Flursil Relief Sugar Free 8.75 mg lozenges

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Flurbiprofen

Disponibil de la:

Rowex Ltd

Codul ATC:

R02AX; R02AX01

INN (nume internaţional):

Flurbiprofen

Dozare:

8.75 milligram(s)

Forma farmaceutică:

Lozenge

Tip de prescriptie medicala:

Product not subject to medical prescription

Zonă Terapeutică:

Other throat preparations; flurbiprofen

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2016-10-28

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLURSIL RELIEF SUGAR FREE 8.75MG LOZENGES
Flurbiprofen_ _
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 has 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 3 days.
WHAT IS IN THIS LEAFLET
1. What Flursil Relief Sugar Free is and what it is used for
2. What you need to know before you take Flursil Relief Sugar Free
3. How to take Flursil Relief Sugar Free
4. Possible side effects
5. How to store Flursil Relief Sugar Free
6. Contents of the pack and other information
1. WHAT FLURSIL RELIEF SUGAR FREE IS AND WHAT IT IS USED FOR
Flursil Relief Sugar Free contains flurbiprofen. It belongs to a group
of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief
by changing the body’s
response to pain, swelling, and high temperature. Flursil Relief Sugar
Free lozenges are used for the
short-term relief of symptoms of sore throat such as throat pain and
soreness in adults and children
over the age of 12 years.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLURSIL RELIEF SUGAR FREE
DO NOT TAKE FLURSIL RELIEF SUGAR FREE IF YOU:

are allergic to flurbiprofen or to any of the other ingredients of
this medicine (listed in section 6)

currently have (or have had two or more episodes of) a stomach ulcer,
intestinal ulcers, or
gastrointestinal bleeding

have ever had asthma, unexpected wheezing or shortness of breath, a
runny nose, facial swelling
or itchy rash (hives) after taking acetylsalicy

Caracteristicilor produsului

Health Products Regulatory Authority
17 November 2019
CRN0093VH
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flursil Relief Sugar Free 8.75 mg lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 8.75 mg Flurbiprofen.
Excipient(s) with known effect
Isomalt 2160 mg/lozenge
Maltitol 383 mg/lozenge
Butylated hydroxyanisole (E320) 0.013 mg/lozenge
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge
Round, orange lozenge with typical line marking and without
debossment, orange flavour.
Diameter: Approximately 19 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flursil Relief Sugar Free 8.75 mg lozenges are indicated for the short
term symptomatic relief of sore throat in adults and
children over the age of 12 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, the elderly and children over the age of 12 years_
One lozenge sucked/dissolved slowly in the mouth every 3-6 hours as
required. Maximum 5 lozenges in a 24 hour period.
It is recommended that this product should be used for a maximum of
three days.
_Pediatric population_
Not indicated for children under 12 years.
_Elderly_
A general dose recommendation cannot be given, since to date clinical
experience is limited. The elderly are at increased risk of
the serious consequences of adverse reactions.
_Hepatic impairment_
In patients with mild to moderate impairment of hepatic function no
dose reduction is required. In patients with severe hepatic
insufficiency flurbiprofen is contraindicated (see section 4.3).
_Renal impairment_
In patients with mild to moderate impairment of renal function no dose
reduction is required. In patients with severe renal
insufficiency flurbiprofen is contraindicated (see section 4.3).
Method of administration
Health Products Regulatory Authority
17 November 2019
CRN0093VH
Page 2 of 10
For oromucosal administration and short-term use only.
As with all lozenges, to avoid local irritation, Flursil Relief Sugar
Free should be moved around