Xyzal 0.5 mg/ml oral solution

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Levocetirizine dihydrochloride

Предлага се от:

IMED Healthcare Ltd.

АТС код:

R06AE09

INN (Международно Name):

Levocetirizine dihydrochloride

дозиране:

0.5 milligram(s)/millilitre

Лекарствена форма:

Oral solution

Терапевтична област:

levocetirizine

Дата Оторизация:

2021-08-27

Листовка

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 kidney disease requiring dialysis.
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 days before testing. This
medicine may affect your

Данни за продукта

Health Products Regulatory Authority
30 August 2021
CRN00C733
Page 1 of 2
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 99%
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Glycerol 85%
Maltitol liquid (E965)
Saccharin sodium
Tutti frutti flavor contains:
Triacetin (E1518)
Benzaldehyde
Orange oil
Vanillin
Ethyl butyrate
Orange oil concentrated
Isoamyl acetate
Allyl caproate
Gamma-undecalactone
Citral
Geraniol
Citronellol
Alpha tocopherol (E307)
Purified water
Health Products Regulatory Authority
30 August 2021
CRN00C733
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container 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
Amber glass bottle closed with a white polypropylene 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
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/170/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date