Strepsils Intensive Orange Sugar Free 8.75mg Lozenges

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Flurbiprofen

Διαθέσιμο από:

Reckitt Benckiser Ireland Ltd

Φαρμακολογική κατηγορία (ATC):

R02AX; R02AX01

INN (Διεθνής Όνομα):

Flurbiprofen

Δοσολογία:

8.75 milligram(s)

Φαρμακοτεχνική μορφή:

Lozenge

Τρόπος διάθεσης:

Product not subject to medical prescription

Θεραπευτική περιοχή:

Other throat preparations; flurbiprofen

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-07-04

Φύλλο οδηγιών χρήσης

STREPSILS INTENSIVE ORANGE SUGAR FREE 8.75MG LOZENGES
FLURBIPROFEN
PATIENT INFORMATION LEAFLET
Please 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 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 Strepsils Intensive Lozenges are and what they are used for
2.
What you need to know before you use Strepsils Intensive Lozenges
3.
How to use Strepsils Intensive Lozenges
4.
Possible side effects
5.
How to store Strepsils Intensive Lozenges
6.
Contents of the pack and other information
1.
WHAT STREPSILS INTENSIVE LOZENGES ARE AND WHAT THEY ARE USED
FOR?
The ingredient which makes this medicine work is called flurbiprofen.
Flurbiprofen belongs to a
group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs), which help reduce
inflammation (swelling) and pain.
Strepsils Intensive Lozenges are for use in adults and children over
12 years of age to help
relieve the symptoms of sore throats, such as soreness, pain and
swelling.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE STREPSILS INTENSIVE
LOZENGES
DO NOT TAKE THESE LOZENGES IF YOU:
•
Have or have ever had a
STOMACH ULCER
•
Are
ALLERGIC
to flurbiprofen, aspirin or other NSAIDs or any of the other
ingredients (see
Section 6)
•
Have previously experienced
GASTROINTESTINAL BLEEDING OR PERFORATION
whilst taking
NSAIDS
•
Have ever had
BLOOD CLOTTING PROBLEMS OR BLEEDING PROBLEMS
after taking NSAIDs
•
Have ever had
WHEEZING, A RUNNY NOSE OR AN ITCHY RASH
(hives) after taking aspirin,
flurbiprofen or medicines containing NSAIDs
•
Are

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
08 February 2022
CRN00CNZC
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Intensive Orange Sugar Free 8.75mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One lozenge contains 8.75 mg of flurbiprofen.
Excipients with known effects:
This product contains
Maltitol Liquid 0.51 g/lozenge. Total maximum daily dose (MDD) is 2.55
g.
Isomalt 2.039 g/lozenge. Total maximum daily dose (MDD) is 10.195 g.
Orange flavour containing allergens (citral, citronellol, d-limonene,
geraniol and linalool)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge
A round pale lozenge with a characteristic orange taste with an icon
intagilated on both sides
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of sore throats.
Strepsils Intensive Lozenge is indicated in adults and adolescents
over 12 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Treatment should be administered for the shortest duration necessary
to control symptoms. It is recommended that this
product should be used for a maximum of three days.
ADULTS:
One lozenge sucked/dissolved slowly in the mouth every 3 – 6 hours
as required. Maximum 5 lozenges in any 24 hour period
PAEDIATRIC POPULATION
ADOLESCENTS OVER THE AGE OF 12 YEARS: As above for adults
CHILDREN: Not indicated for children under 12 years (see section 4.3).
ELDERLY: No dose modification is required.
The elderly are at increased risk of the serious consequences of
adverse reactions to NSAIDs (see section 4.4).
HEPATIC IMPAIRMENT:
In patients with mild to moderate hepatic impairment, 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 renal impairment,
no dose reduction is required. In patients with severe
renal insufficiency flurbiprofen is contraindicated (see section 4.3).
METHOD OF ADMINISTRATION
For oromucosal administration. To b