Xyzal Oral Solution 0.5 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Levocetirizine dihydrochloride

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

R06AE09

Dosage:

0.50 mg/ml

Pharmaceutical form:

SOLUTION

Composition:

Levocetirizine dihydrochloride 0.50 mg/ml

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

AESICA PHARMACEUTICALS S.R.L

Authorization status:

ACTIVE

Authorization date:

2008-05-20

Patient Information leaflet

Page 1 of 6
ZYR-NEX 5 MG FILM-COATED TABLET
LEVOCETIRIZINE DIHYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Zyr-NEX carefully
to get the best results from it.
−
Keep this leaflet. You may need to read it again.
−
Ask your pharmacist if you need more information or advice.
−
You must contact a doctor if your symptoms worsen or do not improve
after 3 days.
−
If any of the side effects gets serious, or if you notice any side
effect not listed in this
leaflet, please tell your doctor or pharmacist.
−
Always read the label to make sure the product is appropriate for your
child’s age.
IN THIS LEAFLET
1.
WHAT ZYR-NEX IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE ZYR-NEX
3.
HOW TO TAKE ZYR-NEX
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ZYR-NEX
6.
FURTHER INFORMATION
Page 2 of 6
1.
WHAT ZYR-NEX IS AND WHAT IT IS USED FOR
The active substance in Zyr-NEX is levocetirizine. Levocetirizine
belongs to a group of antiallergic
medicines called antihistamines.
Zyr-NEX is used to treat symptoms such as sneezing, a runny nose and
watery eyes associated
with allergic rhinitis (including persistent allergic rhinitis).
Zyr-NEX is also used to relieve the rashes and itching of chronic
urticaria (
hives
).
2.
BEFORE YOU TAKE ZYR-NEX
DON’T TAKE ZYR-NEX
•
if you are ALLERGIC (
hypersensitive
) to levocetirizine,
cetirizine, hydroxyzine, any piperazine
derivatives (closely related active substances of other medicines) or
any other ingredients
of Zyr-NEX (listed in Section 6)
•
if you have SEVERE KIDNEY DISEASE
(severe impairment of kidney function with creatinine
clearance below 10 ml/min)
•
if you use other antiallergic medicines

If you think any of these apply to you, DON’T TAKE Zyr-NEX until you
have checked with
your doctor.
TAKE SPECIAL CARE WITH ZYR-NEX
TALK TO YOUR DOCTOR OR PHARMACIST before using Zyr-NEX:
•
if you have DIFFICULTY PASSING URINE or you have conditions that ma

Summary of Product characteristics

[GSK logo]
NAME OF THE MEDICINAL PRODUCT
XYZAL
®
PHARMACEUTICAL FORM AND STRENGTH
Oral drops solution: clear and colourless liquid, each 1 ml
(equivalent to 20 drops) containing 5 mg of
levocetirizine dihydrochloride.
Oral solution: clear and colourless liquid, each 1ml containing 0.5 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
ORAL DROPS SOLUTION:
it should be poured in a spoon or diluted in water, and taken orally.
If dilution is used, it should be considered, especially for
administration to children, that the volume of water to
which the drops are added, needs to be adapted according to the
quantity of water the patient is able to swallow.
The diluted solution should be taken immediately.
When counting the drops, the bottle should be held vertically (top
down). In case of lack of flow of drops, if the
right amount of drops has not been delivered, turn the bottle over in
upright position, then hold it top down
again and continue counting the drops.
The drops can be taken with or without food.
ORAL SOLUTION
: A dosing syringe is included in the package. The appropriate volume
of oral solution should be
measured with the syringe, and poured in a spoon or in another liquid
such as in a glass of water or fruit juice.
The oral solution must be taken orally, and may be taken with or
without food.
Duration of use:
Intermittent allergic rhinitis (symptoms <4days/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 >4days/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 t