Zyrtec 1mg/ml oral solution

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

CETIRIZINE HYDROCHLORIDE

Boleh didapati daripada:

UCB Pharma SA 60 Allee de la Recherche, B-1070 Brussels, Belgium

Kod ATC:

R06AE07

INN (Nama Antarabangsa):

CETIRIZINE HYDROCHLORIDE 1 mg/ml

Borang farmaseutikal:

ORAL SOLUTION

Komposisi:

CETIRIZINE HYDROCHLORIDE 1 mg/ml

Jenis preskripsi:

OTC

Kawasan terapeutik:

ANTIHISTAMINES FOR SYSTEMIC USE

Status kebenaran:

Authorised

Tarikh kebenaran:

2005-07-27

Risalah maklumat

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYRTEC 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 Zyrtec is and what it is used for
2.
What you need to know before you take Zyrtec
3.
How to take Zyrtec
4.
Possible side effects
5.
How to store Zyrtec
6.
Contents of the pack and other information
1. WHAT ZYRTEC IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zyrtec.
Zyrtec is an antiallergic medication.
In adults and children aged 2 years and above, Zyrtec 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 ZYRTEC
DO NOT TAKE ZYRTEC
-
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 Zyrtec.
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.
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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 ep

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1.
NAME OF THE MEDICINAL PRODUCT
Zyrtec 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
Clear and colorless liquid with slightly sweet taste and a banana
flavour
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cetirizine dihydrochloride 1 mg/ml oral solution is indicated in
adults and children aged 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 (10 ml oral solution (2 full spoons)).
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.
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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
5 mg once every 2 days
End-stage renal disease
<15 requiring dialysis
treatment
Contraindicated
_Hepatic impairment_
No dose adjustment