Benylin Dry Coughs Syrup 7.5mg/5ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE

Available from:

McNeil Products Limited

ATC code:

R05DA09

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE

Pharmaceutical form:

SYRUP

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 7.5 milligram(s)/5 millilitre

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-08-10

Patient Information leaflet

DRY COUGHS
7.5MG/5ML SYRUP
DEXTROMETHORPHAN
Q
This medicine is used to help relieve dry, irritating
coughs.
Q
This medicine is for use by adults and children aged
12 years and over.
Q
DO NOT USE THIS MEDICINE:
Q
There are some people who should not use this medicine.
_To find out if you are one of them see section 2_
Q
If you have ever had a BAD REACTION to any of the
ingredients. _For the list of ingredients see section 6_
Q
SPEAK TO YOUR DOCTOR:
Q
If you suffer from any of the conditions mentioned
in section 2. _See section 2_
Q
If you are taking any other medicines. _See section 2_
Q
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These are
shown in the table. _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 AND
WHAT IT IS USED FOR
Benylin Dry Coughs 7.5mg/5ml 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 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 USE THIS MEDICINE…
Q
If you have ever had a bad reaction (e.g. RASH,
SWELLING OF THE FACE AND THROAT, DIFFICULTY
BREATHING) to dextromethorphan or any of the
other ingredients.
Q
If you suffer from LUNG DISEASE.
Q
If you are taking, or have taken in the last
two weeks, DRUGS FOR DEPRESSION known as
Monoamine Oxidase Inhibitors (MAOIs).
Q
If you are taking selective serotonin re-uptake
inhibitors (used to treat DEPRESSION and ANXIETY
such as fluoxetine, paroxetine and sertraline).
Q
For children under 12 years old.
If any of these apply to you, GET ADVICE FROM A DOCTOR
OR PHARMACIST WITHOUT USING BENYLIN DRY COUGHS
7.5MG/5ML SYRUP.
TALK TO YOUR DOCTOR OR PHARMACIST…
Q
If you suffer from LIVER or KIDNEY PROBLEMS.
Q
If

Summary of Product characteristics

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
BENYLIN DRY COUGHS 7.5mg/5ml Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains:
Dextromethorphan hydrobromide
7.5 mg
Each 5ml also contains:
Sucrose 1.6g
Liquid glucose 2.38g
Sorbitol 325mg
Ethanol 240mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pale brown coloured, peach flavoured syrup.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
This product is indicated as an antitussive, for the relief of an
unproductive
cough.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN AGED 12 YEARS AND OVER:
POSOLOGY
10 ml syrup (15 mg dextromethorphan) 4 times a day.
Maximum daily dose: 40 ml syrup (60 mg dextromethorphan)
CHILDREN UNDER 12 YEARS:
This product is contraindicated in children under the age of 12 years
(see
section 4.3).
Page 2 of 9
THE ELDERLY (OVER 65 YEARS)
As for adults above.
Hepatic/renal dysfunction
Due to the extensive hepatic metabolism of dextromethorphan, caution
should
be exercised in the presence of moderate to severe hepatic impairment
(see
Pharmacokinetics).
Do not exceed the stated dose.
Keep out of the sight and reach of children.
METHOD OF ADMINISTRATION
For oral use
4.3.
CONTRAINDICATIONS
This product is contraindicated in individuals with known
hypersensitivity to
the active substance or to any of the excipients.
This product is contraindicated in individuals who are taking, or have
taken,
monoamine oxidase inhibitors within the preceding two weeks.
Dextromethorphan, in common with other centrally acting antitussive
agents,
should not be given to subjects in, or at risk of developing
respiratory failure.
This product is contraindicated in patients taking serotonin reuptake
inhibitors
(SSRIs, see section 4.5).
Not to be used in children under the age of 12 years.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product should not be administered to patients with chronic or
persistent
cough, such as occurs with asthma, or where cough