Actifed Expectorant

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

TRIPROLIDINE HYDROCHLORIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Διαθέσιμο από:

Glaxo Wellcome UK Limited

Φαρμακολογική κατηγορία (ATC):

R01BA52

INN (Διεθνής Όνομα):

TRIPROLIDINE HYDROCHLORIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Φαρμακοτεχνική μορφή:

ORAL SOLUTION

Σύνθεση:

TRIPROLIDINE HYDROCHLORIDE 1.25 mg/5ml; GUAIFENESIN 100 mg/5ml; PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5ml

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

NASAL PREPARATIONS

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2006-05-29

Φύλλο οδηγιών χρήσης

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTIFED EXPECTORANT
Pseudoephedrine hydrochloride 30 mg, Triprolidine hydrochloride 1.25
mg and Guaiphenesin
100mg/5ml Oral Solution
ATTENTION
Actifed Expectorant 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 Expectorant is and what it is used for
2
What you need to know before you use Actifed Expectorant
3
How to use Actifed Expectorant
4
Possible side effects
5
How to store Actifed Expectorant
6
Contents of the pack and other information
1
WHAT ACTIFED EXPECTORANT IS AND WHAT IT IS USED FOR
Actifed Expectorant contains 30 mg Pseudoephedrine hydrochloride, 1.25
mg Triprolidine hydrochloride
and 100 mg Guaiphenesin (the active ingredients) in each 5 ml dose.
There are also some inactive
ingredients in Actifed Expectorant.
Actifed Expectorant is used for the relief of symptoms of chesty
coughs and colds. Pseudoephedrine
hydrochloride is a decongestant, which means it acts to relieve
blocked sinuses and noses. Triprolidine
hydrochloride is an antihistamine, which means it will help stop
sneezing, watering and soreness in the
nose and eyes. Guaiphenesin is an expectorant, which means it helps to
loosen stubborn mucus
(phlegm)

Αρχείο Π.Χ.Π.

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Actifed Expectorant
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Triprolidine Hydrochloride 1.25mg, Pseudoephedrine Hydrochloride 30mg
and Guaiphenesin 100mg in each 5ml
3.
PHARMACEUTICAL FORM
Oral solution
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Actifed Expectorant is indicated for symptomatic relief of upper
respiratory
tract disorders accompanied by productive cough, which benefit from
the
administration of a nasal decongestant.
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 Expectorant 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 Expectorant should not be used in children under 2 years of
age.
Page 2 of 11
Actifed Expectorant 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.
Older people
There have been no specific studies of pseudoephedrine, triprolidine
or
guaifenesin 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
Triprolidine is eliminated primarily by hepatic metabolism therefore
consideration should be given to reducing the dose in those with
severe hepatic
impairment [see Section 4.4.].
Patients with renal impairment
Pseudoephedrine i