XYZAL FILM-COATED TABLET 5 MG

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

Levocetirizine dihydrochloride

Dostopno od:

GLAXOSMITHKLINE PTE LTD

Koda artikla:

R06A E09

Farmacevtska oblika:

TABLET, FILM COATED

Sestava:

Levocetirizine dihydrochloride 5 mg

Pot uporabe:

ORAL

Tip zastaranja:

Prescription Only

Izdeluje:

UCB Farchim SA

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2020-10-14

Lastnosti izdelka

[GSK logo]
NAME OF THE MEDICINAL PRODUCT
XYZAL
PHARMACEUTICAL FORM AND STRENGTH
Film-coated tablet: White to off-white, oval, film-coated tablet with
a Y logo on one side, containing 5 mg of
levocetirizine dihydrochloride.
THERAPEUTIC INDICATIONS
Levocetirizine is indicated for the symptomatic treatment of allergic
rhinitis (including persistent allergic
rhinitis) and chronic idiopathic urticaria.
POSOLOGY AND METHOD OF ADMINISTRATION
FILM-COATED TABLET: it must be taken orally, swallowed whole with
liquid and may be taken with or without
food.
Duration of use:
Intermittent allergic rhinitis (symptoms <4 days/week or for less than
4 weeks a year) has to be treated
according to the disease and its history; it can be stopped once the
symptoms have disappeared and can be
restarted again when symptoms reappear. In case of persistent allergic
rhinitis (symptoms >4 days/week or for
more than 4 weeks a year), continuous therapy can be proposed to the
patient during the period of exposure to
allergens. There is clinical experience with the use of levocetirizine
for treatment periods of at least 6 months.
For chronic urticaria and chronic allergic rhinitis, there is clinical
experience of use of cetirizine (racemate) for
up to one year.
Route of Administration:
For oral use.
Adults and adolescents 12 years and above:
The recommended dose is 5 mg once daily(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)._
Children aged 6 to 12 years:
The recommended dose is 5 mg once daily(1 film-coated tablet).
Adult patients with 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
5 mg once daily
Mildly decreased renal
function
60