BENYLIN Day & Night Tablets, 500mg/60mg tablets and 500/25mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE; Paracetamol; Diphenhydramine hydrochloride

Available from:

JNTL Consumer Health I (Ireland) Limited

ATC code:

N02BE51

INN (International Name):

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE; Paracetamol; Diphenhydramine hydrochloride

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

paracetamol, combinations excl. psycholeptics

Authorization status:

Marketed

Authorization date:

1988-11-10

Patient Information leaflet

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 IS
AND WHAT IT IS USED FOR
Benylin Day & Night Tablets 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
hydrochloride (a decongestant which unblocks stuffy noses) and are for
daytime use.
The blue film-coated tablets contain paracetamol and diphenhydramine
hydrochloride (an
antihistamine which helps clear catarrh and so aids sleep) and are for
night time use only.
Benylin Day & Night is indicated for the short-term symptomatic
treatment of nasal and sinus
congestion associated with symptoms of cold and flu such as pain,
headache and/or fever only
in combination with bedtime symptoms which are causing difficulty in
getting to sleep.
This medicine is for use in adults and adolescents over 15 years.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE B

Summary of Product characteristics

Health Products Regulatory Authority
28 March 2024
CRN00DGPM
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BENYLIN Day & Night Tablets, 500mg/60mg tablets and 500/25mg
film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white (day) tablet contains Paracetamol 500 mg
Pseudoephedrine Hydrochloride 60 mg
Each blue (night) tablet contains Paracetamol 500 mg
Diphenhydramine Hydrochloride 25 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Day Tablet
White biconvex tablet in oblong form, 15.8-16.1mm long, 8.4-8.7mm wide
and 6.5-6.8mm thick with dissecting score on one
side; 'A7C' engraved on both sides of the score. The score line is
only to facilitate breaking for ease of swallowing and not to
divide into equal doses.
Night Tablet
Film-Coated Tablet (Tablet).
Blue, odourless, round and biconvex tablets, 12.6-13mm in diameter and
5.6mm thick.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BENYLIN Day & Night is indicated for the short-term symptomatic
treatment of nasal and sinus congestion associated with
daytime symptoms of cold and flu such as pain, headache and/or fever
when in combination with bedtime symptoms which
are causing difficulty in getting to sleep.
BENYLIN Day & Night is indicated in adult and adolescents aged 15 to
17 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS OVER 15 YEARS:
Four tablets should be taken daily.
One white tablet (paracetamol and pseudoephedrine) to be taken every 4
to 6 hours during the day (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 (paracetamol and diphenhydramine) to be taken at
night.
DO NOT TAKE THE NIGHT-TIME TABLETS DURING THE DAY.
Patients should consult their doctor or pharmacist if symptoms persist
for more than 3 days or worsen (see section 4.4).
Method of administration
For oral use.
Children and adolescents under 15 years
Health Products Regulatory Authority
28 March 2024
CRN00DG