Cetirizine 1mg/ml oral solution sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cetirizine hydrochloride

Available from:

Pinewood Healthcare

ATC code:

R06AE07

INN (International Name):

Cetirizine hydrochloride

Dosage:

1mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5099186003610

Patient Information leaflet

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PATIENT INFORMATION LEAFLET
Cetirizine Hydrochloride 5 mg/5 ml Oral Solution
Cetirizine hydrochloride
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription, however, you still
need to take your medicine carefully to get the best results from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
You must contact a doctor if your symptoms worsen or do not improve
after a few days.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1.
What Cetirizine Hydrochloride is and what it is used for
2.
Before you take Cetirizine Hydrochloride
3.
How to take Cetirizine Hydrochloride
4.
Possible side effects
5.
How to store Cetirizine Hydrochloride
6.
Further information
1.
WHAT CETIRIZINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Cetirizine Hydrochloride 5 mg/5 ml Oral Solution (”Cetirizine
Hydrochloride”) belongs to a group of medicines called
antihistamines. It works by counteracting the
effects of histamine which is produced naturally by your body’s
defence system, but may be over-produced in allergic reactions.
Cetirizine Hydrochloride is used to relieve the symptoms of hayfever
(seasonal rhinitis) in adults and children over the age of 2 years,
which include:
•
sneezing
•
irritated, runny or blocked nose
•
itchy, red and watering eyes
It is used to relieve the symptoms of other allergies in adults and
older children (over the age of 6 years), including:
•
runny and itchy nose (non-seasonal rhinitis)
•
pet or house mite allergies
•
skin allergies such as rash, itching and urticaria (hives)
2.
BEFORE YOU TAKE CETIRIZINE HYDROCHLORIDE
DO NOT TAKE Cetirizine Hydrochloride if you:
•
are allergic to cetirizine hydrochloride, hydroxyzine or any of the
other ingredients of Cetirizine Hydrochloride, or to any piperazine
derivatives
_(_

Summary of Product characteristics

OBJECT 1
CETIRIZINE HYDROCHLORIDE 5 MG/5 ML ORAL
SOLUTION
Summary of Product Characteristics Updated 11-Jun-2018 | Pinewood
Healthcare
1. Name of the medicinal product
Cetirizine Hydrochloride 5 mg/5 ml Oral Solution
2. Qualitative and quantitative composition
Each 5 ml spoonful contains 5mg Cetirizine hydrochloride. Each 5ml
spoonful also contains the
following excipients:
250 mg Propylene glycol
6.75 mg Methyl parahydroxybenzoate (E218)
0.75 mg Propyl parahydroxybenzoate (E216)
2250 mg Liquid Sorbitol (E420)
For a full list of excipients, see Section 6.1.
3. Pharmaceutical form
Oral Solution
Clear or almost clear, colourless solution with taste and odour of
banana.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of perennial rhinitis, seasonal allergic rhinitis
(hay fever) and chronic idiopathic
urticaria in adults and children aged 6 years and over, and for
seasonal rhinitis (hay fever) in children
aged between 2 to 5 years.
4.2 Posology and method of administration
For oral use only.
Adults and children 6 years and above: 10 mg daily.
Adults and children aged 12 years and above: 10 ml once daily.
Children aged between 6 to 11 years: Either 5 ml twice daily or 10 ml
once daily.
Children aged between 2-5 years: 5 mg daily.
Either 5 ml once daily or 2.5 ml twice daily.
At present there is insufficient clinical data to recommend the use of
Cetirizine in children under 2 years
of age.
Elderly subjects: There is no data to suggest that the dose should be
reduced in elderly patients, provided
that the renal function is normal.
For 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 individualised 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 clearanc