Levocetirizine dihydrochloride 5mg film-coated tablets

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

levocetirizine dihydrochloride

Доступно од:

Cipla (EU) Limited

АТЦ код:

R06AE09

INN (Међународно име):

levocetirizine dihydrochloride

Дозирање:

5mg

Фармацеутски облик:

Film-coated tablet

Пут администрације:

oral use

Јединице у пакету:

Pack sizes of 7, 10, 14, 20, 28, 30, 50, 56, 84, and 100 tablets.

Тип рецептора:

Product subject to prescription which may be renewed (B)

Произведен од:

Cipla (EU) Limited

Терапеутска група:

antihistamine for systemic use, piperazine derivative,

Терапеутске индикације:

Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria

Статус ауторизације:

Authorised

Датум одобрења:

2015-03-06

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG 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. See section 4.
The name of this medicine is Levocetirizine Dihydrochloride 5mg
film-coated tablets, which will be referred to as 
Levocetirizine tablets
WHAT IS IN THIS LEAFLET
1. What Levocetirizine tablet is and what it is used for
2. What you need to know before you take Levocetirizine tablets
3. How to take Levocetirizine tablets 
4. Possible side effects 
5. How to store Levocetirizine tablets 
6. Contents of the pack and other information

1. WHAT LEVOCETIRIZINE TABLET IS AND WHAT IT IS USED FOR
This medicine contains levocetirizine dihydrochloride as the active
ingredient 
It is an antiallergic medication.
This medicine is used for 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  TABLETS
DO NOT TAKE LEVOCETIRIZINE TABLETS
•  if you are allergic (hypersensitive) to levocetirizine
dihydrochloride, 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
tablets.
If you are likely to be unable to empty you

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levocetirizine dihydrochloride 5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
Excipients with known effects:
Each film-coated tablets contains 16.50mg Lactose monohydrate and 49.00mg anhydrous lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, oval shaped, biconvex, film coated tablets debossed with ‘C5’ on one side and plain on other side.
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
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).
Paediatric population:
The daily recommended dose is 5 mg (1 film-coated tablet) in children aged 6 to 12 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.
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.
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