Cetirizine Galpharm, 10mg, film-coated Tablets

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

CETIRIZINE HYDROCHLORIDE

Dostupno od:

Galpharm Healthcare Limited

ATC koda:

R06AE07

INN (International ime):

CETIRIZINE HYDROCHLORIDE

Farmaceutski oblik:

FILM-COATED TABLET

Sastav:

CETIRIZINE HYDROCHLORIDE 10 milligram(s)

Tip recepta:

OTC

Područje terapije:

ANTIHISTAMINES FOR SYSTEMIC USE

Status autorizacije:

Authorised

Datum autorizacije:

2012-05-03

Uputa o lijeku

CETIRIZINE DIHYDROCHLORIDE 10MG TABLETS / MAY 2016
PACKAGE LEAFLET: INFORMATION FOR THE USER
CETERIZINE GALPHARM 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
Galpharm 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 GALPHARM IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETERIZINE GALPHARM
3. HOW TO TAKE CETERIZINE GALPHARM
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CETERIZINE GALPHARM
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT CETERIZINE GALPHARM IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Ceterizine
Galpharm.
Ceterizine Galpharm is an anti-allergic medication.
In adults and the children aged 6 years and above, Ceterizine Galpharm
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 GALPHARM
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 G

Svojstava lijeka

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MT: Cetirizine Galpharm, 10 mg, film-coated tablets
PL: Cetirizine Galpharm
DE: Cetirizindihydrochlorid Galpharm, 10 mg filmtabletten
CZ: Cetirizine Galpharm
IT: Cetirizine Galpharm
NL: Cetirizine dihydrochloride Galpharm
HU: Cetirizine Galpharm
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
cleara