Xyzal 0.5mg/ml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levocetirizine dihydrochloride

Available from:

UCB Pharma Ltd

ATC code:

R06AE09

INN (International Name):

Levocetirizine dihydrochloride

Dosage:

500microgram/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5015313013079

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XYZAL 0.5 MG/ML ORAL SOLUTION
For adults and children aged 2 years and above
Levocetirizine dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xyzal is and what it is used for
2.
What you need to know before you take Xyzal
3.
How to take Xyzal
4.
Possible side effects
5.
How to store Xyzal
6.
Contents of the pack and other information
1.
WHAT XYZAL IS AND WHAT IT IS USED FOR
Levocetirizine dihydrochloride is the active ingredient of Xyzal.
Xyzal is an antiallergic medication.
For the treatment of signs of illness (symptoms) associated with:
•
allergic rhinitis (including persistent allergic rhinitis);
•
nettle rash (urticaria).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XYZAL
DO NOT TAKE XYZAL
-
if you are allergic
to levocetirizine dihydrochloride, to cetirizine, to hydroxyzine or
any of the
other ingredients of this medicine (listed in section 6).
-
if you have a severe impairment of kidney function (severe renal
failure with creatinine clearance
below 10 ml/min).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Xyzal.
If you are likely to be unable to empty your bladder (with conditions
such as spinal cord injury or
enlarged prostate), please ask your doctor for advice.
If you suffer from epilepsy or are at risk of convulsions, please ask
your doctor for advice as use of
Xyzal may cause seizure aggravation.
If you are scheduled for allergy testing, ask your doctor if you
should stop taking Xyzal for several
da

Summary of Product characteristics

OBJECT 1
XYZAL 0.5 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 08-Nov-2017 | UCB Pharma
Limited
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.
Excipients with known effect
0.675 mg methyl parahydroxybenzoate/ml
0.075 mg propyl parahydroxybenzoate/ml
0.4 g maltitol liquid/ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
Clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Xyzal 0.5 mg/ml oral solution is indicated for symptomatic treatment
of allergic rhinitis (including
persistent allergic rhinitis) and urticaria in adults and children
aged 2 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 (10 ml of solution).
_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. 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:
Dosing adjustments for patients with impaired renal function:
Group
Creatinine clearance (ml/min)
Dosage and frequency
Normal
≥ 80
5 mg once daily
Mild
50 – 79
5 mg once daily
Moderate
30 – 49
5 mg once every 2 days
Severe
< 30
5 mg once every 3 days
End-stage renal disease - Patients
undergoing dialysis
< 10
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 impairm