Benadryl Allergy Relief 8mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Acrivastine

Available from:

McNeil Products Ltd

ATC code:

R06AX18

INN (International Name):

Acrivastine

Dosage:

8mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5010123722463 5010123669997 7046264111819

Patient Information leaflet

17-0298
365299F
turn over
AGE
ADULTS AND CHILDREN
12-65 YEARS
■
Do not take more than 3 doses in 24 hours.
■
If symptoms persist or worsen talk to your doctor.
DOSE
1 CAPSULE up to 3 times
a day.
Acrivastine
■
This medicine is used to relieve the symptoms of
hay fever and other allergic conditions such as pet
allergies, dust allergies and skin reactions.
■
This medicine is for use by adults and children
aged 12 – 65 years.
■ DO NOT TAKE THIS MEDICINE:
■
There are some people who should not use this
medicine. To find out if you are one of them
_ _
_ _
_See Section 2_
■
If you have ever had a BAD REACTION to any of
the ingredients or any other antihistamine.
_ _
_ _
_See Section 6 for the list of ingredients_
■ SPEAK TO YOUR DOCTOR:
■
If you suffer from any of the conditions mentioned
in section 2. _See Section 2_
■
If you are taking any other medicines.
_ _
_ _
_See Section 2_
■ FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY.
_ _
_See Section 3_
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE
THIS MEDICINE. Keep the leaflet: you might need it again.
1 WHAT THE MEDICINE IS FOR
Benadryl Allergy Relief is 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 acrivastine which is an antihistamine that helps
relieve allergy symptoms such as sneezing, runny nose
and watery eyes.
It can also be used to treat the symptoms of 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 under 65 years old
and children aged 12 years and over.
2 BEFORE TAKING THIS
MEDICINE
This medicine is suitable for most adults under
65 years old 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 any of
the ingredients, or to the antihistamine
_ _
_ triprolidine_.
■
If you have severe KI

Summary of Product characteristics

OBJECT 1
BENADRYL ALLERGY RELIEF (P)
Summary of Product Characteristics Updated 09-Jan-2018 | McNeil
Products Ltd
1. Name of the medicinal product
Benadryl Allergy Relief
2. Qualitative and quantitative composition
Benadryl Allergy Relief contains 8 mg Acrivastine per capsule.
Excipient with known effect:
Lactose 206.80 mg 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.
ELDERLY
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.
PAEDIATRIC POPULATION
The safety and efficacy of Benadryl Allergy Relief in children under
12 years of age has not yet been
established.
RENAL DYSFUNCTION
This product is contraindicated in patients with severe renal
impairment
METHOD OF ADMINISTRATION
For oral use.
4.3 Contraindications
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 severe
renal impairment.
4.4 Special warnings and precautions for use
Concomitant administration of acrivastine with CNS depressants,
including alcohol, sedatives, and
tranquilizers, may produce additional impairment in mental alertness
in some individuals.
Patients with renal impairment should consult with a physician before
use.
This product may cause drowsiness (see section 4.8).
Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase deficiency or glucose-
galactose malabsorpti