ACTIFED 60/2.5 Milligram Tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE

Pieejams no:

McNeil Healthcare (Ireland) Ltd

ATĶ kods:

R01BA02

SNN (starptautisko nepatentēto nosaukumu):

PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE

Deva:

60/2.5 Milligram

Zāļu forma:

Tablets

Receptes veids:

Product not subject to medical prescription

Ārstniecības joma:

Sympathomimetics

Autorizācija statuss:

Authorised

Autorizācija datums:

1993-04-01

Lietošanas instrukcija

60 MG/2.5 MG TABLETS
®
_Pseudoephedrine hydrochloride_
_Triprolidine hydrochloride_
turn over
360092B
17-0128
ACTIFED
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
Always use this medicine exactly as described in this leaflet or as
your
doctor or pharmacist have told you.
■
Keep this leaflet. You may need to read it again.
■
Ask your pharmacist if you need more information or advice.
■
If you get any side-effects, talk to your doctor or pharmacist. This
includes
any possible side-effects not listed in this leaflet. _See section 4_.
■
You must talk to a doctor if you do not feel better or if you feel
worse
after 5 days.
WHAT IS IN THIS LEAFLET
1.
What Actifed Tablets is and what it is used for
2.
What you need to know before you use Actifed Tablets
3.
How to use Actifed Tablets
4.
Possible side-effects
5.
How to store Actifed Tablets
6.
Contents of the pack and other information
1 WHAT ACTIFED TABLETS IS AND WHAT IT IS USED FOR
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 watery eyes.
This medicine is for use in adults and children aged 12 years and
over.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE ACTIFED TABLETS
This medicine is suitable for most adults 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 USE THIS MEDICINE…
■
If you have ever had a BAD REACTION (ALLERGIC REACTION) to
any of the ingredients (_listed in section 6_).
■
If you have DIABETES.
■
If you have an OVERACTIVE THYROID GLAND.
■
If you have GLAUCOMA (increased pressure in the eye).
■
If you have PROSTATE PROBLEMS (difficulty

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actifed 60mg/2.5mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg Pseudoephedrine hydrochloride and 2.5 mg
Triprolidine hydrochloride.
Excipients: contains 127.5 mg lactose monohydrate per tablet.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
White, round biconvex tablet with bisecting score and M2A engraved on
one side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ACTIFED Tablets are indicated for the symptomatic relief of upper
respiratory tract disorders which are benefited by a
combination of a nasal decongestant and H
1
-receptor antagonist, for example allergic rhinitis, vasomoter
rhinitis and the
common cold.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN 12 YEARS AND OVER:
One tablet to be taken every 4-6 hours, up to four times a day.
CHILDREN UNDER 12 YEARS:
This medicine is contraindicated in children under the age of 12 years
(see section 4.3).
THE ELDERLY:
There have been no specific studies of ACTIFED Tablets in the elderly.
Experience has indicated that normal adult
dosage is appropriate.
HEPATIC DYSFUNCTION:
Caution should be exercised when administering Actifed Tablets to
patients with severe hepatic impairment.
RENAL DYSFUNCTION:
Caution should be exercised when administering Actifed Tablets to
patients with mild to moderate renal impairment.
METHOD OF ADMINISTRATION
For oral use.
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