Cetirizine dihydrochloride Pinewood 10 mg film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cetirizine dihydrochloride

Available from:

Pinewood Laboratories Ltd

ATC code:

R06AE07

INN (International Name):

Cetirizine dihydrochloride

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

cetirizine

Authorization status:

Marketed

Authorization date:

2022-06-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CETIRIZINE DIHYDROCHLORIDE PINEWOOD 10 MG FILM-COATED TABLETS
CETIRIZINE DIHYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
-
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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1.
What Cetirizine Tablets are and what they are used for
2.
What you need to know before you take Cetirizine Tablets
3.
How to take Cetirizine Tablets
4.
Possible side effects
5.
How to store Cetirizine Tablets
6.
Contents of the pack and other information
1.
WHAT CETIRIZINE TABLETS ARE AND WHAT THEY ARE USED FOR
Cetirizine Tablets contain the active ingredient cetirizine
dihydrochloride. This is an
antihistamine used to treat seasonal allergic rhinitis (hay fever) and
perennial rhinitis, and
urticaria (hives) in adults and children over 6 years of age.
Antihistamines like Cetirizine relieve the symptoms and discomfort
associated with these
conditions, such as sneezing, an itchy, runny and blocked nose, itchy,
red and watering
eyes and itchy skin rashes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE TABLETS
DO NOT TAKE CETIRIZINE TABLETS IF:

you have severe kidney problems (severe renal failure with creatinine
clearance below 10
ml/min).

you are allergic to cetirizine dihydrochloride, any of the other
ingredients of this medicine
(listed in section 6), to hydroxyzine or piperazine derivatives
(closely related active
ingredients of other medicines).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Cetirizine Tablets:

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 w

Summary of Product characteristics

Health Products Regulatory Authority
03 June 2022
CRN00C5VQ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cetirizine dihydrochloride Pinewood 10 mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10mg cetirizine dihydrochloride.
Excipient with known effect:
One film-coated tablet contains 65mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
White to off white capsule shaped film coated tablets with breakline
on one side & '10' debossed on the other side. The tablet
can be divided into 2 equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cetirizine 10 mg film-coated tablets are 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
10 mg once daily (1 tablet).
Special population
_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 where 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 (CL
cr
) in ml/min is needed. The CL
cr
(ml/min) may be estimated from serum creatinine
(mg/dl) determination using the following formula:
CL
cr
= [140 −age (years)] x weight (kg) (x0.85 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 ≥80 10 mg once daily
Mild 50 – 79 10 mg once daily
Mo