Actifed 60mg/2.5mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

R01BA; R01BA02

INN (International Name):

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Dosage:

60 mg/2.5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics; pseudoephedrine

Authorization status:

Marketed

Authorization date:

1978-04-01

Patient Information leaflet

Package leaflet: Information for the user
ACTIFED ® 60MG/2.5 MG TABLETS
_Pseudoephidrine hydrochloride _
_Triprolidine hydrochloride _
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 Tablets is and what it is 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 IS AND WHAT IT IS USED FOR
Actifed Tablets is a medicine which is used to relieve the symptoms of
colds, flu and allergies including
sneezing,
runny
nose,
watery
eyes,
nasal
congestion
and
blocked
sinuses.
The
tablets
contain
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 12 years and
over.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE ACTIFED TABLETS
This medicine is suitable for most adults and children aged 12 years
and over but a few people should not
use it. If you are in any doubt, talk to your doctor or pharmacist.
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 DIABETES.
■
If you have an OVERACTIVE THYROID GLAND.
■
If you have GLAUCOMA (increased pressure in the eye).
■
If you have difficulty in pa

Summary of Product characteristics

Health Products Regulatory Authority
14 May 2021
CRN00C6PD
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actifed 60mg/2.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg Pseudoephedrine hydrochloride and 2.5 mg
Triprolidine hydrochloride.
Excipients: contains 127.5 mg lactose monohydrate per tablet.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
White, round biconvex tablet with bisecting score and M2A engraved on
one side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ACTIFED Tablets are indicated for the symptomatic relief of upper
respiratory tract disorders which are benefited by a
combination of a nasal decongestant and H
1
-receptor antagonist, for example allergic rhinitis, vasomoter
rhinitis and the
common cold.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN 12 YEARS AND OVER:
One tablet to be taken every 4-6 hours, up to four times a day.
CHILDREN UNDER 12 YEARS:
This medicine is contraindicated in children under the age of 12 years
(see section 4.3).
THE ELDERLY:
There have been no specific studies of ACTIFED Tablets in the elderly.
Experience has indicated that normal adult dosage is
appropriate.
HEPATIC DYSFUNCTION:
Caution should be exercised when administering Actifed Tablets to
patients with severe hepatic impairment.
RENAL DYSFUNCTION:
Caution should be exercised when administering Actifed Tablets to
patients with mild to moderate renal impairment.
METHOD OF ADMINISTRATION
For oral use.
4.3 CONTRAINDICATIONS
ACTIFED Tablets are contra-indicated in individuals with known
hypersensitivity to pseudoephedrine, triprolidine or to any of
the excipients listed in section 6.1.
ACTIFED Tablets are contra-indicated in patients with cardiovascular
disease including hypertension, and in those who are
taking beta-blockers
Health Products Regulatory Authority
14 May 2021
CRN00C6PD
Page 2