Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5m

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Diphenhydramine; Pseudoephedrine; Paracetamol

Διαθέσιμο από:

Imbat Limited

Φαρμακολογική κατηγορία (ATC):

N02BE; N02BE51

INN (Διεθνής Όνομα):

Diphenhydramine; Pseudoephedrine; Paracetamol

Δοσολογία:

500 12.5 22.5 milligram(s)

Φαρμακοτεχνική μορφή:

Film-coated tablet

Τρόπος διάθεσης:

Product not subject to medical prescription

Θεραπευτική περιοχή:

Anilides; paracetamol, combinations excl. psycholeptics

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2009-09-25

Φύλλο οδηγιών χρήσης

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PATIENT INFORMATION LEAFLET
BENYLIN FOUR FLU
® FILM-COATED TABLETS
(paracetamol 500mg / diphenhydramine hydrochloride
12.5mg / pseudoephedrine hydrochloride 22.5mg)
Your medicine is available using the above name but will be
referred to as Benylin Four Flu throughout the leaflet.
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 Four Flu 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 this leaflet, please consult your
doctor or pharmacist.
IN THIS LEAFLET
1.
What Benylin Four Flu is and what it is used for.
2.
Before you take Benylin Four Flu.
3.
How to take Benylin Four Flu.
4.
Possible side effects.
5.
How to store Benylin Four Flu.
6.
Contents of the pack and other information.
7.
Information about treating cough and cold in children
1.
WHAT BENYLIN FOUR FLU IS AND WHAT IT IS
USED FOR
Benylin Four Flu is 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 10 years
and over.
2.
BEFORE TAKING BENYLIN FOUR FLU
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 any of the ingredients.

If you have HEART DISEASE or HIGH BLOOD PRESSURE.

If you h

Αρχείο Π.Χ.Π.

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 500mg
Diphenhydramine hydrochloride 12.5mg
Pseudoephedrine Hydrochloride 22.5mg
Excipients:Contains Sunset yellowing colouring (E110)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablets
_Product imported from_ the UK:
Orange, biconvex, film coated tablets with no markings
4 CLINICAL PARTICULARS
As per PA0823/034/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0823/034/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Pregelatinized maize starch
Povidone
Crospovidone
Stearic acid
Microcrystalline cellulose
Croscarmellose sodium
Magnesium Stearate
Film-coating materials
Hypromellose
Macrogol 6000
Talc
Titanium Dioxide (E171)
Sunset Yellow (E110)
Quinoline Yellow (E104)
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6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister strip 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 cart