Xyzal 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levocetirizine dihydrochloride

Available from:

DE Pharmaceuticals

ATC code:

R06AE09

INN (International Name):

Levocetirizine dihydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XYZAL 5 MG FILM-COATED TABLETS
For adults and children aged 6 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
d

Summary of Product characteristics

OBJECT 1
XYZAL 5MG TABLETS
Summary of Product Characteristics Updated 30-Jul-2019 | UCB Pharma
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Xyzal 5 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
Excipient(s) with known effect
63.50 mg lactose monohydrate/tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White to off-white, oval, film-coated tablet with a Y logo on one
side.
4. Clinical particulars
4.1 Therapeutic indications
Xyzal 5 mg film-coated tablets are indicated in the symptomatic
treatment of allergic rhinitis (including
persistent allergic rhinitis) and urticaria in adults and children
aged 6 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 (1 film-coated tablet).
_Elderly_
Adjustment of the dose is recommended in elde