Benylin Day & Night tablets

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Disponibbli minn:

McNeil Products Ltd

Kodiċi ATC:

N02BE51

Għamla farmaċewtika:

Not applicable

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Never Valid To Prescribe As A VMP

Sommarju tal-prodott:

BNF: 04070100; GTIN: 5010123734039

Fuljett ta 'informazzjoni

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
This medicine is used to relieve the symptoms of cold
and flu.

This medicine is for use by adults and children aged 12
years and over.

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 and
pseudoephedrine and are for daytime use.

The blue tablets contain paracetamol and
diphenhydramine and are for night time use only.

FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. There are
different tablets for day and night time doses. _See_ _section 3__
_

DO NOT USE THIS MEDICINE:

There are some people who should not use this
medicine. _To find out if you are one of them see section 2_

If you have ever had a BAD REACTION to any of the
ingredients. _For the list of ingredients see section 6_

SPEAK TO YOUR DOCTOR:

If you suffer from any of the conditions mentioned in
section 2_. See section 2_

If you are taking any other medicines. _See_ _section 2_
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE
THIS MEDICINE. Keep the leaflet: you might need it again.
1 WHAT THE MEDICINE IS FOR
Benylin Day and Night Tablets are used for the relief of
cold and flu symptoms.
The white day time tablets contain paracetamol, an
analgesic and antipyretic which helps to relieve pain and
fever and pseudoephedrine hydrochloride, a decongestant
which unblocks stuffy noses.
The blue night time tablets contain paracetamol and
diphenhydramine hydrochloride, an antihistamine which
helps clear catarrh and so aids sleep.
This medicine is for use in adults and children aged 12
years and over.
2 BEFORE TAKING THIS
MEDICINE
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 TAKE THIS MEDICINE...

If you have HIGH BLOOD PRESSURE or
HEART DISEASE.

If you have DIABETES.

If you have a PHAEOCHROMOCYTOMA (a rare
tumou

Karatteristiċi tal-prodott

1
NAME OF THE MEDICINAL PRODUCT
Benylin Day and Night Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BLUE (NIGHT) TABLETS
Paracetamol
500.0mg
Diphenhydramine Hydrochloride
25.0mg
WHITE (DAY) TABLET
Paracetamol
500.0mg
Pseudoephedrine Hydrochloride
60.0mg
3
PHARMACEUTICAL FORM
Tablet
White, biconvex oblong tablet with bisecting score on one side and
“AC7”
engraved on both sides of the score.
Film-coated Tablet
Blue, round, biconvex tablet.
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
Posology
Adults and Children over 12 years
Four tablets should be taken daily:
One white tablet to be taken every 4 to 6 hours during the day (no
more than
three white tablets a day).
One blue tablet to be taken at night.
Take only one tablet at a time and only at the times of day indicated
on the
pack. Do not take the nighttime tablets during the day.
Elderly
As for adults (see Pharmacokinetics).
Children
Not recommended for children under 12 years of age.
Method of Administration
For oral use
Hepatic Dysfunction
Caution should be exercised when administering this medicine to
patients with
severe hepatic impairment.
Renal Dysfunction
Caution should be exercised when administering this medicine to
patients with
moderate to severe renal impairment.
4.3
CONTRAINDICATIONS
Use in individuals with known hypersensitivity to diphenhydramine
paracetamol, pseudoephedrine or to any of the excipients listed in
section 6.1.
Concomitant use of other sympathomimetic decongestants, beta-blockers
or
monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping
MAOI
treatment (see section 4.5). The concomitant use of MAOIs may cause a
rise in
blood pressure and/or hypertensive crisis.
Cardiovascular disease including hypertension
Diabetes mellitus
Phaeochromocytoma
Hyperthyroidism
Closed angle glaucoma
Severe renal impairment
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Diphenhydramine may enhance the sedative effects of ce