Zirtek Plus Decongestant 5mg/120mg Prolonged Release Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
30-11-2021
Summary of Product characteristics
(SPC)
30-11-2021
Active ingredient:
PSEUDOEPHEDRINE HYDROCHLORIDE; Cetirizine dihydrochloride
Available from:
UCB (Pharma) Ireland Limited
ATC code:
R01BA; R01BA52
INN (International Name):
PSEUDOEPHEDRINE HYDROCHLORIDE; Cetirizine dihydrochloride
Dosage:
5mg/120 milligram(s)
Pharmaceutical form:
Prolonged-release tablet
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Sympathomimetics; pseudoephedrine, combinations
Authorization status:
Marketed
Authorization date:
2006-06-30
Patient Information leaflet
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENTS
ZIRTEK PLUS DECONGESTANT 5
MG/120
MG PROLONGED-RELEASE TABLETS
(5 mg cetirizine dihydrochloride - 120 mg pseudoephedrine
hydrochloride)
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 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 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 7 days.
WHAT IS IN THIS LEAFLET
:
1.
What Zirtek Plus Decongestant is and what it is used for
2.
What you need to know before you take Zirtek Plus Decongestant
3.
How to take Zirtek Plus Decongestant
4.
Possible side effects
5.
How to store Zirtek Plus Decongestant
6.
Contents of the pack and other information
1.
WHAT ZIRTEK PLUS DECONGESTANT IS AND WHAT IT IS USED FOR
Zirtek Plus Decongestant 5mg/120mg prolonged release tablets contains
two active substances:
cetirizine dihydrochloride which is an antihistamine and
pseudoephedrine hydrochloride which is a
decongestant.
Zirtek Plus Decongestant is a medicine that is used to relieve
allergic symptoms, especially when the
anti-allergy properties of cetirizine are combined with the effects of
pseudoephedrine in reducing
swelling of the mucous membranes inside the nose.
Zirtek Plus Decongestant is indicated for the treatment of symptoms
such as blocked nose, sneezing,
runny nose, itchy nose or itchy eyes, which occur in seasonal allergic
rhinitis (hay fever) or perennial
allergic rhinitis (house-dust allergy).
Zirtek Plus Decongestant is indicated for adults and adolescents from
12 years of age and above.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZIRTEK PLUS DECONGESTANT
DO NOT TAKE ZIRTEK PLUS DECONGESTANT
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
29 November 2021
CRN00CPKY
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zirtek Plus Decongestant 5mg/120mg Prolonged Release Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet provides 5 mg cetirizine dihydrochloride for immediate
release, and 120 mg pseudoephedrine hydrochloride for
prolonged release.
Excipients with known effect: one tablet contains 43.23 mg lactose
monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged release tablet.
White to off-white, round, biconvex circle-embossed, film-coated
tablet, having a circular logo on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cetirizine-pseudoephedrine is indicated for the treatment of symptoms
such as nasal congestion, sneezing, rhinorrhoea, and
nasal and ocular pruritus associated with seasonal or perennial
allergic rhinitis. Cetirizine-pseudoephedrine should be
administered when the anti-allergic properties of cetirizine
dihydrochloride and the nasal decongestant activity of
pseudoephedrine hydrochloride are desired.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
One tablet two times a day (morning and evening), corresponding to the
maximum recommended dose of 10 mg of cetirizine
dihydrochloride and 240 mg of pseudoephedrine hydrochloride daily.
Special populations
_Paediatric population_
Adolescents from 12 years of age and above: 1 tablet two times a day
(morning and evening), with or without food.
Children under 12 years of age: the use of the product is
contraindicated (see sections 4.3 and 4.4).
_ _
_Renal impairment_
The dosing intervals must be individualized according to renal
function. Refer to the following table and adjust the dose as
indicated.
Dosing Adjustments for Adult Patients with Impaired Renal Function
GROUP
GFR (ML / MIN)
DOSAGE AND FREQUENCY
NORMAL RENAL FUNCTION
³ 90
1 TABLET* TWICE DAILY
MILDLY DECREASED RENAL FUNCTION
60 – < 90
1 TABLET* TWICE DAILY
MODERATELY DECREASED RENAL FUNCTIO
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