Triflu 500mg/200mg/25mg, granules for oral solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL, ASCORBIC ACID

Available from:

Dr. Max Pharma Limited First Floor Roxbourghe House, 273-287 Regent Street, London W1B 2HA, United Kingdom

ATC code:

N02BE51

INN (International Name):

PARACETAMOL 500 mg ASCORBIC ACID 200 mg Pheniramine maleate 25 mg

Pharmaceutical form:

GRANULES FOR ORAL SOLUTION

Composition:

PARACETAMOL 500 mg ASCORBIC ACID 200 mg Pheniramine maleate 25 mg

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2015-05-11

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIFLU
Paracetamol, Ascorbic Acid, Pheniramine Maleate
500 mg/200 mg/ 25 mg
granules for oral solution in sachet
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take 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 is Triflu and when is it used?
2.
What you need to know before you take Triflu?
3.
How to take Triflu
4.
Possible side effects
5.
How to store Triflu
6.
Contents of the pack and other information
1.
WHAT TRIFLU IS AND WHAT IT IS USED FOR?
Triflu is indicated for treatment of symptoms associated with the
common cold, influenza and upper
respiratory tract infections such as runny nose, watery eyes,
sneezing, headache and/or fever.
This medicine should only be used if you have all of the following
symptoms - pain and/or fever,
and at the same time runny nose, watery eyes or sneezing. Do not use
it if you have only one of the
symptoms.
Triflu is indicated for adults and adolescent older than 15 years.
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIFLU?
_ _
DO NOT TAKE TRIFLU:
-
if you are allergic to paracetamol, ascorbic acid, pheniramine maleate
or any of the other
ingredients of this medicine (listed in section 6)
-
if you have liver disease
-
if you have narrow-angle
glaucoma
-
if you are taking or have taken within the last two weeks monoamine
oxidase inhibitors (for
depression)
-
if you are a man with prostate problems
-
do not give Triflu to children unde

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Triflu, 500 mg/200 mg/ 25 mg, granules for oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 500 mg paracetamol, 200 mg ascorbic acid,
_ _
25 mg pheniramine maleate.
Excipient(s) with known effect: sucrose, ethanol
Each sachet contains 11.555 g sucrose and less than 15.2 mg ethanol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral solution
White to slightly yellow powder with a characteristic odour of citrus
fruit and rum.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of symptoms associated with the common cold, influenza
and upper respiratory tract
infections.
Triflu is indicated for adults and children older than 15 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children older than 15 years _
The recommended daily dose is one sachet 2 or 3 times daily.
There should be at least 4 hours interval between doses.
It is recommended to dissolve Triflu in a glass of hot water and drink
in the evening during flu
symptoms.
_ _
The maximum duration of treatment is 5 days without seeking medical
advice.
Renal insufficiency
In patients with moderate renal insufficiency (creatinine clearance 10
to 50 ml/min), the interval
between two administrations should be at least minimum 6 hours.
Page 2 of 8
In patients with severe renal insufficiency (creatinine clearance less
than 10 ml/min), the interval
between two administrations should be at least minimum 8 hours.
Method of administration
For oral use.
The sachet content should be dissolved in a sufficient quantity of
cold or hot water.
4.3
CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1

Patients with hepatic insufficiency

Patients with presence of narrow-angle glaucoma

Patients with risk of urinary retention related to urethroprostatic
disorders

Patients who have taken monoamine oxidase (MAOI) within the las