Care Hayfever and Allergy oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cetirizine hydrochloride

Available from:

Thornton & Ross Ltd

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: 5011309062410

Patient Information leaflet

PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
N/A
A
gill.kennedy
562529
11913
Addition of reporting of side
effects statement MHRA approved.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
200ml
23814505
338 x 148mm flat (29 x 148mm folded)
2
09.03.2015
Process Black
Keylines (non-printing)
Care Hayfever and Allergy 1mg/ml
Solution
Helvetica
_Data Matrix:_
_ _
23814505 VERIFIED
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
N/A
A
gill.kennedy
562529
11913
Addition of reporting of side
effects statement MHRA approved.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
200ml
23814505
338 x 148mm flat (29 x 148mm folded)
2
09.03.2015
Process Black
Keylines (non-printing)
Care Hayfever and Allergy 1mg/ml
Solution
Helvetica
_Data Matrix:_
_ _
23814505 VERIFIED
FRONT FACE TOP
CARE HAYFEVER AND ALLERGY
1 MG/ML SOLUTION
(cetirizine hydrochloride)
IMPORTANT INFORMATION ABOUT CARE HAYFEVER
AND ALLERGY 1 MG/ML SOLUTION
• This medicine relieves the symptoms of
hayfever in adults and children over 2 years.
• It can also be used for other allergies in older
children and adults. See section 3.
DO NOT….
• Drink large amounts of alcohol whilst taking
this medicine.
NOW READ THE REST OF THE LEAFLET BEFORE YOU USE
THIS MEDICINE. IT INCLUDES OTHER INFORMATION
WHICH MIGHT BE ESPECIALLY IMPORTANT FOR YOU.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need any more
information or advice.
• 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.
1. WHAT THE MEDICINE IS FOR
Hayfever and Allergy 1 mg/ml Solution contains
cetirizine, an antihistamine, to treat the
symptoms of allergies.
• It can be used for the sym

Summary of Product characteristics

OBJECT 1
CARE HAYFEVER AND ALLERGY 1MG/ML SOLUTION
Summary of Product Characteristics Updated 10-Mar-2015 | Thornton &
Ross Ltd
1. Name of the medicinal product
Care Hayfever and Allergy 1mg/mL Solution
2. Qualitative and quantitative composition
Each 1 ml of solution contains 1mg of cetirizine hydrochloride.
For excipients, see 6.1.
3. Pharmaceutical form
Oral solution.
Clear colourless solution .
4. Clinical particulars
4.1 Therapeutic indications
_Adults and adolescents over 12 years of age:_
Symptomatic treatment of allergic rhinitis (seasonal and perennial),
associated allergic conjunctivitis, and
chronic idiopathic urticaria.
_Children 6-12 years:_
Symptomatic treatment of allergic rhinitis (seasonal and perennial),
and chronic idiopathic urticaria.
_Children 2–6 years_
Symptomatic treatment of seasonal allergic rhinitis
4.2 Posology and method of administration
Adults and adolescents over 12 years of age: 2 x 5 ml once daily.
If drowsiness occurs, the solution can be administered in the evening.
_Children 6-12 years:_
2 x 5ml once daily or 5ml taken twice daily (morning and evening).
_Children 2-6 years or weighing less than 30Kg:_
5ml taken once daily or 2.5ml twice daily.
At present there is insufficient clinical data to recommend the use of
cetirizine in children under 2 years
of age.
Patients with moderate to severe renal impairment: 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 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
50 – 79
10 mg once daily
Moderate
30 – 49
5 mg once daily
Severe
< 30
5 mg once every 2 days
End-stage renal disease - Patients
undergoing dialysis
< 10
Contra-indicated