Cetrine 10 mg Film-coated Tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Cetirizine hydrochloride

Fáanlegur frá:

Rowex Ltd

ATC númer:

R06AE; R06AE07

INN (Alþjóðlegt nafn):

Cetirizine hydrochloride

Skammtar:

10 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Piperazine derivatives; cetirizine

Leyfisstaða:

Marketed

Leyfisdagur:

2004-08-06

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
CETRINE 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.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
the others. It may harm them even
if their signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
3. H
WHAT IS IN THIS LEAFLET:
1. What Cetrine is and what it is used for
2. What you need to know before you take Cetrine
3. How to take Cetrine
4. Possible side effects
5. How to store Cetrine
6. Contents of the pack and other information
1. WHAT CETRINE IS AND WHAT IT IS USED FOR
.
The active ingredient of Cetrine is cetirizine dihydrochloride.
Cetrine is an anti-allergy medicine. It
helps control your allergic reaction and its symptoms.
In adults and children aged 6 years and above: Cetrine 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 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
DO NOT TAKE CETRINE:
- 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 or pharmacist before taking Cetrine:
- if you have
KIDNEY PROBLEMS
. Your treatment may need to be adjusted.
- if you have predisposition factors of urinary retention (e.g. spinal
cord lesions or prostatic
hy

Vara einkenni

Health Products Regulatory Authority
04 April 2019
CRN008NYT
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cetrine 10 mg 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 scoreline is to allow the tablet to be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cetrine 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_: 5mg 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
Severe
<30
5 mg on