Levocetirizine dihydrochloride Fair-Med 5mg film-coated Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

LEVOCETIRIZINE DIHYDROCHLORIDE

Tilgængelig fra:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

ATC-kode:

R06AE09

INN (International Name):

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Lægemiddelform:

FILM-COATED TABLET

Sammensætning:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Recept type:

POM

Terapeutisk område:

ANTIHISTAMINES FOR SYSTEMIC USE

Autorisation status:

Withdrawn

Autorisation dato:

2013-03-05

Indlægsseddel

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
LEVOCETIRIZINE DIHYDROCHLORIDE FAIR-MED 5MG FILM-COATED TABLETS
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.
WHAT IS IN THIS LEAFLET
1.
What Levocetirizine dihydrochloride Fair-Med is and what it is used
for
2.
What you need to know before you take Levocetirizine dihydrochloride
Fair-Med
3.
How to take Levocetirizine dihydrochloride Fair-Med
4.
Possible side effects
5.
How to store Levocetirizine dihydrochloride Fair-Med
6.
Contents of the pack and other information
1.
WHAT LEVOCETIRIZINE DIHYDROCHLORIDE FAIR-MED IS AND WHAT IT IS USED
FOR
Levocetirizine dihydrochloride is the active ingredient of
Levocetirizine dihydrochloride Fair-Med.
Levocetirizine dihydrochloride Fair-Med 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 LEVOCETIRIZINE DIHYDROCHLORIDE
FAIR-MED
DO NOT TAKE LEVOCETIRIZINE DIHYDROCHLORIDE FAIR-MED:

if you are allergic to levocetirizine dihydrochloride or to an
antihistamine 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 Levocetirizine
dihydrochloride Fair-Med.
The use of Levocetirizine dihydrochloride Fair-Med is not recommended
in c

Produktets egenskaber

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Levocetirizine dihydrochloride Fair-Med 5 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, oval film-coated tablets, 2.90 mm to 3.50 mm
thick, 7.8 mm to 8.2 mm long and
4.3 mm to 4.7 mm wide, with plain on both sides.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of allergic rhinitis (including persistent
allergic rhinitis) and urticaria.
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 elderly patients with
moderate to severe renal impairment
(see Patients with renal impairment below).
_Paediatric population _
Children aged 6 to 12 years:
The daily recommended dose is 5 mg (1 film-coated tablet).
For children aged 2 to 6 years no adjusted dosage is possible with the
film-coated tablet formulation. It
is recommended to use a paediatric formulation of levocetirine.
Due to the lack of data in this population, the administration of
levocetirizine to infants and toddlers
aged less than 2 years is not recommended.
Page 2 of 11
Patients with renal impairment:
The dosing intervals must be individualized 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 (CLcr) in ml/min is needed. The CLcr (ml/min) may be
estimated from serum creatinine
(mg/dl) determination using the following formula:
[140 − _age _(_years_)]_x weight _(_kg_) (x 0.85 _for women_)
72 x _serum creatinine _(_mg _/ _dl_)
Dosing Adjustments for Patients with Impaired Renal Function:
Group
Creatinine
clearance
(ml/min)
Dosage and frequency
Normal
≥80
1 tablet once daily
Mild
50 �