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

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Paracetamol; Pseudoephedrine

Disponible desde:

PCO Manufacturing Ltd.

Código ATC:

N02BE; N02BE51

Designación común internacional (DCI):

Paracetamol; Pseudoephedrine

Dosis:

500 mg/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:

2006-09-08

Información para el usuario

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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 PHAEOCHROMOCYTOMA (a tumour which affects
your heart rate and blood pressure).

If you have an OVERACTIVE

Ficha técnica

Health Products Regulatory Authority
12 August 2021
CRN00CFXF
Page 1 of 2
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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the UK:_
White round biconvex tablet.
4 CLINICAL PARTICULARS
As per PA0330/038/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0330/038/001
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
container and outer carton of the product as marketed in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25 ˚C. Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Opaque white PVC and PVDC/Aluminium foil blister.
Packs of 15 tablets
Health Products Regulatory Authority
12 August 2021
CRN00CFXF
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/184/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 8th September 2006
Date of last renewal: 8th September 2011
Date of last review: January 2014
Last updated: August 2016
Last updated: August 2018
Last updated: October 2020
10 DATE OF REVISION OF THE TEXT
August 2021