SUDAFED NON-DROWSY DECONGESTANT 60 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

R01BA02

INN (International Name):

PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage:

60 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics

Authorization status:

Authorised

Authorization date:

1994-04-01

Patient Information leaflet

turn over
360095B
17-0123
_NON-DROWSY_
Pseudoephedrine hydrochloride
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 Non-Drowsy Sudafed Decongestant Tablets is and what it is
used for
2.
What you need to know before you use Non-Drowsy Sudafed
Decongestant Tablets
3.
How to use Non-Drowsy Sudafed Decongestant Tablets
4.
Possible side-effects
5.
How to store Non-Drowsy Sudafed Decongestant Tablets
6.
Contents of the pack and other information
1 WHAT NON-DROWSY SUDAFED DECONGESTANT TABLETS IS AND WHAT IT IS USED FOR
Non-Drowsy Sudafed Decongestant Tablets are a medicine used to
provide relief from cold, flu and allergy symptoms such as blocked
sinuses, stuffy nose and catarrh. The tablets contain pseudoephedrine
hydrochloride, which is a decongestant that relieves nasal and sinus
congestion.
This medicine is for use by adults and children aged 12 years and
over.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE NON-DROWSY SUDAFED DECONGESTANT TABLETS
This medicine is suitable for most people 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
PSEUDOEPHEDRINE or any of the other ingredients (_listed in _
_ _
_ _
_ _
_ _
_ _
_ _
_section 6_).
■
If you have SEVERE KIDNEY PROBLEMS.
■
If you have DIABETES.
■
If you have a PHAEOCHROMOCYTOMA (rare tumour which
affects your heart rate and blood pressure).
■
If you have an OVERA

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Non-Drowsy Sudafed Decongestant 60 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film-Coated tablet contains Pseudoephedrine Hydrochloride 60.0
mg.
Excipients: Contains Lactose Monohydrate 112.0mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Reddish-brown, circular, biconvex, film coated tablets embossed
‘SUDAFED’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is a decongestant of the mucous membranes of the upper
respiratory tract, especially the nasal mucosa
and sinuses and is indicated for the symptomatic relief of nasal
congestion in conditions such as allergic rhinitis,
vasomotor rhinitis, the common cold and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN AGED 12 YEARS AND OVER
The usual dose is 1 tablet (60 mg) every four to six hours, up to four
times a day.
Maximum daily dose: 240 mg pseudoephedrine
CHILDREN UNDER 12 YEARS
This medicine is contraindicated in children under the age of 12 years
(See Section 4.3)
USE IN THE ELDERLY
There have been no specific studies of this medicine in the elderly.
Experience has indicated that normal adult dosage is
appropriate.
HEPATIC DYSFUNCTION
Caution should be exercised when administering this medicine to
patients with severe hepatic impairment.
RENAL DYSFUNCTION
Caution should be exercised when administering this medicine to
patients with mild to moderate renal impairment.
DURATION OF USE:
Patients should be advised not to use this product for more than 5
days and to seek medical advice if symptoms persist.
METHOD OF ADMINISTRATION:
For oral use.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_