Strepsils Intensive Honey and Lemon 8.75mg/dose Oromucosal Spray

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Flurbiprofen

Dostopno od:

Reckitt Benckiser Ireland Ltd

Koda artikla:

R02AX; R02AX01

INN (mednarodno ime):

Flurbiprofen

Odmerek:

8.75 milligram(s)/dose

Farmacevtska oblika:

Oromucosal spray, solution

Terapevtsko območje:

Other throat preparations; flurbiprofen

Datum dovoljenje:

2019-12-06

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
STREPSILS INTENSIVE HONEY AND LEMON 8.75 MG/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 Honey
and Lemon is and what it is used for
2.
What you need to know before you use Strepsils
Intensive Honey
and Lemon
3.
How to use Strepsils
Intensive Honey
and Lemon
4.
Possible side effects
5.
How to store Strepsils
Intensive Honey
and Lemon
6.
Contents of the pack and other information
1
WHAT STREPSILS
INTENSIVE HONEY AND LEMON IS 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 Honey
and Lemon 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 HONEY AND LEMON
DO NOT USE
STREPSILS INTENSIVE HONEY AND LEMON IF YOU:
•
are
ALLERGIC TO FLURBIPROFEN, OTHER NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDs),
ASPIRIN
(acetylsalicylic acid), or to any of the ingredients (listed in
section 6).
•
have had a p
REVIOUS ALLERGIC REACTION AFTER TAKING NON-STEROIDAL ANTI-INFLAMMATORY
DRUGS
(NSAIDs) or
ASPIRIN
(acetylsalicylic acid); e.g. asthma, wheezing, itching, runny nose,
s

Lastnosti izdelka

Health Products Regulatory Authority
25 March 2024
CRN00DY17
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Intensive Honey and Lemon 8.75mg/dose Oromucosal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One actuation contains 2.92 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 Lemon Flavour and Honey Flavour)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray, solution
Clear, colourless to slightly yellow solution with a taste of honey
and lemon.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Strepsils Intensive Honey and Lemon 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 HONEY AND LEMON in
children or adolescents under 18 years has not 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.
Before first use, activate the pump by pointing the nozzle away from
you and spraying a minimum of four times until a fine,
consistent mist is produced. The pump is then primed and ready for
use.
Health Products Regulatory Auth