Benylin Non-Drowsy Dry Coughs, Syrup; Dextromethorphan hydrobromide 7.5mg/5ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE

Available from:

Johnson & Johnson (Ireland) Limited Airton Road Tallaght, Dublin 24, Dublin, Ireland

ATC code:

R05DA09

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/5ml

Pharmaceutical form:

SYRUP

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-08-10

Patient Information leaflet

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.
This medicine can lead to dependence. Therefore the treatment
should be of short duration
X 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).
■

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF PROPRIETARY PRODUCT
BENYLIN Non-Drowsy Dry Coughs, Syrup
Dextromethorphan hydrobromide 7.5mg/5ml
2.
COMPOSITION (QUALITATIVE AND QUANTITATIVE)
BENYLIN Non-Drowsy Dry Coughs, Syrup contains dextromethorphan
hydrobromide 7.5 mg in each 5 ml.
Each 5 ml of BENYLIN Non Drowsy Dry Coughs, Syrup also contains:
Sorbitol solution (70%) E420
325 mg
Sucrose
1625 mg
Glucose
2380 mg
Sodium
4.4 mg
Ethanol
236 mg
Sodium benzoate
25 mg
Propylene glycol
2.7 mg
Invert sugar
6.7 mg
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).
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4.3
CONTRA-INDICATIONS
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
dextromethorphan and MAOIs and the concomitant use of these
medications
may cause a rise in blood pressure and/ or hypertensive crisis (see
section 4.5).
This product is contraindicated in patients taking serotonin reuptake
inhibitors
(SSRIs, see section 4.5).
Dextromethorphan, should not be given to patients in, or at risk of
developing
respiratory failure.
BENYLIN Non