NON-DROWSY SUDAPLUS 30/500 Milligram Tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

זמין מ:

McNeil Healthcare (Ireland) Ltd

קוד ATC:

N02BE51

INN (שם בינלאומי):

PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

כמות:

30/500 Milligram

טופס פרצבטיות:

Tablets

סוג מרשם:

Product not subject to medical prescription

איזור תרפויטי:

Analgesics and antipyretics

מצב אישור:

Authorised

תאריך אישור:

2011-06-29

עלון מידע

turn over
17-0124
360149B
_Paracetamol 500 mg_
_Pseudoephedrine hydrochloride 30 mg_
_NON-DROWSY_
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 Sudaplus Tablets is and what it is used for
2.
What you need to know before you use Non-Drowsy Sudaplus Tablets
3.
How to use Non-Drowsy Sudaplus Tablets
4.
Possible side-effects
5.
How to store Non-Drowsy Sudaplus Tablets
6.
Contents of the pack and other information
1 WHAT NON-DROWSY SUDAPLUS TABLETS IS AND WHAT IT IS USED FOR
Non-Drowsy Sudaplus is used for the relief of nasal congestion when
combined with fever and/or pain such as sore throat, sinus pain or
headache in the common cold or flu.
This medicine contains two active ingredients. Paracetamol is a
painkiller
and reduces your temperature when you have a fever.
Pseudoephedrine hydrochloride is a decongestant which unblocks your
nose and sinuses helping you breathe more easily.
This medicine is for use in adults and children aged 12 years and
over.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE NON-DROWSY SUDAPLUS 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 DIABETES.
■
If you have a PHAEOCHROMOCYTOMA (a tumour which affects your
heart rate and blood pressure).
■
If you have ever had a BAD REACTION (ALLERGIC REACTION) to
PARACETAMOL or PSEUDOEPHEDRINE or any of the other ingredients
(_listed in

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Non-Drowsy Sudaplus Tablets
Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 500 mg and pseudoephedrine
hydrochloride 30 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
White, round, biconvex tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic relief of nasal congestion when combined with fever and/or
pain such as, sore throat, sinus pain or
headache in the common cold or influenza.
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 daily
as required for relief of symptoms.
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.
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
Chronic malnutrition
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