Benylin Dry Coughs Night syrup

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Diphenhydramine hydrochloride; Menthol; Dextromethorphan hydrobromide

Disponibbli minn:

McNeil Products Ltd

Kodiċi ATC:

R05CA10

INN (Isem Internazzjonali):

Diphenhydramine hydrochloride; Menthol; Dextromethorphan hydrobromide

Dożaġġ:

2.8mg/1ml ; 400microgram/1ml ; 1.3mg/1ml

Għamla farmaċewtika:

Oral solution

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Never Valid To Prescribe As A VMP

Sommarju tal-prodott:

BNF: 03090200; GTIN: 5010123731458

Fuljett ta 'informazzjoni

DRY COUGHS NIGHT SYRUP
DIPHENHYDRAMINE, DEXTROMETHORPHAN,
LEVOMENTHOL
■
This medicine is used to help provide night time
relief of dry, irritating coughs and aid a restful sleep.
■
This medicine is for use by adults and children
aged 12 years and over.
■
DO NOT TAKE THIS MEDICINE:
■
T
here 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_
■
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. _See _
_section 3_
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 Dry Coughs NIGHT Syrup is a medicine
which is used to help provide night time relief of dry,
irritating coughs and aid a restful sleep. The liquid
contains diphenhydramine hydrochloride which is
an antihistamine that helps relieve coughing and dry
secretions in the nose and chest, dextromethorphan
hydrobromide which is an antitussive to help stop
coughing and levomenthol which helps you breathe
more easily by relieving congestion.
The 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.
Taking this medicine regularly, particularly for a long time,
can lead to addiction. Only use this medicine as described in
the leaflet. Addiction can cause withdrawal symptoms when
you stop taking this medicine. Withdrawal symptoms can
include restlessness, difficulty sleeping, irritability, agitation,
anxiety, feeling your heartbeat (palpitations), increased
blood pressure, feeling or being sick, diarrhoea, loss of
appetite, shaking, shivering or sweating. Speak to your

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Benylin Dry Coughs Night Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains:
Diphenhydramine hydrochloride
14 mg
Dextromethorphan hydrobromide
6.5 mg
Levomenthol
2 mg
Each 5 ml also contains:
Ethanol
196 mg
Glucose
3.5 g
Sucrose
1 g
Ponceau 4R (E124)
0.25 mg
Sodium
16.7 mg
Benzyl alcohol
0.48 mg
Propylene glycol
2.61 mg
Sodium benzoate (E211)
10 mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Clear red syrup
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This product is indicated as an antitussive, for the night time relief
of persistent, dry,
irritating cough, and aiding restful sleep.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN AGED 12 YEARS AND OVER:
Patients may start with two 5 ml spoonfuls at bedtime followed by two
5 ml
spoonfuls every 6 hours.
Or two 5 ml spoonfuls four times a day.
Do not take more than 4 doses (1 dose = two 5 ml spoonfuls) in 24
hours.
CHILDREN UNDER 12 YEARS:
This product is contraindicated in children under the age of 12 years
(see section 4.3).
THE ELDERLY:
Normal adult dosage is appropriate, [See Pharmacokinetics in the
Elderly].
HEPATIC DYSFUNCTION
Due to the extensive hepatic metabolism of dextromethorphan, caution
should be
exercised in the presence of hepatic impairment (see section 5.2).
RENAL DYSFUNCTION
Caution should be exercised in the presence of moderate to severe
renal impairment
(see section 5.2).
METHOD OF ADMINISTRATION
For oral use
4.3
CONTRAINDICATIONS
This medicine is contraindicated in individuals with known
hypersensitivity to
diphenhydramine, dextromethorphan, levomenthol or to any of the
excipients listed in
section 6.1.
Dextromethorphan should not be used in patients taking monoamine
oxidase
inhibitors (MAOIs), or within 14 days of stopping MAOI treatment (see
section 4.5).
There is a risk of serotonin syndrome with the concomitant use of
dextromethorphan
and MAOIs and the concomitant use of these medications may cause a