Cetirizine 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cetirizine hydrochloride

Available from:

Sandoz 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

Cetirizine hydrochloride
WHAT IS IN THIS LEAFLET:
1.
What Cetirizine is and what it is used for
2.
What you need to know before you take
Cetirizine
3.
How to take Cetirizine
4.
Possible side effects
5.
How to store Cetirizine
6.
Contents of the pack and other information
Cetirizine dihydrochloride is the active ingredient
of Cetirizine. Cetirizine is an antiallergic medication.
In adults and children aged 6 years and above,
Cetirizine 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).
DO NOT TAKE CETIRIZINE:
•
if you have a severe kidney disease (severe
renal failure with creatinine clearance below
10 ml/min);
•
if you are allergic to cetirizine to any of the
other ingredients of this medicine (listed in
section 6), to hydroxyzine or to piperazine
derivatives (closely related active substances
of other medicines).
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before taking
Cetirizine Hydrochloride.
If you have problems passing urine (like spinal
cord problems or prostate or bladder problems),
please ask your doctor for advice.
If you are a patient with renal insufficiency,
please ask your doctor for advice; if necessary,
you will take a lower dose. The new dose will be
determined by your doctor.
If you are an epileptic patient or a patient at risk
of convulsions, you should ask your doctor for
advice.
If you plan having an allergy skin test made. The
use of Cetirizin Sandoz should be interrupted at
least 3 days prior to skin tests.
No interactions susceptible to have a noticeable
impact have been observed between alcohol (at
PACKAGE LEAFLET: INFORMATION FOR THE USER
the blood level of 0.5 per mille corresponding to
one glass of wine) and cetirizine used at the
normal doses. However, as it is the case with all
antihistamines, it is recommended to avoid
concurrent consumption of alcohol.
OTHER MEDICINES AND CETIRIZINE
Tell your doctor or pharmacist if you are taking,
hav

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