LEVOCETIRIZINE TEVA 5 Milligram Film Coated Tablet

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

LEVOCETIRIZINE DIHYDROCHLORIDE

제공처:

Teva Pharma B.V.

ATC 코드:

R06AE09

INN (International Name):

LEVOCETIRIZINE DIHYDROCHLORIDE

복용량:

5 Milligram

약제 형태:

Film Coated Tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Piperazine derivatives

승인 상태:

Authorised

승인 날짜:

2008-12-12

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOCETIRIZINE TEVA 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,pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Levocetirizine Teva 5 mg Film-coated Tablet is and what it is
used for
2.
What you need to know before you take Levocetirizine Teva 5 mg
Film-coated Tablets
3.
How to take Levocetirizine Teva 5 mg Film-coated Tablets
4.
Possible side effects
5.
How to store Levocetirizine Teva 5 mg Film-coated Tablets
6.
Contents of the pack and other information
1.
WHAT LEVOCETIRIZINE TEVA 5 MG FILM-COATED TABLET IS AND WHAT IT IS
USED
FOR
Levocetirizine Teva 5 mg Film-coated Tablets belong to a group of
medicines called antihistamines.
They relieve the unpleasant symptoms and discomfort associated with
the below conditions, such as
sneezing, irritated runny or blocked up nose, itchy, red and watering
eyes and skin rashes.
Your doctor has prescribed Levocetirizine Teva 5 mg Film-coated
Tablets to treat hay fever
(seasonal allergic rhinitis), year round allergies such as dust or pet
allergies (perennial allergic
rhinitis) and urticaria (swelling, redness and itchiness of the skin).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOCETIRIZINE TEVA 5 MG FILM
COATED TABLETS
DO NOT TAKE LEVOCETIRIZINE TEVA 5 MG FILM-COATED TABLETS
-
if you are allergic to Levocetirizine dihydrochlorideor any of the
other ingredients of this
medicine (listed in section 6).
-
if you have severe kidney problems (severe renal failure with
creatinine clearance below

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levocetirizine Teva 5 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film
-coated tablet contains 5 mg of levocetirizine dihydrochloride.
Contains 63.50 mg lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off white, film coated oval shaped tablet; One side of the tablet is debossed with "LC5". The other side of the
tablet is plain.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levocetirizine is indicated for the symptomatic treatment of perennial allergic rhinitis, seasonal allergic rhinitis and
chronic idiopathic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food.
_Adults and adolescents:_
The recommended dose is 5 mg once daily
_Children aged between 6 and 12 years:_
The daily recommended dose is 5 mg once daily
Levocetirizine Teva is not recommended for use in children below the age of 6 due to insufficient data on safety and
efficacy.
Older people:
At present there are no data to suggest that the dose needs to be reduced in elderly subjects provided that their renal
function is normal.
_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:
HEALTH PRODUCTS REGULATORY AUTHORITY
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