Zirtek Allergy 1mg/ml oral solution

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Cetirizine hydrochloride

Tilgængelig fra:

UCB Pharma Ltd

ATC-kode:

R06AE07

INN (International Name):

Cetirizine hydrochloride

Dosering:

1mg/1ml

Lægemiddelform:

Oral solution

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 03040100; GTIN: 5024091747014 5024091747281

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIRTEK ALLERGY SOLUTION 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 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 Zirtek Allergy Solution is and what it is used for
2.
What you need to know before you take Zirtek Allergy Solution
3.
How to take Zirtek Allergy Solution
4.
Possible side effects
5.
How to store Zirtek Allergy Solution
6.
Contents of the pack and other information
1. WHAT ZIRTEK ALLERGY SOLUTION IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zirtek Allergy
Solution.
Zirtek Allergy Solution is an antiallergic medication.
In adults and children aged 2 years and above, Zirtek Allergy 1 mg/ml
oral solution 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 ZIRTEK ALLERGY SOLUTION
DO NOT TAKE ZIRTEK ALLERGY SOLUTION
-
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 (listed in
section 6), to hydroxyzine or to any piperazine derivatives (closely
related active ingredients of
other medicines).
WARNINGS AND PRECAUTIONS
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 probl

Produktets egenskaber

OBJECT 1
ZIRTEK ALLERGY SOLUTION 1MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 12-Jul-2016 | UCB Pharma
Limited
1. Name of the medicinal product
Zirtek Allergy Solution, 1 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml of solution contains 1 mg cetirizine dihydrochloride.
Excipients with known effect:
- 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
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral solution
Clear and colorless liquid with slightly sweet taste and a banana
flavour
4. Clinical particulars
4.1 Therapeutic indications
Cetirizine dihydrochloride 1 mg/ml oral solution is indicated in
adults and children aged 2 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 (10 ml oral solution (2 full spoons)).
Special population
_Older people_
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 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. 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:
Dosing adjustments for adult patients with impaired renal function
Group
Creatinine clearance (ml/min)
Dosage and frequency
Normal
≥80
10 mg