Zyrtec drops oral

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cetirizine (cetirizine dihydrochloride)

Available from:

Aesica Pharmaceuticals S.r.l.

ATC code:

R06AE07

INN (International Name):

cetirizine (cetirizine dihydrochloride)

Dosage:

10mg/ml

Pharmaceutical form:

drops oral

Units in package:

10ml glass bottle

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2022-05-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYRTEC 10 MG/ML ORAL DROPS 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 Zyrtec 10 mg/ml oral dropsis and what it is used for
2.
What you need to know before you take Zyrtec 10 mg/ml oral drops
3.
How to take Zyrtec 10 mg/ml oral drops
4.
Possible side effects
5.
How to store Zyrtec 10 mg/ml oral drops
6.
Contents of the pack and other information
1.
WHAT ZYRTEC 10 MG/ML ORAL DROPS IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zyrtec 10 mg/ml
oral
drops. Zyrtec 10 mg/ml oral drops is an antiallergic medication.
In adults and children aged 2 years and above, Zyrtec 10 mg/ml oral
drops10 mg/ml oral drops
is 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 ZYRTEC 10 MG/ML ORAL
DROPS
DO NOT TAKE ZYRTEC 10 MG/ML ORAL DROPS
-
if you have a severe kidney disease requiring dialysis;
-
if you are allergic to cetirizine dihydrochloride or any of the other
ingredients of this medicine
(listed in section 6), to hydroxyzine or to any piperazine derivatives
(closely related active
ingredients of other medicines).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zyrtec 10 mg/ml oral
drops.
If you are a patient with renal insufficiency, please ask your doctor
for advice; if necessary, you will
take a lower dose. The ne

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Zyrtec oral drops10 mg/ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 10 mg cetirizine dihydrochloride.
Excipients with known effect:
- one ml of solution contains 1.35 mg methylparahydroxybenzoate
- one ml of solution contains 0.15 mg propylparahydroxybenzoate
- glycerol
- propylene glycol
- saccharin sodium
- sodium acetate
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Oral drops
Transparent colorless liquid with a slightly sweet taste and bitter
aroma.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cetirizine dihydrochloride is indicated for:
- 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 (20 drops).
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 eliminated 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.
Dosing adjustments for adult patients with impaired renal function
Group
Estimated Glomerular Filtration
Rate (eGFR) (ml/min)
Dosage and frequency
Normal renal function
≥90
10 mg once daily
Mildly decreased renal function
60 - < 90
10 mg once daily
Moderately decreased renal
function
30 – < 60
5 mg once daily
Severely decreased renal
function
15 - <30 not requiring dialysis
5 mg once every 2 days
End-stage renal disease
<15 requiring dialysis treatment
Contraindicated
_ _
_Hepatic impairment_
No dose adjustment is needed in patients with solely hepatic
impairment. In patients with hepatic
impairment and renal impairment, adjustment of the dose i