Levocetirizine dihydrochloride 5 mg film-coated tablets

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

LEVOCETIRIZINE DIHYDROCHLORIDE

Beschikbaar vanaf:

Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

ATC-code:

R06AE09

INN (Algemene Internationale Benaming):

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

farmaceutische vorm:

FILM-COATED TABLET

Samenstelling:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Prescription-type:

POM

Therapeutisch gebied:

ANTIHISTAMINES FOR SYSTEMIC USE

Autorisatie-status:

Withdrawn

Autorisatie datum:

2015-03-04

Bijsluiter

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 your bladder (with conditions
such as spinal cord injury or enlarged pros

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levocetirizine dihydrochloride 5 mg 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.
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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 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:
Dosing Adjustments for Pat