Strepsils Intensive Sugar-Free 8.75 mg Lozenges

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Flurbiprofen

Tillgänglig från:

Reckitt Benckiser Ireland Ltd

ATC-kod:

R02AX01

INN (International namn):

Flurbiprofen

Läkemedelsform:

Lozenge

Terapiområde:

flurbiprofen

Tillstånd datum:

2022-07-08

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
STREPSILS INTENSIVE SUGAR-FREE 8.75 MG LOZENGES
flurbiprofen
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 you 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 take Strepsils Intensive lozenges
3
How to take 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
Strepsils Intensive lozenges contains flurbiprofen. Flurbiprofen is a
non-steroidal anti-inflammatory drug (NSAID)
which has analgesic, antipyretic and anti-inflammatory properties.
Flurbiprofen 8.75 mg lozenges are used for the short-
term relief of symptoms of sore throat such as throat pain, soreness
and swelling, and difficulty in swallowing in adults
and adolescents 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 USE STREPSILS INTENSIVE LOZENGES
DO NOT TAKE THESE LOZENGES IF YOU:
•
are allergic (hypersensitive) to Flurbiprofen or to any of the other
ingredients of this medicine (listed in section 6)
•
have ever had asthma, unexpected wheezing or shortness of breath, a
runny nose, facial swelling or itchy rash (hives)
after taking acetylsalicylic acid (aspirin) or any other NSAID
medicine
•
currently have or have ever had two or more episodes of a

Produktens egenskaper

Health Products Regulatory Authority
25 March 2024
CRN00DY17
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Intensive Sugar-Free 8.75 mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One lozenge contains 8.75 mg of Flurbiprofen
Excipients with known effect:
Isomalt (E953) 2033.29 mg/lozenge
Liquid Maltitol (E965) 509.31 mg/lozenge
Fragrances containing allergens*
* in the Orange Flavour
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge
A round, white to pale yellow lozenge of 19mm diameter with an icon
intagliated on both sides of the lozenge.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Strepsils Intensive lozenges are indicated for the short term
symptomatic relief of sore throat in adults and adolescents over
the age of 12 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The lowest effective dose should be administered for the shortest
duration necessary to control symptoms (see section 4.4).
Adults and adolescents 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.
Children: 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.
Impaired hepatic: 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).
Impaired renal: 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, flurbiprofen 8.