Non-drowsy Sinutab TabletsParacetamol 500mgPseudoephedrine hydrochloride 30mg

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Disponible desde:

Imbat Limited

Código ATC:

N02BE; N02BE51

Designación común internacional (DCI):

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Dosis:

500/30 milligram(s)

formulario farmacéutico:

Tablet

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Anilides; paracetamol, combinations excl. psycholeptics

Estado de Autorización:

Authorised

Fecha de autorización:

2009-07-31

Información para el usuario

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NON-DROWSY SINUTAB
® TABLETS
(Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg)
Your medicine is available using the above name but will be
referred to as 'Sinutab' throughout this leaflet.
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 Sinutab is and what it is used for
2.
What you need to know before you use Sinutab
3.
How to use Sinutab
4.
Possible side-effects
5.
How to store Sinutab
6.
Contents of the pack and other information
1.
WHAT SINUTAB IS AND WHAT IT IS USED FOR
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
SINUTAB
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 PHAEOCHROMOCYTOMA (a tumour which
affects your heart rate and blood pressure).

If you have an OVERACTIVE THYROID.

Ficha técnica

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
Tablets
_Tablets imported from the UK:_
White, round, biconvex tablets, plain on both sides.
4 CLINICAL PARTICULARS
As per PA0823/005/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0823/005/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Pregelatinised maize starch
Crospovidone
Sodium starch glycolate (Type A)
Povidone
Stearic acid
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strips and outer carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC. Store in the original packaging.
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6.5 NATURE AND CONTENTS OF CONTAINER
Over-labelled carton containing blister strip.
Pack size: 15 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
8 PARALLEL PRODUCT AUT