Septabene 1.5 mg/ml + 5.0 mg/ml oromucosal spray, solution

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

BENZYDAMINE HYDROCHLORIDE; Cetylpyridinium chloride

Dostępny od:

KRKA, d.d., Novo mesto

Kod ATC:

R02AA; R02AA20

INN (International Nazwa):

BENZYDAMINE HYDROCHLORIDE; Cetylpyridinium chloride

Dawkowanie:

1.5 mg/ml+5.0 milligram(s)/millilitre

Forma farmaceutyczna:

Oromucosal spray, solution

Droga podania:

oromucosal use

Sztuk w opakowaniu:

30 ml

Typ recepty:

Product not subject to medical prescription

Wyprodukowano przez:

KRKA, d.d.

Grupa terapeutyczna:

throat preparations, antiseptics

Dziedzina terapeutyczna:

Antiseptics; various

Wskazania:

It is indicated in adults and children over 6 years of age for anti-inflammatory, analgesic and antiseptic treatment of irritations in the throat, mouth and gums, in gingivitis, pharyngitis and laryngitis and before and after tooth extractions

Status autoryzacji:

Not marketed

Data autoryzacji:

2015-07-10

Ulotka dla pacjenta

1.3.1
Benzydamine hydrochloride + Cetylpyridinium
chloride
IE
SPC, Labeling and Package
Leaflet
oromucosal spray 1.5 + 5.0 mg + mg_ml
SmPCPIL158970_1
19.10.2020 – Updated: 19.10.2020
Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEPTABENE 1.5 MG/ML + 5.0 MG/ML
OROMUCOSAL SPRAY, SOLUTION
benzydamine hydrochloride/cetylpyridinium chloride
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 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 Septabene is and what it is used for
2.
What you need to know before you use Septabene
3.
How to use Septabene
4.
Possible side effects
5.
How to store Septabene
6.
Contents of the pack and other information
1.
WHAT SEPTABENE IS AND WHAT IT IS USED FOR
Septabene oromucosal spray, solution is anti-inflammatory, analgesic
and antiseptic medicine for local
oral use. Oromucosal spray disinfects the mouth and throat and reduces
signs of inflammation of
throat such as pain, redness, swelling, heat and impaired function.
Septabene is used in the anti-inflammatory, analgesic and antiseptic
treatment:
-
of irritations in the throat, mouth and gums,
-
in gingivitis and pharyngitis and
-
before and after tooth extractions.
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 SEPTABENE
DO NOT USE SEPTABENE
-
if you are allergic to benzydamine hydrochloride, cetylpyridinium
chloride or any of the other
ingredients of this medicine (listed in section 6).
-
this medicine should not be used in children aged un

Charakterystyka produktu

Health Products Regulatory Authority
15 March 2021
CRN0099HM
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Septabene 1.5 mg/ml + 5.0 mg/ml oromucosal spray, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oromucosal spray, solution contains 1.5 mg benzydamine
hydrochloride and 5 mg cetylpyridinium chloride.
One actuation contains 0.1 ml of oromucosal spray, solution,
containing 0.15 mg benzydamine hydrochloride and 0.5 mg
cetylpyridinium chloride.
Excipient(s) with known effect:

ethanol: 267.60 mg/ml (26.76 mg/one actuation)

macrogolglycerol hydroxystearate: 2.5 mg/ml (0.25 mg/one actuation)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray, solution (oromucosal spray)
Clear, colourless to yellowish liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Septabene oromucosal spray, solution is indicated in adults,
adolescents and children over 6 years of age for anti-inflammatory,
analgesic and antiseptic treatment of irritations in the throat, mouth
and gums, in gingivitis and pharyngitis and before and
after tooth extractions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS: For a single dose, the spray head should be pressed once to
twice. This may be repeated every 2 hours, 3-5 times a day.
For optimal effect, it is not recommended to use the product
immediately before or after cleaning teeth.
The stated dose should not be exceeded.
Septabene can be used for up to 7 days.
Elderly patients
The recommended dose is the same as for adults.
_Paediatric population_
ADOLESCENTS OVER 12 YEARS OF AGE: For a single dose, the spray head
should be pressed once to twice. This may be repeated
every 2 hours, 3-5 times a day.
CHILDREN FROM 6 TO 12 YEARS OF AGE: For a single dose, the spray head
should be pressed once. This may be repeated every 2
hours, 3-5 times a day.
Septabene is contraindicated in children under 6 years of age.
Health Products Regulatory Authority
15 March 2021
CRN0099HM
Page 2 of 6
METHOD OF ADMIN