BENYLIN NON-DROWSY DRY COUGHS 7.5 MG/5ml Syrup

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

DEXTROMETHORPHAN HYDROBROMIDE

Beschikbaar vanaf:

McNeil Healthcare (Ireland) Ltd

ATC-code:

R05DA09

INN (Algemene Internationale Benaming):

DEXTROMETHORPHAN HYDROBROMIDE

Dosering:

7.5 MG/5ml

farmaceutische vorm:

Syrup

Prescription-type:

Product not subject to medical prescription

Therapeutisch gebied:

Opium alkaloids and derivatives

Autorisatie-status:

Authorised

Autorisatie datum:

1994-11-10

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
Non-Drowsy
Dry Coughs Syrup
DEXTROMETHORPHAN HYDROBROMIDE 7.5 MG/ 5 ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet
or as your doctor or pharmacist have 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 5 days.
WHAT IS IN THIS LEAFLET
1.
What Benylin Non-Drowsy Dry Coughs Syrup is and
what it is used for
2.
What you need to know before you use Benylin Non-
Drowsy Dry Coughs Syrup
3.
How to use Benylin Non-Drowsy Dry Coughs Syrup
4.
Possible side-effects
5.
How to store Benylin Non-Drowsy Dry Coughs Syrup
6.
Contents of the pack and other information
1 WHAT BENYLIN NON-DROWSY
DRY COUGHS SYRUP IS AND
WHAT IT IS USED FOR
Benylin Non-Drowsy Dry Coughs Syrup is a medicine
which is used to help relieve dry, irritating coughs. The
liquid contains dextromethorphan hydrobromide which
is an antitussive to help stop persistent coughing.
The medicine is for use in adults and children aged
12 years and over.
2 WHAT YOU NEED TO KNOW
BEFORE YOU USE BENYLIN NON-
DROWSY DRY COUGHS SYRUP
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 USE BENYLIN NON-DROWSY DRY
COUGHS SYRUP…
If you have ever had a BAD REACTION to
dextromethorphan or any of the other ingredients.
If you suffer from LUNG DISEASE.
If you are taking, or have taken in the last
two weeks, DRUGS FOR DEPRESSION known as
Monoamine Oxidase Inhibitors (MAOIs).
If you are taking selective serotonin re-uptake
inhibitors (used to treat DEPRESSION and ANXIETY
such as fluoxetine, paroxetine and sertraline)

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Non-Drowsy Dry Coughs, Syrup
Dextromethorphan hydrobromide 7.5mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Benylin Non-Drowsy Dry Coughs, Syrup contains dextromethorphan
hydrobromide 7.5 mg in each 5 ml.
Each 5ml of
Benylin Non-Drowsy Dry Coughs, Syrup also contains:
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
A clear amber coloured syrup with a characteristic smell of peaches.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BENYLIN Non-Drowsy Dry Coughs, Syrup is indicated for the relief of
non-productive irritating cough.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 12 YEARS AND OVER:
Oral. 15mg (10 ml syrup) 3-4 times a day.
Maximum daily dose: 40 ml syrup
CHILDREN UNDER 12 YEARS:
This product is contraindicated in children under the age of 12 years
(See section 4.3).
HEPATIC DYSFUNCTION
Due to the extensive hepatic metabolism of dextromethorphan, caution
should be exercised in the presence of hepatic
impairment (See sections 4.4 and 5.2).
4.3 CONTRAINDICATIONS
This product is contraindicated in individuals with known
hypersensitivity to dextromethorphan 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
Sorbitol solution
70%
E420
325
mg
Sucrose
1625
mg
Glucose
2380
mg
Sodium
4.4
mg
Ethanol
96% v/v
0.311
ml
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