Multi-Action Actifed 60mg/2.5mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Pseudoephedrine hydrochloride; Triprolidine hydrochloride

Tillgänglig från:

McNeil Products Ltd

ATC-kod:

R01BA52

INN (International namn):

Pseudoephedrine hydrochloride; Triprolidine hydrochloride

Dos:

60mg ; 2.5mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 03100000; GTIN: 5010123708528

Bipacksedel

left 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
left margin
12 mm
right margin
14 mm
6 mm
6 mm
Barcodes placed at 14 mm
Hight for bars : 10 mm
reading way
14
SIZE:
Main body text
(PIL’s only)
145 x 210 mm
Job Bag No.
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COLOURS:
7.5 pts
12-0058
1
Actifed MA Tablets
Pil
UK
25/04/12
Illustrator CS5
Val De Reuil
BLACK
PROFILE
PMS
PROCESS
BLUE
MULTI-ACTION ACTIFED
TABLETS
®
_pseudoephedrine, triprolidine_
■
This medicine is used to relieve the symptoms of
colds, flu and allergies including runny nose, watery
eyes, nasal congestion and blocked sinuses.
■
This medicine is for use by adults and children aged
12 years and over.
■
DO NOT USE THIS MEDICINE:
■
There are some people who should not use this
medicine. _To find out if you are one of them See _
_ _
_ _
_Section 2_
c
■
If you have ever had a
BAD REACTION
to any of the
ingredients. _For the list of ingredients See Section 6_
c
■
SPEAK TO YOUR DOCTOR:
■
If you suffer from any of the conditions mentioned in
Section 2. _See Section 2_
c
■
If you are taking any
OTHER MEDICINES.
_See _
_ _
_ _
_Section 2_
c
■
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY.
_See _
_ _
_ _
_Section 3_
c
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
Multi-Action Actifed Tablets is a medicine which is used
to relieve the symptoms of colds, flu and allergies
including sneezing, runny nose, watery eyes, nasal
congestion and blocked sinuses. The tablets contain
pseudoephedrine hydrochloride, which is a decongestant
that relieves nasal and sinus congestion and triprolidine
hydrochloride which is an antihistamine that helps stop
sneezing, runny nose and water

Produktens egenskaper

OBJECT 1
MULTI-ACTION ACTIFED TABLETS
Summary of Product Characteristics Updated 04-Nov-2009 | McNeil
Products Ltd
1. Name of the medicinal product
Multi-Action ACTIFED Tablets
2. Qualitative and quantitative composition
Each tablet contains:-
Triprolidine hydrochloride 2.5 mg
Pseudoephedrine hydrochloride 60.0 mg
3. Pharmaceutical form
Tablets for oral administration.
4. Clinical particulars
4.1 Therapeutic indications
For the symptomatic relief of upper respiratory tract disorders which
are benefited by a combination of a
nasal decongestant and histamine H
1
-receptor antagonist, for example:
Allergic Rhinitis
Vasomotor Rhinitis
The Common Cold and Influenza
4.2 Posology and method of administration
ADULTS AND CHILDREN OVER 12 YEARS
One tablet every 4-6 hours up to 4 times a day
USE IN THE ELDERLY
No specific studies have been carried out in the elderly, but
triprolidine and pseudoephedrine have been
widely used in older people.
HEPATIC DYSFUNCTION
Caution should be exercised when administering Multi-Action ACTIFED
Tablets to patients with severe
hepatic impairment.
RENAL DYSFUNCTION
Caution should be exercised when administering Multi-Action ACTIFED
Tablets to patients with
moderate to severe renal impairment.
4.3 Contraindications
Multi-Action ACTIFED is contraindicated in individuals who have
previously exhibited intolerance to it
or to pseudoephedrine or triprolidine.
Multi-Action ACTIFED is contraindicated in patients who are taking or
have taken monoamine oxidase
inhibitors within the preceding two weeks. The concomitant use of
pseudoephedrine and this type of
product may occasionally cause a rise in blood pressure.
Multi-Action ACTIFED is contraindicated in patients with severe
hypertension or severe coronary artery
disease.
The antibacterial agent furazolidone, is known to cause a dose-related
inhibition of monoamine oxidase.
Although there are no reports of hypertensive crises caused by the
concurrent administration of Multi-
Action ACTIFED Tablets and furazolidone they should not be taken
together.
4.