BENYLIN DAY & NIGHT 500/60 & 25 Milligram Tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

PARACETAMOL, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

Dostupné s:

McNeil Healthcare (Ireland) Ltd

ATC kód:

N02BE51

INN (Mezinárodní Name):

PARACETAMOL, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

Dávkování:

500/60 & 25 Milligram

Léková forma:

Tablets

Druh předpisu:

Product not subject to medical prescription

Terapeutické oblasti:

Analgesics and antipyretics

Stav Autorizace:

Authorised

Datum autorizace:

1993-11-10

Informace pro uživatele

1
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 7 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 IS AND WHAT IT IS 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 medicine (listed in sec

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Day & Night Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Day Tablet
Tablet
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)
Blue, odourless, round and biconvex tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of the symptoms associated with colds and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
ADULTS AND CHILDREN OVER 12 YEARS:
Four tablets should be taken daily.
One white tablet to be taken every 4 to 6 hours (one tablet in the
morning, at midday and in the afternoon). Do not take
more than 3 white day-time tablets in 24 hours.
One blue tablet to be taken at night.
DO NOT TAKE THE NIGHT-TIME TABLETS DURING THE DAY.
ELDERLY
As for adults.
CHILDREN
Not recommended for children under 12 years.
Each white (day) tablet contains:
Paracetamol 500mg
Pseudoephedrine hydrochloride 60mg
Each blue (night) tablet contains:
Paracetamol 500mg
Diphenhydramine hydrochloride 25mg
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4.3 CONTRAINDICATIONS
Use in patients hypersensitive to the active ingredien