Tiritek Allergy 10 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cetirizine hydrochloride

Available from:

Chanelle Medical

ATC code:

R06AE; R06AE07

INN (International Name):

Cetirizine hydrochloride

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Piperazine derivatives; cetirizine

Authorization status:

Not marketed

Authorization date:

2004-02-06

Patient Information leaflet

ID: PL14M IRL (MAH) Version: 10 Revision Date: 28/09/2020
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
TIRITEK 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 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 Tiritek Allergy is and what it is used for
2.
What you need to know before you take Tiritek Allergy
3.
How to take Tiritek Allergy
4.
Possible side effects
5.
How to store Tiritek Allergy
6.
Contents of the pack and other information
1.
WHAT TIRITEK ALLERGY IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Tiritek Allergy
10 mg
Tablets.
Tiritek Allergy 10 mg Tablets is an antiallergic medication.
In adults and children aged 6 years and above, Tiritek Allergy 10 mg
Tablets
are indicated
- for the relief of nasal and ocular symptoms of seasonal and
perennial allergic
rhinitis
- for the relief of urticaria
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TIRITEK ALLERGY
DO NOT TAKE TIRITEK ALLERGY:

if you have severe kidney disease (severe renal failure with
creatinine
clearance below 10 ml/min).

if you are allergic to Cetirizine dihydrochloride, to any of the other
ingredients (listed in section 6), to hydroxyzine or to piperazine
derivatives
(closely related active ingredients of other medicines).
ID: PL14M IRL (MAH) Version: 10 Revision Date: 28/09/2020
Page 2 of 7
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Tiritek Allergy
If you are a patient with renal insu

Summary of Product characteristics

Health Products Regulatory Authority
14 December 2020
CRN009ZQN
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tiritek Allergy 10 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg Cetirizine dihydrochloride.
Excipients with known effect: one film-coated tablet contains 101.83
mg lactose.
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 2 equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cetirizine dihydrochloride 10 mg film-coated tablets are indicated in
adults and paediatric
patients 6 year 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 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:
Dosing adjustments for adult patients with impaired renal function
Health Products Regulatory Authority
14 December 2020
CRN009ZQN
Page 2 of 9
Group
​
Creatinine clearance (ml/min)
Dosage and frequency
Normal
≥80
10 mg once daily
Mild
50 – 79
10 mg once daily
Moderate
30 – 49
5 mg once d