Cetrine Allergy 1 mg/ml oral solution

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Cetirizine dihydrochloride

Tilgjengelig fra:

Rowex Ltd

ATC-kode:

R06AE; R06AE07

INN (International Name):

Cetirizine dihydrochloride

Dosering :

1 milligram(s)/millilitre

Legemiddelform:

Oral solution

Terapeutisk område:

Piperazine derivatives; cetirizine

Autorisasjon status:

Marketed

Autorisasjon dato:

2019-07-15

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
CETRINE ALLERGY 1 MG/ML ORAL SOLUTION
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 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 3 days
WHAT IS IN
THIS LEAFLET
1. What Cetrine Allergy is and what it is used for
2
What you need to know before you take Cetrine Allergy
3. How to take Cetrine Allergy
4. Possible side effects
5. How to store Cetrine Allergy
6. Contents of the pack and other information
1. WHAT CETRINE ALLERGY IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Cetrine
Allergy. Cetrine Allergy is an antiallergic
medication.
In adults and children aged 2 years and above, Cetrine Allergy 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 CETRINE ALLERGY
DO NOT TAKE CETRINE ALLERGY
-
if you have a 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 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 before taking Cetrine Allergy.
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 will be determined by your doctor.
If you have problems passing urine (like spinal cord proble

Preparatomtale

Health Products Regulatory Authority
29 June 2020
CRN009TKZ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cetrine Allergy 1 mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 1 mg cetirizine dihydrochloride.
Excipients:
- one ml of solution contains 450 mg sorbitol (solution at 70 %,
non-crystallizing)
- one ml of solution contains 1.35 mg methylparahydroxybenzoate
- one ml of solution contains 0.15 mg propylparahydroxybenzoate
- one ml of solution contains 49.0 mg propylene glycol
- one ml of solution contains 0.82 mg sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, colourless liquid with banana flavour
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults and children 2 years and above:
- Cetrine Allergy is indicated for the relief of nasal and ocular
symptoms of seasonal and perennial allergic rhinitis.
- Cetrine Allergy is indicated for the relief of symptoms of chronic
idiopathic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Children aged from 2 to 6 years
2.5 mg twice daily (2.5 ml oral solution twice daily (a half measuring
spoon twice daily))
Children aged from 6 to 12 years
5 mg twice daily (5 ml oral solution (a full measuring spoon twice
daily))
Adults and adolescents over 12 years of age
10 mg once daily (10 ml oral solution (2 full measuring spoons))
Elderly patients
Data do not suggest that the dose needs to be reduced in elderly
subjects provided that the renal function is normal.
Patients with moderate to severe 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 m