ACTIFED 30mg/1.25mg per 5ml Syrup

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Διαθέσιμο από:

Johnson & Johnson (Ireland) Limited

Φαρμακολογική κατηγορία (ATC):

R01BA; R01BA02

INN (Διεθνής Όνομα):

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Δοσολογία:

30 mg/1.25 mg/5ml

Φαρμακοτεχνική μορφή:

Syrup

Τρόπος διάθεσης:

Product not subject to medical prescription

Θεραπευτική περιοχή:

Sympathomimetics; pseudoephedrine

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1978-04-01

Φύλλο οδηγιών χρήσης

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or
as your doctor or pharmacist have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side-effects, talk to your doctor or pharmacist.
This includes any possible side-effects not listed in this
leaflet.
_See section 4_
.
- You must talk to a doctor if you do not feel better or if you
feel worse after 5 days.
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 is a medicine which is used to relieve the
symptoms of colds and allergies including sneezing, runny
nose, watery eyes, nasal congestion and blocked sinuses. The
liquid contains pseudoephedrine hydrochloride, which is a
decongestant that relieves nasal and sinus congestion and
triprolidine hydrochloride which is an antihistamine that helps
stop sneezing, runny nose and watery eyes.
This medicine is for use in adults and children aged 6 years and
over.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE ACTIFED
SYRUP
This medicine is suitable for most adults and children
aged 6 years and over but a few people should not use it.
If you are in any doubt, talk to your doctor or pharmacist.
X DO NOT USE THIS MEDICINE…
■ If you have ever had a
BAD REACTION (ALLERGIC REACTION)
to any of the ingredients
_(listed in section 6_
).
■ If you have
HIGH BLOOD PRESSURE
or
HEART DISEASE
.
■ If you are taking
_beta blockers _
(used to treat
HIGH BLOOD
PRESSURE
).
■ If you are taking, or have taken in the last two
weeks, drugs for
DEPRESSION
known as Monoamine
Oxidase Inhibitors (MAOIs) or Reversible Inhibitors of
Monoamine Oxidase (RIMAs).
■ I

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
14 May 2021
CRN00C6PD
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ACTIFED 30mg/1.25mg per 5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIFED Syrup contains 1.25 mg Triprolidine hydrochloride and 30 mg
Pseudoephedrine hydrochloride in each 5 ml.
Excipients: Also includes the following substances in each 5 ml:
Sucrose 3.5 g
Methyl Hydroxybenzoate (E218) 5.0 mg
Sunset Yellow (E110) 0.005 mg
Sodium benzoate 5.0 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Syrup
A clear, golden yellow syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ACTIFED Syrup contains a decongestant and antihistamine and is
indicated for the management of upper respiratory tract
conditions such as the common cold, hay fever, allergic and vasomotor
rhinitis and aerotitis (otitis barotrauma).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN 12 YEARS AND OVER:
10 ml every 4-6 hours, up to four times a day.
CHILDREN 6 - 12 YEARS:
5 ml every 4-6 hours, up to three times a day.
Maximum daily dose: 15ml syrup.
A pharmacist or other healthcare professional should be consulted
before use in children aged 6 to 12 years.
Use only when simple measures have failed to provide adequate relief.
Use for more than 5 consecutive days is not recommended.
CHILDREN UNDER 6 YEARS:
This medicine is contraindicated in children under 6 years. [See
section 4.3]
THE ELDERLY:
There have been no specific studies of ACTIFED Syrup in the elderly.
Experience has indicated that normal adult dosage is
appropriate.
HEPATIC DYSFUNCTION:
Caution should be exercised when administering Actifed Syrup to
patients with severe hepatic impairment.
RENAL DYSFUNCTION:
Caution should be exercised when administering Actifed Syrup to
patients with mild to moderate renal impairment
Health Products Regulatory Authority
14 May 2021
CRN00C6PD
Page 2 of 9
METHOD OF ADMINISTRATION
For oral use.
4.3 CONTRAINDICATIONS
ACTIFED Syrup is contra-indicated in individuals