Levocetirizine Teva 5mg Film-Coated Tablets

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

LEVOCETIRIZINE DIHYDROCHLORIDE

제공처:

Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC 코드:

R06AE09

INN (International Name):

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

약제 형태:

FILM-COATED TABLET

구성:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

처방전 유형:

POM

치료 영역:

ANTIHISTAMINES FOR SYSTEMIC USE

승인 상태:

Withdrawn

승인 날짜:

2011-10-17

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 TABLETS ARE AND WHAT THEY
ARE
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

제품 특성 요약

Page 1 of 12
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
Page 2 of 12
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:
Dosing Adjustments for Patients with Impaired Renal Function:
Group
Creatinine
clearance (ml/min)
Dosage and frequency
Normal
80
1 tablet once daily
Mild
50 – 79
1 tablet once daily
Moderate
30 – 49
1 tablet once every 2 days
Severe
< 30
1 tablet once every 3 days
End-stage renal disease -
Patients
undergoing
dialysis
< 10-
Contra-indicated
In