Zirtek Allergy Relief for Children 1mg/ml oral solution

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Cetirizine hydrochloride

זמין מ:

UCB Pharma Ltd

קוד ATC:

R06AE07

INN (שם בינלאומי):

Cetirizine hydrochloride

כמות:

1mg/1ml

טופס פרצבטיות:

Oral solution

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 03040100; GTIN: 5024091747274 05024091747274

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIRTEK
®
ALLERGY RELIEF FOR CHILDREN 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 Relief for Children is and what it is used for
2. What you need to know before you take Zirtek Allergy Relief for
Children
3. How to take Zirtek Allergy Relief for Children
4. Possible side effects
5. How to store Zirtek Allergy Relief for Children
6. Contents of the pack and other information.
1. WHAT ZIRTEK ALLERGY RELIEF FOR CHILDREN IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride, the active ingredient of the solution is
an antihistamine. It blocks
the effects of a substance called histamine which occurs naturally in
the body. Histamine is
involved in allergic reactions.
Zirtek Allergy Relief for Children is used to treat adults and
children aged 6 years and over
who have hay fever (seasonal allergic rhinitis), year round allergies
such as dust or pet
allergies (perennial allergic rhinitis) and urticaria (swelling,
redness and itchiness of the skin).
Antihistamines like Zirtek Allergy Relief for Children relieve the
unpleasant symptoms and
discomfort associated with these conditions, such as sneezing,
irritated, runny and blocked up
nose, itchy, red and watering eyes and skin rashes.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZIRTEK ALLERGY RELIEF FOR
CHILDREN
DO NOT TAKE ZIRTEK ALLERGY RELIEF FOR CHILDREN

if you have a severe kidney disease (se

מאפייני מוצר

OBJECT 1
ZIRTEK ALLERGY RELIEF FOR CHILDREN 1 MG/ML ORAL
SOLUTION
Summary of Product Characteristics Updated 03-Jan-2018 | UCB Pharma
Limited
1. Name of the medicinal product
Zirtek Allergy Relief for Children 1 mg/mL oral solution
2. Qualitative and quantitative composition
Each mL of solution contains 1 mg cetirizine dihydrochloride
Excipients with known effects:
- 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 6 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
_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. 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 once daily
Mild