Non-drowsy Sinutab Tablets Paracetamol 500mg Pseudoephedrine hydrochloride 30mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage:

500 mg/ 30 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Marketed

Authorization date:

1998-02-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NON-DROWSY SINUTAB TABLETS
PARACETAMOL 500 MG
PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG
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.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE NON-DROWSY SINUTAB 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
PARACETAMOL
or
PSEUDOEPHEDRINE
or any of the other ingredients (
_listed in section 6_
).
■
If you have
HIGH BLOOD PRESSURE
or
HEART DISEASE
.
■
If you have
DIABETES
.
■
If you have a
PHEOCHROMOCYTOMA
(a tumour which affects your heart rate and blood
pressure).
■
If you have an
OVERACTIVE THYROI

Summary of Product characteristics

Health Products Regulatory Authority
07 April 2022
CRN00CSYR
Page 1 of 13
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).
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 Non-drowsy Sinutab 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