Anti-Hist Allergy 10mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cetirizine dihydrochloride

Available from:

Clonmel Healthcare Ltd

ATC code:

R06AE; R06AE07

INN (International Name):

Cetirizine dihydrochloride

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Piperazine derivatives; cetirizine

Authorization status:

Marketed

Authorization date:

2006-06-23

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANTI-HIST ALLERGY 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 Anti-Hist Allergy is and what it is used for
2.
What you need to know before you take Anti-Hist Allergy
3.
How to take Anti-Hist Allergy
4.
Possible side effects
5.
How to store Anti-Hist Allergy
6.
Contents of the pack and other information
1.
WHAT ANTI-HIST ALLERGY IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Anti-Hist
Allergy. Anti-Hist Allergy is an
antiallergic medication.
In adults and children aged 6 years and above, Anti-Hist Allergy 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).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANTI-HIST ALLERGY
DO NOT TAKE ANTI-HIST ALLERGY

if you are allergic to cetirizine dihydrochloride or any of the other
ingredients of this medicine
(listed in section 6).

if you are allergic to hydroxyzine or piperazine derivatives (closely
related active substances of
other medicines).

if you have a severe kidney disease (severe renal failure with
creatinine clearance below 10
ml/min).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Anti-Hist Allergy
If you are a patient with renal insufficiency, please ask your doctor
for advice; if necessary, you will
take

Summary of Product characteristics

Health Products Regulatory Authority
13 August 2019
CRN008YTZ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anti-Hist Allergy 10mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cetirizine dihydrochloride 10mg.
Excipient(s) with known effect
Each tablet contains 101.83 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
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 doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anti-Hist Allergy is indicated in adults and children 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
_Adults and adolescents over 12 years of age_
10 mg once daily (1 tablet).
_Elderly _
Data do not suggest that the dose needs to be reduced in elderly
subjects provided that the renal function is normal.
_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)
Health Products Regulatory Authority
13 August 2019
CRN008YTZ
Page 2 of 9
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
10m