Actifed Tablets

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

TRIPROLIDINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Fáanlegur frá:

Glaxo Wellcome UK Limited

ATC númer:

R01BA52

INN (Alþjóðlegt nafn):

TRIPROLIDINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Lyfjaform:

TABLET

Samsetning:

TRIPROLIDINE HYDROCHLORIDE 2.5 mg; PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

NASAL PREPARATIONS

Leyfisstaða:

Authorised

Leyfisdagur:

2007-05-07

Upplýsingar fylgiseðill

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTIFED TABLETS
Pseudoephedrine hydrochloride 60 mg, Triprolidine hydrochloride 2.5 mg
per tablet
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 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 Tablets are and what they are used for
2
What you need to know before you use Actifed Tablets
3
How to use Actifed Tablets
4
Possible side effects
5
How to store Actifed Tablets
6
Contents of the pack and other information
1
WHAT ACTIFED TABLETS ARE AND WHAT THEY ARE USED FOR
Actifed Tablets contain 60 mg Pseudoephedrine hydrochloride and 2.5 mg
Triprolidine hydrochloride
(the active ingredients) per tablet. There are also some inactive
ingredients in Actifed Tablets.
Actifed
Tablets
are
used
for
the
relief of
symptoms
of
cold,
flu
and
hayfever. 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 TABLETS
DO NOT USE ACTIFED TABLETS:

If you or your child are allergic (hypersensitive) to Pseudoephedrine
hydrochloride, Triprolidine
hydrochloride or any of the other ingredients of Actifed Tablets
(listed in Section 6).

If you or your child suffered or suffer from severe kidney disease or
liver disease.

If you or your child have high blood pressure or heart disease.
Page 2 of 4

If you or your child are taking or have recently

Vara einkenni

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Actifed Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pseudoephedrine Hydrochloride 60mg per tablet
Triprolidine Hydrochloride 2.5mg per tablet
3.
PHARMACEUTICAL FORM
Tablet
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Actifed Tablets are 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.).
Adults (including the elderly) and children aged 12 years and over
1 tablet every 4-6 hours as required.
Maximum daily dose: 4 tablets in any 24 hours.
Actifed Tablets should not be used in children under 12 years of age.
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
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.]
Page 2 of 7
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 renal impairment (see contraindications) and should be use with
caution in
those with moderate renal impairment [see Section 4.4.].
For oral administration.
4.3.
CONTRA-INDICATIONS
Hypersensitivity to pseudoephedrine hydrochloride, triprolidine
hydrochloride, or
excipients.
Severe hypertension or severe coronary artery disease.
Severe renal impairment.
Patients recei