Cetirizine Chefaro, 10mg, film-coated Tablets

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

CETIRIZINE HYDROCHLORIDE

Dostupno od:

Chefaro Ireland DAC The Sharp Building, Hogan Place, Dublin 2,, Ireland

ATC koda:

R06AE07

INN (International ime):

CETIRIZINE HYDROCHLORIDE 10 mg

Farmaceutski oblik:

FILM-COATED TABLET

Sastav:

CETIRIZINE HYDROCHLORIDE 10 mg

Tip recepta:

OTC

Područje terapije:

ANTIHISTAMINES FOR SYSTEMIC USE

Status autorizacije:

Authorised

Datum autorizacije:

2012-05-03

Uputa o lijeku

CETIRIZINE DIHYDROCHLORIDE 10MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
CETERIZINE CHEFARO 10MG FILM-COATED TABLETS (CETIRIZINE
DIHYDROCHLORIDE)
READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
This medicine is available without a prescription, however you still
need to use Ceterizine
Chefaro carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
_(Non-Prescription Products _
_Only) _
•
If you have any further questions, ask your doctor or pharmacist.
(Prescription products
•
only)
•
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 ours. (Prescription products only _ _
•
You must contact a doctor if your symptoms worsen or do not improve
after 3 days. _(Non _
_Prescription Products Only) _
•
If any of the side effects gets serious, or if notice any side effects
not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. WHAT CETERIZINE CHEFARO IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETERIZINE CHEFARO
3. HOW TO TAKE CETERIZINE CHEFARO
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CETERIZINE CHEFARO
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT CETERIZINE CHEFARO IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Ceterizine
Chefaro.
Ceterizine Chefaro is an anti-allergic medication.
In adults and the children aged 6 years and above, Ceterizine Chefaro
is indicated
•
For the relief of nasal and ocular symptoms of seasonal and perennial
allergic rhinitis.
•
For the relief of chronic nettle rash (chronic idiopathic urticaria).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETERIZINE CHEFARO
This medicine can be taken by adults, and children aged 6 years and
over.
Some people should not take this medicine or should talk to their
pharmacist or doctor first.
DO NOT TAKE CETERIZINE CHEFARO:
•
If you h

Svojstava lijeka

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cetirizine Chefaro, 10 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 10 mg cetirizine dihydrochloride
Excipients:
one film-coated tablet contains 53.50 mg lactose-monohydrate For a
full list
of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablets
Cetirizine Dihydrochloride 10 mg Tablets are white to off white, film
coated, capsule shaped
tablets, with one face of the tablet plain and a break-line on the
other. The tablet can be divided into
equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adults and paediatric patients 6 year and above:
•
Cetirizine is indicated for the relief of nasal and ocular symptoms of
seasonal and perennial
allergic rhinitis.
•
Cetirizine is indicated for the relief of symptoms of chronic
idiopathic urticaria.
Page 2 of 10
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Children below 6 years of age: not recommended
Children aged from 6 to 12 years: 5 mg twice daily (a half tablet
twice daily).
Adults and adolescents over 12 years of age: 10 mg once daily (1
tablet).
The tablets need to be swallowed with a glass of liquid.
Elderly subjects: data do not suggest that the dose needs to be
reduced in elderly subjects
provided that the renal function is normal.
Patients
with
moderate
to
severe
renal
impairment:
there
are
no
data
to
document
the
efficacy/safety ratio in patients with renal impairment. Since
cetirizine is mainly excreted via renal
route (see section 5.2), in cases no alternative treatment can be
used, 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 (CL
cr
) in ml/min
is needed. The CL
cr
(ml/min) may be estimated from serum
creatinine (mg/dl) determination using
the following formula:
CL
cr
=
Dosing adjustments for adult patients with impai