Benylin Day & Night Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Diphenhydramine hydrochloride; PSEUDOEPHEDRINE HYDROCHLORIDE; Paracetamol

Διαθέσιμο από:

Imbat Limited

Φαρμακολογική κατηγορία (ATC):

N02BE; N02BE51

INN (Διεθνής Όνομα):

Diphenhydramine hydrochloride; PSEUDOEPHEDRINE HYDROCHLORIDE; Paracetamol

Δοσολογία:

500/60 & 25 milligram(s)

Φαρμακοτεχνική μορφή:

Tablet

Τρόπος διάθεσης:

Product not subject to medical prescription

Θεραπευτική περιοχή:

Anilides; paracetamol, combinations excl. psycholeptics

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-01-12

Φύλλο οδηγιών χρήσης

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENYLIN DAY & NIGHT TABLETS
Day Tablet: Paracetamol 500mg,
pseudoephedrine hydrochloride 60mg
Night tablet: Paracetamol 500mg,
diphenhydramine hydrochloride 25mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet
or as your doctor or pharmacist has 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 3 days.
WHAT IS IN THIS LEAFLET
1.
What Benylin Day & Night Tablets are and what they are
used for
2.
What you need to know before you take Benylin Day &
Night Tablets
3.
How to take Benylin Day & Night Tablets
4.
Possible side effects
5.
How to store Benylin Day & Night Tablets
6.
Contents of the pack and other information
1.
WHAT BENYLIN DAY & NIGHT TABLETS ARE AND
WHAT THEY ARE USED FOR
Benylin Day & Night Tablets are used for the relief of cold and
flu symptoms.
This pack contains 2 different coloured tablets, for use at
different times of the day. Read the leaflet carefully to ensure
that you take the correct tablet at the appropriate time of
day. The white tablets contain paracetamol (to relieve pain)
and pseudoephedrine (a decongestant which unblocks stuffy
noses) and are for daytime use.
The blue tablets contain paracetamol and diphenhydramine
(an antihistamine which helps clear catarrh and so aids sleep)
and are for night time use only.
This medicine is for use in adults and children over 12 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BENYLIN DAY & NIGHT TABLETS
DO NOT TAKE BENYLIN DAY & NIGHT TABLETS:

If you are allergic to paracetamol, pseudoephedrine,
diphenhydramine or any of the other ingredients of this
m

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Day & Night Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white (day) tablet contains:
Paracetamol 500mg
Pseudoephedrine hydrochloride 60mg
Each blue (night) tablet contains:
Paracetamol 500mg
Diphenhydramine hydrochloride 25mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Day Tablet
Tablet
_Product imported from the UK_
White biconvex tablet in oblong form with dissecting score on one
side; ‘A7C’ engraved on both sides of the score.
The score is to allow breaking for ease of swallowing.
Night Tablet
Film coated tablet (tablet)
_Product imported from the UK_
Blue, odourless, round and biconvex tablets.
4 CLINICAL PARTICULARS
As per PA0823/019/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0823/019/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Each white (day) tablet contains:
Pregelatinised maize starch
Povidone
Crospovidone
Stearic acid
Microcrystalline cellulose
Croscarmellose sodium
Magnesium stearate
Each blue (night) tablet contains:
Microcrystalline cellulose
Maize starch
Sodium starch glycollate
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Hydroxypropylcellulose
Pregelatinised maize starch
Croscarmellose sodium
Stearic acid
Magnesium stearate
_Film coating (blue tablet only):_
Hypromellose
Indigo carmine (E132)
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