Xyzal 5mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Levocetirizine dihydrochloride

Mevcut itibaren:

UCB Pharma Ltd

ATC kodu:

R06AE09

INN (International Adı):

Levocetirizine dihydrochloride

Doz:

5mg

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 03040100; GTIN: 5024091001307

Bilgilendirme broşürü

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

Ürün özellikleri

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 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
≥
90
1 tablet once daily
Mildly decreased renal
function
60 – < 90
1 tablet once daily
Moderately decreased renal
function
30 – < 60
1 tablet once every 2 days
Severely decreased renal
function
15 - < 30 (not requiring dialysis)
1 tablet 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 impairment_
No dose adjustment is needed in patients with solely hepatic
impairment. In patients with
hepatic impairment an