Benadryl Allergy Relief Plus Decongestant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pseudoephedrine hydrochloride; Acrivastine

Available from:

McNeil Products Ltd

ATC code:

R01BA52

INN (International Name):

Pseudoephedrine hydrochloride; Acrivastine

Dosage:

60mg ; 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: 5010123708399

Patient Information leaflet

■
This medicine is used to relieve the symptoms
of hay fever and similar allergic conditions.
■
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. _See Section 2 to find out if _
_you are one of them_
■
If you have ever had a bad reaction to any of
the ingredients.
_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 Plus Decongestant
Capsules are a medicine which are used to
relieve the symptoms of hay fever and similar
allergic conditions. The capsules contain
pseudoephedrine hydrochloride, which is a
decongestant that relieves nasal and sinus
congestion and acrivastine which is an
antihistamine that helps relieve allergy
symptoms such as sneezing, runny nose and
watery eyes.
2
BEFORE TAKING THIS
MEDICINE
This medicine is suitable for most adults under
65 years old and children aged 12 years and
over. 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
pseudoephedrine hydrochloride,
acrivastine or any of the ingredients (listed
in Section 6), or to the antihistamine
_triprolidine_.
■
If you have HIGH BLOOD PRESSURE OR
HEART DISEASE.
■
If you are
takin
g
_beta blockers_ (used to
treat HIGH BLOO
D PRESSURE).
■
If you are taking STIMULANTS or APPETITE
SUPPRESSANTS or DRUGS USED TO TREAT
CONGESTION AND ASTHMA
(Sympathomimetic drugs).
■
If you have DIABETES.
■
If you have PHAEOCHROMOCYTOMA (a rare
tumour which affects your heart rate and
blood pressure).
■
If you have GLAUCOMA (increased pressure
in the eye).
■
If you have

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Benadryl Allergy Relief Plus Decongestant Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
This product contains 8 mg acrivastine and 60 mg pseudoephedrine
hydrochloride.
Excipient with known effect: Lactose monohydrate 146.8 mg per capsule,
sodium (in sodium starch glycollate) 1.9mg per capsule
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsules
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This product is indicated for the symptomatic relief of allergic
rhinitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND CHILDREN 12 YEARS AND OVER:
One capsule as necessary, up to three times a day.
CHILDREN UNDER 12 YEARS:
This product is not currently recommended for use in children under 12
years
of age.
ELDERLY:
This product is not currently recommended for use in the elderly.
HEPATIC DYSFUNCTION:
Caution should be exercised when administering Benadryl Allergy Relief
Plus
Decongestant Capsules to patients with severe hepatic impairment.
RENAL DYSFUNCTION:
Caution should be exercised when administering Benadryl Allergy Relief
Plus
Decongestant Capsules to patients with moderate to severe renal
impairment.
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substances, triprolidine or to any of
the
excipients listed in section 6.1.
-
Cardiovascular disease including hypertension
-
Concomitant use of beta blockers (see section 4.5)
-
Concomitant use of other sympathomimetic decongestants.
-
Diabetes mellitus
-
Phaeochromocytoma
-
Closed angle glaucoma
-
Hyperthyroidism
-
Severe renal impairment.
The concomitant use of a pseudoephedrine-containing product and
monoamine
oxidase inhibitors may cause a rise in blood pressure and/or
hypertensive crisis.
This product is therefore contraindicated in patients who are taking,
or have
taken, monoamine oxidase inhibitors within the preceding 14 days (see
section
4.5).
Renal excretion is the principal route of elimination of ac