Cetirizine 10mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Cetirizine hydrochloride

Dostupno od:

Bell,Sons & Co (Druggists) Ltd

ATC koda:

R06AE07

INN (International ime):

Cetirizine hydrochloride

Doziranje:

10mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 03040100; GTIN: 5017848252442

Uputa o lijeku

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

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cetirizine Hydrochloride 10 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cetirizine hydrochloride 10 mg.
Excipient: This product contains 101.83 mg lactose per tablet
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet (tablets).
White circular biconvex film-coated tablets, embossed ‘A’ on one
side and a deep
score on the other.
The tablet can be divided into equal halves.
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.
CLINICAL PARTICULARS
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
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).
Older people: 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:
CLcr =
[140 − _age _(_years_)] _x weight _(_kg_)
_____________________________ (_x 0.85 for women_)
72 x serum creatinine (mg / dl)
Dosing adjustments for adult patients with impaired renal function
Group
Creatinine clearance (ml/min)
Dosage and frequency
Normal
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