Levocetirizine dihydrochloride 5 mg Film-Coated Tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Levocetirizine dihydrochloride

متاح من:

Brillpharma (Ireland) Limited

ATC رمز:

R06AE; R06AE09

INN (الاسم الدولي):

Levocetirizine dihydrochloride

جرعة:

5 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

المجال العلاجي:

Piperazine derivatives; levocetirizine

الوضع إذن:

Marketed

تاريخ الترخيص:

2012-09-07

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG FILM-COATED TABLETS
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.
THE NAME OF YOUR MEDICINE IS LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG
FILM-COATED TABLETS. HERE
AFTER IT WILL BE REFERRED TO AS LEVOCETIRIZINE TABLETS THROUGHOUT THE
LEAFLET.
WHAT IS IN THIS LEAFLET:
1. What Levocetirizine Tablets are and what they are used for
2. What you need to know before you take Levocetirizine Tablets
3. How to take Levocetirizine Tablets
4. Possible side-effects
5. How to store Levocetirizine Tablets
6. Contents of the pack and other information
1. WHAT LEVOCETIRIZINE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Levocetirizine 5 mg Film-coated Tablets
and the active substance is
Levocetirizine dihydrochloride. Levocetirizine Tablets 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 LEVOCETIRIZINE TABLETS
DO NOT TAKE LEVOCETIRIZINE TABLETS:

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 impairment of kidney function (severe renal
failure with creatinine clearance
below 10 ml/min).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Levocetirizine
Tablets.
If you are likely

خصائص المنتج

Health Products Regulatory Authority
15 December 2020
CRN009YPR
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levocetirizine dihydrochloride 5 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of levocetirizine
dihydrochloride.
Excipient with known effect: Also contains, Lactose Monohydrate 70.0mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated Tablets
White to off white, oval, biconvex film coated tablets with 'BL'
debossed on one side and '5' debossed on the other side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levocetirizine is indicated in the symptomatic treatment of allergic
rhinitis (including persistent allergic rhinitis) and urticaria in
adults and children aged 6 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 (1 film-coated tablet).
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. 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 PATIENTS WITH IMPAIRED RENAL FUNCTION:
GROUP
CREATININE CLEARANCE (ML/MIN)
DOSAGE AND FREQUENCY
Normal
≥80
1 tablet once daily
Mild
50 – 79
1 tablet once daily
Moderate
30 – 49
1 tablet once every 3 days
Severe
< 30
1 tablet once every 3 days
End-stage renal disease - Patients undergoing dialysis
< 10-
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 d