Zitrease Allergy 10 mg Film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Cetirizine hydrochloride

제공처:

Bluefish Pharmaceuticals AB

ATC 코드:

R06AE; R06AE07

INN (국제 이름):

Cetirizine hydrochloride

약제 형태:

Film-coated tablet

치료 영역:

Piperazine derivatives; cetirizine

승인 상태:

Not marketed

승인 날짜:

2004-02-06

환자 정보 전단

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZITREASE ALLERGY 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 Zitrease Allergy is and what it is used for
2.
What you need to know before you take Zitrease Allergy
3.
How to take Zitrease Allergy
4.
Possible side effects
5.
How to store Zitrease Allergy
6.
Contents of the pack and other information
1.
WHAT ZITREASE ALLERGY IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zitrease
Allergy 10 mg
Tablets.
Zitrease Allergy 10 mg Tablets is an antiallergic medication.
In adults and children aged 6 years and above, Zitrease Allergy 10 mg
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 ZITREASE ALLERGY
DO NOT TAKE ZITREASE ALLERGY:
•
if you have 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).
Page 2 of 7
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zitrease Allergy
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 pr

제품 특성 요약

Health Products Regulatory Authority
16 August 2023
CRN00DM80
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zitrease Allergy 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 101.83
mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White circular biconvex film-coated tablets, embossed ‘A’ on one
side and a deep score on the other.
The tablet can be divided into 2 equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cetirizine dihydrochloride 10 mg film-coated tablets are indicated in
adults and paediatric
patients 6 year 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. To use this dosing table, an
estimate of the patient's creatinine clearance (CLcr) in ml/min is
needed. The CLcr (ml/min) may be estimated from serum
creatinine (mg/dl) determination using the following formula:
Dosing adjustments for adult patients with impaired renal function
Group
Estimated Glomeular 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
Health Products Regulatory Authority
16 August 20