Cetrine Allergy 10mg Film-coated Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Cetirizine hydrochloride

Tilgjengelig fra:

Rowex Ltd

ATC-kode:

R06AE; R06AE07

INN (International Name):

Cetirizine hydrochloride

Dosering :

10 milligram(s)

Legemiddelform:

Film-coated tablet

Resept typen:

Product not subject to medical prescription

Terapeutisk område:

Piperazine derivatives; cetirizine

Autorisasjon status:

Marketed

Autorisasjon dato:

2004-08-06

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
CETRINE ALLERGY 10 MG 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, pharmacist or nurse
has 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, pharmacist or
nurse. 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
3. H
WHAT IS IN THIS LEAFLET:
1. What Cetrine Allergy is and what it is used for
2. What you need to know before you take Cetrine Allergy
3. How to take Cetrine Allergy
4. Possible side effects
5. How to store Cetrine Allergy
6. Contents of the pack and other information
1. WHAT CETRINE ALLERGY IS AND WHAT IT IS USED FOR
.
The active ingredient of Cetrine Allergy is cetirizine
dihydrochloride. Cetrine Allergy is an anti-
allergy medicine. It helps control your allergic reaction and its
symptoms.
In adults and children aged 6 years and above: Cetrine Allergy
relieves symptoms associated with, for
example, hay fever, allergy to dust mites (allergic rhinitis) such as:
• sneezing,
• runny or itchy nose,
• itchy palate,
• itchy, red or tearing eyes.
Cetrine Allergy is also used to relieve symptoms such as itching and
hives (associated with chronic
urticaria of unknown cause).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETRINE ALLERGY
DO NOT TAKE CETRINE ALLERGY:
- if you are allergic to cetirizine or any of the other ingredients of
this medicine (listed in section 6), to
hydroxyzine or piperazine derivatives (closely related active
substances of other medicines)
- if you have severe kidney problems.
WARNINGS AND PRECAUTIONS:
- Talk to your doctor, pharmacist or nurse before taking Cetrine
Allergy:
-if you have
KIDNEY PROB

Preparatomtale

Health Products Regulatory Authority
04 April 2019
CRN008NYT
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cetrine Allergy 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg cetirizine dihydrochloride.
Excipients with known effect: Also contains 81.8mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
White, oblong film-coated tablet, scored on one side.
The score line is to allow the tablet to be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cetrine Allergy is indicated in adults and paediatric patients 6 years
and above:
- for the relief of nasal and ocular symptoms of seasonal and
perennial allergic rhinitis.
- 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 a 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 individualised according to renal
function. Refer to the following table and adjust the dose
as indicated. To use the 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 adjustments for adult patients with impaired renal function
GROUP
Creatinine Clearance (ml/min)
Dosage and frequency
Normal
≥80
10mg once daily
Mild
50 – 79
10mg once daily
Moderate
30 – 49
5mg once daily
Sev