Xyzal 5mg tablets

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Levocetirizine dihydrochloride

থেকে পাওয়া:

Waymade Healthcare Plc

এটিসি কোড:

R06AE09

INN (আন্তর্জাতিক নাম):

Levocetirizine dihydrochloride

ডোজ:

5mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 03040100

তথ্য লিফলেট

CHILDREN
The use of Xyzal is not recommended in children less than 6 years
since the film-coated
tablets do not allow for dose adaptation.
OTHER MEDICINES AND XYZAL
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any
other medicines.
XYZAL WITH FOOD, DRINK AND ALCOHOL
Caution is advised if Xyzal is taken at the same time as alcohol or
other agents acting on
the brain.
In sensitive patients, the concurrent administration of Xyzal and
alcohol or other agents
acting on the brain may cause additional reductions in alertness and
impairment of
performance.
Xyzal can be taken with or without food.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have
a baby, ask your doctor or pharmacist for advice before taking this
medicine.
DRIVING AND USING MACHINES
Some patients being treated with Xyzal may experience somnolence /
drowsiness, tired-
ness and exhaustion. Use caution when driving or operating machinery
untill you know
how this medicine affects you. However, special tests have revealed no
impairment of
mental alertness, the ability to react or the ability to drive in
healthy test persons after taking
levocetirizine in the recommended dosage.
XYZAL CONTAINS LACTOSE
These tablets contain lactose, if you have been told by your doctor
that you have an intoler-
ance to some sugars you should contact your doctor before taking them.
3.
HOW TO TAKE XYZAL
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with
your doctor or pharmacist if you are not sure.
The recommended dose for adults and children aged 6 years and over is
one tablet daily.
Special dosage instructions for specific populations:
Renal and hepatic impairment
Patients with impaired kidney function may be given a lower dose
according to the severity
of their kidney disease, and in children the dose will also be chosen
on the basis of body
weight; the dose will be determined by your doctor.
Patients who have severe impairme

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Xyzal 5 mg film coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
Excipient(s) with known effect
63.50 mg lactose monohydrate/tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, oval, film-coated tablet with a Y logo on one
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xyzal 5 mg film-coated tablets are 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 Patients with renal impairment below).
_Renal impairment: _
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 (CL
cr
) in ml/min is needed. The CL
cr
(ml/min) may be estimated
from serum creatinine (mg/dl) determination using the following
formula:
(
)
[
]
(
)
(
)
(
)
_women_
_for_
_dl_
_mg_
_creatinine_
_serum_
_kg_
_weight_
_years_
_age_
_CL_
_cr_
85
.
0
*
*
72
*
140
−
=
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 2 days
Severe
< 30
1 tablet once every 3 days
End-stage renal disease -
Patients undergoing dialysis
< 10
Contra-indicated
In pediatric 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 a