derivatives; cetirizine

Authorization date:

2023-06-02

Patient Information leaflet

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
What Zirtek is and what it is used for
What you need to know before you take Zirtek
How to take Zirtek
Possible side effects
How to store Zirtek
Contents of the pack and other information 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. 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 patient at risk of convulsions,
you should
ask your doctor for advice.
No clinically significant interactions have been observe

Summary of Product characteristics

Health Products Regulatory Authority
02 June 2023
CRN00DHS0
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 (E422)
Propylene glycol
Saccharin sodium
Methylparahydroxybenzoate (E218)
Propylparahydroxybenzoate (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 is the date shown on the
container and outer carton of this product as marketed in the
country of origin.
After first opening: 3 months
Health Products Regulatory Authority
02 June 2023
CRN00DHS0
Page 2 of 2
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 (type III Ph. Eur.) containing volume 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 AND OTHER HANDLING
No special requirements.
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3,
Harcourt Centre,
Har