NON-DROWSY SINUTAB TABLETS 30/500 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PSEUDOEPHEDRINE HYDROCHLORIDE, PARACETAMOL

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

N02BE51

INN (International Name):

PSEUDOEPHEDRINE HYDROCHLORIDE, PARACETAMOL

Dosage:

30/500 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Analgesics and antipyretics

Authorization status:

Transfer Pending

Authorization date:

1998-02-06

Patient Information leaflet

turn over
17-0125
360154B
®
SIZE:
MAIN BODY TEXT
(PILS ONLY) 145 X 250 MM
JOB BAG NO.
VERSION
PRODUCT
DESCRIPTION
COUNTRY
DATE
MANUFACTURER
SOFTWARE
A print out of this image should not be used for exact colour matching
but to check if the layout,
spelling, text and colour references are correct. Please check
thoroughly.
COLOURS:
7 PTS
17-0125
4
SINUTAB ND TABLETS
PIL
IRE
24/01/2018
ILLUSTRATOR CS6
VAL DE REUIL
BLACK
PROFILE
PMS
REFLEX
BLUE
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 = 51.6 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
code Laetus 951
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 Sinutab Tablets is and what it is used for
2.
What you need to know before you use Non-Drowsy Sinutab Tablets
3.
How to use Non-Drowsy Sinutab Tablets
4.
Possible side-effects
5.
How to store Non-Drowsy Sinutab Tablets
6.
Contents of the pack and other information
1 WHAT NON-DROWSY SINUTAB TABLETS IS AND WHAT IT IS USED FOR
Non-Drowsy Sinutab relieves the symptoms of colds and flus including
aches, pains, fever, nasal and sinus congestion. The tablets contain
paracetamol, an analgesic and antipyretic to relieve pain and fever,
and pseudoephedrine, a decongestant to clear nasal congestion and
blocked sinuses.
This medicine is for use in adults and children aged 12 years and
over.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Non-drowsy Sinutab Tablets
Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg Pseudoephedrine hydrochloride and 500 mg
Paracetamol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White round biconvex tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Non-drowsy Sinutab is indicated for the short term symptomatic relief
of conditions where congestion of the mucous
membranes of the upper respiratory tract, especially nasal mucosa and
sinuses, is accompanied by mild to moderate
pain or pyrexia, eg the common cold, influenza, sinusitis and
nasopharyngitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
ADULTS AND CHILDREN AGED 16 YEARS AND OVER
Two tablets to be taken every four to six hours, up to four times a
day.
Maximum daily dose: 8 tablets (240 mg pseudoephedrine and 4 g
paracetamol).
Children aged 12 to 15 years:
One tablet every four to six hours, up to four times a day. Maximum
daily dose: 4 tablets (i.e. 120 mg pseudoephedrine
hydrochloride, 2 g paracetamol).
CHILDREN UNDER 12 YEARS:
This medicine is contraindicated in children under the age of 12 years
(see section 4.3).
USE IN THE ELDERLY
Experience has indicated that normal adult dosage is usually
appropriate. However, in frail, immobile, elderly subjects
or in elderly patients with renal or hepatic impairment, a reduction
in the amount or frequency of dosing may be
appropriate.
The maximum daily dose should not exceed 60mg/kg/day (up to a maximum
of 2g paracetamol per day) in the
following situations, unless directed by a physician:
Weight less than 50kg
Chronic alcoholism
Dehydration
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