BENYLIN FOUR FLU 500, 12.5 & 22.5 Milligram Film Coated Tablet

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

可用日期:

PCO Manufacturing

ATC代码:

N02BE51

INN（国际名称）:

DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

剂量:

500, 12.5 & 22.5 Milligram

药物剂型:

Film Coated Tablet

给药途径:

Oral use

每包单位数:

24 tablets (two strips of 12 tablets)

处方类型:

Product not subject to medical prescription

厂商:

PCO Manufacturing

治疗领域:

Analgesics and antipyretics

疗效迹象:

For the relief of symptoms associated with colds and flu; including relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract, sneezing, runny nose, coughing, fever, headache, muscular aches and pains.

授权状态:

Authorised

授权日期:

2015-07-01

资料单张

BENYLIN 4FLU 
FILM-COATED TABLETS

PARACETAMOL 500MG 
DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG 
PSEUDOEPHEDRINE HYDROCHLORIDE 22.5MG 

READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU. 
This medicine is available without prescription. However you
still need to take Benylin 4 Flu tablets carefully to get the 
best results from it. 


  Keep this leaflet, you may need to read it again. 

  Ask your pharmacist if you need more
information or advice. 

  You must contact a doctor if your symptoms worsen or do
not improve. 

  If any of the side effects get serious or if you notice
any side effects not listed in the leaflet, please
consult your 
doctor or pharmacist. 

IN THIS LEAFLET: 
1.  What Benylin 4 Flu tablets are
and what they are used for 
2.  Before you take Benylin 4 Flu tablets 
3.  How to take Benylin 4 Flu tablets 
4.  Possible side effects 
5.  How to store Benylin 4 Flu tablets 
6.  Further information 

1.  WHAT BENYLIN 4 FLU TABLETS ARE AND WHAT THEY ARE USED FOR 
Benylin 4 Flu Tablets are used to help relieve cold and flu
symptoms. The tablets contain paracetamol which helps to 
relieve aches and pains and fever
(high temperature), diphenhydramine, which
is an antihistamine that helps relieve 
coughing, sneezing and runny nose and pseudoephedrine, which
is a decongestant that helps unblock stuffy noses. 
The medicine is for use in adults and children aged
6 years and over. 

2. BEFORE TAKING BENYLIN 4 FLU 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
are taking any other medicines containing PARACETAMOL 

  If you have ever
had an ALLERGIC (HYPERSENSITIVITY) REACTION to

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Four Flu Film-Coated Tablets.
Paracetamol 500mg
Diphenhydramine hydrochloride 12.5mg
Pseudoephedrine hydrochloride 22.5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Paracetamol 500 mg
Diphenhydramine hydrochloride 12.5 mg
Pseudoephedrine hydrochloride 22.5 mg
Also contains: Sunset yellow E110
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets
_Product imported from the UK:_
Orange, oval, biconvex, film coated tablets
4 CLINICAL PARTICULARS
As per PA0823/034/002
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Sunset yellow (E110) may cause allergic reactions.
5 PHARMACOLOGICAL PROPERTIES
As per PA0823/034/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Pregelatinized maize starch
Povidone
Crospovidone
Macrogol 6000
Croscarmellose Sodium
Stearic acid
Magnesium stearate
Hypromellose
Titanium dioxide (E171)
Quinoline yellow (E104)
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 24/08/2016_
_CRN 2182039_
_page number: 1_
Sunset yellow (E110)
Talc
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be 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
Do not store above 25°C. Store in the original package. Keep container in the outer carton.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack containing 24 tablets (two strips of 12 tablets).
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit 10, Ashbourne Business Park
Rath 
Ashbourne