Xyzal 5 mg/ml oral drops, solution

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Levocetirizine dihydrochloride

可用日期:

UCB (Pharma) Ireland Limited

ATC代码:

R06AE; R06AE09

INN（国际名称）:

Levocetirizine dihydrochloride

剂量:

5 milligram(s)/millilitre

药物剂型:

Oral drops, solution

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Piperazine derivatives; levocetirizine

授权状态:

Not marketed

授权日期:

2005-12-02

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XYZAL 5 MG/ML ORAL DROPS, SOLUTION
For adults and children aged 2 years and above
Levocetirizine dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET
1.
What Xyzal is and what it is used for
2.
What you need to know before you take Xyzal
3.
How to take Xyzal
4.
Possible side effects
5.
How to store Xyzal
6.
Contents of the pack and other information
1.
WHAT XYZAL IS AND WHAT IT IS USED FOR
Levocetirizine dihydrochloride is the active ingredient of Xyzal.
Xyzal is an antiallergic medication.
For the treatment of signs of illness (symptoms) associated with:
•
allergic rhinitis (including persistent allergic rhinitis);
•
nettle rash (urticaria).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XYZAL
DO NOT TAKE XYZAL
-
if you are allergic to levocetirizine dihydrochloride, to cetirizine,
to hydroxyzine or any of the other
ingredients of this medicine (listed in section 6).
-
if you have a severe kidney disease requiring dialysis.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Xyzal.
If you are likely to be unable to empty your bladder (with conditions
such as spinal cord injury or enlarged
prostate), please ask your doctor for advice.
If you are scheduled for allergy testing, ask your doctor if you
should stop taking Xyzal for several days
before testing. This medicine may affect your allergy test results.
If you suffer from epilepsy or are at risk of convulsions, please ask
your doctor for advice as use of Xyzal
may cause seizur

产品特点

Health Products Regulatory Authority
22 November 2022
CRN00CX6H
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xyzal 5 mg/ml oral drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml (which is equivalent to 20 drops) contains 5 mg levocetirizine
dihydrochloride.
Excipients with known effect
0.3375 mg methyl parahydroxybenzoate/ml
0.0375 mg propyl parahydroxybenzoate/ml
350 mg propylene glycol/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution.
Clear solution from colourless to slightly brownish-yellow.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Xyzal 5 mg/ml oral drops, solution is indicated for symptomatic
treatment of allergic rhinitis (including persistent allergic
rhinitis) and urticaria in adults and children aged 2 years and above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and adolescents 12 years and above:
The daily recommended dose is 5 mg (20 drops).
_Elderly_
Adjustment of the dose is recommended in elderly patients with
moderate to severe renal impairment (see Renal impairment
below).
_Renal impairment_
The dosing intervals must be individualised according to renal
function (eGFR – estimated Glomerular Filtration Rate). Refer to
the following table and adjust the dose as indicated.
Dosing adjustments for patients with impaired renal function:
Group
eGFR
(ml/min)
Dosage and frequency
Normal renal function
³ 90
5 mg once daily
Mildly decreased renal function
60 – < 90
5 mg once daily
Moderately decreased renal function
30 – < 60
5 mg once every 2 days
Severely decreased renal function
15 – < 30
(not requiring dialysis)
5 mg once every 3 days
End stage renal disease (ESRD)
< 15
(requiring dialysis treatment)
Contra-indicated
In paediatric patients suffering from renal impairment, the dose will
have to be adjusted on an individual basis taking into
account the renal clearance of the patient and his body weight. There
are no specific data for children with renal impairment.
_Hepatic i