Zyrtec 10mg film-coated Tablets

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

CETIRIZINE HYDROCHLORIDE

Tilgjengelig fra:

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

ATC-kode:

R06AE07

INN (International Name):

CETIRIZINE HYDROCHLORIDE 10 mg

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

CETIRIZINE HYDROCHLORIDE 10 mg

Resept typen:

OTC

Terapeutisk område:

ANTIHISTAMINES FOR SYSTEMIC USE

Autorisasjon status:

Authorised

Autorisasjon dato:

2005-07-27

Informasjon til brukeren

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYRTEC 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. 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.
Content of the pack and further 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 6 years and above, Zyrtec 10 mg
film-coated tablets are 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, 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 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 epileptic patient or a pat

Preparatomtale

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1.
NAME OF THE MEDICINAL PRODUCT
Zyrtec 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 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 treatment
5 mg once every 2 days
End-stage renal disease
<15 requiring dialysis
treatment
Contraindicated
_Hepatic impairment_
No dose adjustment is needed in patients with solely hepatic
impairment. In patients with
hepatic impairment and renal impair