Benadryl Allergy Relief

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

ACRIVASTINE

Доступна с:

McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

код АТС:

R06AX18

ИНН (Международная Имя):

ACRIVASTINE 8 mg

Фармацевтическая форма:

CAPSULE

состав:

ACRIVASTINE 8 mg

Тип рецепта:

OTC

Терапевтические области:

ANTIHISTAMINES FOR SYSTEMIC USE

Статус Авторизация:

Withdrawn

Дата Авторизация:

2006-08-10

тонкая брошюра

lef
t margin
14 mm
right margin
12 mm
6 mm
6 mm
spot = 12 x 2 centered in
the margin of 14 mm
Distance between cutted line/middel of the spot =
 83.6 MM
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Ask your doctor or pharmacist for advice before
taking this medicine if you are pregnant or
breast-feeding.
SSP
PEECCIIAALL  W
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NGGSS  AAB
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I
Do not drink GGRRAAP
PEEFFRRU
UIITT  JJU
UIICCEE while taking
Benadryl Allergy Relief.
I
In most people this product does not cause
drowsiness. However, there are rare exceptions
and you should take care when you use this
product for the first time. If this product makes
you feel drowsy, do not drive or operate
machinery. 
I
As with all antihistamines, it is advisable to
avoid excessive alcohol consumption when
taking this medicine.
SSO
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I
This product contains lactose. If you have been
told by your doctor that you have an intolerance
to some sugars, contact your doctor before
taking this medicine.
3
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I
For oral use only.
I
Do not take more than the stated dose shown in 
the table.
C
CH
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N  U
UN
ND
DEERR  1
12
2  YYEEAARRSS  O
OLLD
D
This medicine is not recommended for children aged
under 12 years.
I
This medicine is used to relieve the symptoms of
hay fever and other allergic conditions such as pet
allergies, dust allergies and skin reactions.
I
This medicine is for use by adults and children
aged 12 – 65 years.
I
D
DO
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There are some people who should not use this
medicine. To find out if you are one of them 
_See Section 2_
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If

Характеристики продукта

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
Benadryl Allergy Relief
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benadryl Allergy Relief contains 8 mg Acrivastine per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Benadryl Allergy Relief is indicated for the symptomatic relief of
allergic rhinitis,
including
hay
fever.
Benadryl
Allergy
Relief
is
also
indicated
for
chronic
idiopathic urticaria.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN 12 -65 YEARS:
One 8 mg capsule, as necessary up to three times a day.
USE IN THE ELDERLY (OVER 65 YEARS)
As yet, no specific studies have been carried out in the elderly.
Until further
information is available, Benadryl Allergy Relief should not be given
to elderly
patients.
METHOD OF ADMINISTRATION
For oral use.
4.3.
CONTRAINDICATIONS
Benadryl
Allergy
Relief
is
contraindicated
in
individuals
with
known
hypersensitivity to acrivastine, triprolidine or to any of the
excipients listed in
section 6.1. Renal excretion is the principal route of elimination of
acrivastine.
Until specific studies have been carried out Benadryl Allergy Relief
should not be
given to patients with significant renal impairment.
Page 2 of 5
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The following statements will appear on the pack:
Do not store above 30°C. Store in the original package. Keep out of
the reach and
sight of children.
4.5.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
It is usual to advise patients not to undertake tasks requiring mental
alertness
whilst under the influence of alcohol and other CNS depressants.
Concomitant
administration
of
acrivastine
may,
in
some
individuals,
produce
additional
impairment.
There
are
no
data
to
demonstrate
an
interaction
between
acrivastine
and
ketoconazole,
erythromycin
or
grapefruit
juice.
However,
due
to
known
interactions between these compounds and other