Cetriz 10mg Film-coated Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Cetirizine hydrochloride

可用日期:

Teva B.V.

ATC代码:

R06AE; R06AE07

INN（国际名称）:

Cetirizine hydrochloride

药物剂型:

Film-coated tablet

治疗领域:

Piperazine derivatives; cetirizine

授权状态:

Marketed

授权日期:

2006-07-07

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
CETRIZ 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 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 CETRIZ IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETRIZ
3
HOW TO TAKE CETRIZ
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE CETRIZ
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT CETRIZ IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Cetriz 10 mg
Film-coated Tablets. Cetriz 10
mg Film-coated Tablets are an antiallergic medication.
In adults and children aged 6 years and above, Cetriz 10 mg
Film-coated Tablets are indicated:
• for the relief of symptoms of hayfever (seasonal allergic
rhinitis) and allergies such as dust or
pet allergies (perennial allergic rhinitis) such as sneezing, itchy,
runny and blocked nose, red and
watery eyes.
• for the relief of swelling, redness and itchiness of the skin
(symptoms of chronic idiopathic
urticaria, which is also known as chronic nettle rash).
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETRIZ
DO NOT TAKE CETRIZ
• if you are allergic to cetirizine, to any of the other ingredients
of this medicine (listed in section
6), to hydroxyzine or to drugs from the piperazine family, for example
buclizine, cyclizine,
meclozine, levocetirizine.
• if you have a severe kidney disease (severe renal failure with
creatinine clearance

产品特点

Health Products Regulatory Authority
19 April 2023
CRN00DFG4
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cetriz 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains cetirizine dihydrochloride 10 mg.
Excipients with known effect: contains lactose monohydrate 117.00 mg.
For the full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
Film-coated, white or almost white convex, oval shaped, tablets.
Scored on one side. 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
Posology
Adults and adolescents over 12 years of age: 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 case no alternative treatment
can be used, the dosing intervals must be individualised
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 requiring dialysis treatment
5 mg once every 2 days
End-stage renal disease
<15 requiring dialysis treatment
Contraindicated
_Hepatic impairment_
No dos