Actifed DM Cough Linctus Oral Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC code:

R01BA52

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5ml TRIPROLIDINE HYDROCHLORIDE 1.25 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5ml TRIPROLIDINE HYDROCHLORIDE 1.25 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5ml

Prescription type:

POM

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-05-29

Patient Information leaflet

Page 1 of 5
_ Package Leaflet: Information for the User _
ACTIFED DM COUGH LINCTUS
Pseudoephedrine hydrochloride 30 mg, Triprolidine hydrochloride 1.25
mg and
Dextromethorphan hydrobromide 10 mg/5ml Oral Solution
ATTENTION
Actifed DM Cough Linctus is authorised for use without the need of a
medical prescription in
Adults and Children over 12 years as recommended by your pharmacist.
In Children between 2-
11 years of age, this product is authorised for use only against a
medical prescription as
recommended by your doctor.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed/recommended for you or your child
only. Do not pass it
on to others. It may harm them, even if their signs of illness are the
same.
•
If you or your child get any side effects, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
What Actifed DM Cough Linctus is and what it is used for
2
What you need to know before you use Actifed DM Cough Linctus
3
How to use Actifed DM Cough Linctus
4
Possible side effects
5
How to store Actifed DM Cough Linctus
6
Contents of the pack and other information
1
WHAT ACTIFED DM COUGH LINCTUS IS AND WHAT IT IS USED FOR
Actifed DM Cough Linctus contains 30 mg Pseudoephedrine hydrochloride,
1.25 mg Triprolidine
hydrochloride and 10 mg Dextromethorphan hydrobromide (the active
ingredients) in each 5 ml
dose. There are also some inactive ingredients in Actifed DM Cough
Linctus.
Actifed
DM
Cough
Linctus
is
used
for
the
relief
of
symptoms
of
coughs
and
colds.
Pseudoephedrine hydrochloride is a decongestant, which means it acts
to relieve blocked sinuses
and noses. Dextromethorphan hydrobromide is an antitussive, which
helps to stop dry coughs.
Triprolidine hydrochloride is an antihistamine, which me

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Actifed DM Cough Linctus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dextromethorphan Hydrobromide 10mg, Pseudoephedrine Hydrochloride 30mg
and
Triprolidine Hydrochloride 1.25mg in each 5ml.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Actifed DM Cough Linctus is indicated for the symptomatic relief of
nasal congestion,
rhinitis and cough associated with upper respiratory tract disorders.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
Users should be advised to seek medical advice if symptoms persist for
more than
7 days.
Do not exceed the stated dose or frequency of dosing.
Avoid use with other anti-histamine-containing products, including
cough and
cold medicines (see Section 4.4.).
Children aged 6 to 11 years
5ml every 4-6 hours as required.
Maximum daily dose: 20ml syrup in any 24 hours.
Children aged 2 years to 5 years
Actifed DM Cough Linctus is not suitable for administration to
children aged
under 6 years, except on the advice of a physician.
Dosage recommendations are given below:
2.5ml every 4-6 hours as required.
Maximum daily dose: 10ml syrup in any 24 hours.
Actifed DM Cough Linctus should not be used in children under 2 years
of age.
Actifed DM Cough Linctus may be diluted 1:1 (1 in 2) or 1:3 (1 in 4)
with unpreserved
Syrup BP. These dilutions have a shelf life of 4 weeks if stored at 25
o
C.
Page 2 of 8
Older people
There have been no specific studies of Actifed DM Cough Linctus in the
elderly. The
elderly are more likely to experience the neurological anticholinergic
effects of
triprolidine, including confusion, and to develop paradoxical
excitation [see Section 4.4.].
Patients with hepatic impairment
Severe liver disease can impair the metabolism of dextromethorphan.
Medical advice
should be sought before use in those with severe hepatic impairment.
(see Section 4.4.).
Triprolidine is eliminated primarily by hepatic metabol