Septabene eucalyptus 3 mg/1 mg lozenges

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BENZYDAMINE HYDROCHLORIDE; Cetylpyridinium chloride (as monohydrate)

Available from:

KRKA, d.d., Novo mesto

ATC code:

R02AA; R02AA20

INN (International Name):

BENZYDAMINE HYDROCHLORIDE; Cetylpyridinium chloride (as monohydrate)

Dosage:

3mg/1 milligram(s)

Pharmaceutical form:

Lozenge

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antiseptics; various

Authorization status:

Not marketed

Authorization date:

2017-04-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEPTABENE EUCALYPTUS 3 MG/1 MG LOZENGES
benzydamine hydrochloride/cetylpyridinium chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take 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 eucalyptus is and what it is used for
2.
What you need to know before you take Septabene eucalyptus
3.
How to take Septabene eucalyptus
4.
Possible side effects
5.
How to store Septabene eucalyptus
6.
Contents of the pack and other information
1.
WHAT SEPTABENE EUCALYPTUS IS AND WHAT IT IS USED FOR
Septabene eucalyptus lozenges contain the active substances
benzydamine hydrochloride and
cetylpyridinium chloride.
Septabene eucalyptus lozenges are anti-inflammatory, analgesic and
antiseptic medicine for local
oromucosal use. Septabene eucalyptus disinfects the mouth and throat
and reduces signs of
inflammation of throat such as pain, redness, swelling, heat and
impaired function.
Septabene eucalyptus is used for the treatment of symptoms of sore
throat associated with mild
infections in the mouth and throat (including pharyngitis)
in adults, adolescents and children over
6 years of age
.
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 TAKE SEPTABENE EUCALYPTUS
DO NOT TAKE SEPTABENE EUCALYPTUS:
-
if you are allergic to benzydamine hydrochloride, cetylpyridinium
chloride or any of the other
ingredients of this medicine (listed in section 6).
-
this medicine must not be used in children aged under

Summary of Product characteristics

Health Products Regulatory Authority
13 April 2023
CRN00DJ13
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Septabene eucalyptus 3 mg/1 mg lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 3 mg benzydamine hydrochloride and 1 mg
cetylpyridinium chloride.
Excipient with known effect:
isomalt (E953): 2471.285 mg/lozenge
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge
Round, blue-white to blue lozenges with bevelled edges. Some small
scratches could be present. Lozenge diameter: 18.0 mm –
19.0 mm, thickness: 7.0 mm – 8.0 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Septabene eucalyptus is indicated in adults, adolescents and children
over 6 years of age for anti-inflammatory, analgesic and
antiseptic treatment of symptoms of sore throat associated with upper
respiratory infections including pharyngitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS: The recommended dosage is 3-4 lozenges a day. The lozenge
should be slowly dissolved in the mouth every 3 to 6
hours.
ELDERLY PATIENTS: The recommended dose is the same as for adults.
_ _
_Paediatric population_
ADOLESCENTS OVER 12 YEARS OF AGE: The recommended dosage is 3-4
lozenges a day. The lozenge should be slowly dissolved
in the mouth every 3 to 6 hours.
CHILDREN AGED FROM 6 TO 12 YEARS OF AGE: The recommended dosage is 3
lozenges a day. The lozenge should be slowly
dissolved in the mouth every 3 to 6 hours. An adult should supervise
the application of lozenges in children from 6 to 12 years
of age.
CHILDREN LESS THAN 6 YEARS OF AGE: Septabene eucalyptus is
contraindicated in children less than 6 years of age (see section
4.3).
The stated dose should not be exceeded.
Septabene eucalyptus can be used for up to 7 days.
Method of administration
The lozenge should be slowly dissolved in the mouth every 3 to 6
hours.
It is not recommended to use the product immediately before or after
cleaning teeth.
Health Products Regulatory Authority
13 April 2023
CRN00D