Septabene Lemon and Honey 3 mg/1 mg lozenges

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BENZYDAMINE HYDROCHLORIDE; Cetylpyridinium chloride

Available from:

KRKA, d.d., Novo mesto

ATC code:

R02AA20

INN (International Name):

BENZYDAMINE HYDROCHLORIDE; Cetylpyridinium chloride

Dosage:

3 mg/1 mg mg/mg

Pharmaceutical form:

Lozenge

Therapeutic area:

various

Authorization status:

Not marketed

Authorization date:

2019-03-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEPTABENE LEMON AND HONEY 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 lemon and honey is and what it is used for
2.
What you need to know before you take Septabene lemon and honey
3.
How to take Septabene lemon and honey
4.
Possible side effects
5.
How to store Septabene lemon and honey
6.
Contents of the pack and other information
1.
WHAT SEPTABENE LEMON AND HONEY IS AND WHAT IT IS USED FOR
Septabene lemon and honey lozenge contains the active substances
benzydamine hydrochloride and
cetylpyridinium chloride.
Septabene lemon and honey lozenge is anti-inflammatory, analgesic
(causing pain relief) and
antiseptic (preventing the spread of pathogens) medicine for local
oral use. Septabene lemon and
honey disinfect the mouth and throat and reduces signs of inflammation
of throat such as pain,
redness, swelling, heat and difficulty swallowing.
Septabene lemon and honey is intended for the treatment of sore throat
associated with mild infections
in the mouth and throat (including inflammation of the pharynx) in
adults, adolescents and children
from 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 LEMON AND HONEY
DO NOT TAKE SEPTABENE LEMON AND HONEY
-
if you are allergic to benzydamine hydrochloride, cetylpyridinium
chloride or any o

Summary of Product characteristics

Health Products Regulatory Authority
03 November 2023
CRN00DCXW
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Septabene Lemon and Honey 3 mg/1 mg lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 3 mg benzydamine hydrochloride and 1 mg
cetylpyridinium chloride.
Excipient(s) with known effect:
- isomalt (E-953): 2452.8 mg/lozenge
- sodium benzoate (E-211): up to 0.0009 mg/lozenge
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge
Round lozenges with bevelled edges and rough surface from light yellow
to yellow colour. White patches, uneven colouring,
presence of air bubbles in the hard candy mass and small jagged edges
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 lemon and honey is intended for anti-inflammatory, analgesic
and antiseptic treatment of sore throat associated
with upper respiratory infections including pharyngitis in adults,
adolescents and children from 6 years of age.
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.
CHILDREN LESS THAN 6 YEARS OF AGE: Septabene lemon and honey is
contraindicated in children less than 6 years of age (see
section 4.3).
The stated dose should not be exceeded.
Septabene lemon and honey 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