Straben 8.75 mg lozenges

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. 14th Km National Road Athens - Lamia 1, GR-145 64 Kifissia, Greece

ATC code:

R02AX01

INN (International Name):

FLURBIPROFEN 8.75 mg

Pharmaceutical form:

LOZENGE

Composition:

FLURBIPROFEN 8.75 mg

Prescription type:

OTC

Therapeutic area:

THROAT PREPARATIONS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-08-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
STRABEN 8.75 MG 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
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 3 days.
WHAT IS IN THIS LEAFLET
1.
What Straben is and what it is used for
2.
What you need to know before you take
Straben
3.
How to take Straben
4.
Possible side effects
5.
How to store Straben
6.
Contents of the pack and other information
1.
WHAT STRABEN IS AND WHAT IT IS USED FOR
Straben 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. Straben is 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE STRABEN
DO NOT TAKE STRABEN
-
if you are allergic to flurbiprofen, acetylsalicylic acid and other
non-steroidal drugs anti-
inflammatory drugs (NSAIDs) or any of the other ingredients of this
medicine (listed in
section 6).
-
if you currently have (or have had two or more episodes of) a stomach
ulcer, intestinal
ulcer, or gastrointestinal bleeding.
-
if you have ever had allergy symptoms such as difficulty breathing
(asthma), unexpected
wheezing or shortness of breath, a runny nose, facial swelling
(angioedema) or itchy rash
(hives) after taking acetylsalicylic acid or any other NSAID medicine.
-
if you have had gastrointestinal bleeding or perforation, severe
colitis (inflammation o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Straben 8.75 mg lozenges
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 8.75 mg of flurbiprofen.
Excipients with known effect:
This medicinal product contains 577.34 mg sorbitol per lozenge.
This medicinal product contains 86.91 mg lactose per lozenge.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lozenges.
Flat-faced plain, white lozenges with a diameter of 12.0 mm.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Straben is 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 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 3
days.
_Paediatric population _
Straben is contraindicated in children under 12 years.
_Elderly patients _
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
For oromucosal administration and short-term use only.
As with all lozenges, to avoid local irritation, Straben should be
moved around the mouth
whilst sucking.
The lowest effective dose should be used for the shortest duration
necessary to relieve
symptoms (see section 4.4).
4.3.
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or other NSAIDs or to any of
th