Strepsils Intensive Cherry & Mint 8.75mg/dose Oromucosal Spray

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flurbiprofen

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

R02AX; R02AX01

INN (International Name):

Flurbiprofen

Dosage:

8.75 milligram(s)/dose

Pharmaceutical form:

Oromucosal spray, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other throat preparations; flurbiprofen

Authorization status:

Marketed

Authorization date:

2014-11-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
STREPSILS INTENSIVE CHERRY & MINT 8.75MG/DOSE OROMUCOSAL SPRAY
Flurbiprofen
For use in adults
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 CHERRY & MINT 8.75MG/DOSE OROMUCOSAL SPRAY
is and what
it is used for
2.
What you need to know before you use
STREPSILS INTENSIVE CHERRY & MINT
8.75MG/DOSE OROMUCOSAL SPRAY
3.
How to use
STREPSILS INTENSIVE CHERRY & MINT 8.75MG/DOSE OROMUCOSAL SPRAY
4.
Possible side effects
5.
How to store
STREPSILS INTENSIVE CHERRY & MINT 8.75MG/DOSE OROMUCOSAL SPRAY
6.
Contents of the pack and other information
1.
WHAT STREPSILS INTENSIVE CHERRY & MINT 8.75MG/DOSE
OROMUCOSAL SPRAY AND WHAT IT IS USED FOR?
The active substance is flurbiprofen. Flurbiprofen belongs to a group
of medicines called Non-
Steroidal Anti-Inflammatory Drugs (NSAIDs), which work by changing how
the body responds
to pain, swelling and high temperature.
Strepsils Intensive is used for the short-term relief of symptoms of
sore throats such as throat
soreness, pain, difficulty swallowing and swelling in adults aged 18
and over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE STREPSILS INTENSIVE
CHERRY & MINT 8.75MG/DOSE OROMUCOSAL SPRAY
DO NOT USE STREPSILS INTENSIVE CHERRY & MINT 8.75 MG/DOSE OROMUCOSAL
SPRAY IF YOU:
•
Are
ALLERGIC
to flurbiprofen, other
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDs),
acetylsalicylic acid or to any of the ingredients listed in section 6
•
Have had a
PREVIOUS

Summary of Product characteristics

Health Products Regulatory Authority
25 March 2024
CRN00DY17
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Intensive Cherry & Mint 8.75mg/dose Oromucosal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One actuation contains 2.91 mg of Flurbiprofen, three actuations equal
to one dose contains 8.75mg, corresponding to 16.2
mg/ml Flurbiprofen.
Excipients with known effect:
Methyl parahydroxybenzoate (E218) 1.181 mg/dose
Propyl parahydroxybenzoate (E216) 0.2362 mg/dose
Fragrances containing allergens (in Cherry flavour and Mint flavour)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray, solution
Clear, colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Strepsils Intensive Cherry & Mint 8.75mg/dose Oromucosal Spray is
indicated for the short term symptomatic relief of acute
sore throat in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For short-term use only.
Adults aged 18 years and over:
One dose (3 actuations) administered to the back of the throat every
3‑6 hours as required, up to a maximum of 5 doses in a
24 hour period.
Paediatric Population:
The safety and efficacy of Strepsils Intensive Cherry & Mint
8.75mg/dose Oromucosal Spray in children or adolescents under 18
years has not yet been established.
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.
The lowest effective dose should be administered for the shortest
duration necessary to control symptoms (see section 4.4).
METHOD OF ADMINISTRATION
For oromucosal administration
Do not inhale whilst spraying.
It is recommended that this product should be used for a maximum of
three days.
Health Products Regulatory Authority
25 March 2024
CRN00DY17
Page 2 of 9
Before first use, activate the pump by pointing the nozzle away from
you and spraying a minimum of four times until a fine,
consist