Benadryl Allergy One A Day 10mg tablets

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:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 3574661202662 3574661202655 3574661253848

Patient Information leaflet

IF ANYONE HAS TOO MUCH
If anyone has too much contact a doctor or
your nearest Accident and Emergency
department (Casualty) taking this leaflet and
pack with you.
IF YOU FORGET TO TAKE THE MEDICINE
If you forget to take a dose, take the next dose
when needed provided that you only take a
maximum of 1 tablet in 24 hours. Do not take
a double dose.
4 POSSIBLE SIDE-EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
IF YOU EXPERIENCE ANY OF THE FOLLOWING,
STOP TAKING THIS MEDICINE AND SEEK
IMMEDIATE MEDICAL HELP:
■
Sudden onset of fever, reddening of the skin,
or many small pustules (possible symptoms
of Acute Generalised Exanthematous
Pustulosis - AGEP) may occur within the first
2 days of treatment with this medicine (See
section 2).
■
Sudden signs of allergy such as rash, itching
or hives on the skin, swelling of the face,
lips, tongue or other parts of the body,
shortness of breath, wheezing or trouble
breathing
■
Bruising or bleeding more easily than
normal
■
Convulsions (fits) or hallucinations
■
Loss of consciousness
■
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 One a Day 10 mg Tablets is a
medicine which is used to relieve the symptoms of
hay fever and other allergic conditions such as pet
or dust allergies. The tablets 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 a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Benadryl One A Day Relief
Benadryl Allergy One A Day 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 10 mg cetirizine dihydrochloride
Excipients: one film-coated tablet contains 66.40 mg
lactose-monohydrate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
FILM-COATED TABLETS
White, oblong, film-coated tablet, with breakline and Y-Y logo
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Benadryl Allergy One a Day 10mg Tablets are indicated in children aged
12
years and above, adolescents and adults:
-
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
Adults and adolescents over 12 years of age: 10 mg once daily (1
tablet).
The tablets 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: there are no data
to document the
efficacy/safety ratio in patients with renal impairement. Since
cetirizine is mainly
excreted 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
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
In p