Xyzal 0.5 mg/ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levocetirizine dihydrochloride

Available from:

LTT Pharma Limited

ATC code:

R06AE; R06AE09

INN (International Name):

Levocetirizine dihydrochloride

Dosage:

0.5 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Piperazine derivatives; levocetirizine

Authorization status:

Authorised

Authorization date:

2017-04-28

Patient Information leaflet

DRIVING AND USING MACHINES
Some patients being treated with Xyzal may
experience somnolence / drowsiness, tiredness and
exhaustion. Use caution when driving or operating
machinery until 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 MALTITOL LIQUID, METHYL
PARAHYDROXYBENZOATE AND PROPYL
PARAHYDROXYBENZOATE
– This medicine contains maltitol liquid. If you have
been told by your doctor that you have intolerance
to some sugars, contact your doctor before taking
Xyzal.
– Methyl parahydroxybenzoate and propyl
parahydroxybenzoate may cause allergic
reactions (possibly delayed), such as headache,
stomach upset, and diarrhoea.
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 is:
– Adults and adolescents from the age of 12 years:
10 ml solution once 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 impairment of kidney
function must not take Xyzal.
Patients who only have impaired liver function
should take the usual prescribed dose.
Patients who have both impaired liver and kidney
function may be given a lower dose depending on
the severity of the 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.
_Elderly patients aged 65 years and above_
No adaptation of the dose is necessary in elderly
patients, provided their renal function is normal.
USE IN CHILDREN
Children from the age of 6 to 12 years: 10 ml
solution once dai

Summary of Product characteristics

Health Products Regulatory Authority
11 October 2018
CRN008N54
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xyzal 0.5 mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral solution contains 0.5 mg levocetirizine dihydrochloride.
Excipient(s) with known effect
methyl parahydroxybenzoate
propyl parahydroxybenzoate
maltitol liquid
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
_Product imported from Czech Republic_
Clear and colourless solution.
4 CLINICAL PARTICULARS
As per PA0891/003/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0891/003/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
sodium acetate trihydrate
acetic acid
methyl parahydroxybenzoate (E218)
propyl parahydroxybenzoate (E216)
glycerol 85%
maltitol (E965)
saccharin sodium
Fruit flavour contains
triacetin (E1518)
Health Products Regulatory Authority
11 October 2018
CRN008N54
Page 2 of 3
benzaldehyde
orange oil
vanillin
ethyl butyrate
orange oil concentrated
isoamyl acetate
allyl hexanoate
gamma-undecalactone
citral
geraniol
citronellol
tocopherol (E307)
purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and
outer package of the product on the market in the country of origin.
After first opening: 3 months
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Glass bottle closed with a white child-resistant closure in a
cardboard box also
containing a 10 ml oral syringe graduated at 0.25 ml.
Pack size: 200 ml
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE
MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF
THE
PRODUCT
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Health Products Regulatory Authority
11 October 2018
CRN008N54
Page 3 of 3
LTT Pharma Limited
Unit 18
Oxleasow Ro