L-Histasin 5mg Film-Coated Tablets

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

LEVOCETIRIZINE DIHYDROCHLORIDE

から入手可能:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATCコード:

R06AE09

INN（国際名）:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

医薬品形態:

COATED TABLET

構図:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

処方タイプ:

POM

治療領域:

ANTIHISTAMINES FOR SYSTEMIC USE

認証ステータス:

Withdrawn

承認日:

2009-12-15

情報リーフレット

dimensions: 
pharmacode: 
date sent:
TECHNICAL APPROVAL
min pt size:
[e-mail]
print proof no: 
origination date: 
originated by: 
revision date: 
supplier:
technically app. date*: 
* Please note the technical approval is provided by the supplier and
is valid on the date indicated.
Any technical changes made by the supplier after approval are not
the responsibility of the Artwork Studio.
Non Printing Colours
colours/plates
revised by: 
approved for print/date
1.
2.
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black
1
10pt
160x440
24.09.2012
24.09.2012
05.10.2012
K. Mutafchieva
Synthon Spain
AAAE3520
Levocetirizine, 5mg, PIL (MARCHESINI), Malta
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 
START TAKING THIS MEDICINE.
•  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. 
Do not pass it on to others. It may harm 
them, even if their symptoms are the same 
as yours.
•   If any of the side effects gets serious, or if 
you notice any side effects not listed in this 
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What L-Histasin is and what it is used for
2. Before you take L-Histasin
3. How to take L-Histasin
4. Possible side effects
5. How to store L-Histasin
6. Further information
1. WHAT L-HISTASIN IS AND WHAT IT IS USED 
FOR
Levocetirizine is an anti-allergic agent. It is 
used to treat symptoms associated with aller-
gic conditions, such as:
•   hay fever
•   (persistent) runny nose
•   chronic nettle rash
2. BEFORE YOU TAKE  L-HISTASIN
DO NOT TAKE L-HISTASIN IF:
•   you are ALLERGIC (HYPERSENSITIVE) TO LEVOCE-
TIRIZINE, ANY RELATED SUBSTANCE, OR ANY OF 
THE OTHER INGREDIENTS of L-Histasin (see sec-
tion 6 ‘What L-Histasin contains’).
•   you suffer from SEVERE KIDNEY FAILURE
•   you have been told by your doctor that you 
have an INTOLERANCE TO SOME SUGARS (since 
the tablets contain lactose)
TAK

製品の特徴

Page 1 of 8 
SUMMARY OF PRODUCT CHARACTERISTICS 
1  
NAME OF THE MEDICINAL PRODUCT 
L-Histasin 5mg, film-coated tablets  

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Levocetirizine dihydrochloride 

Each film-coated tablet contains 5mg levocetirizine dihydrochloride
(equivalent to 4.2 mg of 
levocetirizine). 

Excipient: each film-coated tablet contains 64.0 mg lactose
monohydrate.  

For a full list of excipients, see section 6.1. 

3 
PHARMACEUTICAL FORM 
Film-coated tablet. 

The film-coated tablets are white to off-white, oval, biconvex
tablets, debossed with ‘L9CZ’ on one 
side and ‘5’ on the other side. 

4 
CLINICAL PARTICULARS 
4.1  
THERAPEUTIC INDICATIONS 
Symptomatic treatment of allergic rhinitis (including persistent
allergic rhinitis) and chronic idiopathic 
urticaria. 

4.2  
POSOLOGY AND METHOD OF ADMINISTRATION 
The film-coated tablet must be taken orally, swallowed whole
with liquid and may be taken with or 
without food. It is recommended to take the daily dose in one single
intake.  

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).  

Children aged 6 to 12 years 
The daily recommended dose is 5 mg (1 film-coated tablet).  

Page 2 of 8 
Children aged 2 to 6 years 
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 levocetirizine. 

The administration of levocetirizine to infants and toddlers aged less
than 2 years is not recommended 
due to the lack of data in this population  (see also section
4.4). 

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 us