Cetirizine 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cetirizine hydrochloride

Available from:

C P Pharmaceuticals Ltd

ATC code:

R06AE07

INN (International Name):

Cetirizine hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100

Patient Information leaflet

PACKAGE LEAFLET:
Information for the user
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.
- Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET:
1. What Cetirizine Dihydrochloride 10mg film-coated
Tablets are and what they are used for
2. What you need to know before you take Cetirizine Dihydrochloride
10mg film-coated
Tablets
3. How to take Cetirizine Dihydrochloride 10mg film-coated
Tablets
4. Possible side effects
5. How to store Cetirizine Dihydrochloride 10mg film-coated
Tablets
6. Contents of the pack and other information
1. WHAT CETIRIZINE DIHYDROCHLORIDE 10MG
FILM-COATED
TABLETS ARE AND WHAT THEY ARE USED FOR
Cetirizine dihydrochloride is the active ingredient of Cetirizine
Dihydrochloride 10mg film-coated
Tablets.
Cetirizine Dihydrochloride 10mg film-coated Tablets is an antiallergic
medication.
In adults and children aged 6 years and above, Cetirizine
Dihydrochloride 10mg film-coated Tablets is
indicated
-
for the relief of nasal and ocular symptoms of seasonal and perennial
allergic rhinitis.
-
for the relief of urticaria.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE DIHYDROCHLORIDE
FILM-COATED
10MG TABLETS
DO NOT TAKE CETIRIZINE DIHYDROCHLORIDE FILM-COATED 10MG TABLETS
• if you are allergic to cetirizine dihydrochloride, to any of the
other ingredients of this medicine (listed
in section 6), to hydroxyzine or to piperazine derivatives (closely
related active ingredients of other
medicines).
• if you have a severe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cetirizine Hydrochloride 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10mg of Cetirizine Hydrochloride.
Excipient: 81,80 mg lactose /film-coated tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablet.
White, oblong, scored on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adults and paediatric patients 6 years 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 patients
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:
CL
cr
= _ [140 - age(years)] x weight (kg) _
_ _
_72 x serum creatinine (mg/dl) _
Dosing adjustments for adult patients with impaired renal function
Group
Creatinine clearance
(ml/min)
Dosage and frequency
Normal
Mild
Moderate
Severe
End-stage renal disease-
Patients undergoing
dialysis
≥
80
50-79
30-49
<30
<10
10 mg once daily
10 mg once daily
5 mg once daily
5 mg once every 2 days
Contra-indicated