Actifed Syrup Oral Solution 30mg/1.25mg per 5ml

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

Mevcut itibaren:

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

ATC kodu:

R01BA52

INN (International Adı):

TRIPROLIDINE HYDROCHLORIDE 1.25 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5ml

Farmasötik formu:

ORAL SOLUTION

Kompozisyon:

TRIPROLIDINE HYDROCHLORIDE 1.25 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5ml

Reçete türü:

POM

Terapötik alanı:

NASAL PREPARATIONS

Yetkilendirme durumu:

Withdrawn

Yetkilendirme tarihi:

2006-05-29

Bilgilendirme broşürü

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTIFED SYRUP
Pseudoephedrine hydrochloride 30 mg and Triprolidine hydrochloride
1.25 mg/5ml Oral Solution
ATTENTION
Actifed Syrup 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 Syrup is and what it is used for
2
What you need to know before you use Actifed Syrup
3
How to use Actifed Syrup
4
Possible side effects
5
How to store Actifed Syrup
6
Contents of the pack and other information
1
WHAT ACTIFED SYRUP IS AND WHAT IT IS USED FOR
Actifed Syrup contains 30 mg Pseudoephedrine hydrochloride and 1.25 mg
Triprolidine hydrochloride
(the active ingredients) in each 5 ml dose. There are also some
inactive ingredients in Actifed Syrup.
Actifed Syrup is for the relief of symptoms of cold, flu and hay
fever. Pseudoephedrine hydrochloride is a
decongestant, which means it acts to relieve blocked noses and
sinuses. Triprolidine hydrochloride is an
antihistamine, which means it will help stop sneezing, watering and
soreness in the nose and eyes.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE ACTIFED SYRUP
DO NOT USE ACTIFED SYRUP:

If your child is less than 2 years old.
Page 2 of 5

If you or your child are allergic (hypersensitive) to

Ürün özellikleri

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Actifed Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pseudoephedrine Hydrochloride BP 30mg and Triprolidine Hydrochloride
BP 1.25mg
in each 5ml
3.
PHARMACEUTICAL FORM
Oral solution
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Actifed Syrup is indicated for the symptomatic relief of nasal
congestion and rhinitis
associated with upper respiratory tract disorders.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
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 to 5 years
Actifed Syrup is not suitable for administration to children aged
under 6 years, except
on the advice of a physician.
Dosage recommendations are given below:
2.5 ml every 4-6 hours as required.
Maximum daily dose: 10ml syrup in any 24 hours.
Actifed Syrup should not be used in children under 2 years of age.
Actifed Syrup may be diluted 1:1 (1 in 2) or 1:3 (1 in 4) with 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 or triprolidine
in the elderly.
The elderly are more likely to experience the neurological
anticholinergic effects of
Page 2 of 7
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 is primarily excreted renally. Renal impairment will
increase
plasma levels of pseudoephedrine. Pseudoephedrine should not be used
by those with
severe rena