Non-Drowsy Sudaplus Tablets Paracetamol 500mg Pseudoephedrine hydrochloride 30mg

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Tilgængelig fra:

JNTL Consumer Health I (Ireland) Limited

ATC-kode:

N02BE; N02BE51

INN (International Name):

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Lægemiddelform:

Tablet

Terapeutisk område:

Anilides; paracetamol, combinations excl. psycholeptics

Autorisation status:

Marketed

Autorisation dato:

2011-06-29

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
NON-DROWSY
SUDAPLUS®
TABLETS
PARACETAMOL 500MG
PSEUDOEPHEDRINE HYDROCHLORIDE 30MG
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 PHEOCHROMOCYTOMA (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 othe

Produktets egenskaber

Health Products Regulatory Authority
01 March 2024
CRN00DH53
Page 1 of 13
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.
HEPATIC IMPAIRMENT:
In patients with hepatic impairment or Gilbert's Syndrome, the dose
should be reduced or the dosing interval prolonged.
The daily dose should not exceed 2g paracetamol/day unless directed by
a physician.
RENAL IMPAIRMENT:
Caution should be exercised when administering this medicine to
patients with mild to moderate renal impairment.
It is recommended, when giving paracetamol to patients with renal
impairment, to reduce the dose and to increase the
minimum interval between each administration to at least 6 hours
unless directed otherwise by a physician. See Table below:
Adults:
Glomerular filtration rate
Dose
10-50 ml/min
500mg every 6 hours
<10ml/min
500mg every 8 hours
Health Products Regulatory Authority
01 March 2024
CRN00DH53
Page 2 of 13
USE IN THE ELDERLY
Experience has indicated that normal