Benadryl Allergy Liquid Release 10mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cetirizine hydrochloride

Available from:

McNeil Products Ltd

ATC code:

R06AE07

INN (International Name):

Cetirizine hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 3574660634655

Patient Information leaflet

■
This medicine is used to relieve the symptoms of hay
fever and other allergic conditions such as pet or dust
allergies and skin reactions.
■
This medicine is for use by adults and children aged
12 years and over.
■
A doctor must be contacted if symptoms worsen or do
not improve after 3 days.
READ THE LEAFLET CAREFULLY BEFORE USE. Keep this leaflet,
you might need it again.
1 WHAT THE MEDICINE IS FOR
Benadryl Allergy Liquid Release 10 mg Capsules are a
medicine which is used to relieve the symptoms of hay
fever and other allergic conditions such as pet or dust
allergies. The capsules contain 10 mg cetirizine
dihydrochloride which is an antihistamine that helps
relieve allergy symptoms such as sneezing, runny nose
and watery eyes. It can also be used to treat allergic skin
reactions. These include urticaria, also known as hives,
where the skin looks blotchy, with white raised wheals
(bumps) surrounded by redness.
This medicine is for use in adults and children aged
12 years and over.
2 BEFORE TAKING THIS MEDICINE
This medicine is suitable for most adults and children
aged 12 years and over, but a few people should not use
it. If you are in any doubt, talk to your doctor or
pharmacist.
DO NOT TAKE THIS MEDICINE…
■
If you have ever had a BAD REACTION to cetirizine
dihydrochloride, to hydroxyzine or piperazine
derivatives or any other ingredients of this
medicine (_See section 6_).
■
If you have moderate or serious KIDNEY
PROBLEMS.
Benadryl Allergy Liquid Release 10 mg Capsules
contain soya oil. If you are allergic to PEANUT OR
SOYA, do not use this medicinal product.
TALK TO YOUR DOCTOR OR PHARMACIST…
■
If you are an EPILEPTIC or at RISK OF CONVULSIONS
(FITS).
If this applies to you, TALK TO A DOCTOR OR PHARMACIST.
WARNINGS AND PRECAUTIONS
If you are a patient with both liver and kidney
disease, 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 difficulty passing urine, you should ask
your doctor for advice.
IF YO

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Benadryl Allergy Liquid Release 10 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 10 mg cetirizine dihydrochloride.
For the full list of excipients, see section 6.1. The product contains
soya oil and a
maximum of 19.3 mg sorbitol per capsule dose.
3
PHARMACEUTICAL FORM
Capsule, soft.
Each capsule has a colourless to slightly yellow, clear shell
containing a clear,
colourless viscous fill. Each soft gel capsule has the logo "C10"
printed with
black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Benadryl Allergy Liquid Release 10mg Capsules is indicated in children
aged
12 years and above, adolescents and adults:
o
for the relief of nasal and ocular symptoms of seasonal and perennial
allergic rhinitis.
o
for the relief of symptoms of chronic idiopathic urticaria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and adolescents 12 years of age and over: 10mg once daily (1
capsule).
The capsules need to be swallowed with a glass of liquid.
Elderly subjects: 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: 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 CLcr
(ml/min)
may be estimated from serum creatinine (mg/dl) determination using the
following formula:
CL
cr
=
[
]
(
)
_women_
_for_
_x_
_dl_
_mg_
_creatinine_
_serum_
_x_
_kg_
_weight_
_x_
_years_
_age_
85
.
0
)
/
(
72
)
(
)
(
140
−
Dosing adjustments for adult patients with impaired renal function
GROUP
CREATININE CLEARANCE
(ML/MIN)
DOSAGE AND FREQUENCY
Normal
≥
80
10mg once daily
Mild
50 – 79
10mg once daily
Moderate
30 – 49
5mg once daily*
Severe
< 30
5mg once every 2 days*
End-stage renal disease -
Patients undergoing dialysis
< 10
Co