Cetirizine dihydrochloride 10mg film-coated tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

cetirizine dihydrochloride

Available from:

Crescent Pharma Limited

ATC code:

R06AE07

INN (International Name):

cetirizine dihydrochloride

Dosage:

10mg

Pharmaceutical form:

Film-coated tablets

Administration route:

Oral use

Units in package:

Boxes of 7 or 30 tablets

Prescription type:

GSL - General Sales List

Manufactured by:

Crescent Pharma Limited

Therapeutic group:

Piperazine derivatives

Therapeutic indications:

It is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and for the relief of symptoms of chronic idiopathic urticaria.

Authorization status:

Authorised

Authorization date:

2015-04-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CETIRIZINE DIHYDROCHLORIDE 10mg
FILM-COATED TABLETS
Cetirizine dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
ALWAYS TAKE THIS MEDICINE EXACTLY AS DESCRIBED IN THIS LEAFLET OR AS YOUR DOCTOR OR PHARMACIST HAVE TOLD YOU.
Ÿ
THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL NEED TO TAKE IT CAREFULLY TO GET THE BEST RESULTS.
Ÿ
KEEP THIS LEAFLET.YOU MAY NEED TO READ IT AGAIN.
Ÿ
ASK YOUR PHARMACIST IF YOU NEED MORE INFORMATION OR ADVICE.
Ÿ
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.
Ÿ
YOU MUST TALK TO A DOCTOR IF YOU DO NOT FEEL BETTER OR IF YOU FEEL WORSE AFTER A FEW DAYS.
WHAT IS IN THIS LEAFLET:
1
WHAT CETIRIZINE DIHYDROCHLORIDE TABLETS ARE AND WHAT THEY ARE
.
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE DIHYDROCHLORIDE
TABLETS
3. HOW TO TAKE CETIRIZINE DIHYDROCHLORIDETABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CETIRIZINE DIHYDROCHLORIDETABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT CETIRIZINE DIHYDROCHLORIDE TABLETS
AND
ARE
WHAT
USED FOR
THEY ARE
THE FULL NAME OF THIS MEDICINE IS CETIRIZINE DIHYDROCHLORIDE 10MG
FILM-COATED TABLETS BUT WITHIN THE LEAFLET IT WILL BE REFERRED TO AS
CETIRIZINE DIHYDROCHLORIDE TABLETS. CETIRIZINE DIHYDROCHLORIDE, THE
ACTIVE INGREDIENT OF THE TABLETS IS AN ANTIHISTAMINE. IT BLOCKS THE
EFFECTS OF A SUBSTANCE CALLED HISTAMINE WHICH OCCURS NATURALLY IN THE
BODY. HISTAMINE IS INVOLVED IN ALLERGIC REACTIONS.
CETIRIZINE DIHYDROCHLORIDE TABLETS ARE USED TO TREAT PEOPLE WHO HAVE
HAY FEVER (SEASONAL ALLERGIC RHINITIS), YEAR ROUND ALLERGIES SUCH AS
DUST OR PET ALLERGIES (PE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Cetirizine dihydrochloride 10 mg film-coated tablets  

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One film-coated tablets contains 10
mg cetirizine dihydrochloride 

Excipients with known effect: one film-coated tablet contains
53.50 mg 
lactose-monohydrate 
For the full list of excipients, see section 6.1 

3 PHARMACEUTICAL 
FORM 

Film-coated tablets 
White to off white, film coated, capsule shaped tablet, one face
of the tablet 
plain and break line on the other. 

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. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

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). 

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 (CLcr) in mL/min is needed. The CLcr (mL/min)
may be estimated 
from serum creatinine (mg/dl) determination using
the following formula: 

Dosing adjustmen