Robitussin Dry Cough 7.5mg/5ml Oral Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE

Available from:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC code:

R05DA09

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/5ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2007-08-20

Patient Information leaflet

ROBITUSSIN DRY COUGH 7.5 MG / 5ML ORAL SOLUTION
Dextromethorphan Hydrobromide
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use
ROBITUSSIN DRY COUGH medicine carefully to get the best results from
it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact a doctor or pharmacist if your symptoms worsen, do
not
improve after 7 days or are accompanied by fever, rash or persistent
headaches.
•
If any of the side effects gets serious, or if you notice any side
effect not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1
What
ROBITUSSIN DRY COUGH
medicine is and what it is used for
2
Before you take ROBITUSSIN DRY COUGH medicine
3
How to take ROBITUSSIN DRY COUGH medicine
4
Possible side effects
5
How to store ROBITUSSIN DRY COUGH medicine
1 WHAT ROBITUSSIN DRY COUGH MEDICINE IS AND WHAT IT IS USED FOR
ROBITUSSIN DRY COUGH
medicine contains the active ingredient dextromethorphan
hydrobromide. This active ingredient belongs to a group of medicines
called cough
suppressants that work by providing relief from persistent dry
irritant coughs.
2 BEFORE YOU TAKE ROBITUSSIN DRY COUGH MEDICINE
DO NOT TAKE THIS MEDICINE IF:
•
You are allergic (hypersensitive) to dextromethorphan hydrobromide or
any of
the other ingredients of ROBITUSSIN DRY COUGH medicine (list in
section 6).
•
You are taking a prescription monoamine oxidase inhibitor (MAOI) or a
selective serotonin reuptake inhibitor (SSRI) or have taken either
medicine
within the last 14 days.
TALK TO YOUR DOCTOR BEFORE TAKING THIS MEDICINE IF:
•
You have had a cough for a long time or if you have asthma or are
suffering
from an asthma attack, or if your cough is accompanied by a fever,
rash, or
persistent headache.
•
Your cough produces too much phlegm (mucus), lasts or is chronic, such
as occurs with smoking, asthma or emphysema.
•
You

Summary of Product characteristics

RESTRICTED
GlaxoSmithKline Consumer Healthcare
(Ireland) Limited
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Robitussin Dry Cough 7.5 mg / 5ml Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of liquid contains;
Active ingredient:
Dextromethorphan Hydrobromide
7.5 mg
Excipients:
Ethanol (96%)
98 mg
Amaranth
0.165 mg
Liquid Maltitol
242 mg
Sorbitol Solution 70%
1.454 g
For a full list of ingredients, see 6.1
3.
PHARMACEUTICAL FORM
Oral Solution
A clear, red liquid with the characteristic odour and taste of cherry
/ grenadine
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As a cough suppressant for the relief of non-productive irritant cough
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Taken orally
ADULTS AND CHILDREN OVER 12 YEARS:
10 ml 3 to 4 times daily
CHILDREN UNDER 12 YEARS:
Do not use
4.3
CONTRA-INDICATIONS
Use in children under 12 years of age.
Use in patients taking a prescription monoamine oxidase inhibitor
(MAOI), a
selective serotonin reuptake inhibitor (SSRI), or for 2 weeks after
stopping the
RESTRICTED
GlaxoSmithKline Consumer Healthcare
(Ireland) Limited
medication. (see section 4.5).
_ _
Severe and sometimes fatal reactions have been
reported after use of dextromethorphan in patients receiving MAOIs.
Hypersensitivity to the active substance or to any of the excipients.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Robitussin Dry Cough should only be used under medical supervision for
persistent
or chronic cough such as occurs with smoking, asthma or emphysema, or
where the
cough is accompanied by excessive secretions.
Cases of dextromethorphan abuse and dependence have been reported.
Caution is
particularly recommended for adolescents and young adults as well as
in patients
with a history of drug abuse or psychoactive substances.
Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The
activity of
this enzyme is genetically determined. About 10% of the general
population are poor
metabolisers of CYP2D6. Poor metabolisers and pati